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Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)

NCT00972816 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1357

Last updated 2016-04-14

Study results available
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Summary

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

Conditions

Interventions

BIOLOGICAL

MF59-eH1N1

MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).

Sponsors & Collaborators

  • Novartis Vaccines

    lead INDUSTRY

Principal Investigators

  • Novartis Vaccines and Diagnostics · Novartis

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2009-11-30
Completion
2010-10-31

Countries

  • United States
  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00972816 on ClinicalTrials.gov