NCT02451358

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

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.

Detailed description

All participants were vaccinated with the QIV (split-virion, inactivated) Northern Hemisphere (NH) or Southern Hemisphere (SH) formulations by the intramuscular (IM) route. Immunogenicity of the vaccine was assessed at baseline (Day 0) and 28 days after the last injection. Safety data were collected up to 28 days after each injection. Serious adverse events (SAEs) were collected throughout the trial.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent Inactivated Influenza Vaccine (2016-2017 NH formulation), No Preservative	0.25 mL, Intramuscular
BIOLOGICAL	Quadrivalent Inactivated Influenza Vaccine (2016 SH formulation), No Preservative	0.5 mL, Intramuscular
BIOLOGICAL	Quadrivalent Inactivated Influenza Vaccine (2015-2016 NH formulation), No Preservative	0.5 mL, Intramuscular
BIOLOGICAL	Quadrivalent Inactivated Influenza Vaccine (2015 SH formulation), No Preservative	0.5 mL, Intramuscular

Timeline

• Start date: 2015-07-27
• Primary completion: 2017-01-28
• Completion: 2017-01-28
• First posted: 2015-05-22
• Last updated: 2022-04-19
• Results posted: 2018-03-01

Locations

8 sites across 1 country: India

Regulatory

• FDA-regulated drug study