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A/H1N1 Immunogenicity and Safety in Infants, Children and Adolescents

NCT00976469 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2015-10-09

No results posted yet for this study

Summary

The purpose of this study is to determine the preferred dose of H1N1 pandemic influenza vaccine in a pediatric population, aged 6 months to 17 years, based upon assessments of immunogenicity and safety.

Conditions

Interventions

BIOLOGICAL

H1N1 pandemic influenza vaccine (whole virion, Vero cell-derived, inactivated)

2-dose priming at a 21-day interval, intramuscular injection in either the upper arm or thigh, depending on the subject´s age

BIOLOGICAL

Seasonal trivalent influenza vaccine (licensed) for the season 2010/2011

Booster vaccination at Day 360 after first vaccination (only in subjects who received the 7.5 µg dose of the H1N1 pandemic influenza vaccine)

Sponsors & Collaborators

  • Alachua Government Services, Inc.

    lead INDUSTRY

Principal Investigators

  • Eva-Maria Pöllabauer, MD · Baxter Healthcare Corporation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-04-30
Completion
2011-03-31

Countries

  • Austria
  • Germany

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 NCT00976469 on ClinicalTrials.gov