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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

NCT00996307 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 654

Last updated 2017-05-30

Study results available
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Summary

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

Conditions

Interventions

BIOLOGICAL

MF59-eH1N1_f

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

BIOLOGICAL

MF59-eH1N1_f

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

BIOLOGICAL

MF59-eH1N1_f

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

BIOLOGICAL

MF59-eH1N1_f

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

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Novartis Vaccines

    lead INDUSTRY

Principal Investigators

  • Novartis Vaccines and Diagnostics · Novartis

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
35 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2009-12-31
Completion
2010-12-31

Countries

  • United States
  • Mexico

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00996307 on ClinicalTrials.gov