PENBRAYA™ Adverse Reactions

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

6 ADVERSE REACTIONS

The most commonly reported (≥15%) solicited adverse reactions after Dose 1 and Dose 2, respectively, were pain at the injection site (89% and 84%), fatigue (52% and 48%), headache (47% and 40%), muscle pain (26% and 23%), injection site redness (26% and 23%), injection site swelling (25% and 24%), joint pain (20% and 18%), and chills (20% and 16%).

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.

The safety of PENBRAYA in individuals 10 through 25 years of age was evaluated in 3 clinical studies (2 active-controlled and 1 non-controlled study). In the controlled studies, 2306 participants received at least 1 dose of PENBRAYA. Of 946 participants who had previously received a meningococcal conjugate vaccine (categorized as MenACWY conjugate vaccine-exposed), 802 participants had received 1 dose of any U.S.-licensed Meningococcal Groups A, C, W, and Y conjugate vaccine, 51 participants had received a non-U.S.-licensed monovalent Meningococcal Group C conjugate vaccine (MenC conjugate vaccine), and 93 participants had received an unspecified U.S.-licensed or non-U.S.-licensed MenACWY conjugate or a MenC conjugate vaccine at least 4 years prior to enrollment. In the non-controlled study, 300 participants received a single dose of PENBRAYA.

Study 1 (NCT04440163) was an active-controlled, observer-blinded, multicenter study in which participants 10 through 25 years of age in the U.S. and Europe received at least 1 dose of PENBRAYA (N=1763) or Meningococcal Group B Vaccine (Trumenba) (N=650) at 0 and 6 months. Meningococcal Groups A, C, Y, and W-135 Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MenACWY-CRM, GSK Vaccines, SRL) was concomitantly administered with Trumenba at Month 0. All participants were MenB vaccine-naïve. Both MenACWY conjugate vaccine-naïve and MenACWY conjugate vaccine-exposed participants were part of the study.

Study 2 (NCT03135834) was an active-controlled, observer-blinded, multicenter study in which participants 10 through 25 years of age in the U.S. and Europe received at least 1 dose of PENBRAYA (N=543) or Trumenba (N=1057) at 0 and 6 months. MenACWY-CRM was co-administered with Trumenba at Month 0. All participants were MenB vaccine-naïve. Both MenACWY conjugate vaccine-naïve and MenACWY conjugate vaccine-exposed participants were part of this study.

Study 3 (NCT04440176) was a descriptive non-controlled study in which participants 11 through 14 years of age in the U.S. received PENBRAYA 12 months apart. All participants were naïve to any meningococcal vaccine.

In Study 1 and Study 2, solicited local and systemic adverse reactions were monitored for 7 days after study vaccination using an electronic diary. In all studies, spontaneous reports of adverse events (AEs) were collected through at least 1 month after the last vaccination, and through 6 months after the last vaccination for serious adverse events (SAEs).

In controlled studies, demographic characteristics were generally similar with regard to gender, race, and ethnicity among participants who received PENBRAYA and those who received control (Trumenba and MenACWY-CRM). Among participants who received PENBRAYA in controlled studies, 47.4% were male, 79.4% were White, 10.2% were Black or African-American, 2.1% were Asian, and 2.6% were of other racial groups, and 21.6% were of Hispanic/Latino ethnicity.

Solicited Local and Systemic Adverse Reactions

Table 1 presents the solicited local adverse reactions and Table 2 presents the solicited systemic adverse reactions and use of antipyretic medication reported within 7 days following each dose of PENBRAYA in Study 1.

Table 1. Percentage of Participants Reporting Solicited Local Adverse Reactions Within 7 Days After PENBRAYA or Trumenba Vaccination in Study 1*
Abbreviations: N = number of participants; MenACWY-CRM = meningococcal (serogroups A, C, W and Y) oligosaccharide diphtheria CRM197 conjugate vaccine; Trumenba = meningococcal serogroup B factor H binding protein.
*
NCT04440163
Trumenba and MenACWY-CRM were administered at 0 month followed by Trumenba alone at 6 months. Local reactions were recorded only for PENBRAYA and Trumenba injection sites.
Mild (does not interfere with activity); Moderate (interferes with activity); Severe (prevents daily activity).
§
"Any" is defined as the cumulative frequency of participants who reported a reaction as "mild", "moderate", or "severe" within 7 days of vaccination.
Mild (2.0 to 5 cm); Moderate (>5 to 10 cm); Severe (>10 cm).

Injection Site Reactions

PENBRAYA

Trumenba + MenACWY-CRM

Dose 1

Dose 2

Dose 1

Dose 2

N=1724-1725

%

N=1456

%

N=630-631

%

N=529

%

Pain

  Any§

89.3

84.4

85.1

78.6

    Mild

32.3

29.1

31.1

33.1

    Moderate

49.4

48.8

47.7

40.3

    Severe

7.5

6.5

6.3

5.3

Redness

  Any§

25.9

23.2

19.5

14.7

    Mild

8.9

7.7

7.3

6.6

    Moderate

14.4

12.6

10.0

7.2

    Severe

2.6

3.0

2.2

0.9

Swelling

  Any§

25.0

24.2

21.4

14.7

    Mild

10.6

10.4

8.3

6.4

    Moderate

13.3

12.8

12.4

8.1

    Severe

1.2

1.0

0.8

0.2

Table 2. Percentage of Participants Reporting Solicited Systemic Adverse Reactions and Use of Antipyretic Medications Within 7 Days After Each Vaccination in Study 1
Abbreviations: N = number of participants; MenACWY-CRM = meningococcal (serogroups A, C, W and Y) oligosaccharide diphtheria CRM197 conjugate vaccine; Trumenba= meningococcal serogroup B factor H binding protein.
*
Trumenba and MenACWY-CRM were administered at 0 month followed by Trumenba alone at 6 months.
Mild (1 to 2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (requires intravenous hydration).
"Any" is defined as the cumulative frequency of participants who reported a reaction as "mild", "moderate", or "severe" within 7 days of vaccination.
§
Mild (2 to 3 loose stools in 24 hours); Moderate (4 to 5 loose stools in 24 hours); Severe (6 or more loose stools in 24 hours).
Mild (does not interfere with activity); Moderate (interferes with activity); Severe (prevents daily activity).

Systemic Reactions

PENBRAYA

Trumenba + MenACWY-CRM*

Dose 1

Dose 2

Dose 1

Dose 2

N=1739-1740

%

N=1459

%

N=638

%

N=532

%

Fever (≥38°C)

  ≥38.0°C

5.9

2.4

5.8

1.5

    38.0° to 38.4°C

3.7

1.9

2.0

0.4

    >38.4° to 38.9°C

1.6

0.3

2.8

0.9

    >38.9° to 40.0°C

0.6

0.2

0.9

0.2

    >40.0°C

0.0

0.0

0.0

0.0

Vomiting

  Any

3.2

1.5

3.0

0.9

    Mild

2.5

1.4

2.0

0.8

    Moderate

0.6

0.1

0.9

0.2

    Severe

0.0

0.0

0.0

0.0

Diarrhea§

  Any

11.0

8.2

13.5

8.5

    Mild

8.7

6.9

11.9

6.0

    Moderate

2.0

1.4

1.6

2.4

    Severe

0.3

0.0

0.0

0.0

Headache

  Any

46.8

39.8

46.9

37.8

    Mild

25.7

21.3

24.5

21.1

    Moderate

19.2

16.8

20.4

16.2

    Severe

1.9

1.7

2.0

0.6

Fatigue

  Any

52.1

47.6

54.7

43.6

    Mild

23.5

22.8

25.7

22.0

    Moderate

25.5

21.8

25.7

19.9

    Severe

3.2

2.9

3.3

1.7

Chills

  Any

20.1

16.4

19.6

16.2

    Mild

12.6

9.9

10.2

8.8

    Moderate

6.7

6.0

7.8

5.8

    Severe

0.8

0.4

1.6

1.5

Muscle pain (other than muscle pain at the injection site)

  Any

25.7

22.8

27.4

22.2

    Mild

13.6

10.0

13.5

10.0

    Moderate

10.5

11.9

11.9

11.5

    Severe

1.6

0.8

2.0

0.8

Joint pain

  Any

20.2

18.3

22.6

15.6

    Mild

10.7

9.6

12.9

7.9

    Moderate

8.6

8.3

8.6

6.8

    Severe

1.0

0.4

1.1

0.9

Use of antipyretic medication

29.5

25.1

28.1

20.5

Serious Adverse Events

In Study 1, during the 30 days after vaccination visit 1 (at 0 months), <0.1% (1/1763) of PENBRAYA and 0% (0/649) of Trumenba + MenACWY-CRM participants reported at least 1 SAE. During the 30 days after vaccination visit 2 (at 6 months), 0.1% (2/1558) of PENBRAYA and 0% (0/562) of Trumenba participants reported at least 1 SAE. None of the SAEs were determined to be related to PENBRAYA vaccination.

In Study 2, during the 30 days after vaccination visit 1 (at 0 months), 0.4% (2/543) of PENBRAYA and 0% (0/1057) of Trumenba + MenACWY-CRM participants reported at least 1 SAE. During the 30 days after vaccination visit 2 (at 6 months), 0.2% (1/486) of PENBRAYA and 0% (0/946) of Trumenba participants reported at least 1 SAE. None of the SAEs were determined to be related to PENBRAYA vaccination.

In non-controlled Study 3, no SAEs (0/294) were reported within 30 days after either vaccination (0, 12 months).

6.2 Postmarketing Experience

The postmarketing safety experience with Trumenba and a non-U.S.-licensed Meningococcal Groups A, C, W, and Y polysaccharide tetanus toxoid (TT) conjugate vaccine (MenACWY-TT vaccine; Pfizer Inc.) is relevant to PENBRAYA since PENBRAYA includes the same group A, C, W, and Y TT-conjugated polysaccharide components and MenB recombinant protein components. Because these events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to vaccination. The following adverse reactions have been spontaneously reported during postmarketing use of Trumenba and MenACWY-TT and may also be seen in postmarketing experience with PENBRAYA.

Immune System Disorders: allergic reactions, including anaphylaxis

Nervous System: syncope (fainting)

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Adverse Reactions

6 ADVERSE REACTIONS

The most commonly reported (≥15%) solicited adverse reactions after Dose 1 and Dose 2, respectively, were pain at the injection site (89% and 84%), fatigue (52% and 48%), headache (47% and 40%), muscle pain (26% and 23%), injection site redness (26% and 23%), injection site swelling (25% and 24%), joint pain (20% and 18%), and chills (20% and 16%).

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.

The safety of PENBRAYA in individuals 10 through 25 years of age was evaluated in 3 clinical studies (2 active-controlled and 1 non-controlled study). In the controlled studies, 2306 participants received at least 1 dose of PENBRAYA. Of 946 participants who had previously received a meningococcal conjugate vaccine (categorized as MenACWY conjugate vaccine-exposed), 802 participants had received 1 dose of any U.S.-licensed Meningococcal Groups A, C, W, and Y conjugate vaccine, 51 participants had received a non-U.S.-licensed monovalent Meningococcal Group C conjugate vaccine (MenC conjugate vaccine), and 93 participants had received an unspecified U.S.-licensed or non-U.S.-licensed MenACWY conjugate or a MenC conjugate vaccine at least 4 years prior to enrollment. In the non-controlled study, 300 participants received a single dose of PENBRAYA.

Study 1 (NCT04440163) was an active-controlled, observer-blinded, multicenter study in which participants 10 through 25 years of age in the U.S. and Europe received at least 1 dose of PENBRAYA (N=1763) or Meningococcal Group B Vaccine (Trumenba) (N=650) at 0 and 6 months. Meningococcal Groups A, C, Y, and W-135 Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MenACWY-CRM, GSK Vaccines, SRL) was concomitantly administered with Trumenba at Month 0. All participants were MenB vaccine-naïve. Both MenACWY conjugate vaccine-naïve and MenACWY conjugate vaccine-exposed participants were part of the study.

Study 2 (NCT03135834) was an active-controlled, observer-blinded, multicenter study in which participants 10 through 25 years of age in the U.S. and Europe received at least 1 dose of PENBRAYA (N=543) or Trumenba (N=1057) at 0 and 6 months. MenACWY-CRM was co-administered with Trumenba at Month 0. All participants were MenB vaccine-naïve. Both MenACWY conjugate vaccine-naïve and MenACWY conjugate vaccine-exposed participants were part of this study.

Study 3 (NCT04440176) was a descriptive non-controlled study in which participants 11 through 14 years of age in the U.S. received PENBRAYA 12 months apart. All participants were naïve to any meningococcal vaccine.

In Study 1 and Study 2, solicited local and systemic adverse reactions were monitored for 7 days after study vaccination using an electronic diary. In all studies, spontaneous reports of adverse events (AEs) were collected through at least 1 month after the last vaccination, and through 6 months after the last vaccination for serious adverse events (SAEs).

In controlled studies, demographic characteristics were generally similar with regard to gender, race, and ethnicity among participants who received PENBRAYA and those who received control (Trumenba and MenACWY-CRM). Among participants who received PENBRAYA in controlled studies, 47.4% were male, 79.4% were White, 10.2% were Black or African-American, 2.1% were Asian, and 2.6% were of other racial groups, and 21.6% were of Hispanic/Latino ethnicity.

Solicited Local and Systemic Adverse Reactions

Table 1 presents the solicited local adverse reactions and Table 2 presents the solicited systemic adverse reactions and use of antipyretic medication reported within 7 days following each dose of PENBRAYA in Study 1.

Table 1. Percentage of Participants Reporting Solicited Local Adverse Reactions Within 7 Days After PENBRAYA or Trumenba Vaccination in Study 1*
Abbreviations: N = number of participants; MenACWY-CRM = meningococcal (serogroups A, C, W and Y) oligosaccharide diphtheria CRM197 conjugate vaccine; Trumenba = meningococcal serogroup B factor H binding protein.
*
NCT04440163
Trumenba and MenACWY-CRM were administered at 0 month followed by Trumenba alone at 6 months. Local reactions were recorded only for PENBRAYA and Trumenba injection sites.
Mild (does not interfere with activity); Moderate (interferes with activity); Severe (prevents daily activity).
§
"Any" is defined as the cumulative frequency of participants who reported a reaction as "mild", "moderate", or "severe" within 7 days of vaccination.
Mild (2.0 to 5 cm); Moderate (>5 to 10 cm); Severe (>10 cm).

Injection Site Reactions

PENBRAYA

Trumenba + MenACWY-CRM

Dose 1

Dose 2

Dose 1

Dose 2

N=1724-1725

%

N=1456

%

N=630-631

%

N=529

%

Pain

  Any§

89.3

84.4

85.1

78.6

    Mild

32.3

29.1

31.1

33.1

    Moderate

49.4

48.8

47.7

40.3

    Severe

7.5

6.5

6.3

5.3

Redness

  Any§

25.9

23.2

19.5

14.7

    Mild

8.9

7.7

7.3

6.6

    Moderate

14.4

12.6

10.0

7.2

    Severe

2.6

3.0

2.2

0.9

Swelling

  Any§

25.0

24.2

21.4

14.7

    Mild

10.6

10.4

8.3

6.4

    Moderate

13.3

12.8

12.4

8.1

    Severe

1.2

1.0

0.8

0.2

Table 2. Percentage of Participants Reporting Solicited Systemic Adverse Reactions and Use of Antipyretic Medications Within 7 Days After Each Vaccination in Study 1
Abbreviations: N = number of participants; MenACWY-CRM = meningococcal (serogroups A, C, W and Y) oligosaccharide diphtheria CRM197 conjugate vaccine; Trumenba= meningococcal serogroup B factor H binding protein.
*
Trumenba and MenACWY-CRM were administered at 0 month followed by Trumenba alone at 6 months.
Mild (1 to 2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (requires intravenous hydration).
"Any" is defined as the cumulative frequency of participants who reported a reaction as "mild", "moderate", or "severe" within 7 days of vaccination.
§
Mild (2 to 3 loose stools in 24 hours); Moderate (4 to 5 loose stools in 24 hours); Severe (6 or more loose stools in 24 hours).
Mild (does not interfere with activity); Moderate (interferes with activity); Severe (prevents daily activity).

Systemic Reactions

PENBRAYA

Trumenba + MenACWY-CRM*

Dose 1

Dose 2

Dose 1

Dose 2

N=1739-1740

%

N=1459

%

N=638

%

N=532

%

Fever (≥38°C)

  ≥38.0°C

5.9

2.4

5.8

1.5

    38.0° to 38.4°C

3.7

1.9

2.0

0.4

    >38.4° to 38.9°C

1.6

0.3

2.8

0.9

    >38.9° to 40.0°C

0.6

0.2

0.9

0.2

    >40.0°C

0.0

0.0

0.0

0.0

Vomiting

  Any

3.2

1.5

3.0

0.9

    Mild

2.5

1.4

2.0

0.8

    Moderate

0.6

0.1

0.9

0.2

    Severe

0.0

0.0

0.0

0.0

Diarrhea§

  Any

11.0

8.2

13.5

8.5

    Mild

8.7

6.9

11.9

6.0

    Moderate

2.0

1.4

1.6

2.4

    Severe

0.3

0.0

0.0

0.0

Headache

  Any

46.8

39.8

46.9

37.8

    Mild

25.7

21.3

24.5

21.1

    Moderate

19.2

16.8

20.4

16.2

    Severe

1.9

1.7

2.0

0.6

Fatigue

  Any

52.1

47.6

54.7

43.6

    Mild

23.5

22.8

25.7

22.0

    Moderate

25.5

21.8

25.7

19.9

    Severe

3.2

2.9

3.3

1.7

Chills

  Any

20.1

16.4

19.6

16.2

    Mild

12.6

9.9

10.2

8.8

    Moderate

6.7

6.0

7.8

5.8

    Severe

0.8

0.4

1.6

1.5

Muscle pain (other than muscle pain at the injection site)

  Any

25.7

22.8

27.4

22.2

    Mild

13.6

10.0

13.5

10.0

    Moderate

10.5

11.9

11.9

11.5

    Severe

1.6

0.8

2.0

0.8

Joint pain

  Any

20.2

18.3

22.6

15.6

    Mild

10.7

9.6

12.9

7.9

    Moderate

8.6

8.3

8.6

6.8

    Severe

1.0

0.4

1.1

0.9

Use of antipyretic medication

29.5

25.1

28.1

20.5

Serious Adverse Events

In Study 1, during the 30 days after vaccination visit 1 (at 0 months), <0.1% (1/1763) of PENBRAYA and 0% (0/649) of Trumenba + MenACWY-CRM participants reported at least 1 SAE. During the 30 days after vaccination visit 2 (at 6 months), 0.1% (2/1558) of PENBRAYA and 0% (0/562) of Trumenba participants reported at least 1 SAE. None of the SAEs were determined to be related to PENBRAYA vaccination.

In Study 2, during the 30 days after vaccination visit 1 (at 0 months), 0.4% (2/543) of PENBRAYA and 0% (0/1057) of Trumenba + MenACWY-CRM participants reported at least 1 SAE. During the 30 days after vaccination visit 2 (at 6 months), 0.2% (1/486) of PENBRAYA and 0% (0/946) of Trumenba participants reported at least 1 SAE. None of the SAEs were determined to be related to PENBRAYA vaccination.

In non-controlled Study 3, no SAEs (0/294) were reported within 30 days after either vaccination (0, 12 months).

6.2 Postmarketing Experience

The postmarketing safety experience with Trumenba and a non-U.S.-licensed Meningococcal Groups A, C, W, and Y polysaccharide tetanus toxoid (TT) conjugate vaccine (MenACWY-TT vaccine; Pfizer Inc.) is relevant to PENBRAYA since PENBRAYA includes the same group A, C, W, and Y TT-conjugated polysaccharide components and MenB recombinant protein components. Because these events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to vaccination. The following adverse reactions have been spontaneously reported during postmarketing use of Trumenba and MenACWY-TT and may also be seen in postmarketing experience with PENBRAYA.

Immune System Disorders: allergic reactions, including anaphylaxis

Nervous System: syncope (fainting)

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