Regulatory Decision Summary for Infanrix hexa
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
Infanrix hexa is a combination hepatitis B-containing vaccine that is indicated for active primary immunization against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and disease caused by Haemophilis influenzae type b in infants and children 6 weeks to 2 years.
This submission proposed to update the Clinical Trials section of the Product Monograph (PM) with results from two new post-marketing studies about the persistence of the immune response to hepatitis B (HB). After evaluation of the submitted data package, Health Canada authorized changes to the information in the PM about persistence of immune response that support moving the upper boundary of the age range from 12 years to 15 years of age.
Why was the decision issued?
- Authorization was based on two post-marketing, open-label, non-randomised, multi-centre studies conducted in Germany (DTPa-HBV-IPV-114 and DTPa-HBV-IPV-115). In each study, 300 healthy subjects were enrolled (aged 12-13 years and 14-15 years). Every subject enrolled was to have been previously vaccinated in routine clinical practice with four doses of Infanrix hexa in the first two years of life.
- The persistence of the immune response to HB is evaluated by measuring antibodies against HB (anti-HBs) before and after giving a HB vaccine challenge dose to each subject. HB vaccine challenge represents clinical infection with HB (without causing disease) and the immune response measured one month after the challenge signifies protection from HB. The level of anti-HBs which is widely considered protective against HB infection is equal to or greater than 10 IU/L. In these two studies, a higher standard was used to show persistence of the immune response - anti-HBs equal to or greater than 100 IU/L, after vaccine challenge.
- In study DTPa-HBV-IPV - 114, 94% of subjects reached this antibody level whereas in study DTPa-HBV-IPV - 115, only 87% did so. However, between 93% and 97% of subjects in these studies developed protective anti-HBs levels equal to or greater than 10 IU/L, regardless of their antibody levels before the vaccine challenge.
- In post-marketing reports for INFANRIX hexa that were included in this submission, no new concerns were identified. The safety profile of the HB challenge vaccine used in these studies (Engerix B Pediatric) has not changed.
- These studies about persistence of immune response to HB support moving the upper boundary of the age range from 12 years to 15 years of age and support a favourable benefit-risk balance.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.