Adverse reactions : תופעות לוואי

4.8     Undesirable effects

Summary of the safety profile
The safety profile presented in Table 1 is based on data from clinical trials where Boostrix Polio was administered to 908 children (from 4 to 8 years of age) and 955 adults, adolescents and children (from 10 to 93 years of age).

The most common events occurring after Boostrix Polio administration in both groups were local injection site reactions (pain, redness and swelling) reported by 31.3 – 82.3% of subjects overall.
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)

•     Clinical trials

Table 1: Adverse reactions reported in clinical trials with Boostrix-Polio Adverse reactions
System Organ Class        Frequency
Subjects aged 4 - 8 years       Subjects aged 10 - 93
(N=908)                   years (N = 955)


Infections and             Uncommon                                 oral herpes infestations
Blood and lymphatic        Uncommon       lymphadenopathy           lymphadenopathy system disorders
Metabolism and             Common         anorexia nutrition disorders
Uncommon                                 decreased appetite

Psychiatric disorders      Common         irritability

Uncommon       sleep disorder, apathy
Nervous system disorders   Very common somnolence                   headache 
Common         headache

Uncommon                                 paraesthesia, somnolence,
dizziness
Respiratory, thoracic      Uncommon       dry throat                asthma and mediastinal disorders
Gastrointestinal           Common                                   gastrointestinal disorders disorders                                                           (such as vomiting, abdominal pain, nausea)

Uncommon       diarrhoea, vomiting,
abdominal pain, nausea
Skin and subcutaneous      Uncommon                                 pruritus tissue disorders
Musculoskeletal and        Uncommon                                 arthralgia, myalgia connective tissue disorders
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), fatigue, pain                         injection site pain
Common      pyrexia (fever ≥ 37.5°C,     pyrexia (fever  37.5°C), including fever > 39°C),     injection site reactions extensive swelling of        (such as haematoma,
vaccinated limb              pruritus, induration and
(sometimes involving the     warmth numbness) adjacent joint), injection site reactions (such as haemorrhage, pruritus and induration)
Uncommon    fatigue                      extensive swelling of vaccinated limb
(sometimes involving the adjacent joint), pyrexia
(fever > 39.0°C), chills,
pain

Coadministration with MMR/V vaccines in children aged 3-6 years

Boostrix-Polio was coadministered with MMR/V vaccines in 2 clinical studies with 406 children aged 3-6 years. In these studies, upper respiratory tract infection and rash were commonly reported. Fever, irritability, fatigue, loss of appetite and gastrointestinal disorders (including diarrhoea and vomiting) were reported with a higher frequency (very common) when compared to Table 1 while all other adverse reactions occurred at the same or lower frequency.

Adverse reactions additionally reported during clinical studies with Boostrix (dTpa component of Boostrix-Polio), administered to 839 children (from 4 to 8 years of age) and 1931 adults, adolescents and children (from 10 to 76 years of age), are listed in Table 2.

Table 2: Adverse reactions reported in clinical trials with Boostrix
Adverse reactions
System Organ Class       Frequency
Subjects aged 4 - 8 years       Subjects aged 10 - 76
(N=839)                   years (N = 1931)
Infections and             Uncommon                                      upper respiratory tract infestations                                                             infection, pharyngitis Nervous system disorders   Uncommon        disturbances in attention     syncope 
Eye disorders              Uncommon        conjunctivitis

Respiratory, thoracic      Uncommon                                      cough and mediastinal disorders
Gastrointestinal           Uncommon                                      diarrhoea disorders
Skin and subcutaneous      Uncommon                                      hyperhidrosis, rash tissue disorders
Musculoskeletal and        Uncommon                                      joint stiffness, connective tissue                                                        musculoskeletal stiffness disorders
General disorders and      Very                                          malaise administration site        common conditions                 Common                                        injection site reactions (such as injection site mass and injection site abscess sterile)
Uncommon        pain                          influenza like illness


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

Subjects aged 15 years onwards without recent vaccination for diphtheria, tetanus, pertussis and poliomyelitis, who received a dose of Boostrix-Polio or another reduced-antigen content vaccine, followed by an additional dose of Boostrix-Polio 10 years after, showed no increased reactogenicity after this second dose compared to the first one.

•     Post-marketing surveillance
Because these events were reported spontaneously, it is not possible to reliably estimate their frequency.

Table 3: Adverse reactions reported with Boostrix-Polio 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).