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H5N1 Mix and Match With AS03

NCT01317758 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2013-01-18

No results posted yet for this study

Summary

Approximately 216, and up to 240, healthy males and non-pregnant females, 18 to 49 years old, inclusive, will be enrolled over a 5-month period into this multicenter, randomized, double-blinded, controlled Phase I study. Subjects who meet the entry criteria for the study and provide informed consent will be randomized 2:1 between adjuvanted and unadjuvanted vaccine and placed into one of 6 groups (see table) to receive two doses of an intramuscular subvirion inactivated monovalent influenza A/H5N1 virus vaccine at 3.75, 7.5, or 15 mcg given with the adjuvant AS03 or diluent (N=216, up to 240). All eligible subjects will receive 2 doses separated by approximately 21 days.

Conditions

Interventions

DRUG

AS03 Adjuvant

Adjuvant/diluent manufactured by GlaxoSmithKline (GSK)

OTHER

Phosphate Buffered Saline (PBS) diluent

Placebo/diluent provided by sanofi pasteur

BIOLOGICAL

Sanofi H5N1 Antigen

Subvirion inactivated monovalent influenza A/H5N1 (Hemagglutinin (HA) of A/Indonesia/05/2005) virus vaccine manufactured by sanofi pasteur, at 2 doses levels 21 days apart, administered at 3.75, 7.5, or 15mcg, with either AS03 adjuvant or PBS.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01317758 on ClinicalTrials.gov