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Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults

NCT00510874 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 780

Last updated 2018-08-17

Study results available
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Summary

The purpose of this study is to evaluate the safety and immune response of two-doses of GSK Biologicals' candidate influenza vaccine GSK 1557484A with or without adjuvant in adults. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Interventions

BIOLOGICAL

Pumarix™

Two doses administered intramuscularly (IM), the first in the deltoid region of the non-dominant arm and the second in the deltoid region of the dominant arm.

BIOLOGICAL

Pandemrix ™

Two doses administered intramuscularly (IM), the first in the deltoid region of the non-dominant arm and the second in the deltoid region of the dominant arm.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-07-28
Primary Completion
2008-06-17
Completion
2008-10-24

Countries

  • United States
  • Canada

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 NCT00510874 on ClinicalTrials.gov