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Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Children Aged 10 to Less Than 18 Years

NCT01035749 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2018-08-17

Study results available
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Summary

The purpose of this study is to show that vaccination with a single dose of GSK Biologicals' pandemic H1N1 vaccine results in an immune response that meets or exceeds European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) guidance criteria for a pandemic influenza vaccine.

Conditions

Interventions

BIOLOGICAL

GSK Biologicals' Influenza investigational vaccine GSK2340274A

One or two doses administered intramuscularly

BIOLOGICAL

GSK Biologicals' Influenza investigational vaccine GSK2340273A

Two doses intramuscularly

BIOLOGICAL

Placebo (saline)

One dose intramuscularly

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-01
Primary Completion
2010-09-27
Completion
2011-05-10

Countries

  • Estonia
  • Slovakia

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 NCT01035749 on ClinicalTrials.gov