PENBRAYA™ Clinical Studies

(meningococcal groups A, B, C, W, and Y vaccine)

14 CLINICAL STUDIES

The effectiveness of PENBRAYA was assessed in Study 1 by measuring antibodies with assays that used human complement to assess serum bactericidal activity (hSBA). For serogroups A, C, W, and Y, one strain was utilized per group. For serogroup B, four meningococcal serogroup B strains expressing different fHbp variants that represent the A and B subfamilies of meningococcal serogroup B strains causing invasive disease in the U.S. and Europe were utilized. The proportions of subjects with a 4-fold or greater increase in hSBA titer for each strain, and the proportion of subjects with a titer greater than or equal to the lower limit of quantitation (LLOQ) of the assay for all four serogroup B strains (composite response) were assessed.

14.1 Immunogenicity

Study 1 was a Phase 3, randomized, active-controlled, observer-blinded, multicenter study in which participants 10 through 25 years of age in the U.S. and Europe received PENBRAYA at 0 and 6 months or Trumenba at 0 and 6 months and MenACWY-CRM at 0 months. All participants were MenB vaccine-naïve. Both MenACWY conjugate vaccine -naïve and MenACWY conjugate vaccine-exposed participants were part of the study.

Seroresponse for serogroups A, B, C, W, and Y and composite response for serogroup B following 2 doses of PENBRAYA in Study 1 are presented in Tables 3 and 4.

Among both ACWY-naïve and ACWY-exposed participants, seroresponse rates to serogroups A, C, W, and Y following 2 doses of PENBRAYA were demonstrated to be non-inferior to seroresponse rates following a single dose of MenACWY-CRM. Seroresponse and composite response rates to serogroup B primary strains among participants who received 2 doses of PENBRAYA were demonstrated to be non-inferior to seroresponse and composite response rates following 2 doses of Trumenba.

Table 3. Percentage of Subjects Achieving Seroresponses 1 Month after Receiving 2 Doses of PENBRAYA (0 and 6 Months) versus 1 Month after Single Dose of MenACWY CRM for Serogroups A, C, W, and Y (Study 1)*,
Abbreviations: CI = confidence interval; hSBA = serum bactericidal assay using human complement; LLOQ = lower limit of quantitation; LOD = limit of detection; MenACWY-CRM = meningococcal (serogroups A, C, W and Y) oligosaccharide diphtheria CRM197 conjugate vaccine; Trumenba= meningococcal serogroup B factor H binding protein.
Note: The LLOQ is an hSBA titer = 1:16 for A22 and 1:8 for A56, B24, and B44 and serogroups A, C, W, and Y.
Note: Seroresponse is defined as the 4-fold increase as follows: (1) For participants with a baseline hSBA titer <1:4 (LOD), a 4-fold response was defined as an hSBA titer ≥1:16. (2) For participants with a baseline hSBA titer ≥ LOD and < LLOQ, a response is defined as an hSBA titer ≥4 times the LLOQ. (3) For participants with a baseline hSBA titer ≥ LLOQ, a response is defined as an hSBA titer ≥4 times the baseline titer.
*
Evaluable immunogenicity populations.
NCT04440163
Non-inferiority was demonstrated (using 10% margin) post-vaccination by assessing the difference between vaccination serogroups.

Serogroup

PENBRAYA

%

Trumenba + MenACWY-CRM

%

PENBRAYA – MenACWY-CRM

Difference

N=439-451 (Naïve)

N=376-387 (Exposed)

N=244-254 (Naïve)

N=222-227 (Exposed)

Difference %

(95% CI)

A

  ACWY-naïve

97.8

95.3

2.5

(-0.2, 6.0)

  ACWY-exposed

93.8

96.9

-3.2

(-6.5, 0.5)

C

  ACWY-naïve

93.3

52.4

41.0

(34.4, 47.5)

  ACWY-exposed

93.8

94.7

-0.9

(-4.6, 3.3)

W

  ACWY- naïve

97.3

73.0

24.3

(18.8, 30.4)

  ACWY-exposed

97.1

96.4

0.7

(-2.2, 4.3)

Y

  ACWY- naïve

94.4

70.6

23.8

(18.0, 30.1)

  ACWY-exposed

93.0

93.7

-0.7

(-4.6, 3.8)

Table 4. Percentage of Participants Achieving Seroresponses and Composite Response 1 Month after Receiving 2 Doses of PENBRAYA (0 and 6 Months) versus 2 Doses of Trumenba (0 and 6 Months) For Serogroup B (Study 1)*
Abbreviations: CI = confidence interval; hSBA = serum bactericidal assay using human complement; LLOQ = lower limit of quantitation; LOD = limit of detection; MenACWY-CRM = meningococcal (serogroups A, C, W and Y) oligosaccharide diphtheria CRM197 conjugate vaccine; Trumenba= meningococcal serogroup B factor H binding protein.
Note: The LLOQ is an hSBA titer = 1:16 for A22 and 1:8 for A56, B24, and B44 and serogroups A, C, W, and Y.
Note: Seroresponse is defined as the 4-fold increase as follows: (1) For participants with a baseline hSBA titer <1:4 (LOD), a 4-fold response was defined as an hSBA titer ≥1:16. (2) For participants with a baseline hSBA titer ≥ LOD and < LLOQ, a response is defined as an hSBA titer ≥4 times the LLOQ. (3) For participants with a baseline hSBA titer ≥ LLOQ, a response is defined as an hSBA titer ≥4 times the baseline titer.
*
Evaluable immunogenicity populations.
NCT04440163
Non-inferiority was demonstrated (using 10% margin) post-vaccination by assessing the difference between vaccination serogroups.
§
Composite response = hSBA ≥ LLOQ for all 4 primary meningococcal B strains.

PENBRAYA

%

Trumenba + MenACWY-CRM

%

PENBRAYA – MenACWY-CRM

Difference

Serogroup B Variant

N=755-845

N=383-419

Difference %

(95% CI)

Seroresponse

A22

83.0

79.0

4.0

(-0.7, 8.9)

A56

95.9

94.5

1.4

(-1.0, 4.3)

B24

68.1

57.2

10.9

(5.2, 16.6)

B44

86.5

79.2

7.3

(2.9, 11.9)

Composite§

Pre-Dose 1

1.2

2.0

-

Post-Dose 2

78.3

68.7

9.6

(4.2, 15.2)

Find PENBRAYA™ medical information:

Find PENBRAYA™ medical information:

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

PENBRAYA™ Quick Finder

Prescribing Information
Download Prescribing Information

Health Professional Information

Clinical Studies

14 CLINICAL STUDIES

The effectiveness of PENBRAYA was assessed in Study 1 by measuring antibodies with assays that used human complement to assess serum bactericidal activity (hSBA). For serogroups A, C, W, and Y, one strain was utilized per group. For serogroup B, four meningococcal serogroup B strains expressing different fHbp variants that represent the A and B subfamilies of meningococcal serogroup B strains causing invasive disease in the U.S. and Europe were utilized. The proportions of subjects with a 4-fold or greater increase in hSBA titer for each strain, and the proportion of subjects with a titer greater than or equal to the lower limit of quantitation (LLOQ) of the assay for all four serogroup B strains (composite response) were assessed.

14.1 Immunogenicity

Study 1 was a Phase 3, randomized, active-controlled, observer-blinded, multicenter study in which participants 10 through 25 years of age in the U.S. and Europe received PENBRAYA at 0 and 6 months or Trumenba at 0 and 6 months and MenACWY-CRM at 0 months. All participants were MenB vaccine-naïve. Both MenACWY conjugate vaccine -naïve and MenACWY conjugate vaccine-exposed participants were part of the study.

Seroresponse for serogroups A, B, C, W, and Y and composite response for serogroup B following 2 doses of PENBRAYA in Study 1 are presented in Tables 3 and 4.

Among both ACWY-naïve and ACWY-exposed participants, seroresponse rates to serogroups A, C, W, and Y following 2 doses of PENBRAYA were demonstrated to be non-inferior to seroresponse rates following a single dose of MenACWY-CRM. Seroresponse and composite response rates to serogroup B primary strains among participants who received 2 doses of PENBRAYA were demonstrated to be non-inferior to seroresponse and composite response rates following 2 doses of Trumenba.

Table 3. Percentage of Subjects Achieving Seroresponses 1 Month after Receiving 2 Doses of PENBRAYA (0 and 6 Months) versus 1 Month after Single Dose of MenACWY CRM for Serogroups A, C, W, and Y (Study 1)*,
Abbreviations: CI = confidence interval; hSBA = serum bactericidal assay using human complement; LLOQ = lower limit of quantitation; LOD = limit of detection; MenACWY-CRM = meningococcal (serogroups A, C, W and Y) oligosaccharide diphtheria CRM197 conjugate vaccine; Trumenba= meningococcal serogroup B factor H binding protein.
Note: The LLOQ is an hSBA titer = 1:16 for A22 and 1:8 for A56, B24, and B44 and serogroups A, C, W, and Y.
Note: Seroresponse is defined as the 4-fold increase as follows: (1) For participants with a baseline hSBA titer <1:4 (LOD), a 4-fold response was defined as an hSBA titer ≥1:16. (2) For participants with a baseline hSBA titer ≥ LOD and < LLOQ, a response is defined as an hSBA titer ≥4 times the LLOQ. (3) For participants with a baseline hSBA titer ≥ LLOQ, a response is defined as an hSBA titer ≥4 times the baseline titer.
*
Evaluable immunogenicity populations.
NCT04440163
Non-inferiority was demonstrated (using 10% margin) post-vaccination by assessing the difference between vaccination serogroups.

Serogroup

PENBRAYA

%

Trumenba + MenACWY-CRM

%

PENBRAYA – MenACWY-CRM

Difference

N=439-451 (Naïve)

N=376-387 (Exposed)

N=244-254 (Naïve)

N=222-227 (Exposed)

Difference %

(95% CI)

A

  ACWY-naïve

97.8

95.3

2.5

(-0.2, 6.0)

  ACWY-exposed

93.8

96.9

-3.2

(-6.5, 0.5)

C

  ACWY-naïve

93.3

52.4

41.0

(34.4, 47.5)

  ACWY-exposed

93.8

94.7

-0.9

(-4.6, 3.3)

W

  ACWY- naïve

97.3

73.0

24.3

(18.8, 30.4)

  ACWY-exposed

97.1

96.4

0.7

(-2.2, 4.3)

Y

  ACWY- naïve

94.4

70.6

23.8

(18.0, 30.1)

  ACWY-exposed

93.0

93.7

-0.7

(-4.6, 3.8)

Table 4. Percentage of Participants Achieving Seroresponses and Composite Response 1 Month after Receiving 2 Doses of PENBRAYA (0 and 6 Months) versus 2 Doses of Trumenba (0 and 6 Months) For Serogroup B (Study 1)*
Abbreviations: CI = confidence interval; hSBA = serum bactericidal assay using human complement; LLOQ = lower limit of quantitation; LOD = limit of detection; MenACWY-CRM = meningococcal (serogroups A, C, W and Y) oligosaccharide diphtheria CRM197 conjugate vaccine; Trumenba= meningococcal serogroup B factor H binding protein.
Note: The LLOQ is an hSBA titer = 1:16 for A22 and 1:8 for A56, B24, and B44 and serogroups A, C, W, and Y.
Note: Seroresponse is defined as the 4-fold increase as follows: (1) For participants with a baseline hSBA titer <1:4 (LOD), a 4-fold response was defined as an hSBA titer ≥1:16. (2) For participants with a baseline hSBA titer ≥ LOD and < LLOQ, a response is defined as an hSBA titer ≥4 times the LLOQ. (3) For participants with a baseline hSBA titer ≥ LLOQ, a response is defined as an hSBA titer ≥4 times the baseline titer.
*
Evaluable immunogenicity populations.
NCT04440163
Non-inferiority was demonstrated (using 10% margin) post-vaccination by assessing the difference between vaccination serogroups.
§
Composite response = hSBA ≥ LLOQ for all 4 primary meningococcal B strains.

PENBRAYA

%

Trumenba + MenACWY-CRM

%

PENBRAYA – MenACWY-CRM

Difference

Serogroup B Variant

N=755-845

N=383-419

Difference %

(95% CI)

Seroresponse

A22

83.0

79.0

4.0

(-0.7, 8.9)

A56

95.9

94.5

1.4

(-1.0, 4.3)

B24

68.1

57.2

10.9

(5.2, 16.6)

B44

86.5

79.2

7.3

(2.9, 11.9)

Composite§

Pre-Dose 1

1.2

2.0

-

Post-Dose 2

78.3

68.7

9.6

(4.2, 15.2)

Medication Guide

Health Professional Information

{{section_name_patient}}

{{section_body_html_patient}}

Resources

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985*

*Speak with a Pfizer Medical Information Professional regarding your medical inquiry. Available 9AM-5Pm ET Monday to Friday; excluding holidays.

Medical Inquiry

Submit a medical question for Pfizer prescription products.

Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.