CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 474 enrolled
Drug / intervention
Monovalent Subvirion A/H1N1 Influenza vaccine +2 morebiological
Likely dose
Monovalent Subvirion A/H1N1 Influenza vaccine 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/NCT00952419
NCT00952419Phase 2Completed
CompareCT.gov

Immunogenicity and Safety of Multiple Formulations of an A/H1N1 Pandemic Vaccine in Healthy Subjects Aged 6 Months to 9 Years

Sanofi Pasteur, a Sanofi Company·interventional·Posted Aug 6, 2009·Updated Apr 14, 2016

In Brief

A Phase 2 clinical trial evaluating Monovalent Subvirion A/H1N1 Influenza vaccine and Normal saline solution (placebo) for Influenza and Swine-origin A/H1N1 Influenza. Completed, enrolled 474 participants across 20 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza, Swine-origin A/H1N1 Influenza
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 6, 2009
Enrollment StartAug 1, 2009
Primary CompletionMar 1, 2010
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 16.9 years ago

Interventions

Monovalent Subvirion A/H1N1 Influenza vaccinebiological

0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on Day 0 and Day 21 (6 months to 35 Months)

Monovalent Subvirion A/H1N1 Influenza vaccinebiological

0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months)

Normal saline solution (placebo)biological

0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months)