Grading of Recommendations, Assessment, Development, and Evaluation (GRADE): GSK's Pentavalent Meningococcal Vaccine (MenACWY-CRM/MenB-4C)

About

CDC vaccine recommendations are developed using an explicit evidence-based method based on the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.

Introduction

On February 14, 2025, the U.S. Food and Drug Administration approved the use of a pentavalent meningococcal vaccine (MenACWY-CRM/MenB-4C [Penmenvy, GSK]) for prevention of invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y among persons aged 10–25 years. On April 16, 2025, CDC's Advisory Committee on Immunization Practices (ACIP) recommended MenACWY-CRM/MenB-4C may be used when both MenACWY and MenB are indicated at the same visit for 1) healthy persons aged 16–23 years (routine schedule) when shared clinical decision-making favors administration of MenB vaccine and 2) persons aged ≥10 years who are at increased risk for meningococcal disease (e.g., because of persistent complement deficiencies, complement inhibitor use or functional or anatomic asplenia).

A systematic review and Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach was used to inform ACIP’s deliberations regarding use of MenACWY-CRM/MenB-4C. The policy questions under consideration (Tables 1a–c) were:

  1. Should the pentavalent vaccine be included as an option for MenACWY/MenB vaccination in people currently recommended to receive both vaccines?
  2. Should the pentavalent vaccine be included as an option for MenACWY vaccination in people currently recommended to receive only MenACWY vaccine?
  3. Should the pentavalent vaccine be included as an option for MenB vaccination in people currently recommended to receive only MenB vaccine?

Methods

Members of ACIP's Meningococcal Vaccines Work Group ("Work Group") selected policy questions, specified relevant outcomes, and rated the importance of specified outcomes (including benefits and harms) before the GRADE assessment. Tables 1a–c present the population, intervention, comparison, and outcome(s) (PICO) relevant for each policy question, while Table 2 presents the judged importance of specified outcomes. All Work Group members and CDC staff participating in the GRADE assessment met ACIP requirements for reporting conflicts of interest.

A systematic literature search was conducted using Medline, Embase, Global Health, CINAHL, Cochrane, Scopus, and clinicaltrials.gov databases from 2015 to July 2024. Duplicates were identified using the Endnote “Find Duplicates” function set to match on title, author, and year.1 Efforts were also made to obtain unpublished or other relevant data. Two reviewers independently screened titles and abstracts and reviewed full-text records in Microsoft Excel.2 Records were included if they presented primary immunogenicity or safety data on GSK’s pentavalent meningococcal vaccine. Characteristics of all records meeting inclusion criteria are shown in Appendix 1.

Records were then excluded if 1) GSK’s pentavalent meningococcal vaccine was only administered as a booster dose following two doses of experimental pentavalent vaccine or currently licensed MenB vaccine, or 2) if no relevant comparator groups were included (either a single dose of currently licensed MenACWY vaccine or ≥1 dose of currently licensed MenB vaccine). For studies included in the final assessment, specific trial arm regimens, number of participants in each trial arm, and presence of information about specified outcomes are shown in Appendix 2.

The strategy for evidence search and retrieval is in Appendix 3. When multiple studies contributed data to the GRADE assessment for a specified outcome, a random-effects meta-analysis was used to generate estimates of relative and absolute risk across all contributing studies.

Results

A summary of the GRADE assessment was presented to ACIP on October 24, 2024 and reviewed on April 16, 2025. Overall, 113 records were identified and screened. Sixty records were excluded based on the title and abstract, and 46 records were excluded based on full-text review (Appendix 3). Three of the records excluded during full-text review met inclusion criteria (i.e., they presented primary data on GSK's pentavalent meningococcal vaccine) but either only administered GSK's pentavalent meningococcal vaccine as a booster dose or had no relevant comparator group for the policy questions under consideration.345 The remaining seven records described results from seven randomized controlled trials,6789101112 of which all but one were blinded.10 These records were included in the evidence synthesis and GRADE assessment (Appendix 2). Data on the specified outcomes of interest (Table 2) are summarized in Tables 3a–3d, and the GRADE assessment is summarized in Tables 4a and 4b. When the available data applied to multiple policy questions, only one harmonized table is shown; separate sub-tables were created when the data only applied to 1 or 2 policy questions. For example, study data on short-term immunogenicity regarding serogroups A, B, C, W, and Y are presented in Table 3a, which is split into two sub-tables: one sub-table for serogroup A, C, W, and Y immunogenicity (applicable to PICOs 1 and 2) and another for serogroup B immunogenicity (applicable to PICOs 1 and 3). Two outcomes — meningococcal disease caused by serogroups A, B, C, W, and Y and interferences with other recommended vaccines administered concurrently — lacked data (Table 2).

Summary

For all outcomes with identified data, the initial evidence level was high because the available data were from randomized controlled clinical trials. Summaries of the final evidence certainty for each PICO are presented in Tables 5a–5c. The evidence certainty for short-term immunity against serogroups A, B, C, W, and Y (PICOs 1–3) was moderate for healthy persons and low for persons at increased risk. The evidence certainty for persistent immunity against serogroup B (PICOs 1 and 3) was low for healthy persons and very low for persons at increased risk. No evidence was available for persistent immunity against serogroups A, C, W, and Y (PICOs 1 and 2).

For serious adverse events possibly related to study vaccination, the evidence certainty was moderate for healthy persons and low for persons at increased risk. The evidence certainty for non-serious adverse events varied by PICO. When comparing MenABCWY to concomitant administration of MenACWY and MenB (PICO 1) or to administration of only MenACWY (PICO 2), the evidence certainty was moderate for healthy persons and low for persons at increased risk. When comparing MenABCWY to administration of only MenB (PICO 3), the evidence certainty was high for healthy persons and moderate for persons at increased risk.

Table 1a: Policy Question and PICO 1

Policy Question

Should the pentavalent vaccine be included as an option for MenACWY/MenB vaccination in people currently recommended to receive both vaccines?

Population

All individuals aged ≥10 years currently recommended to receive MenACWY and MenB vaccines

Intervention

Vaccination with the pentavalent vaccine

Comparison

Vaccination with currently licensed MenACWY and MenB vaccines

Outcomes

  • Disease caused by serogroups A, B, C, W, and Y
  • Short-term immunity
  • Persistent immunity
  • Interference with other recommended vaccines administered concurrently
  • Serious adverse events
  • Non-serious adverse events

Table 1b: Policy Question and PICO 2

Policy Question

Should the pentavalent vaccine be included as an option for MenACWY vaccination in people currently recommended to receive only MenACWY vaccine?

Population

All individuals aged ≥10 years currently recommended to receive MenACWY vaccine

Intervention

Vaccination with the pentavalent vaccine

Comparison

Vaccination with currently licensed MenACWY vaccine

Outcomes

  • Disease caused by serogroups A, B, C, W, and Y
  • Short-term immunity
  • Persistent immunity
  • Interference with other recommended vaccines administered concurrently
  • Serious adverse events
  • Non-serious adverse event

Table 1c: Policy Question and PICO 3

Policy Question

Should the pentavalent vaccine be included as an option for MenB vaccination in people currently recommended to receive only MenB vaccine?

Population

All individuals aged ≥10 years currently recommended to receive MenB vaccine

Intervention

Vaccination with the pentavalent vaccine

Comparison

Vaccination with currently licensed MenB vaccine

Outcomes

  • Disease caused by serogroups B
  • Short-term immunity
  • Persistent immunity
  • Interference with other recommended vaccines administered concurrently
  • Serious adverse events
  • Non-serious adverse events

Table 2: Outcomes and Rankings

Outcome Importance Included in Evidence Profile
Meningococcal disease caused by serogroups A, B, C, W, and Y Critical Yesa
Short-term immunity Critical Yes
Persistent immunity Important Yes
Interference with other recommended vaccines administered concurrently Important Yesa
Serious adverse events Critical Yes
Non-serious adverse events Important Yes

Table 2 Footnote

aThis outcome was included in the final list of outcomes to evaluate in the evidence assessment; however, data for this outcome was lacking.

Table 3a: Summary of Studies Reporting Short-Term Immunity — PICOs 1, 2, and 3

Intervention Comparator Author, year or Study ID Population Serogroup Time since last study dose Percent (N) Intervention Percent (N) Comparator Study limitations (risk of bias)
Seroprotection based on hSBA titersa for serogroups A, C, W, and Y
MenABCWY (1 dose) MenACWY-CRM (1 dose) Saez-Llorens 2015b,c 11–18 years;
ACWY naïve		 A Baseline 4% (82) 5% (82) Not serious
1 month 80% (79) 88% (80)
C Baseline 38% (82) 32% (81)
1 month 93% (80) 84% (81)
W Baseline 68% (82) 68% (82)
1 month 100% (79) 98% (82)
Y Baseline 28% (82) 40% (82)
1 month 91% (79) 100% (83)
Beran 2021d,e 10–25 years;
ACWY naïve		 A Baseline 2.1% (98) 3.1% (97) Not serious
1 month 65.3% (98) 68.8% (97)
C Baseline 45.9% (98) 41.7% (97)
1 month 89.6% (98) 86.6% (97)
W Baseline 21.9% (98) 26.3% (97)
1 month 71.9% (98) 66.0% (97)
Y Baseline 6.1% (98) 12.5% (97)
1 month 83.2% (98) 85.4% (97)
MenACWY-CRM + MenB-4C administered in same arm (1 dose) A Baseline 1.0% (101)
1 month 73.5% (101)
C Baseline 48.0% (101)
1 month 94.1% (101)
W Baseline 26.3% (101)
1 month 70.6% (101)
Y Baseline 11.0% (101)
1 month 81.8% (101)
MenACWY-CRM + MenB-4C administered in different arms (1 dose) A Baseline 3.2% (97)
1 month 80.2% (97)
C Baseline 51.5% (97)
1 month 92.8% (97)
W Baseline 28.7% (97)
1 month 74.2% (97)
Y Baseline 11.6% (97)
1 month 88.4% (97)
MenACWY-CRM (1 dose) V72_72f,g 10–25 years;
ACWY naïve or primed		 A Baseline 9.2% (1,452) 11.7% (137) Not serious
1 month 79.5% (132) 90.2% (133)
C Baseline 29.8% (1,487) 28.8% (139)
1 month 74.8% (139) 64.0% (136)
W Baseline 12.6% (1,473) 12.9% (140)
1 month 80.3% (142) 69.3% (137)
Y Baseline 12.2% (1,489) 13.5% (141)
1 month 82.2% (146) 80.0% (140)
MenABCWY_019f,h 15–25 years;
ACWY primed		 A Baseline 27.7% (546) 28.8% (549) Not serious
1 month 98.3% (605) 98.1% (585)
C Baseline 57.7% (601) 56.2% (584)
1 month 98.9% (609) 99.0% (593)
W Baseline 36.3% (597) 33.4% (583)
1 month 98.4% (607) 96.8% (592)
Y Baseline 37.5% (600) 34.9% (576)
1 month 97.9% (606) 97.6% (591)
Seroprotection based on hSBA titers for serogroup B
MenABCWY (2 doses at 0,6 months) MenB-4C (2 doses at 0,6 months)i V72_72g,i 10–25 years;
B naïve		 fHbp Baseline 5.4% (762) 3.4% (730) Not serious
1 month 95.9% (738) 94.6% (707)
NadA Baseline 6.2% (780) 4.4% (731)
1 month 96.2% (734) 98.0% (707)
NHBA Baseline 18.5% (764) 20.9% (731)
1 month 95.3% (738) 97.5% (711)
PorA Baseline 2.1% (751) 1.4% (716)
1 month 75.3% (709) 82.6% (684)

Table 3A Footnotes

ahSBA stands for serum bactericidal assay using human complement. Seroprotection refers to the proportion of participants with an hSBA titer above a particular threshold.
bSeroprotection based on hSBA titer ≥1:8.
cThe relevant results were primarily reported via figures in the published scientific manuscript. The percentages and Ns reported here were provided directly by GSK.
dSeroprotection based on hSBA titer ≥1:22.7 (serogroup A), ≥1:5.2 (serogroup C), ≥1:39.6 (serogroup W), and ≥1:14.7 (serogroup Y).
eThe percentages were reported in the supplemental material for the published scientific manuscript. The Ns reported here were provided directly by GSK.
fSeroprotection based on hSBA titer ≥1:12 (serogroup A), ≥1:8 (serogroup C), ≥1:8 (serogroup W), and ≥1:10 (serogroup Y). This information was provided directly by GSK.
gThe relevant results were reported at the study’s clinicaltrials.gov record, last updated March 5, 2024.
hThe relevant results were reported at the study’s clinicaltrials.gov records, last updated July 3, 2024.
iSeroprotection based on hSBA titer ≥1:5 (fHbp), ≥1:15 (NadA), ≥1:4 (NHBA), and ≥1:6 (PorA). This information was provided directly by GSK.

Table 3b: Summary of Studies Reporting Persistent Immunity — PICOs 1, 2, and 3

Intervention Comparator Author, year or Study ID Population Serogroup Time since last study dose Percent (N) Intervention Percent (N) Comparator Study limitations (risk of bias)
Seroprotection based on hSBA titersa for serogroups A, C, W, and Y
No relevant studies
Seroprotection based on hSBA titersa for serogroup B
MenABCWY (2 doses at 0,6 months) MenB-4C (2 doses at 0,2 months) Vesikari 2021b 10–18 years;
B naïve		 fHbp Two years 26% (70) 18% (119) Not serious
NadA 74% (72) 82% (121)
NHBA 37% (71) 28% (122)
PorA 18% (71) 16% (121)

Table 3B Footnotes

ahSBA stands for serum bactericidal assay using human complement. Seroprotection refers to the proportion of participants with an hSBA titer above a particular threshold.
bSeroprotection based on hSBA titer ≥1:8.0 (fHbp), ≥1:8.6 (NadA), ≥1:8.9 (NHBA), and ≥1:8.2 (PorA).

Table 3c: Summary of Studies Reporting Serious Adverse Events Assessed as Possibly Related to Vaccinationa — PICOs 1, 2, and 3

Author, year or Study ID Intervention Comparator Population Event window n/Nb Intervention n/Nb Comparator Study limitations (risk of bias)
Saez-Llorens 2015 MenABCWY
(2 doses at 0,2 months)		 MenACWY-CRM (1 dose) 11–18 years 91 days 0/83 0/83 Not serious
Block 2015 10–25 years 241 days 0/120 0/121 Not serious
MenB-4C
(2 doses at 0,2 months)		 0/122
Welsch 2018 MenACWY-CRM (1 dose) 10–18 years 6 months 0/150 0/146 Not serious
Vesikari 2021 MenB-4C
(2 doses at 0,2 months)		 10–18 years ­­13 months 1/228c 0/221 Not serious
MenABCWY
(2 doses at 0,6 months)		 0/129
MenABCWY
(3 doses at 0,2,6 months)		 0/157
MenABCWY
(2 doses at 0,1 months)		 1/151d
MenABCWY
(2 doses at 0,11 months)		 0/147
MenABCWY primary series
(2 doses at 0,2 months) with 2-year booster dose		 MenB-4C primary series
(2 doses at 0,2 months) with 2-year booster dose		 12–20 years 3 months 0/127 0/126
MenABCWY primary series
(2 doses at 0,6 months) with 2-year booster dose		 0/74
MenABCWY primary series
(3 doses at 0,2,6 months) with 2-year booster dose		 0/77
MenABCWY
(2 doses at 0,2 months)		 MenB-4C
(2 doses at 0,2 months)		 12–20 years 3 months 0/99 0/101
Beran 2021 MenABCWY
(2 doses at 0,2 months)		 MenACWY-CRM + MenB-4C administered in same arm (2 doses at 0,2 months) 10–25 years 91 days 0/100 0/104 Not serious
MenACWY-CRM + MenB-4C administered in different arms
(2 doses at 0,2 months)		 0/100
MenB-4C
(2 doses at 0,2 months)		 1/94e
MenACWY-CRM (1 dose) 0/102
v72_72f MenABCWY
(2 doses at 0,6 months)g		 MenB-4C
(3 doses at 0,2,6 months)		 10–25 years 361 days 1/1,657h 0/897 Not serious
MenB-4C
(2 doses at 0,6 months)		 1/906i
MenACWY-CRM (1 dose) 1/178j
MenABCWY_019f 10–25 years 361 days 0/626 0/621 Not serious

Table 3C Footnotes

aA serious adverse event is an untoward medical occurrence that results in death, disability, or incapacity; is life threatening; or requires hospitalization or prolongation of existing hospitalization. The possible relationship of a serious adverse event to the study vaccine was judged by the study investigator, not the sponsor. SAEs assessed as possibly related to study vaccination by the study investigator are presented.

bIf a specific denominator was not provided, these denominators reflect the number of participants enrolled. Studies had little, if any, participant attrition.

cOne participant experienced a seizure. This event was assessed as related to study vaccination.
dOne participant experienced a connective tissue disorder. This event was assessed as related to study vaccination.
eOne participant experienced syncope. This event was assessed as possibly or probably related to study vaccination.
fSerious adverse events assessed as related to vaccination and reported here were provided directly by GSK on October 7, 2024.
gThree trial arms received MenABCWY on this schedule. The only difference was the vaccine lot used. Therefore, although serious adverse events are reported separately for each arm with a different vaccine lot, data are pooled here.
hOne participant experienced neuromyelitis optica. This event was assessed as related to study vaccination by the study investigators; however, it was not considered an adverse drug reaction related to vaccination after both GSK and independent evaluation.
iOne participant experienced ulcerative colitis. This event was assessed as related to study vaccination; however, it was not considered an adverse drug reaction related to vaccination after both GSK and independent evaluation.
jOne participant experienced pyrexia. This event was assessed as related to study vaccination; however, it was not considered an adverse drug reaction related to vaccination after both GSK and independent evaluation.

Table 3d: Summary of Studies Reporting Nonserious Adverse Eventsa — PICOs 1, 2, and 3

Author, year or Study ID Intervention Comparator Population n/Nb Intervention n/Nb Comparator Study limitations (risk of bias)
Solicited non-serious adverse events after receiving the first planned study vaccine dose
Saez-Llorens 2015 MenABCWY
(2 doses at 0,2 months)		 MenACWY-CRM (1 dose) 11–18 years 79/83 56/82 Not serious
Block 2015 10–25 years ≥92/107 ≥39/92c Not serious
MenB-4C
(2 doses at 0,2 months)		 ≥103/114
Welsch 2018 MenACWY-CRM (1 dose) 10–18 years ≥121/147 ≥49/135c Not serious
Vesikari 2021 MenB-4C
(2 doses at 0,2 months)		 10–18 years ≥223/231 ≥213/227 Not serious
MenABCWY
(2 doses at 0,6 months)		 ≥126/134
MenABCWY
(3 doses at 0,2,6 months)		 ≥146/159
MenABCWY
(2 doses at 0,1 months)		 ≥142/154
MenABCWY
(2 doses at 0,11 months)		 ≥135/144
MenABCWY
(2 doses at 0,2 months)d		 MenB-4C
(2 doses at 0,2 months)d		 12–20 years ≥94/99 ≥93/101
Beran 2021 MenABCWY
(2 doses at 0,2 months)		 MenACWY-CRM + MenB-4C administered in same arm (2 doses at 0,2 months) 10–25 years 93/100 102/104 Not serious
MenACWY-CRM + MenB-4C administered in different arms
(2 doses at 0,2 months)		 97/100
MenB-4C
(2 doses at 0,2 months)		 93/94
MenACWY-CRM (1 dose) 76/102
v72_72e MenABCWY
(2 doses at 0,6 months)		 MenB-4C
(3 doses at 0,2,6 months)		 10–25 years ≥1,503/1,638 ≥807/885 Not serious
MenB-4C
(2 doses at 0,6 months)		 ≥819/894
MenACWY-CRM (1 dose) ≥78/178
MenABCWY_019f 10–25 years ≥486/608 ≥222/600 Not serious
Solicited non-serious adverse events after completing a real-world vaccine seriesg
Vesikari 2021 MenABCWY
(2 doses at 0,6 months)		 MenB-4C
(2 doses at 0,2 months)h		 10–18 years ≥106/120 ≥193/212 Not serious
MenABCWY
(2 doses at 0,11 months)		 ≥119/132
v72_72e MenABCWY
(2 doses at 0,6 months)		 MenB-4C
(2 doses at 0,6 months)		 10–25 years ≥1,258/1,428 ≥676/759 Not serious
MenB-4C
(2 of 3 doses at 0,2,6 months)		 ≥714/823
MenB-4C
(3 of 3 doses at 0,2,6 months)		 ≥677/765
MenACWY-CRM (1 dose)i ≥78/178
MenABCWY_019f 10–25 years ≥377/507 ≥222/600 Not serious

Table 3D Footnotes

aNonserious adverse events are adverse events that did not meet the definition of a serious adverse event and may range in severity. Solicited adverse events were used as a surrogate for nonserious adverse events.

bMost studies did not report the number of participants experiencing at least one non-serious adverse event. When presented as ≥n/N, this reflects the occurrence of the most common non-serious adverse event, which serves as the lower bound for the number of participants that experienced at least one non-serious adverse event.
cTaken from post-dose 2 data since the first study dose was placebo and the second dose was MenACWY-CRM.
dNewly enrolled participants in the extension study.
eThe relevant results were reported at the study’s clinicaltrials.gov record, last updated March 5, 2024.
fThe relevant results were reported at the study’s clinicaltrials.gov records, last updated July 3, 2024.
gBased on current and recent, prior meningococcal vaccine recommendations. Practically, this translates to two or more MenB-4C doses with at least two months between doses or one dose of MenACWY-CRM. Here data are restricted to studies where two MenABCWY doses were administered at least six months apart, as this was the anticipated recommended interval.
hOnly includes the participants randomized to this trial arm in the parent study, since the extension study did not randomize any newly enrolled participants to receive two MenABCWY doses at least six months apart.
iSince this group only needed to receive one vaccine dose to be considered “series complete,” the non-serious adverse event data are the same as those used for non-serious adverse events after the first planned vaccine study dose.

Table 4a: GRADE Summary of Findings for Healthy Persons — PICOs 1, 2, and 3

Certainty Assessment No. of patients Effecta Certainty Importance
No. of studies Study design Risk of bias Inconsistencyb Indirectness Imprecision Other considerations GSK MenABCWY Comparator Relative
(95% CI)		 Absolute
(95% CI)
per 100,000
Short-term immunity after one dose vs MenACWY-CRM (follow-up: 1 month)
4c Randomized trials Not serious Not serious Seriousd Not serious GSK funded Serogroup A Moderate Critical
914 1,093 0.94
(0.86, 1.01)		 5,437 fewer (11,705 fewer to 832 more)
Serogroup C
926 1,105 1.03
(0.97, 1.10)		 2,726 more (2,545 fewer to 7,997 more)
Serogroup W
926 1,106 1.02
(1.00, 1.04)		 1,930 more (314 to 3,546 more)
Serogroup Y
929 1,109 0.98
(0.93, 1.03)		 1,930 fewer (6,528 fewer to 2,668 more)
Short-term immunity after two doses vs MenB-4C (follow-up: 1 month)
1 Randomized trials Not serious None Seriousd Not serious GSK funded fHbp Moderate Critical
738 707 1.01
(0.99, 1.04)		 1,300 more (896 fewer to 3,496 more)
NadA
734 707 0.98
(0.96, 1.00)		 1,800 fewer (3,526 to 74 fewer)
NHBA
738 711 0.98 (0.96,1.00) 2,200 fewer (4,110 to 290 fewer)
PorA
709 684 0.91
(0.86, 0.96)		 7,300 fewer (11,560 to 3,040 fewer)
Persistent immunity after one dose vs MenACWY-CRM
0 Important
Persistent immunity after two doses vs MenB-4C (follow-up: 2 years)
1 Randomized trials Not serious None Seriousd Seriouse GSK funded fHbp Low Important
70 119 1.46
(0.84, 2.54)		 8,000 more (4,379 fewer to 20,379 more)
NadA
72 121 0.90
(0.77, 1.06)		 8,000 fewer (20,228 fewer to 4,228 more)
NHBA
71 122 1.31
(0.86, 2.00)		 9,000 more (4,770 fewer to 22,770 more)
PorA
71 121 1.17
(0.61, 2.22)		 2,000 more (9,069 fewer to 13,069 more)
Serious adverse events assessed as related to vaccination after any dose
7 Randomized trials Not serious Not serious Not serious Seriousf GSK funded 3,925 (0-2 events per study) 3,922 (0-2 events per study) 1.08
(0.31, 3.77)		 6 fewer (150 fewer to 138 more) Moderate Critical
Non-serious adverse events after one dose
4 Randomized trials Not serious vs MenB-4C (one dose) Important
Not serious Not serious Not serious GSK funded 2,766 2,315 0.99
(0.96, 1.02)		 1,148 fewer (4,123 fewer to 1,827 more) High
1 vs MenB-4C + MenACWY-CRM (one dose each)
None Not serious Seriouse GSK funded 100 204 0.95
(0.90, 1.01)		 4,549 fewer (9,981 fewer to 883 more) Moderate
6 vs MenACWY-CRM (one dose)
Not serious Not serious Seriousf GSK funded 2,683 1,189 1.80
(1.46, 2.22)		 37,892 more (28,361 to 47,423 more) Moderate
Non-serious adverse events after ≥2 doses
2 Randomized trials Not serious vs MenB-4C (≥2 doses) Important
Not serious Not serious Not serious GSK funded 1,680 2,559 1.00
(0.98, 1.02)		 213 fewer (2,196 fewer to 1,770 more) High
2 vs MenACWY-CRM (one dose)
Not serious Not serious Seriousf GSK funded 1,935 778 2.01
(1.83, 2.21)		 40,317 more (33,610 to 47,023 more) Moderate

Table 4A Footnotes

aWhere >1 study is included in an outcome’s assessment, the presented effects and 95% confidence intervals (CIs) are derived from a random-effects meta-analysis. Where only 1 study is included, the presented 95% CIs are traditional Wald confidence intervals.
bInconsistency could not be assessed if only 1 study was included.
cIncludes one study where some comparator participants received MenB concomitantly with MenACWY; meta-analysis suggested no statistically significant subgroup differences between a MenACWY-only comparator and a concomitant MenACWY/MenB comparator.
dhSBA titers are the established correlate of protection for serogroup C meningococcal disease. This correlation is assumed to extend to other serogroups, but direct evidence for these serogroups is limited. Goldschneider et al. Human immunity to the meningococcus. I. The role of humoral antibodies. J Exp Med. 1969;129(6):1307–26. Findlow et al. Correlates of protection for meningococcal surface protein vaccines: current approaches for the determination of breadth of coverage. Expert Rev Vaccines 2022;21:753–69.
eDowngraded because the absolute effect confidence intervals are wide.
fDowngraded because the relative effect confidence intervals are wide.

Table 4b: GRADE Summary of Findings for Persons at Increased Risk due to Underlying Medical Conditions — PICOs 1, 2, and 3

Certainty Assessment No. of patients Effecta Certainty Importance
No. of studies Study design Risk of bias Inconsistencyb Indirectness Imprecision Other considerations GSK MenABCWY Comparator Relative
(95% CI)		 Absolute
(95% CI)
per 100,000
Short-term immunity after one dose vs MenACWY-CRM (follow-up: 1 month)
4c Randomized trials Not serious Not serious Very seriousd,e Not serious GSK funded Serogroup A Low Critical
914 1,093 0.94
(0.86, 1.01)		 5,437 fewer (11,705 fewer to 832 more)
Serogroup C
926 1,105 1.03
(0.97, 1.10)		 2,726 more (2,545 fewer to 7,997 more)
Serogroup W
926 1,106 1.02
(1.00, 1.04)		 1,930 more (314 to 3,546 more)
Serogroup Y
929 1,109 0.98
(0.93, 1.03)		 1,930 fewer (6,528 fewer to 2,668 more)
Short-term immunity after two doses vs MenB-4C (follow-up: 1 month)
1 Randomized trials Not serious None Very seriousd,e Not serious GSK funded fHbp Low Critical
738 707 1.01 (0.99, 1.04) 1,300 more (896 fewer to 3,496 more)
NadA
734 707 0.98 (0.96, 1.00) 1,800 fewer (3,526 to 74 fewer)
NHBA
738 711 0.98 (0.96,1.00) 2,200 fewer (4,110 to 290 fewer)
PorA
709 684 0.91 (0.86, 0.96) 7,300 fewer (11,560 to 3,040 fewer)
Persistent immunity after one dose vs MenACWY-CRM
0 Important
Persistent immunity after two doses vs MenB-4C (follow-up: 2 years)
1 Randomized trials Not serious None Very seriousd,e Seriousf GSK funded fHbp Very low Important
70 119 1.46 (0.84, 2.54) 8,000 more (4,379 fewer to 20,379 more)
NadA
72 121 0.90 (0.77, 1.06) 8,000 fewer (20,228 fewer to 4,228 more)
NHBA
71 122 1.31 (0.86, 2.00) 9,000 more (4,770 fewer to 22,770 more)
PorA
71 121 1.17 (0.61, 2.22) 2,000 more (9,069 fewer to 13,069 more)
Serious adverse events assessed as related to vaccination after any dose
7 Randomized trials Not serious Not serious Seriouse Seriousg GSK funded 3,925 (0-2 events per study) 3,922 (0-2 events per study) 1.08
(0.31, 3.77)		 6 fewer (150 fewer to 138 more) Low Critical
Non-serious adverse events after one dose
4 Randomized trials Not serious vs MenB-4C (one dose) Important
Not serious Seriouse Not serious GSK funded 2,766 2,315 0.99
(0.96, 1.02)		 1,148 fewer (4,123 fewer to 1,827 more Moderate
1 vs MenB-4C + MenACWY-CRM (one dose each)
None Seriouse Seriousf GSK funded 100 204 0.95 (0.90, 1.01) 4,549 fewer (9,981 fewer to 883 more) Low
6 vs MenACWY-CRM (one dose)
Not serious Seriouse Seriousg GSK funded 2,683 1,189 1.80 (1.46, 2.22) 37,892 more (28,361 to 47,423 more) Low
Non-serious adverse events after ≥2 doses
2 Randomized trials Not serious vs MenB-4C (≥2 doses) Important
Not serious Seriouse Not serious GSK funded 1,680 2,559 1.00 (0.98, 1.02) 213 fewer (2,196 fewer to 1,770 more) Moderate
2 vs MenACWY-CRM (one dose)
Not serious Seriouse Seriousg GSK funded 1,935 778 2.01 (1.83, 2.21) 40,317 more (33,610 to 47,023 more) Low

Table 4B Footnotes

aWhere >1 study is included in an outcome’s assessment, the presented effects and 95% confidence intervals (CIs) are derived from a random-effects meta-analysis. Where only 1 study is included, the presented 95% CIs are traditional Wald confidence intervals.

bInconsistency could not be assessed if only 1 study was included.
cIncludes one study where some comparator participants received MenB concomitantly with MenACWY; meta-analysis suggested no statistically significant subgroup differences between a MenACWY-only comparator and a concomitant MenACWY/MenB comparator.
dhSBA titers are the established correlate of protection for serogroup C meningococcal disease. This correlation is assumed to extend to other serogroups, but direct evidence for these serogroups is limited. Goldschneider et al. Human immunity to the meningococcus. I. The role of humoral antibodies. J Exp Med. 1969;129(6):1307–26. Findlow et al. Correlates of protection for meningococcal surface protein vaccines: current approaches for the determination of breadth of coverage. Expert Rev Vaccines 2022;21:753–69.
eAll evidence derived from trials enrolling healthy participants. Data for persons at increased risk due to underlying medical conditions were lacking.
fDowngraded because the absolute effect confidence intervals are wide.
gDowngraded because the relative effect confidence intervals are wide.

Table 5a: Summary of Evidence — PICO 1

Outcome Importance Included in Evidence Profile Certainty for Healthy Individuals Certainty for Individuals at Increased Risk
Short-term immunity Critical Yes Moderate Low
Persistent immunity Important Yes N/Aa, Low N/A, Very Low
Serious adverse events Critical Yes Moderate Low
Non-serious adverse events Important Yes Moderate, N/Ab Low, N/Ab

Table 5A Footnotes

aThe certainty of evidence for 1 dose of MenABCWY versus 1 dose of MenACWY could not be evaluated because no studies with relevant data were identified.
bThe certainty of evidence for 2 doses of MenABCWY 6 months apart versus 2 doses of MenACWY-CRM + MenB-4C 6 months apart could not be evaluated because no studies with relevant data were identified.

Table 5b: Summary of Evidence — PICO 2

Outcome Importance Included in Evidence Profile Certainty for Healthy Individuals Certainty for Individuals at Increased Risk
Short-term immunity Critical Yes Moderate Low
Persistent immunity Important No N/Aa N/Aa
Serious adverse events Critical Yes Moderate Low
Non-serious adverse events Important Yes Moderate Low

Table 5B Footnotes

aThe certainty of evidence for 1 dose of MenABCWY versus 1 dose of MenACWY could not be evaluated because no studies with relevant data were identified.

Table 5c: Summary of Evidence — PICO 3

Outcome Importance Included in Evidence Profile Certainty for Healthy Individuals Certainty for Individuals at Increased Risk
Short-term immunity Critical Yes Moderate Low
Persistent immunity Important Yes Low Very Low
Serious adverse events Critical Yes Moderate Low
Non-serious adverse events Important Yes High Moderate

Appendix 1: Potentially Relevant Studies Identified in Review of Evidence

Study Registration(s) Location(s) Study Design Phase Blinding Population Author, year or Study ID Period Included in final GRADE assessment?
NCT01210885
NCT01367158 NCT02451514		 Chile, Colombia, Panama RCT II Observer-blind Healthy, immuno-naïve individuals aged 11–18 years Saez-Llorens 2015 Dec 2010–Jul 2011 Yes
Saez-Llorens 2015_2 Jul 2011–Jul 2012 No
Open-labela Prior participants + individuals with no meningococcal vaccine history Saez-Llorens 2018 Jun–Dec 2015 No
NCT01272180
NCT01992536		 Poland, USA RCT II Observer-blind Healthy, immuno-naïve individuals aged 10–25 years Block 2015 Aug 2011–Sep 2012 Yes
Szenborn 2018 Dec 2013–Apr 2015 No
NCT02140762 NCT02285777 USA RCT IIb Observer-blind Healthy, immuno-naïve individuals aged 10–18 years Welsch 2018 May 2014–Jun 2015 Yes
NCT02212457
NCT02946385		 Finland, Poland RCT IIb Observer-blind Healthy, immuno-naïve individuals aged 10–20 years Vesikari 2021 Aug 2014–Mar 2016
Nov 2016–Feb 2018		 Yes
NCT03587207 Czechia RCT II Open-label Healthy, immuno-naïve individuals aged 10–25 years Beran 2021 Jul–Dec 2018 Yes
NCT04502693 Australia, Canada, Czechia, Estonia, Finland, Turkey, USA RCT III Observer-blind Healthy individuals aged 10–25 years with no history of meningococcal disease or MenB vaccination V72_72 Aug 2020–Sep 2022 Yes
NCT04707391 Argentina, Australia, Canada, USA RCT III Observer-blind Healthy individuals aged 15–25 years with no meningococcal disease history vaccinated with MenACWY ≥4 years prior MenABCWY_019 Jan 2021–Sep 2023 Yes

Appendix 1 Footnotes

aThis extension study did not randomize participants. All participants received ≥1 dose MenABCWY, with number of doses based on enrollment history.
bThe parent study enrolled individuals aged 10–18. The extension study, conducted two years later, enrolled age-matched (ages 12–20 years) participants.

Appendix 2: Summary of Studies Included in Final GRADE Assessment

Three studies from Appendix 1 (Saez-Llorens 2015b, Saez-Llorens 2018, and Szenborn 2018) were excluded from all components of the final assessment. These studies either evaluated booster doses after a primary series of meningococcal vaccine (not relevant to the recommendations being considered) or evaluated primary series schedules not aligned with the recommendations being considered.

Author, year MenABCWY Comparator(s) MenABCWY vs Comparator Included in GRADE for...
Regimen # enrolled # completed Regimen # enrolled # completed Short-Term Immunity Long-Term Immunity Adverse Events
Saez-Llorens 2015a 0,2 mos 83 81 0 mos Q 83 83 Yes No Yes
Block 2015b 0,2 mos 120 103 2 mos Q 121 107 No No Yes
0,2 mos B 122 109 No No Yes
Welsch 2018 0,2 mos 154 139 2 mos Q 151 135 No No Yes
Vesikari 2021 0,2 mos 232 211 0,2 mos B 228 228 No No Yes
0,6 mos 134 123 No No Yes
0,2,6 mos 160 147 No No Yes
0,1 mos 157 141 No No Yes
0,11 mos 152 137 No No Yes
0,2 mosc+P 127 127 0,2 mosc+B 126 126 No No Yes
0,6 mosc+P 74 74 No Yes Yes
0,2 mosd 101 99 0,2 mos Bd 99 96 No No Yes
Beran 2021 0,2 mos 100 100 0,2 mos QB/S 104 104 Yes No Yes
0,2 mos QB/D 100 100 Yes No Yes
0,2 mos B 94 94 No No Yes
0 mos Q 102 102 Yes No Yes
v72_72 0,6 mos 1,657 1,497 0,2,6 mos B 897 797 No No Yes
0 mos Q 178 163 Yes No Yes
0,6 mos B 906 811 Yes No Yes
MenABCWY_019 0,6 mos 626 541 0 mos Q 621 542 Yes No Yes

Abbreviations: MenB vaccine dose (B); MenABCWY vaccine dose (P); MenACWY vaccine dose (Q)

Appendix 2 Footnotes

aMenB data not considered because the MenB formulation used did not include the outer membrane vesicle component normally found in Bexsero
bData from one MenABCWY trial arm not considered because the MenABCWY formulation used included a substantially reduced amount of the outer membrane vesicle component contained in the licensed MenABCWY formulation.
cOriginal participants subsequently enrolled in the extension study
dNew participants enrolled during the extension study

Appendix 3: Strategy for Evidence Search and Screening

Databases searched: Medline, Embase, Global Health, CINAHL, Cochrane, Scopus, and clinicaltrials.gov

Search terms

exp Neisseria meningitidis/ OR (Neisseria meningitidis OR meningococcal OR MenB-4C).ti,ab,kf.) AND pentavalent.ti,ab,kf.))

AND

vaccin*.ti,ab,kf. (in addition to clinical trials identifiers using "OR")

Efforts were made to obtain unpublished or other relevant data

View Larger
Appendix 3 - references identified
After applying the strategy for evidence search and screening, the GRADE analysis included 7 data sources.

Appendix 4: Summary of Studies Reporting Seroresponse

Intervention Comparator Author, year or Study ID Population Serogroup Percent (N) Intervention Percent (N) Comparator Study limitations (risk of bias)
Seroresponse based on hSBA titersa for serogroups A, C, W, and Y 1 month after 1 vaccine dose
MenABCWY MenACWY-CRM Saez-Llorens 2015b,c 11–18 years;
ACWY naïve		 A 80% (79) 86% (78) Not serious
C 74% (80) 68% (78)
W 56% (79) 60% (80)
Y 77% (79) 78% (81)
Beran 2021d 10–25 years;
ACWY naïve		 A 61.7% (98) 67.4% (97) Not serious
C 54.2% (98) 52.1% (97)
W 60.6% (98) 41.4% (97)
Y 77.9% (98) 76.8% (97)
MenACWY-CRM + MenB-4C administered in same arm A 71.3% (101)
C 46.5% (101)
W 52.0% (101)
Y 75.5% (101)
MenACWY-CRM + MenB-4C administered in different arms A 80.6% (97)
C 51.0% (97)
W 51.6% (97)
Y 78.3% (97)
MenACWY-CRM V72_72e,f 10–25 years;
ACWY naïve or primed		 A 74.0% (127) 86.0% (129) Not serious
C 66.9% (139) 56.7% (134)
W 74.1% (139) 66.2% (136)
Y 76.0% (146) 72.1% (140)
MenABCWY_019e,g 15–25 years;
ACWY primed		 A 92.5% (509) 95.0% (505) Not serious
C 94.0% (570) 94.0% (546)
W 94.3% (565) 93.9% (544)
Y 93.7% (567) 94.4% (537)
Seroresponse based on hSBA titersa for serogroup B 1 month after 2 vaccine doses
MenABCWY (2 doses at 0,6 months) MenB-4C (2 doses at 0,6 months) V72_72f,h 10–25 years;
B naïve		 fHbp 78.9% (729) 82.4% (699) Not serious
NadA 92.3% (725) 95.3% (700)
NHBA 61.1% (731) 69.5% (704)
PorA 42.4% (693) 57.2% (664)

Appendix 4 Footnotes

ahSBA stands for serum bactericidal assay using human complement. Seroresponse refers to the proportion of participants whose hSBA titers increased by a certain amount between the baseline (pre-vaccination) and post-vaccination measurements.
bSeroresponse defined as ≥4x increase in hSBA titer (if the pre-vaccination titer was ≥1:4) or hSBA titer ≥1:8 (if the pre-vaccination titer was <1:4).
cThe relevant results were primarily reported via figures in the published scientific manuscript. The percentages and Ns reported here were provided directly by GSK.
dSeroresponse defined as ≥4x increase in hSBA titer. The percentages were reported in the supplemental material for the published scientific manuscript. The Ns reported here were provided directly by GSK.
eSeroresponse defined as ≥4x increase in hSBA titer (if the pre-vaccination titer was ≥1:LLOQ [lower limit of quantitation]), ≥4x LLOQ (if the pre-vaccination titer was <1:LLOQ and ≥1:4), or hSBA titer ≥1:16 (if the pre-vaccination titer was <1:4). LLOQs were 12 (serogroup A), 8 (serogroup C), 8 (serogroup W), and 10 (serogroup Y). This information was provided directly by GSK.
fThe relevant results were reported at the study’s clinicaltrials.gov record, last updated March 5, 2024.
gThe relevant results were reported at the study’s clinicaltrials.gov records, last updated July 3, 2024.
hSeroresponse defined as ≥4x increase in hSBA titer (if the pre-vaccination titer was ≥1:LLOQ [lower limit of quantitation]), ≥4x LLOQ (if the pre-vaccination titer was <1:LLOQ and ≥1:4), or hSBA titer ≥1:16 (if the pre-vaccination titer was <1:4). LLOQs were 5 (fHbp), 15 (NadA), 4 (NHBA), and 6 (PorA). This information was provided directly by GSK.
Non-inferiority of MenABCWY compared to MenB-4C was demonstrated if the lower limits of the two-sided 95% CIs for group differences were above -10%. In comparisons of MenABCWY to 2 doses of MenB-4C at 0 and 6 months, the criterion for non-inferiority was met for fHbp and NadA but not for NHBA and PorA. Nolan et al. Breadth of immune response, immunogenicity, reactogenicity, and safety for a pentavalent meningococcal ABCWY vaccine in healthy adolescents and young adults: results from a phase 3, randomized, controlled observer-blinded trial. Lancet Infect Dis. 2025;25:560–73.

Appendix 5: Summary of Studies Reporting Geometric Mean Titer (GMT)

Intervention Comparator Author, year or Study ID Population Serogroup
(test strain)		 Time since last study dose GMT (N) Intervention GMT (N) Comparator Study limitations (risk of bias)
Short-term geometric mean hSBA titersa for serogroups A, C, W, and Y
MenABCWY (1 dose) MenACWY-CRM (1 dose) Saez-Llorens 2015b 11–18 years;
ACWY naïve		 A Baseline 1.28 (82) 1.4 (82)
1 month 49 (79) 105 (78)
C Baseline 4.57 (82) 4.04 (81)
1 month 76 (80) 59 (79)
W Baseline 20 (82) 19 (82)
1 month 183 (79) 188 (80)
Y Baseline 4.35 (82) 5.76 (82)
1 month 67 (79) 77 (81)
Beran 2021c 10–25 years;
ACWY naïve		 A Baseline 3.19 (98) 3.27 (97)
1 month 31.38 (98) 52.03 (97)
C Baseline 5.12 (98) 5.01 (97)
1 month 41.35 (98) 34.66 (97)
W Baseline 9.17 (98) 16.11 (97)
1 month 108.91 (98) 80.11 (97)
Y Baseline 1.59 (98) 1.84 (97)
1 month 75.07 (98) 92.41 (97)
MenACWY-CRM + MenB-4C administered in same arm (1 dose) A Baseline 3.12 (101)
1 month 67.95 (101)
C Baseline 4.62 (101)
1 month 33.76 (101)
W Baseline 11.69 (101)
1 month 81.38 (101)
Y Baseline 1.83 (101)
1 month 76.48 (101)
MenACWY-CRM + MenB-4C administered in different arms (1 dose) A Baseline 3.21 (97)
1 month 88.29 (97)
C Baseline 5.64 (97)
1 month 40.33 (97)
W Baseline 12.17 (97)
1 month 92.84 (97)
Y Baseline 2.05 (97)
1 month 100.30 (97)
MenACWY-CRM (1 dose) V72_72d 10–25 years;
ACWY naïve or primed		 A Baseline 11.1 (1,452) 12.7 (137)
1 month 175.3 (132) 474.8 (133)
C Baseline 12.0 (1,487) 11.4 (139)
1 month 674.8 (139) 379.0 (136)
W Baseline 8.0 (1,473) 7.4 (140)
1 month 374.0 (142) 194.3 (137)
Y Baseline 9.3 (1,489) 9.9 (141)
1 month 375.4 (146) 320.9 (140)
MenABCWY_019e 15–25 years;
ACWY primed		 A Baseline 15.30 (546) 16.34 (549)
1 month 670.78 (605) 1,282.56 (585)
C Baseline 31.90 (601) 29.76 (584)
1 month 2,945.68 (609) 2,552.27 (593)
W Baseline 12.08 (597) 11.08 (583)
1 month 1,899.60 (607) 1,665.64 (592)
Y Baseline 12.84 (600) 11.86 (576)
1 month 1,590.71 (606) 1,578.42 (591)
Short-term geometric mean hSBA titersa for serogroup B
MenABCWY (2 doses at 0,6 months) MenB-4C (2 doses at 0,6 months) V72_72d 10–25 years;
B naïve		 fHbp Baseline 2.8 (762) 2.7 (730)
1 month 25 (738) 28.1 (707)
NadA Baseline 8.5 (780) 8.3 (731)
1 month 150.6 (734) 215.1 (707)
NHBA Baseline 3.1 (764) 3.2 (731)
1 month 25.2 (738) 33.2 (711)
PorA Baseline 3.1 (751) 3.1 (716)
1 month 12.9 (709) 17.7 (684)
Persistent geometric mean hSBA titersa for serogroups A, C, W, and Y
No relevant studies
Persistent geometric mean hSBA titersa for serogroup B
MenABCWY (2 doses at 0,6 months) MenB-4C (2 doses at 0,2 months) Vesikari 2021 10–18 years; B naïve fHbp Two years 2.62 (70) 2.04 (119)
NadA 16 (72) 20 (121)
NHBA 5.30 (71) 4.24 (122)
PorA 2.17 (71) 1.72 (121)

Appendix 5 Footnotes

ahSBA stands for serum bactericidal assay using human complement.
bThe relevant results were primarily reported via figures in the published scientific manuscript. The percentages and Ns reported here were provided directly by GSK.
cThe percentages were reported in the supplemental material for the published scientific manuscript. The Ns reported here were provided directly by GSK.
dThe relevant results were reported at the study’s clinicaltrials.gov record, last updated March 5, 2024.
eThe relevant results were reported at the study’s clinicaltrials.gov records, last updated July 3, 2024.
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