CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 780 enrolled
Drug / intervention
Pumarix™ +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00510874
NCT00510874Phase 1Completed
CompareCT.gov

A Phase I/II, Observer-Blind, Randomized, Active-Controlled Trial to Evaluate the Safety and Immunogenicity of a Two-Dose Series of GSK Biologicals' Candidate Influenza Vaccine GSK 1557484A Antigens With or Without Adjuvant

GlaxoSmithKline·interventional·Posted Aug 2, 2007·Updated Aug 17, 2018

In Brief

A Phase 1 clinical trial evaluating Pumarix™ and Pandemrix ™ for Influenza. Completed, enrolled 780 participants across 10 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesCanada, United States
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 2, 2007
Enrollment StartJul 28, 2007
Primary CompletionJun 17, 2008
Study CompletionOct 24, 2008
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 18.9 years ago

Interventions

Pumarix™biological

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.

Pandemrix ™biological

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.