Trial intelligence / Profile preview

Sanofi Unadjuvanted H1N1 Vaccine Safety and Immunogenicity in Children

NCT00944073Phase 2

Key facts

Status: Completed
Start: Aug 2009
Primary completion: Apr 2010
Countries: 1
Sponsor: National Institute of Allergy and Infectious Diseases
Modality: Live Attenuated Vaccines, Whole Inactivated Vaccines

Drugs: Influenza A (H1N1) vaccine
Conditions: influenza

Overview

Phase 2, randomised, double-blind trial of Influenza A (H1N1) vaccine in influenza (2 arms), sponsored by National Institute of Allergy and Infectious Diseases. Primary endpoints: Number of Participants Reporting Solicited Subjective Local Reactions, Number of Participants Reporting Solicited Quantitative Local Reactions and 5 more. Started Aug 2009; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Group 1: 15 mcg
15 mcg H1N1 Vaccine
Group 2: 30 mcg
30 mcg H1N1 Vaccine

Who it enrols

Healthy infants, children, and adolescents aged 6 months to 17 years without history of H1N1 2009 infection or vaccination, and no egg allergy or immunosuppression.

Endpoints

Primary

Number of Participants Reporting Solicited Subjective Local ReactionsDay 0-7
Number of Participants Reporting Solicited Quantitative Local ReactionsDay 0-7
Number of Participants Reporting Solicited Quantitative Systemic ReactionsDay 0-7
Number of Participants Reporting Solicited Subjective Systemic ReactionsDay 0-7
Number of Participants Reporting Vaccine-associated Serious Adverse EventsDay 0-180 post last vaccination

Secondary

Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Following Second DoseDay 21 post-dose 2
Number of Participants With 4-Fold or Greater HAI Antibody Titer Increases Following Second DoseDay 21 post-dose 2

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