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Safety and Immunogenocity Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Japanese Children

NCT01001169 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-08-17

Study results available
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Summary

The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational influenza vaccine GSK2340274A following one dose and following a second dose, using the same dosage as has been used in the H5N1 development program in Japanese children aged 10-17 years and an alternative dose in children aged 6 months to 9 years.

Conditions

Interventions

BIOLOGICAL

GSK Biologicals' Pandemic influenza (H1N1) candidate vaccine (GSK2340274A)

Two intramuscular injections

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-01
Primary Completion
2010-05-17
Completion
2010-05-17

Countries

  • Japan

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 NCT01001169 on ClinicalTrials.gov