Infanrix-IPV+Hib Adverse Reactions

Clinical Trial Data: The safety profile presented as follows is based on data from more than 3500 subjects.
As has been observed for DTPa and DTPa-containing combinations, an increase in local reactogenicity and fever was reported after booster vaccination with Infanrix-IPV+Hib with respect to the primary course.
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.
Infections and infestations: Uncommon: upper respiratory tract infection.
Blood and lymphatic system disorders: Uncommon: lymphadenopathy.
Metabolism and nutrition disorders: Very common: appetite lost.
Psychiatric disorders: Very common: irritability, crying abnormal, restlessness.
Nervous system disorders: Very common: somnolence.
Respiratory, thoracic and mediastinal disorders: Uncommon: cough, bronchitis, rhinorrhoea.
Gastrointestinal disorders: Common: diarrhoea, vomiting.
Skin and subcutaneous tissue disorders: Uncommon: rash, urticaria.
Rare: pruritus, dermatitis.
General disorders and administration site conditions: Very common: injection site reactions such as pain and redness, local swelling at the injection site (≤50 mm), fever (≥38.0°C).
Common: injection site reactions including induration, local swelling at the injection site (>50 mm)¹.
Uncommon: fever² >39.5°C, fatigue, diffuse swelling of the injected limb, sometimes involving the adjacent joint¹.
Post Marketing Data: Blood and lymphatic system disorders: Thrombocytopenia⁴.
Immune system disorders: Allergic reactions (including anaphylactic³ and anaphylactoid reactions).
Nervous system disorders: Convulsions (with or without fever), collapse or shock-like state (hypotonic-hyporesponsiveness episode).
Respiratory, thoracic and mediastinal disorders: Apnoea³ [see Precautions for apnoea in very premature infants (≤28 weeks of gestation)].
Skin and subcutaneous tissue disorders: Angioneurotic oedema³.
General disorders and administration site conditions: Swelling of the entire injected limb¹, injection site vesicles³.
¹Children primed with acellular pertussis vaccines are more likely to experience swelling reactions after booster administration in comparison with children primed with whole cell vaccines. These reactions resolve over an average of 4 days.
²Common with booster vaccination.
³Reported with GSK's DTPa containing vaccines.
⁴Reported with D and T vaccines.