Infanrix Hexa Adverse Reactions

Clinical Trial Data: The safety profile presented as follows is based on data from more than 16,000 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 hexa 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: ≥ 1/1000 to < 1/100, Rare: ≥ 1/10000 to < 1/1000, Very rare: < 1/10000. (See Table 5.)

Click on icon to see table/diagram/image

Post-Marketing Data: The following drug-related adverse reactions were reported during post-marketing surveillance. (See Table 6.)

Click on icon to see table/diagram/image

Safety in preterm infants: Infanrix hexa has been administered to more than 1000 preterm infants (born after a gestation period of 24 to 36 weeks) in primary vaccination studies and in more than 200 preterm infants as a booster dose in the second year of life. In comparative studies, similar rates of symptoms were observed in preterm and full-term infants.
Safety in infants and toddlers born to mothers vaccinated with dTpa during pregnancy: In clinical studies, Infanrix hexa has been administered to more than 500 subjects born to mothers vaccinated with dTpa or placebo during pregnancy. The safety profile of Infanrix hexa was similar regardless of exposure/non-exposure to dTpa during pregnancy.
Experience with hepatitis B vaccine: Paralysis, neuropathy, encephalopathy, encephalitis, meningitis, allergic reactions mimicking serum sickness, neuritis, hypotension, vasculitis, lichen planus, erythema multiforme, arthritis and muscular weakness have been reported during post-marketing surveillance following GlaxoSmithKline Biologicals' hepatitis B vaccine in infants and toddlers < 2 years old. The causal relationship to the vaccine has not been established.