Subjects in US/Poland trial (10-25 years of age) with adverse reactions within 7 days after vaccination.1,*
| 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 Adverse Reactions
Severe=unable to perform normal daily activities
| Pain | 90% (20%) | 27% (2%) | 83% (29%) | 43% (8%) |
| Erythema: Any (≥1 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% |
| 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% |
*
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 specifically severe pain (8%) in the United Kingdom trial.1
Additional Prelicensure Safety Experience1
In additional prelicensure safety experience, 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.
