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Bexsero is generally well-tolerated 1

The safety of Bexsero was evaluated in 17 studies including 10 randomised controlled clinical trials with 10565 subjects (from 2 months of age) who received at least one dose of Bexsero.

Among Bexsero recipients,
6837 were infants and children (less than 2 years of age),
1051 were children (2 to 10 years of age) and
2677 were adolescents and adults.

Of the subjects who received primary infant series of Bexsero,
3285 received a booster dose in the second year of life.

In infants and children (less than 2 years of age) the most common local and systemic adverse reactions observed in clinical trials were tenderness and erythema at the injection site, fever and irritability.

BEXSERO given alone 1

  • The frequency of fever was similar to that associated with routine infant vaccines administered during clinical trials. 
  • When fever occurred, it generally followed a predictable pattern, with the majority resolving by the day after vaccination.

BEXSERO given with other vaccines 1

  • In clinical studies in infants vaccinated at 2, 4 and 6 months of age, fever (≥ 38°C) was reported by 69% to 79% of subjects when Bexsero was co-administered with routine vaccines (containing the following antigens:
    pneumococcal 7-valent conjugate,
    diphtheria,
    tetanus,
    acellular pertussis,
    hepatitis B,
    inactivated poliomyelitis and
    Haemophilus influenzae type b)
    compared with 44% to 59% of subjects receiving the routine vaccines alone. 
  • Higher rates of antipyretic use were also reported for infants vaccinated with Bexsero and routine vaccines 
  • Separate vaccinations can be considered when possible.

Adverse events with BEXSERO 1

In infants and children (less than 2 years of age) the most common local and systemic adverse reactions observed in clinical trials were tenderness and erythema at the injection site, fever and irritability.

In adolescents and adults the most common local and systemic adverse reactions observed were pain at the injection site, malaise and headache. 

No increase in the incidence or severity of the adverse reactions was seen with subsequent doses of the vaccination series.

Adverse reactions (following primary immunisation or booster dose) considered as being at least possibly related to vaccination have been categorised by frequency.

Frequencies are defined as follows:

  • Very common: (≥1/10)
  • Common: (≥1/100 to <1/10)
  • Uncommon: (≥1/1,000 to <1/100)
  • Rare: (≥1/10,000 to <1/1,000)
  • Very rare: (<1/10,000)
  • Not known: (cannot be estimated from the available data)

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Very common, common & Not known side effects* 1:

Subjects

Frequency

Reactions

 Infants and children (up to 10 years   of age)

Very common

 

Eating disorders

Sleepiness,

Unusual crying,

Headache

Diarrhoea, Vomiting (uncommon after booster)

Rash (children aged 12 to 23 months) (uncommon after booster)

Arthralgia

Fever (≥38°C)

Injection site tenderness (including severe injection site tenderness defined as crying when injected limb is moved)

Injection site erythema

Injection site swelling

Injection site induration

Irritability

Common

Rash (infants and children aged 2 to 10 years of age)

 

Not known

Injection site reactions (including extensive swelling of the vaccinated limb, blisters at or around the injection site and injection site nodule which may persist for more than one month), allergic reactions.

Hypotonic-hyporesponsive episode, meningeal irritation (signs of meningeal irritation, such as neck stiffness or photophobia, have been sporadically reported shortly after vaccination. These symptoms have been of mild and transient nature)

Adolescents from 11 years of age and adults

Very common

Headache

Nausea

Myalgia

Arthralgia

Injection site pain (including severe injection site pain defined as unable to perform normal daily activity)

Injection site swelling

Injection site induration

Injection site erythema

Malaise

Common

None reported

 

Not Known

Fever, injection site reactions (including extensive swelling of the vaccinated limb, blisters at or around the injection site, injection nodule which may persist for more than one month), allergic reactions,syncope or vasovagal responses to injection, meningeal irritation (signs of meningeal irritation, such as neck stiffness or photophobia, have been sporadically reported shortly after vaccination. These symptoms have been of mild and transient nature)

*For the full list, please consult the BEXSERO summary of product characteristics

In addition to reports in clinical trials, worldwide voluntary reports of adverse reactions received for Bexsero since market introduction are included in the list. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency and they are consequently listed with the frequency unknown.

This information does not contain all safety information. For a complete description of adverse events, special warnings and precautions, please consult the full SmPC before prescribing this medicine, which you can access by clicking on product SmPC, request from GSK or you can access from the Website of the Pharmaceutical Services of the Ministry of Health
http://www.phs.moh.gov.cy/web/guest/drug-search

References:

  1. BEXSERO summary of product characteristics 

Prescription Only Medicine.
Before prescribing please consult the full SPC which you can request from GSK or access on the website of the Pharmaceutical Services of the Ministry of Health http://www.phs.moh.gov.cy/web/guest/drug-search

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