At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 789 enrolled

Drug / intervention

AS03 +1 moredrug

Likely dose

AS03 15 mcgfrom 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/NCT00963157

NCT00963157Phase 2Completed

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A Phase II Study in Healthy Adult and Elderly Populations to Assess the Safety and Immunogenicity of a Sanofi Pasteur H1N1 Influenza Vaccine Administered at Different Dose Levels Given With and Without GlaxoSmithKline AS03 Adjuvant

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Aug 21, 2009·Updated Dec 24, 2014

In Brief

A Phase 2 clinical trial evaluating AS03 and Influenza Virus Vaccine, Monovalent A/H1N1 A/California/7/2009 NYMC X-179A for Influenza. Completed, enrolled 789 participants across 7 sites.

Detailed Summary

The purpose of this study is to see how the body reacts to different strengths of the H1N1 flu shot when it is given with or without an "adjuvant." An adjuvant is a substance that may cause the body to produce more antibodies when it is given with a vaccine. This study will also compare how age affects the body's response to the H1N1 flu shot. In this study, 3 strengths of the H1N1 flu shot will be tested combined with an adjuvant. In addition, 2 strengths of the H1N1 flu shot will be tested without adjuvant. Two H1N1 flu shots of the same strength, with or without adjuvant, will be given about 3 weeks apart. Participants will include up to 800 healthy adults, approximately 500 individuals ages 18-64 and 250 individuals greater than or equal to age 65. Study procedures include: physical exam, blood samples, completing a memory aid to record vaccine side effects, medications and daily oral temperature. Participants will be involved in study related procedures for up to 13 months.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsInfluenza

CountriesUnited States

Collaborators--

Timeline

Phase 2CompletedFinished

20102011201220132014201520162017201820192020202120222023202420252026

First PostedAug 2009

Enrollment StartSep 2009

Primary CompletionDec 2010

TodayJul 2026

First PostedAug 21, 2009

Enrollment StartSep 1, 2009

Primary CompletionDec 1, 2010

TodayJul 2, 2026

Enrollment to primary: 1.3 yearsPosted 16.9 years ago

Interventions

AS03drug

AS03 adjuvant administered with 3.75, 7.5, or 15 mcg inactivated H1N1 vaccine.

Influenza Virus Vaccine, Monovalent A/H1N1 A/California/7/2009 NYMC X-179Abiological

Inactivated influenza H1N1 vaccine with AS03 adjuvant, delivered intramuscularly (IM) as 3.75, 7.5, or 15 micrograms per dose; and inactivated influenza H1N1 vaccine without adjuvant, delivered intramuscularly as 7.5 or 15 micrograms per dose. All doses of the vaccine with or without adjuvant will be administered as a single 0.5 mL IM injection in the deltoid muscle of the preferred arm.