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1 Pfizer ConfidentialMenABCWY
Meningococcal Vaccine
Jason D. Maguire, MD, MPH
Clinical Lead, Phase 3 Program
Pfizer Vaccines Clinical R&D
2 Pfizer Confidential
For Internal and Restricted Pfizer Use Only –Not for Distribution. Privileged and Confidential.MenABCWY vaccine composition
Confidential•MenABCWY vaccine is composed of drug substance from:
–Trumenba®(MenB-fHbp): licensed in the US for the prevention of invasive disease caused by Neisseria meningitidis group
B in individuals 10 through 25 years of age
–Nimenrix® (MenACWY- TT): licensed ex -US for the prevention of invasive disease caused by Neisseria meningitidis
serogroups A, C, W, and Y in individuals 6 weeks of age and older. •Active immunization of individuals 10 through 25 years of age against invasive meningococcal diseases
caused by Neisseria meningitidis serogroups A, B, C, W, Y
•Dosing:
–Administer two doses at least 6 months apart for prevention of meningococcal disease caused by serogroups A, B, C, W
and Y .
–Administer one dose for prevention of meningococcal disease caused by serogroups A, C, W and Y .
–A booster dose may be administered to individuals who have previously completed a primary series with MenABCWY or
MenB-fHbp vaccine or who have previously received MenACWY conjugated vaccinesIndication and dosing being sought for MenABCWY vaccineMenABCWY Vaccine Overview
3 Pfizer ConfidentialAdolescent meningococcal vaccination platform options for MenABCWY
vaccine
11-12 years 16-23 years
B B ACWY ACWY
ABCWY ABCWY ABCWY
ABCWY ABCWY ABCWY
Study Population 10- 25 years (ACWY -naïve and primed)Current Vaccine
Recommendation
MenABCWY
vaccine options
MenABCWY
vaccine clinical
data
0, 6-12 monthsACWY
protectionABCWY
pr
otectionBooster dos e (4 years)
for ABCWY protection
4 Pfizer ConfidentialMenABCWY vaccine clinical program overview
Blood vial image source: Flaticon.com•ABCWY responses after 2
doses (0,6m)
•ACWY responses after 1 doseKey immunogenicity ( hSBA) data to
be discussed
•ABCWY responses after 2 doses (0,12m)
•ABCWY 4 -year persistence
and booster response
•All participants were meningococcal serogroup B vaccine naïve prior to study entry
•80% of participants in the Phase 3 study were Caucasian; 10% black and African Americans; 25% of participants being Hispanic or Latino
5 Pfizer Confidential Breakthroughs that change patients’ livesImmunogenicity
6 Pfizer ConfidentialImmunogenicity objectives and endpoints
Abbreviations: hSBA=human serum bactericidal assay; GMT=geometric mean titer ;MenB =serogroup B
*For participants with a baseline hSBA titer <1:4, seroresponse is defined as a titer ≥1:16. For those with a baseline hSBA titer ≥1:4 and <1:8 (<1:16 for A22), seroresponse is a titer ≥4 times the 1:8
(1:16 for A22). For those with a baseline hSBA titer ≥1:8 (≥1:16 for A22), seroresponse is a titer ≥4 times the baseline titer. †hSBA titer ≥1:8 (1:16 for A22) for all 4 primary strains 1 month after Dose 2.MenB immunogenicity analysis: Same approach taken as for Trumenba licensure in the US
•4 MenB test strains utilized, 2 from Factor H Binding Protein ( fHbp ) subfamily A (A22, A56) and 2 from subfamily B (B24, B44)
•hSBA results provide information on breadth of coverage against MenB strains
•All strains express vaccine -heterologous fHbp variants
•Strains and fHbp variants expressed are representative of known genetic diversity; strains were randomly selected
•hSBA seropositivity defined as titers ≥1:8 or ≥1:16, which is greater than the 1:4 correlate of protectionFDA agreement for licensure
ACWY evaluation
(non-inferiority after 1 and 2
doses of MenABCWY vaccine
versus MenACWY -CRM)B ev aluation
(non
-inferiority after 2 doses of
MenABCWY vaccine versus
MenB -fHbp)A BCWY evaluation
(O
ther endpoints)
•h
SBA seroresponse* (4 - fold)
•Naïve and primed participants•hSBA seroresponse* (4 - fold)
•Composite response†•hSBA thresholds (1:4, 1:8, 1:16)
•G
MTs
7 Pfizer ConfidentialImmunogenicity
ACWY-naive
8 Pfizer Confidential
A single dose of MenABCWY vaccine can be used as an alternative to
ACWY vaccines in ACWY-naïve adolescentsStudy C3511001 | Evaluable Immunogenicity Population
Percentage of participants achieving hSBA seroresponse*1 month after
vaccination for serogroups
0102030405060708090100
A C W Y%ACWY
Abbreviations: hSBA=serum bactericidal assay using human complement.
*For participants with a baseline hSBA titer <1:4, seroresponse is defined as a titer ≥1:16. For those with a baseline hSBA titer ≥1:4 and <1:8, seroresponse is a titer ≥4 times the 1:8. For those with a baseline hSBA
titer ≥1:8, seroresponse is a titer ≥4 times the baseline titer.
N=492- 501 for MenABCWY group; N=244- 254 for MenB -fHbp + MenACWY -CRM group.
Data on File, Study C3511001 (NCT04440163) Aug 2022, Pfizer Inc.MenABCWY MenB -fHbp + MenACWY -CRM
•1 dose of MenABCWY vaccine was noninferior to 1 dose of MenACWY -CRM in ACWY -naïve participants
•82.4% -99.4% of participants had serogroups ACWY hSBA titers ≥1:8 after 1 dose of MenABCWY vaccineComparisons (ACWY -naïve participants):
•MenABCWY vaccine 1 month after first dose
•MenACWY -CRM 1 month after single dose
9 Pfizer Confidential0102030405060708090100
A C W Y%Percentage of participants achieving hSBA seroresponse*1 month after
vaccination for serogroups ACWY
MenABCWY MenB -fHbp + MenACWY -CRM2 doses of MenABCWY vaccine elicit higher responses versus a single
dose of MenACWY-CRM in ACWY -naïve participants
Abbreviations: hSBA=serum bactericidal assay using human complement.
*For participants with a baseline hSBA titer <1:4, seroresponse is defined as a titer ≥1:16. For those with a baseline hSBA titer ≥1:4 and <1:8, seroresponse is a titer ≥4 times the 1:8. For those with a baseline hSBA
titer ≥1:8, seroresponse is a titer ≥4 times the baseline titer.
N=439- 451 or MenABCWY group; N=244- 254 for MenB -fHbp + MenACWY -CRM group.
Data on File, Study C3511001 (NCT04440163) Aug 2022, Pfizer Inc.Study C3511001 | Evaluable Immunogenicity Population
•2 doses of MenABCWY vaccine were noninferior to 1 dose of MenACWY -CRM in ACWY -naïve participants
•99.1-99.8% of participants had serogroups ACWY hSBA titers ≥1:8 after 2 doses of MenABCWY vaccine
Comparisons (ACWY -naïve participants):
•MenABCWY vaccine 1 month after second dose
•MenACWY -CRM 1 month after single dose
10 Pfizer Confidential0102030405060708090100
A22 A56 B24 B44 Composite%
MenABCWY MenB -fHbp + MenACWY -CRMresponse†1 month after vaccination for serogroup B Percentage of participants achieving hSBA seroresponse*and composite Study C3511001 | Evaluable Immunogenicity Population
Abbreviations: hSBA=serum bactericidal assay using human complement .
*For participants with a baseline hSBA titer <1:4, seroresponse is defined as a titer ≥1:16. For those with a baseline hSBA titer ≥1:4 and <1:8 (<1:16 for A22), seroresponse is a titer ≥4 times the 1:8 (1:16 for A22).
For those with a baseline hSBA titer ≥1:8 (≥1:16 for A22), seroresponse is a titer ≥4 times the baseline titer. †hSBA titer ≥1:8 (≥1:16 for A22) for all 4 MenB strains 1 month after Dose 2. ^≥1:16 for A22 strain
N=755- 845 for MenABCWY group; N=383- 419 for MenB -fHbp + MenACWY -CRM group.
Data on File, Study C3511001 (NCT04440163) Aug 2022, Pfizer Inc.•2 doses of MenABCWY vaccine were noninferior to 2 doses of MenB -fHbp
•83.4-98.7% of participants had serogroup B hSBA titers ≥1:8^after 2 doses of MenABCWY vaccine2 doses of MenABCWY vaccine elicit higher responses versus 2 doses of
MenB -fHbp in B-naïve participants
Comparisons (B -naïve participants):
•MenABCWY vaccine 1 month after second dose
•MenB -fHbp 1 month after second dose
11 Pfizer ConfidentialMenABCWY vaccine protects against all 5 serogroups with 2 doses given 6
to 12 months apart
Seroresponse* 1m PD2MenABCWY 0, 6m
(Study 1001)MenABCWY 0, 12m
(Study 1004)
Serogroups N^ % 95% CI N^ % 95% CI
A 447 97.8 95.9, 98.9 116 99.1 95.3, 100
C 451 93.3 90.6, 95.5 115 99.1 95.3, 100
W 439 97.3 95.3, 98.6 113 99.1 95.2, 100
Y 446 94.4 91.8, 96.3 111 98.2 93.6, 99.8
MenB strain
A22 778 83.0 80.2, 85.6 111 95.5 89.8, 98.5
A56 807 95.9 94.3, 97.2 115 100 96.8, 100
B24 833 68.1 64.8, 71.2 113 92.9 86.5, 96.9
B44 845 86.5 84.0, 88.7 116 94.8 89.1, 98.1
MenB composite hSBA response†
Before Dose 1 812 1.2 0.6, 2.3 114 0.9 0.0, 4.8
1 Month after Dose 2 755 78.3 75.2, 81.2 110 96.4 91.0, 99.0Study C3511001, Evaluable Immunogenicity Population │ Study C3511004, Evaluable Immunogenicity Population
Abbreviations: hSBA=serum bactericidal assay using human complement; MenB =serogroup B.
*For participants with a baseline hSBA titer <1:4, seroresponse is defined as a titer ≥1:16. For those with a baseline hSBA titer ≥1:4 and <1:8 (<1:16 for A22), seroresponse is a titer ≥4 times the 1:8
(1:16 for A22). For those with a baseline hSBA titer ≥1:8 (≥1:16 for A22), seroresponse is a titer ≥4 times the baseline titer. ^ Number of subjects with valid and determinate hSBA titer for the given
strain; for study 1001, population includes ACWY -naïve participants for serogroups ACWY.†hSBA titer ≥ 1:8 (1:16 for A22) for all 4 MenB strains 1 month after Dose 2.
Data on File, Study C3511001 (NCT04440163) and C3511004 (NCT04440176) Aug 2022, Pfizer Inc.•2 doses of MenABCWY vaccine given 12 months apart elicit higher serogroup B responses
•98.3-100% of participants had serogroups ABCWY hSBA titers ≥1:8 following 2 doses of MenABCWY
vaccine given 12 months apart
12 Pfizer ConfidentialMenACWY seroprotection persists up to 4 years in ACWY -naïve participantsStudy B1971057 | mITT and Booster Evaluable Immunogenicity Populations
Percentage of individuals* with hSBA titers ≥ 1:8 at all timepoints
A
WC
Y020406080100
Baseline 1m PD2 12m PD2 24m PD2 36m PD2 48m PD2Percentage (%)
020406080100
Baseline 1m PD2 12m PD2 24m PD2 36m PD2 48m PD2
020406080100
Baseline 1m PD2 12m PD2 24m PD2 36m PD2 48m PD2Percentage (%)020406080100
Baseline 1m PD2 12m PD2 24m PD2 36m PD2 48m PD2Baseline 7m PD1 18m PD1 30m PD1 42m PD1 54m PD1
Baseline 7m PD1 18m PD1 30m PD1 42m PD1 54m PD1Baseline 7m PD1 18m PD1 30m PD1 42m PD1 54m PD1
Baseline 7m PD1 18m PD1 30m PD1 42m PD1 54m PD1
MenABCWY MenB -fHbp + MenACWY -CRM
Abbreviations: hSBA=serum bactericidal assay using human complement; PB=post booster; PD1=post dose 1; PD2=post dose 2.
*Number of subjects with valid and determinate hSBA titer for the given strain ranged from 95- 112 for MenABCWY and 54- 64 for MenB -fHbp + MenACWY -CRM (Stage 2 mITT population [baseline through
36m PD2/42m PD1]), and 59- 60 for MenABCWY and 36- 37 for MenB -fHbp + MenACWY -CRM (Booster evaluable immunogenicity population [48m PD2 /54m PD1 Post Primary and Post Booster]).
Data on File, Study B1971057 (NCT03135834) Aug 2022, Pfizer Inc.
13 Pfizer ConfidentialStudy B1971057 | Booster Evaluable Immunogenicity Population
Booster response observed following a dose of MenABCWY vaccine 4
years after a 2 dose primary series (0,6m) in ACWY -naïve participants
100% of participants had ACWY hSBA titers ≥1:8 following a booster dose of MenABCWY vaccine at 4 years
Abbreviations: hSBA=serum bactericidal assay using human complement; GMT= geometric mean titer; Post primary series =2 doses for MenABCWY and a single dose for MenACWY -CRM.
*Number of subjects with valid and determinate hSBA titer for the given strain ranged from 59- 60 for MenABCWY and 35- 37 for MenB -fHbp + MenACWY -CRM. ^Pre booster= 4 years after
second dose of MenABCWY and 4.5 years after single dose of MenACWY -CRM.
Data on File, Study B1971057 (NCT03135834) Aug 2022, Pfizer Inc.
Comparisons (ACWY -naïve participants):
•MenABCWY vaccine 4 years^ after second dose (pre booster) and 1 month after
booster
•MenACWY -CRM 4.5 years^ after single dose (pre booster) and 1 month after
boosterA C W Y
248163264128256512102420484096
Post
primaryPre^ Post Post
primaryPre^ Post Post
primaryPre^ Post Post
primaryPre^ PostGMTGMTs* 4 years after primary vaccination and 1 month after booster for
serogroups ACWY
booster booster booster booster
MenABCWY MenB -fHbp + MenACWY -CRM
14 Pfizer Confidential020406080100
Baseline 1m PD2 12m PD2 24m PD2 36m PD2 48m PD2Percentage (%)A22†
B24A56
B44020406080100
Baseline 1m PD2 12m PD2 24m PD2 36m PD2 48m PD2Percentage (%)
020406080100
Baseline 1m PD2 12m PD2 24m PD2 36m PD2 48m PD2
020406080100
Baseline 1m PD2 12m PD2 24m PD2 36m PD2 48m PD2
MenABCWY MenB -fHbp + MenACWY -CRMMenB seroprotection up to 4 years after 2 doses of MenABCWYStudy B1971057 | mITT and Booster Evaluable Immunogenicity Populations
Percentage of individuals* with hSBA titers ≥ 1:8†at all timepoints
Abbreviations: hSBA=serum bactericidal assay using human complement; PD2=post dose 2.
*Number of subjects with valid and determinate hSBA titer for the given strain ranged from 162- 212 for MenABCWY and 83- 137 for MenB -fHbp + MenACWY -CRM (Stage 2 mITT population [baseline through
36m PD2]), and 121- 129 for MenABCWY and 81- 87 for MenB -fHbp + MenACWY -CRM (Booster evaluable immunogenicity population [48m PD2 Post Primary and Post Booster]).†hSBA ≥1:16 for A22.
Data on File, Study B1971057 (NCT03135834) Aug 2022, Pfizer Inc.
15 Pfizer ConfidentialStudy B1971057 | Booster Evaluable Immunogenicity Population
A22 A56 B24serogroup B
B441024
512
256128
64MT G
3216
84
2
Post Pre Post Post Pre Post Post Pre Post Post Pre Post
primary booster primary booster primary booster primary booster
MenABCWY MenB -fHbp + MenACWY -CRMGMTs* 4 years after primary vaccination and 1 month after booster for
•95.1-100% of participants had B hSBA titers ≥1:8^ following a booster dose of MenABCWY vaccine 4 years
Abbreviations: hSBA=serum bactericidal assay using human complement; GMT= geometric mean tier; Post primary series (2 doses for both MenABCWY and MenB -fHbp )
*Number of subjects with valid and determinate hSBA titer for the given strain ranged from 121- 130 for MenABCWY and 81- 88 for MenB -fHbp + MenACWY -CRM. ^≥1:16 for A22 strain
Data on File, Study B1971057 (NCT03135834) Aug 2022, Pfizer Inc.Comparisons (B -naïve participants):
•MenABCWY vaccine 4 years after second dose (pre booster) and 1
month after booster
•MenB -fHbp 4 years after second dose (pre booster) and 1 month after
booster
Booster response observed following a dose of MenABCWY vaccine 4
years after a 2 dose primary series (0,6m) in B-naïve participants
16 Pfizer ConfidentialImmunogenicity
ACWY-primed
17 Pfizer Confidential0102030405060708090100
A C W Y(%)Percentage of participants achieving hSBA seroresponse*1 month after
vaccination for serogroups ACWY
MenABCWY MenB -fHbp + MenACWY -CRM
•1 dose of MenABCWY vaccine was noninferior to 1 dose of MenACWY -CRM in ACWY -primed participants
•99.5-100% of participants had serogroups ACWY hSBA titers ≥1:8 after 1 dose of MenABCWY vaccineA single dose of MenABCWY vaccine can be used as an alternative to
ACWY vaccines in ACWY-primed adolescentsStudy C3511001 | Evaluable Immunogenicity Population
Abbreviations: hSBA=serum bactericidal assay using human complement.
*For participants with a baseline hSBA titer <1:4, seroresponse is defined as a titer ≥1:16. For those with a baseline hSBA titer ≥1:4 and <1:8, seroresponse is a titer ≥4 times the 1:8. For those with a baseline
hSBA titer ≥1:8, seroresponse is a titer ≥4 times the baseline titer.
N=428- 442 for MenABCWY group; N=222- 227 for MenB -fHbp + MenACWY -CRM group.
Data on File, Study C3511001 (NCT04440163) Aug 2022, Pfizer Inc. Comparisons (ACWY -primed participants):
•MenABCWY vaccine 1 month after first dose
•MenACWY -CRM 1 month after single dose
18 Pfizer Confidential0102030405060708090100
A C W Y A22 A56 B24 B44 Composite%Percentage of participants achieving hSBA seroresponse*1 month after
vaccination
MenB -fHbp + MenACWY -CRM MenABCWYSerogroups ACWY Serogroup B
•2 doses of MenABCWY vaccine were noninferior to 1 dose of MenACWY-CRM in ACWY- primed participants
•99-100% had serogroups ACWY hSBA titers ≥1:8 after 2 doses of MenABCWY vaccine
•100% of ACWY -primed participants have protective titers four years after 2 doses of MenABCWY vaccine (Study B1971057)2 doses of MenABCWY vaccine can be used as an alternative to 1 dose
MenACWY -CRM and 2 doses MenB -fHbp in ACWY -primed adolescentsStudy C3511001 | Evaluable Immunogenicity Population
Abbreviations: hSBA=serum bactericidal assay using human complement.
*For participants with a baseline hSBA titer <1:4, seroresponse is defined as a titer ≥1:16. For those with a baseline hSBA t iter ≥1:4 and <1:8, seroresponse is a titer ≥4 times the 1:8. For those with a baseline
hSBA titer ≥1:8, seroresponse is a titer ≥4 times the baseline titer.N=376- 387 for MenABCWY group; N=22- 227 for MenB -fHbp + MenACWY -CRM group.
Data on File, Study C3511001 (NCT04440163) and Study B1971057 (NCT03135834) Aug 2022, Pfizer Inc
Comparisons (ACWY -primed participants):
•MenABCWY vaccine 1 month after second dose
•MenACWY -CRM 1 month after single dose
Comparisons (All participants group B vaccine naive):
•MenABCWY vaccine 1 month after second dose
•MenB -fHbp 1 month after second dose
19 Pfizer Confidential020406080100
Baseline 1m PD2 12m PD2 24m PD2 36m PD2 48m PD2Percentage (%)
020406080100
Baseline 1m PD2 12m PD2 24m PD2 36m PD2 48m PD2A
WC
Y020406080100
Baseline 1m PD2 12m PD2 24m PD2 36m PD2 48m PD2Percentage (%)
020406080100
Baseline 1m PD2 12m PD2 24m PD2 36m PD2 48m PD2
Baseline 7m PD1 18m PD1 30m PD1 42m PD1 54m PD1
Baseline 7m PD1 18m PD1 30m PD1 42m PD1 54m PD1Baseline 7m PD1 18m PD1 30m PD1 42m PD1 54m PD1
Baseline 7m PD1 18m PD1 30m PD1 42m PD1 54m PD1
MenABCWY MenB -fHbp + MenACWY -CRMMenACWY seroprotection persists up to 4 years in ACWY -primed populationStudy B1971057 | mITT and Booster Evaluable Immunogenicity Populations
Percentage of participants* (95% CI) with hSBA titers ≥ 1:8
Abbreviations: hSBA=serum bactericidal assay using human complement; PB=post booster; PD1=post dose 1; PD2=post dose 2.
*Number of subjects with valid and determinate hSBA titer for the given strain. Lower N for groups A, W, Y compared to C due to receipt of monovalent C vaccine prior to study entr y.
For groups A, W, and Y, N=48- 61 for MenABCWY and 22- 38 for MenB -fHbp + MenACWY -CRM (Stage 2 mITT population [baseline through 36m PD2/42m PD1]), and 32- 33 for MenABCWY and 16- 17 for MenB -
fHbp + MenACWY -CRM (Booster evaluable immunogenicity population [48m PD2 /54m PD1 Post Primary and Post Booster]). For group C, N=54- 100 for MenABCWY and 23- 72 for MenB -fHbp + MenACWY -
CRM (Stage 2 mITT population), and 68- 70 for MenABCWY and 51 for MenB -fHbp + MenACWY -CRM (Booster evaluable immunogenicity population).
Data on File, Study B1971057 (NCT03135834) Aug 2022, Pfizer Inc.
20 Pfizer ConfidentialSafety
21 Pfizer ConfidentialLocal reactions*within 7 days after vaccinationLocal reactogenicity by doseStudy C3511001 | Safety Population
0255075100 Percentage of participants (%)
0255075100Dose 1
Pain† Redness‡Swelling‡MenABCWY MenB -fHbp MenABCWY MenB -fHbp MenABCWY MenB -fHbpMenABCWY MenB -fHbp MenABCWY MenB -fHbp MenABCWY MenB -fHbp89.3% 85.1%
25.8%
19.5%24.9%21.4%
84.4%78.6%
23.2%
14.7%24.2%
14.7%Dose 2
Percentage of participants (%)
*Local reactions are summarized only for the left arm, which is the MenABCWYvaccine or MenB+fHbp injection site; †Mild=does not interfere with activity, moderate=interferes with activity, severe=prevents daily activity.
‡Mild=>2.0 to 5.0 cm, moderate=>5.0 to 10.0 cm, and severe is >10.0 cm.
Data on File, Study C3511001 (NCT04440163) Aug 2022, Pfizer Inc.Mild Moderate SevereSeverity10-25 years
No differences observed between: ACWY -Naïve and Primed participants or Primary and Booster vaccination
22 Pfizer ConfidentialSystemic events within 7 days after vaccinationSystemic reactogenicity by doseStudy C3511001 | Safety Population
1 e Dos 2 e Dos0255075100
MenABCWY MenB -fHbp +
MenACWY -CRM*46.8%52.1%54.7%
25.7%27.4%
20.2%22.6%46.9%
Fatigue† Headache† Muscle Pain† Joint Pain†Percentage of participants (%)
MenABCWY MenB -fHbp +
MenACWY -CRM*MenABCWYMenB -fHbp +
MenACWY -CRM*MenABCWY MenB -fHbp +
MenACWY -CRM*
0255075100
39.8%47.6%43.6%
22.8% 22.2% 18.3%15.6%37.8%
MenABCWY MenB -fHbp * MenABCWYMenB -fHbp * MenABCWY MenB -fHbp * MenABCWY MenB -fHbp *Percentage of participants (%)Mild Moderate SevereSeverity
*MenB -fHbp + MenACWY -CRM group: MenB -fHbp and MenACWY -CRM given at dose 1 and 3, MenB -fHbp given at dose 2.
†Mild: does not interfere with activity; Moderate: some interference with activity; Severe: prevents daily routine activity.
Data on File, Study C3511001 (NCT04440163) Aug 2022, Pfizer Inc.10-25 years
No differences observed between: ACWY -Naïve and Primed participants or Primary and Booster vaccination
23 Pfizer Confidential0255075100Dose 1 Dose 2MenABCWY MenB -fHbp +
MenACWY -CRM*11.0%20.1% 19.6%
3.2% 3.0%5.9% 5.8%13.5%
Chills† Diarrhea‡ Vomiting§ FeverǁMenABCWY MenB -fHbp +
MenACWY -CRM*MenABCWYMenB -fHbp +
MenACWY -CRM*MenABCWY MenB -fHbp +
MenACWY -CRM*
0255075100
8.2%16.4% 16.2%
1.5% 0.9% 2.3% 1.5%8.5%
MenABCWY MenB -fHbp * MenABCWYMenB -fHbp * MenABCWY MenB -fHbp * MenABCWY MenB -fHbp *Percentage of participants (%) Percentage of participants (%)38.0- 38.4 39.0- 40.0 38.5- 38.9Systemic events within 7 days after vaccinationSystemic reactogenicity by doseStudy C3511001 | Safety Population
*MenB -fHbp + MenACWY -CRM group: MenB -fHbp and MenACWY -CRM given at dose 1 and 3, MenB -fHbp given at dose 2. †Mild: does not interfere with activity; Moderate: some interference with activity;
Severe: prevents daily routine activity. ‡Mild: 2 –3 loose stools in 24 hours; Moderate: 4– 5 loose stools in 24 hours; Severe: 6 or more loose stools in 24 hours.
§Mild: 1 –2 times in 24 hours; Moderate: >2 times in 24 hours; Severe: requires intravenous hydration. ǁNofevers >40oCwere reported.
Data on File, Study C3511001 (NCT04440163) Aug 2022, Pfizer Inc.10-25 years
Moderate Mild SevereSeverity
Fever Severity (oC)
No differences observed between: ACWY -Naïve and Primed participants or Primary and Booster vaccination
24 Pfizer ConfidentialNumber (%) of participants reporting ≥ 1 adverse event during the vaccination phase*
MenABCWY + Saline
N=1763MenB-fHbp + MenACWY -CRM
N=649
Endpointn % (95% CI)Number of
Events n % (95% CI)Number of
Events
All AEs 368 20.9 (19.0, 22.8) 638 132 20.3 (17.3, 23.6) 202
Related 11 0.6 (0.3, 1.1) 19 4 0.6 (0.2, 1.6) 5
Severe 13 0.7 (0.4, 1.3) 17 4 0.6 (0.2, 1.6) 4
All SAEs 7 0.4 (0.2, 0.8) 9 0 0 (0.0, 0.6) 0
Related 0 0 (0.0, 0.2) 0 0 0 (0.0, 0.6) 0
All MAEs 263 14.9 (13.3, 16.7) 436 93 14.3 (11.7, 17.3) 141
Related 2 0.1 (0.0, 0.4) 2 1 0.2 (0.0, 0.9) 1
Severe 8 0.5 (0.2, 0.9) 9 3 0.5 (0.1, 1.3) 3
All NDCMCs 20 1.1 (0.7, 1.7) 23 2 0.3 (0.0, 1.1) 2
Related 0 0 (0.0, 0.2) 0 0 0 (0.0, 0.6) 0
Severe 1 <0.1 (0.0, 0.3) 2 0 0 (0.0, 0.6) 0Study C3511001 | Safety Population
Abbreviations: AE=adverse event; MAE=medically attended event (nonserious AE that results in an evaluation at a medical facil ity); NDCMC=newly diagnosed chronic medical condition (a disease
or medical condition, not previously identified, that is expected to be persistent or is otherwise long- lasting in its effects); SAE=serious adverse event.
*Vaccination phase refers to the time from the first study vaccination (Visit 1) through 1 month after the second study vacci nation (Visit 4).
Data on File, Study C3511001 (NCT04440163) Aug 2022, Pfizer Inc.
Higher number of NDCMCs of ADHD in the MenABCWY group – most of them with ADHD- related symptoms before
entering the study10-25 years
25 Pfizer ConfidentialOverall conclusion: Data support the use of MenABCWY vaccine in the
US adolescent meningococcal vaccination platform
•MenABCWY vaccine was safe and well tolerated in adolescents and young adults
Safety
•A single dose of MenABCWY vaccine can be used as an alternative to ACWY vaccines in
ACWY -naïve or primed adolescents and young adults
ACWY protection
•MenABCWY vaccine protects against all 5 serogroups with 2 doses given 6 to 12 months
apart
•Booster response was observed following a dose of MenABCWY vaccine 4 years after a 2 dose primary series (0,6m) for all 5 serogroups
•If 2 doses of MenABCWY vaccine are administered at 11-12 yrsof age, data support that a
single (booster) dose from 16 years of age can provide protection against all 5 serogroups
ABCWY protection
26 Pfizer ConfidentialPfizer wishes to thank:
•The clinical trial participants
•Sites, investigators, CRO, our partners, and their staffA
cknowledgements