Title: "Immune lot-to-lot consistency and non-inferiority of SHAN6™ vaccine in comparison to SHAN 5® + SHANIPV™ when administered as three doses at 6-8, 10-12 and 14-16 weeks of age in healthy Indian infants concomitantly with oral rotavirus vaccine".

Objective: This is ongoing at KEM Hospital Research centre, Vadu Rural Health Program. Objectives of the study are "to demonstrate the equivalence of three lots of SHAN6, non-inferiority of SHAN6 with SHAN5+SHANIPV, immunogenicity and safety with control vaccine and immune response of co-administered oral rotavirus vaccine". This study, will be conducted in the India and will generate data to primarily support the licensing of the SHAN6™ in India and also pre-qualification by WHO. This will allow deployment of vaccine in global alliance for vaccines and immunization (GAVI)-countries [i.e., United Nations Children's Fund (UNICEF) procured countries] not needing a license. Sponsor of the study is "Shantha Biotechnics Private Limited, Hyderabad.


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