Evaluation of Immunogenicity and Safety of DTPa-IPV/Hib Conjugate Vaccine (Infanrix™-IPV/Hib) Administered at 6, 10 and 14 Weeks in Healthy Indian Infants

Summary

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.

Timeline

Start

2017-12-01

Primary completion

2018-08-01

Completion

2018-08-01

Outcome

Outcome not reported

Stopped: “The study is cancelled due to reassessment of the medical need for the vaccine in India. Cancellation is not related to vaccine's safety and/or efficacy.”

Drugs

Indications