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Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine (Egg-Derived) in Healthy Subjects From 6 Months to 17 Years of Age

NCT00971542 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 778

Last updated 2011-10-12

No results posted yet for this study

Summary

The present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate immunogenicity, safety and tolerability of two doses of adjuvanted and not-adjuvanted new swine-origin influenza A/H1N1 virus monovalent subunit vaccine in healthy children and adolescents. A booster dose will be administered 12 months after the first vaccination.

Conditions

  • Pandemic Influenza

Interventions

BIOLOGICAL

Monovalent A/H1N1 influenza vaccine

This trial will be performed at multiple study sites in a population of healthy children and adolescent. Subjects will be randomized to receive 2 IM injections of low dose of antigen \& adjuvant, or high dose of antigen \& adjuvant, or high dose of antigen, according to the study groups.

Sponsors & Collaborators

  • Novartis Vaccines

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-02-28
Completion
2011-07-31

Countries

  • Belgium
  • Chile
  • Dominican Republic
  • Germany
  • Netherlands

Study Locations

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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 NCT00971542 on ClinicalTrials.gov