Infanrix Hexa Adverse Reactions

Summary of the safety profile: 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.
Tabulated summary of adverse reactions: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
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).
The following drug-related adverse reactions were reported in clinical studies (data from more than 16,000 subjects) and during post-marketing surveillance. (See Table 6.)

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Experience in co-administration: Analysis of postmarketing reporting rates suggests a potential increased risk of convulsions (with or without fever) and HHE when comparing groups which reported use of Infanrix hexa with Prevenar 13 to those which reported use of Infanrix hexa alone.
In clinical studies in which some of the vaccinees received Infanrix hexa concomitantly with Prevenar (PCV7) as a booster (4^th) dose of both vaccines, fever ≥38.0°C was reported in 43.4% of infants receiving Prevenar and Infanrix hexa at the same time as compared to 30.5% of infants receiving the hexavalent vaccine alone. Fever ≥39.5°C was observed in 2.6% and 1.5% of infants receiving Infanrix hexa with or without Prevenar, respectively (see Precautions and Interactions). The incidence and severity of fever following co-administration of the two vaccines in the primary series was lower than that observed after the booster dose.
Data from clinical studies show similar incidences of fever when Infanrix hexa is co-administered with other pneumococcal saccharide conjugated vaccine.
In a clinical study in which some of the vaccinees received a booster dose of Infanrix hexa concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine, fever ≥38.0°C was reported in 76.6% of children receiving MMRV vaccine and Infanrix hexa at the same time, as compared to 48% of children receiving Infanrix hexa alone and 74.7% of children receiving MMRV vaccine alone. Fever of greater than 39.5°C was reported in 18% of children receiving Infanrix hexa wth MMRV vaccine, as compared to 3.3% of children receiving Infanrix hexa alone and 19.3% of children receiving MMRV alone (see Precautions and Interactions).
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 clinical studies, similar rates of symptoms were observed in preterm and full-term infants (refer to Precautions for information on apnoea).
Safety in infants and toddlers born to mothers vaccinated with dTpa during pregnancy: In two clinical studies, Infanrix hexa has been administered to more than 500 subjects born to mothers vaccinated with dTpa (n=341) or placebo (n=346) during the third trimester of pregnancy (see Pharmacology: Pharmacodynamics under Actions). The safety profile of Infanrix hexa was similar regardless of exposure/non-exposure to dTpa during pregnancy.
Experience with hepatitis B vaccine: In extremely rare cases, allergic reactions mimicking serum sickness, paralysis, neuropathy, neuritis, hypotension, vasculitis, lichen planus, erythema multiforme, arthritis, muscular weakness, Guillain-Barré syndrome, encephalopathy, encephalitis and meningitis have been reported. The causal relationship to the vaccine has not been established.