Demonstrated safety profile in more than 3,000 patients across 4 clinical trials1

Subjects in the US/Poland trial (10-25 years of age) with adverse reactions within 7 days after vaccination.1,*

DOSE 1: Any (Severe)

BEXSERO
(N=110-114)
SALINE PLACEBO
(N=94-96)
Solicited Local Adverse Reactions Severe=unable to perform normal daily activities
Pain 90% (20%) 27% (2%)
Erythema: Any (≥1 mm) 50% 13%
>100 mm 0% 0%
Induration: Any (≥1 mm) 32% 10%
>100 mm 0% 0%
Solicited Systemic Adverse Reactions
Fatigue 37% (4%) 22% (0%)
Nausea 19% (4%) 4% (0%)
Myalgia 49% (12%) 26% (1%)
Arthralgia 13% (2%) 4% (0%)
Headache 33% (4%) 20% (1%)
Fever (≥38 °C) 1% 1%
DOSE 2: Any (Severe)

BEXSERO
(N=107-109)
MENVEO
(N=90-92)
Solicited Local Adverse Reactions Severe=unable to perform normal daily activities
Pain 83% (29%) 43% (8%)
Erythema: Any (≥1 mm) 45% 26%
>100 mm 0% 2%
Induration: Any (≥1 mm) 28% 23%
>100 mm 0% 2%
Solicited Systemic Adverse Reactions
Fatigue 35% (6%) 20% (2%)
Nausea 18% (4%) 4% (0%)
Myalgia 48% (13%) 25% (4%)
Arthralgia 16% (2%) 4% (0%)
Headache 34% (6%) 23% (3%)
Fever (≥38 °C) 5% 0%
DOSE 1: Any (Severe) DOSE 2: Any (Severe)

BEXSERO
(N=110-114)
SALINE PLACEBO
(N=94-96)
BEXSERO
(N=107-109)
MENVEO
(N=90-92)
Solicited Local Averse Reactions Severe=unable to perform normal daily activities
Pain 90% (20%) 27% (2%) 83% (29%) 43% (8%)
Erythema: Any (≥ mm) 50% 13% 45% 26%
>100 mm 0% 0% 0% 2%
Induration: Any (≥1 mm) 32% 10% 28% 23%
>100 mm 0% 0% 0% 2%
Solicited Systemic Adverse Reactions
Fatigue 37% (4%) 22% (0%) 35% (6%) 20% (2%)
Nausea 19% (4%) 4% (0%) 18% (4%) 4% (0%)
Myalgia 49% (12%) 26% (1%) 48% (13%) 25% (4%)
Arthralgia 13% (2%) 4% (0%) 16% (2%) 4% (0%)
Headache 33% (4%) 20% (1%) 34% (6%) 23% (3%)
Fever (≥38 °C) 1% 1% 5% 0%

*The US/Poland study was a randomized, controlled study. 120 participants 10-25 years of age received at least 1 dose of BEXSERO, including 112 participants who received 2 doses of BEXSERO 2 months apart. 97 participants received saline placebo followed by MENVEO [Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine].
Administered 2 months after Dose 1.

 

Solicited adverse reaction rates in 3 other clinical trials among participants 11 through 24 years of age who received BEXSERO were comparable to the US/Poland trial, with the exception of severe myalgia (3%-7%), and severe pain (8%), specifically in the UK trial.

 

 

Additional Prelicensure Safety Experience1
In response to outbreaks of serogroup B meningococcal disease at 2 universities in the US, BEXSERO was administered as a 2-dose series at least 1 month apart. Information on serious adverse events was collected for a period of 30 days after each dose from 15,351 individuals 16 through 65 years of age who received at least 1 dose. Overall, 50 individuals (0.3%) reported serious adverse events, including one event considered related to vaccination: a case of anaphylaxis within 30 minutes following vaccination.

Vaccination may not protect all recipients.

CDC=Centers for Disease Control and Prevention.

Reference:

1. Prescribing Information for BEXSERO.