Infanrix-IPV Adverse Reactions

Clinical trials data: The safety profile presented as follows is based on data from more than 2,200 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 with respect to the primary course.
Frequencies per dose 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.
Blood and lymphatic system disorders: Rare: lymphadenopathy¹.
Metabolism and nutrition disorders: Very common: appetite lost.
Psychiatric disorders: Very common: restlessness, crying abnormal, irritability.
Nervous system disorders: Very common: headache¹ (age range 6-13 years old), somnolence.
Respiratory, thoracic and mediastinal disorders: Rare: bronchitis², cough².
Gastrointestinal disorders: Common: nausea¹, vomiting, diarrhoea.
Skin and subcutaneous tissue disorders: Uncommon: dermatitis allergic.
Rare: urticaria, rash^2,3.
General disorders and administration site conditions: Very common: injection site reactions such as pain, redness, local swelling at the injection site (≤ 50 mm), fever ≥ 38.0°C.
Common: local swelling at the injection site (> 50 mm)⁴, asthenia, malaise¹, injection site reactions including induration.
Uncommon: diffuse swelling of the injected limb, sometimes involving the adjacent joint⁴, fever⁵ (> 39.5°C).
Post-marketing data: Blood and lymphatic system disorders: Thrombocytopenia⁶.
Immune system disorders: Allergic reactions, including anaphylactic² and anaphylactoid reactions.
Nervous system disorders: Collapse or shock-like state (hypotonic-hyporesponsiveness episode), convulsions (with or without fever) within 2 to 3 days of vaccination.
Respiratory disorders, thoracic and mediastinal disorders: Apnoea² (see Use in Children under Precautions).
Skin and subcutaneous tissue disorders: Pruritus, angioneurotic oedema².
General disorders and administration site conditions: Swelling of the entire injected limb⁴, injection site vesicles.
¹ reported only with booster vaccination.
² reported with GSK's DTPa containing vaccines.
³ uncommonly reported with booster vaccination.
⁴ Children primed with acellular pertussis vaccines are more likely to experience swelling reactions after booster administration in comparison with children primed with whole cell vaccines. Local swelling at the injection site (>50 mm) and diffuse swelling may be more frequent (very common and common, respectively) when the booster dose is administered between 4 and 6 years. These reactions resolve over an average of 4 days.
⁵ commonly reported with booster vaccination.
⁶ reported with D and T vaccines.