Tetanus Clinical Trial
Official title:
Immunogenicity and Safety of GSK Biologicals' DTPa-IPV/Hib Conjugate Vaccine (Infanrix™-IPV/Hib) (SB213503) in Healthy Indian Infants
The purpose of this study is to assess the immunogenicity and safety of DTPa-IPV/Hib when administered at 6, 10 and 14 weeks to healthy Indian infants, as per guidance from the Indian regulatory authority. The 6, 10 and 14 week schedule reflects the current Indian standard of care.
- Experimental design: Phase III, open-label, non-randomised, multi-centric,
single-country study with a single group.
- Duration of the study: The intended duration of the study will be approximately 3 months
per subject.
- Treatment group and vaccination schedule: All subjects will receive three doses of the
vaccine at 6, 10 and 14 weeks of age.
- DTPa-IPV/Hib Group: Subjects who will receive DTPa-IPV/Hib vaccine
(Infanrix-IPV/Hib).
Other routine registered childhood vaccinations as part of National Immunisation Programme
are permitted. Information regarding vaccine administered since birth until study completion
will be collected and documented.
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