CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 548 enrolled
Drug / intervention
Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant +4 morebiological
Likely dose
Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant 0.5 mLfrom 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/NCT00952276
NCT00952276Phase 2Completed

Immunogenicity and Safety of Multiple Formulations of an Adjuvanted A/H1N1 Pandemic Vaccine in Healthy Adult and Elderly Subjects

Sanofi·interventional·Posted Aug 6, 2009·Updated Oct 3, 2011

In Brief

A Phase 2 clinical trial evaluating Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant, Monovalent Subvirion A/H1N1 influenza vaccine, and 1 other intervention for Influenza and Swine-origin A/H1N1 Influenza. Completed, enrolled 548 participants across 15 sites.

Detailed Summary

The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in adults and the elderly. Primary Objectives: * To describe the immunogenicity of the candidate vaccines after a single injection. * To describe the safety of the candidate vaccines after a single injection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 6, 2009
Enrollment StartOct 1, 2009
Primary CompletionDec 1, 2010
Study CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 16.9 years ago

Interventions

Monovalent Subvirion A/H1N1 influenza vaccine with adjuvantbiological

0.5 mL, Intramuscular on Day 0

Monovalent Subvirion A/H1N1 influenza vaccine with adjuvantbiological

0.5 mL, Intramuscular on Day 0

Monovalent Subvirion A/H1N1 influenza vaccinebiological

0.5 mL, Intramuscular on Day 0

Monovalent Subvirion A/H1N1 influenza vaccinebiological

0.5 mL, Intramuscular on Day 0

Normal saline solutionbiological

0.5 mL, Intramuscular on Day 0