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Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza (H1N1 Influenza Virus) Vaccine in Adults, Using Two Different Manufacturing Processes

NCT00992511 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2019-01-31

Study results available
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Summary

The objective of this study is to evaluate the immunogenicity and safety of one or two doses of GSK Biologicals' investigational influenza vaccine GSK2340272A, manufactured using two different processes, in adults aged 18 to 60 years.

Conditions

Interventions

BIOLOGICAL

GSK investigational vaccine GSK2340272A

One intramuscular injection of initial process-manufactured GSK2340272A vaccine

BIOLOGICAL

GSK investigational vaccine GSK2340272A

Two intramuscular injections of initial process-manufactured GSK2340272A vaccine

BIOLOGICAL

GSK investigational vaccine GSK2340272A

One intramuscular injection of new process-manufactured GSK2340272A vaccine

BIOLOGICAL

GSK investigational vaccine GSK2340272A

Two intramuscular injections of new process-manufactured GSK2340272A vaccine

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-14
Primary Completion
2010-11-09
Completion
2010-11-09

Countries

  • Germany

Study Locations

More Related Trials

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 NCT00992511 on ClinicalTrials.gov