Pfizer Confidential 1

MenABCWY 

Meningococcal 

Vaccine

Jason D. Maguire, MD, MPH

Clinical Lead, Phase 3 Program 

Pfizer Vaccines Clinical R&D
Pfizer Confidential 2

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 vaccines

Indication and dosing being sought for MenABCWY vaccine

MenABCWY Vaccine Overview
Pfizer Confidential 3

Adolescent meningococcal vaccination platform options for MenABCWY

vaccine

11-12 years 16-23 years

ACWY ACWY B B

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 months

ACWY 

protection

ABCWY 

protection

Booster dose (4 years) 

for ABCWY protection
Pfizer Confidential 4

MenABCWY vaccine clinical program overview

Blood vial image source: Flaticon.com

• ABCWY responses after 2 

doses (0,6m) 

• ACWY responses after 1 dose

Key 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
Breakthroughs that change patients’ lives Pfizer Confidential 5

Immunogenicity
Pfizer Confidential 6

Immunogenicity 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 protection

FDA agreement for licensure

ACWY evaluation

(non-inferiority after 1 and 2 

doses of MenABCWY vaccine 

versus MenACWY-CRM)

B evaluation

(non-inferiority after 2 doses of 

MenABCWY vaccine versus 

MenB-fHbp)

ABCWY evaluation

(Other endpoints)

• hSBA seroresponse* (4-fold)

• Naïve and primed participants

• hSBA seroresponse* (4-fold) 

• Composite response†

• hSBA thresholds (1:4, 1:8, 1:16) 

• GMTs
Pfizer Confidential 7

Immunogenicity

ACWY-naive
Pfizer Confidential 8

A single dose of MenABCWY vaccine can be used as an alternative to 

ACWY vaccines in ACWY-naïve adolescents

Study C3511001 | Evaluable Immunogenicity Population

Percentage of participants achieving hSBA seroresponse* 1 month after 

vaccination for serogroups ACWY 

0

10

20

30

40

50

60

70

80

90

100

A C W Y

%

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 vaccine

Comparisons (ACWY-naïve participants):

• MenABCWY vaccine 1 month after first dose 

• MenACWY-CRM 1 month after single dose
Pfizer Confidential 9

0

10

20

30

40

50

60

70

80

90

100

A C W Y

%

Percentage of participants achieving hSBA seroresponse* 1 month after 

vaccination for serogroups ACWY

2 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

MenABCWY MenB-fHbp + MenACWY-CRM
Pfizer Confidential 10

0

10

20

30

40

50

60

70

80

90

100

A22 A56 B24 B44 Composite

%

MenABCWY MenB-fHbp + MenACWY-CRM

Percentage of participants achieving hSBA seroresponse* and composite 

response† 1 month after vaccination for serogroup B 

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 vaccine

2 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
Pfizer Confidential 11

MenABCWY vaccine protects against all 5 serogroups with 2 doses given 6 

to 12 months apart

Seroresponse* 1m PD2 MenABCWY 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, 99.0

Study 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
Pfizer Confidential 12

MenACWY seroprotection persists up to 4 years in ACWY-naïve participants

Study B1971057 | mITT and Booster Evaluable Immunogenicity Populations

Percentage of individuals* with hSBA titers ≥ 1:8 at all timepoints

A

W

C

Y

0

20

40

60

80

100

Baseline 1m PD2 12m PD2 24m PD2 36m PD2 48m PD2

Percentage (%)

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.

0

20

40

60

80

100

Baseline 1m PD2 12m PD2 24m PD2 36m PD2 48m PD2

0

20

40

60

80

100

Baseline 1m PD2 12m PD2 24m PD2 36m PD2 48m PD2

Percentage (%)

0

20

40

60

80

100

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 PD1

Baseline 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
Pfizer Confidential 13

Study 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 

booster

A C W Y

2

4

8

16

32

64

128

256

512

1024

2048

4096

Post 

primary

Pre^ Post Post 

primary

Pre^ Post Post 

primary

Pre^ Post Post 

primary

Pre^ Post

GMT

GMTs* 4 years after primary vaccination and 1 month after booster for 

serogroups ACWY 

booster booster booster booster

MenABCWY MenB-fHbp + MenACWY-CRM
Pfizer Confidential 14

0

20

40

60

80

100

Baseline 1m PD2 12m PD2 24m PD2 36m PD2 48m PD2

Percentage (%)

MenB seroprotection up to 4 years after 2 doses of MenABCWY

Study B1971057 | mITT and Booster Evaluable Immunogenicity Populations

Percentage of individuals* with hSBA titers ≥ 1:8† at all timepoints

A22†

B24

A56

B44

0

20

40

60

80

100

Baseline 1m PD2 12m PD2 24m PD2 36m PD2 48m PD2

Percentage (%)

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.

0

20

40

60

80

100

Baseline 1m PD2 12m PD2 24m PD2 36m PD2 48m PD2

0

20

40

60

80

100

Baseline 1m PD2 12m PD2 24m PD2 36m PD2 48m PD2

MenABCWY MenB-fHbp + MenACWY-CRM
Pfizer Confidential 15

Study B1971057 | Booster Evaluable Immunogenicity Population

A22 A56 B24 B44

• 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.

GMTs* 4 years after primary vaccination and 1 month after booster for 

serogroup B

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

2

4

8

16

32

64

128

256

512

1024

Post 

primary

Pre Post Post 

primary

Pre Post Post 

primary

Pre Post Post 

primary

Pre Post

GMT

booster booster booster booster

MenABCWY MenB-fHbp + MenACWY-CRM
Pfizer Confidential 16

Immunogenicity

ACWY-primed
Pfizer Confidential 17

0

10

20

30

40

50

60

70

80

90

100

A C W Y

(%)

• 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 vaccine

A single dose of MenABCWY vaccine can be used as an alternative to 

ACWY vaccines in ACWY-primed adolescents

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, 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

Percentage of participants achieving hSBA seroresponse* 1 month after 

vaccination for serogroups ACWY 

MenABCWY MenB-fHbp + MenACWY-CRM
Pfizer Confidential 18

0

10

20

30

40

50

60

70

80

90

100

A C W Y A22 A56 B24 B44 Composite

%

• 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 adolescents

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, 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

Percentage of participants achieving hSBA seroresponse* 1 month after 

vaccination

MenABCWY MenB-fHbp + MenACWY-CRM

Serogroups ACWY Serogroup B
Pfizer Confidential 19

MenACWY seroprotection persists up to 4 years in ACWY-primed population

Study B1971057 | mITT and Booster Evaluable Immunogenicity Populations

Percentage of participants* (95% CI) with hSBA titers ≥ 1:8

0

20

40

60

80

100

Baseline 1m PD2 12m PD2 24m PD2 36m PD2 48m PD2

Percentage (%)

0

20

40

60

80

100

Baseline 1m PD2 12m PD2 24m PD2 36m PD2 48m PD2

A

W

C

Y

0

20

40

60

80

100

Baseline 1m PD2 12m PD2 24m PD2 36m PD2 48m PD2

Percentage (%)

0

20

40

60

80

100

Baseline 1m PD2 12m PD2 24m PD2 36m PD2 48m PD2

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 entry. 

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 MenBfHbp + 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 + MenACWYCRM (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.

Baseline 7m PD1 18m PD1 30m PD1 42m PD1 54m PD1

Baseline 7m PD1 18m PD1 30m PD1 42m PD1 54m PD1

Baseline 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
Pfizer Confidential 20

Safety
Pfizer Confidential 21

Local reactions* within 7 days after vaccination

Local reactogenicity by dose

Study C3511001 | Safety Population

0

25

50

75

100

Percentage of participants (%)

0

25

50

75

100

Dose 1

Pain† Redness‡ Swelling‡

*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.

MenABCWY MenB-fHbp MenABCWY MenB-fHbp MenABCWY MenB-fHbp

MenABCWY MenB-fHbp MenABCWY MenB-fHbp MenABCWY MenB-fHbp

Mild Moderate Severe

89.3% 85.1%

25.8%

19.5% 24.9% 21.4%

Severity

84.4% 78.6%

23.2%

14.7%

24.2%

14.7%

Dose 2

10-25 years

Percentage of participants (%)

No differences observed between: ACWY-Naïve and Primed participants or Primary and Booster vaccination
Pfizer Confidential 22

Systemic events within 7 days after vaccination

Systemic reactogenicity by dose

Study C3511001 | Safety Population Dose 1

Mild Moderate Severe

Severity

Dose 2

0

25

50

75

100

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*

MenABCWY MenB-fHbp + 

MenACWY-CRM*

MenABCWY MenB-fHbp + 

MenACWY-CRM*

0

25

50

75

100

39.8%

47.6% 43.6%

22.8% 22.2% 18.3% 15.6%

37.8%

MenABCWY MenB-fHbp* MenABCWY MenB-fHbp* MenABCWY MenB-fHbp* MenABCWY MenB-fHbp*

*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

Percentage of participants (%)

No differences observed between: ACWY-Naïve and Primed participants or Primary and Booster vaccination
Pfizer Confidential 23

0

25

50

75

100

Systemic events within 7 days after vaccination

Systemic reactogenicity by dose

Study C3511001 | Safety Population Dose 1 Dose 2

MenABCWY MenB-fHbp + 

MenACWY-CRM*

11.0%

20.1% 19.6%

3.2% 3.0% 5.9% 5.8%

13.5%

Chills† Diarrhea‡ Vomiting§ Feverǁ

MenABCWY MenB-fHbp + 

MenACWY-CRM*

MenABCWY MenB-fHbp + 

MenACWY-CRM*

MenABCWY MenB-fHbp + 

MenACWY-CRM*

0

25

50

75

100

8.2%

16.4% 16.2%

1.5% 0.9% 2.3% 1.5% 8.5%

MenABCWY MenB-fHbp* MenABCWY MenB-fHbp * MenABCWY MenB-fHbp* MenABCWY MenB-fHbp*

*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. ǁ

No fevers >40 oC were reported.

Data on File, Study C3511001 (NCT04440163) Aug 2022, Pfizer Inc.

Percentage of participants (%)

10-25 years

Percentage of participants (%)

Mild Moderate Severe

Severity

Fever Severity (oC)

38.0-38.4 38.5-38.9 39.0-40.0

No differences observed between: ACWY-Naïve and Primed participants or Primary and Booster vaccination
Pfizer Confidential 24

Number (%) of participants reporting ≥1 adverse event during the vaccination phase*

MenABCWY + Saline

N=1763

MenB-fHbp + MenACWY-CRM

N=649

Endpoint n % (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) 0

Study C3511001 | Safety Population

Abbreviations: AE=adverse event; MAE=medically attended event (nonserious AE that results in an evaluation at a medical facility); 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 vaccination (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 study

10-25 years
Pfizer Confidential 25

Overall 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 yrs of age, data support that a 

single (booster) dose from 16 years of age can provide protection against all 5 serogroups

ABCWY protection
Pfizer Confidential 26

Pfizer wishes to thank: 

• The clinical trial participants

• Sites, investigators, CRO, our partners, and their staff

Acknowledgements