CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 654 enrolled
Drug / intervention
MF59-eH1N1_f +3 morebiological
Likely dose
MF59-eH1N1_f 3.75 µgfrom 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/NCT00996307
NCT00996307Phase 3Completed
CompareCT.gov

Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1) 2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months

Novartis Vaccines·interventional·Posted Oct 16, 2009·Updated May 30, 2017

In Brief

A Phase 3 clinical trial evaluating MF59-eH1N1_f for Influenza. Completed, enrolled 654 participants across 29 sites in 2 countries.

Detailed Summary

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 2009 (swine flu) vaccine in healthy young children

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesMexico, United States
CollaboratorsNovartis

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 16, 2009
Enrollment StartOct 1, 2009
Primary CompletionDec 1, 2009
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 16.7 years ago

Interventions

MF59-eH1N1_fbiological

3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.

MF59-eH1N1_fbiological

7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.

MF59-eH1N1_fbiological

15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.

MF59-eH1N1_fbiological

7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.