The safety profile of BEXSERO has been investigated across 4 clinical trials in 3058 individuals.
Solicited adverse reaction rates in a randomized, controlled study in the US/Poland were similar among participants 11 through 24 years of age who received BEXSERO to the other 3 clinical trials except for severe myalgia, which was reported by 3%-7% of subjects. Severe pain was reported by 8% of university students in the UK.
The most common solicited adverse reactions observed in clinical trials were pain at the injection site (≥83%), myalgia (≥48%), erythema (≥45%), fatigue (≥35%), headache (≥33%), induration (≥28%), nausea (≥18%), and arthralgia (≥13%).
Percentage of US & Polish Subjects (10-25 years of age) With Solicited Adverse Reactions
|Dose 1||Dose 2a|
|LOCAL ADVERSE REACTIONS|
|Any (≥ 1 mm)||50||13||45||26|
|Any (≥ 1 mm)||32||10||28||23|
|SYSTEMIC ADVERSE REACTIONSb|
Administered 2 months after Dose 1.
For pain and systemic reactions: mild (transient with no limitation in normal daily activity); moderate (some limitation in normal daily activity); severe (unable to perform normal daily activity).
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 1 event considered related to vaccination, a case of anaphylaxis within 30 minutes following vaccination.
Selected Important Safety Information
Appropriate observation and medical treatment should always be readily available in case of an anaphylactic event following the administration of the vaccine.
Syncope (fainting) can occur in association with administration of BEXSERO. Ensure procedures are in place to avoid injury from falling associated with syncope.