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drugset / Trial / NCT02451358

Study of a Single Dose or Two Doses of a Quadrivalent Influenza Vaccine in Subjects Aged 6 Months or Older in India

NCT02451358 ↗

Phase 3 Completed 400 enrolled Sanofi Pasteur, a Sanofi Company
RandomizedParallel-groupOpen-labelPrevention

Summary

The aim of the study was to generate immunogenicity and safety data in the whole population to support registration of the Quadrivalent Influenza Vaccine (QIV) in India: Primary objective: * To describe in each age group the immune response induced by a single injection (participants aged \>9 years) or 2 injections (participants aged 6 months to 8 years) of QIV. Secondary objective: * To describe in each age group the safety profile of QIV.

Timeline

Start
2015-07-27
Primary completion
2017-01-28
Completion
2017-01-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Quadrivalent Inactivated Influenza Vaccine (2015 SH formulation), No Preservative Vaccine 0.5 ml Intramuscular
Subject Quadrivalent Inactivated Influenza Vaccine (2015-2016 NH formulation), No Preservative Vaccine 0.5 ml Intramuscular
Subject Quadrivalent Inactivated Influenza Vaccine (2016 SH formulation), No Preservative Vaccine 0.5 ml Intramuscular
Subject Quadrivalent Inactivated Influenza Vaccine (2016-2017 NH formulation), No Preservative Vaccine 0.25 ml Intramuscular

Indications

influenza