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Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children 6 to 35 Months of Age

NCT01711736 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 606

Last updated 2021-11-01

Study results available
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Summary

The purpose of this study is to investigate the immunogenicity, reactogenicity and safety of the new influenza vaccine GSK2282512A (FLU-Q-QIV) and compare its activity to the marketed vaccine Fluarix® (TIV) in young children 6 to 35 months of age.

Conditions

Interventions

BIOLOGICAL

Quadrivalent influenza GSK2282512A vaccine

1 or 2 doses administered intramuscularly (IM) in deltoid muscle or anterolateral thigh on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects) respectively.

BIOLOGICAL

Fluarix

1 or 2 doses administered IM in deltoid muscle or anterolateral thigh, on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects) respectively.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
35 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-11-01
Primary Completion
2013-02-21
Completion
2013-06-19

Countries

  • Canada
  • Dominican Republic
  • Honduras

Study Locations

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Entities

Diseases
Companies

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 NCT01711736 on ClinicalTrials.gov