CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 400 enrolled
Drug / intervention
Quadrivalent Inactivated Influenza Vaccine (2016-2017 NH formulation), No Preservative +3 morebiological
Likely dose
Quadrivalent Inactivated Influenza Vaccine (2016-2017 NH formulation), No Preservative 0.25 mLfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02451358
NCT02451358Phase 3Completed
CompareCT.gov

Immunogenicity and Safety of a Single Dose or Two Doses Given 28 Days Apart of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Subjects Aged 6 Months or Older in India

Sanofi Pasteur, a Sanofi Company·interventional·Posted May 22, 2015·Updated Apr 19, 2022

In Brief

A Phase 3 clinical trial evaluating Quadrivalent Inactivated Influenza Vaccine (2016-2017 NH formulation), No Preservative, Quadrivalent Inactivated Influenza Vaccine (2016 SH formulation), No Preservative, and 2 other interventions for Influenza. Completed, enrolled 400 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesIndia
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 22, 2015
Enrollment StartJul 27, 2015
Primary CompletionJan 28, 2017
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.1 years ago

Interventions

Quadrivalent Inactivated Influenza Vaccine (2016-2017 NH formulation), No Preservativebiological

0.25 mL, Intramuscular

Quadrivalent Inactivated Influenza Vaccine (2016 SH formulation), No Preservativebiological

0.5 mL, Intramuscular

Quadrivalent Inactivated Influenza Vaccine (2015-2016 NH formulation), No Preservativebiological

0.5 mL, Intramuscular

Quadrivalent Inactivated Influenza Vaccine (2015 SH formulation), No Preservativebiological

0.5 mL, Intramuscular