Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Summary of the safety profile
The safety profile presented below is based on data from clinical trials where Boostrix was administered to 839 children (from 4 to 8 years of age) and 1931 adults, adolescents and children (from 10 to 76 years of age) (Table 1).

The most common events occurring after Boostrix administration in both groups were local injection site reactions (pain, redness and swelling) reported by 23.7 – 80.6% of subjects in each trial. These usually had their onset within the first 48 hours after vaccination. All resolved without sequelae.

Tabulated list of adverse reactions

Adverse reactions reported are listed according to the following frequency: 
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)

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

•        Clinical trials

Table 1: Adverse reactions reported in clinical trials with Boostrix

Adverse reactions
System Organ Class          Frequency                                        Subjects aged 10 - 76 Subjects aged 4 - 8 years years
(N=839)
(N = 1931)
Infections and              Uncommon          upper respiratory tract        upper respiratory tract infestations                                  infection                      infection, pharyngitis Blood and lymphatic         Uncommon                                         lymphadenopathy system disorders
Metabolism and              Common            anorexia nutrition disorders
Psychiatric disorders       Very common       irritability

Nervous system disorders Very common          somnolence                     headache 
Common            headache                       dizziness

Uncommon          disturbances in attention      syncope
Eye disorders               Uncommon          conjunctivitis

Respiratory, thoracic       Uncommon                                         cough and mediastinal disorders
Gastrointestinal            Common            diarrhoea, vomiting,           nausea, gastrointestinal disorders                                     gastrointestinal disorders     disorders 
Uncommon                                      diarrhoea, vomiting

Skin and subcutaneous      Uncommon         rash                         hyperhidrosis, pruritus, tissue disorders                                                         rash Musculoskeletal and        Uncommon                                      arthralgia, myalgia, joint connective tissue                                                        stiffness, musculoskeletal disorders                                                                stiffness General disorders and      Very common      injection site reactions     injection site reactions administration site                         (such as redness and/or      (such as redness and/or conditions                                  swelling), injection site    swelling), malaise, fatigue, pain, fatigue                injection site pain
Common           pyrexia (fever ≥ 37.5°C      pyrexia (fever ≥ 37.5°C), including fever >            injection site reactions
39.0°C), extensive           (such as injection site mass swelling of vaccinated       and injection site abscess limb (sometimes              sterile) involving the adjacent joint)
Uncommon         other injection site         pyrexia (fever > 39.0°C), reactions (such as           influenza like illness, pain induration), pain

Reactogenicity after repeat dose

Data on 146 subjects suggest that there might be a small increase in local reactogenicity (pain, redness, swelling) with repeated vaccination according to a 0, 1, 6 months schedule in adults (> 40 years of age).

Data suggest that in subjects primed with DTP in childhood a second booster dose might give an increase of local reactogenicity.

•       Post-marketing surveillance


Because these events were reported spontaneously, it is not possible to reliably estimate their frequency.

Table 2: Adverse reactions reported with Boostrix during post-marketing surveillance 

System Organ Class           Frequency                      Adverse reactions 
Immune system disorders          unknown       allergic reactions, including anaphylactic and anaphylactoid reactions
Nervous system disorders         unknown       hypotonic-hyporesponsiveness episodes, convulsions (with or without fever)
Skin and subcutaneous tissue     unknown       urticaria, angioedema disorders

General disorders and              unknown        asthenia administration site conditions

Following administration of tetanus toxoid containing vaccines, there have been very rare reports of adverse reactions on the central or peripheral nervous systems, including ascending paralysis or even respiratory paralysis (e.g. Guillain-Barré syndrome).

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/
Additionally, you should also report to GSK Israel, (il.safety@gsk.com).