BEXSERO®

BEXSERO is contraindicated in cases of hypersensitivity, including severe allergic reaction, to any component of the vaccine, or after a previous dose of BEXSERO

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Safety Demonstrated in More Than 3000 Patients"toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"[8]

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

Solicited
Reaction

Dose 1 Dose 2a
BEXSERO
N=110-114
Placebo (saline)
N=94-96
BEXSERO
N=107-109
MENVEO
N=90-92
LOCAL ADVERSE REACTIONS
PAINb
Any 90 27 83 43
Mild 27 20 18 26
Moderate 44 5 37 9
Severe 20 2 29 8
ERYTHEMA
Any (≥ 1 mm) 50 13 45 26
1-25 mm 41 11 36 13
>25-50 mm 6 1 5 6
>50-100 mm 3 0 5 4
>100 mm 0 0 0 2
INDURATION
Any (≥ 1 mm) 32 10 28 23
1-25 mm 24 9 22 16
>25-50 mm 7 0 4 0
>50-100 mm 1 1 2 4
>100 mm 0 0 0 2
SYSTEMIC ADVERSE REACTIONSb
FATIGUE
Any 37 22 35 20
Mild 19 17 18 11
Moderate 14 5 10 7
Severe 4 0 6 2
NAUSEA
Any 19 4 18 4
Mild 12 3 10 3
Moderate 4 1 5 1
Severe 4 0 4 0
MYALGIA
Any 49 26 48 25
Mild 21 20 16 14
Moderate 16 5 19 7
Severe 12 1 13 4
ARTHRALGIA
Any 13 4 16 4
Mild 9 3 8 2
Moderate 3 1 6 2
Severe 2 0 2 0
HEADACHE
Any 33 20 34 23
Mild 19 15 21 8
Moderate 9 4 6 12
Severe 4 1 6 3
FEVER
≥38°C 1 1 5 0
38.0-38.9°C 1 1 4 0
39.0-39.9°C 0 0 1 0
≥40°C 0 0 0 0
a

Administered 2 months after Dose 1.


b

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.

References

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709301R0 May 2016