Clinical Trials Data:
The safety profile presented as follows is based on data from >2200 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: ≥10%; common: ≥1% and <10%; uncommon: ≥0.1% and <1%; rare: ≥0.01% and <0.1%; very rare: <0.01%.
Blood and Lymphatic System Disorders: Rare:
Metabolism and Nutrition Disorders: Very Common:
Loss of appetite.
Psychiatric Disorders: Very Common:
Restlessness, abnormal crying, irritability.
Nervous System Disorders: Very Common:
(age range 6-13 years), somnolence.
Respiratory, Thoracic and Mediastinal Disorders: Rare:
Gastrointestinal Disorders: Common:
, vomiting, diarrhoea.
Skin and Subcutaneous Tissue Disorders: Uncommon:
Allergic dermatitis. Rare:
General Disorders and Administration Site Conditions: Very Common:
Injection site reactions eg, pain, redness, local swelling at the injection site (≤50 mm), fever ≥38°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
Post-Marketing Data: Blood and Lymphatic System Disorders:
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 2-3 days of vaccination.
(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.
Reported only with booster vaccination.
Reported with GlaxoSmithKline's DTPa-containing vaccines.
Uncommonly reported with booster vaccination.
Children primed with Pa vaccines are more likely to experience swelling reactions after booster vaccination 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.
Commonly reported with booster vaccination.
Reported with diphtheria and tetanus vaccines.