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

NCT02451358 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2022-04-19

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur SA

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-27
Primary Completion
2017-01-28
Completion
2017-01-28
FDA Drug
Yes

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02451358 on ClinicalTrials.gov