Immunogenicity, Safety and Tolerability of Two Doses of a Pre-pandemic Influenza Vaccine in Participants Aged 6 Months to 17 Years

February 14, 2012 updated by: Novartis Vaccines

A Phase II, Randomized, Controlled, Observer-blind, Single-center Study to Evaluate the Immunogenicity, Safety and Tolerability of Two Doses of an H5N1 Influenza Vaccine in Subjects Aged 6 Months to 17 Years

Evaluate the immune response and reactogenicity of H5N1 vaccination in subjects aged 6 months to 17 years compared to seasonal flu vaccination

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

471

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Tampere, Finland, 33014
        • University of Tampere Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy subjects

Exclusion Criteria:

  • Receipt of Seasonal Influenza Vaccine for season 2007/2008
  • Receipt of another vaccine within 3 weeks before and after each vaccination
  • Previous vaccination with a pandemic candidate vaccine and/or vaccine containing the adjuvant MF59 or a similar adjuvant
  • Children who are in the local recommendation for influenza vaccination due to underlying diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
0.5mL of H5N1 vaccine 7.5ug
Biological: H5N1 Influenza Vaccine
Two 0.5mL injections of H5N1 influenza vaccine containing 7.5μg of H5N1 antigen (A/Vietnam/1194/2004), administered 3 weeks apart, and one 0.5mL injection of H5N1 vaccine 12 months after the second dose, IM into the deltoid muscle (preferably of the non-dominant arm) or anterolateral thigh (depending on the muscle mass).
Biological: H5N1 Influenza Vaccine
Two 0.25mL or 0.5mL injections of H5N1 influenza vaccine, administered 3 weeks apart, IM into the deltoid muscle (preferably of the non-dominant arm) or anterolateral thigh (depending on the muscle mass).
Active Comparator: Arm 2
0.25 or 0.5mL of H5N1 vaccine
Biological: H5N1 Influenza Vaccine
Two 0.5mL injections of H5N1 influenza vaccine containing 7.5μg of H5N1 antigen (A/Vietnam/1194/2004), administered 3 weeks apart, and one 0.5mL injection of H5N1 vaccine 12 months after the second dose, IM into the deltoid muscle (preferably of the non-dominant arm) or anterolateral thigh (depending on the muscle mass).
Biological: H5N1 Influenza Vaccine
Two 0.25mL or 0.5mL injections of H5N1 influenza vaccine, administered 3 weeks apart, IM into the deltoid muscle (preferably of the non-dominant arm) or anterolateral thigh (depending on the muscle mass).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
safety and tolerability of, and magnitude of antibody responses to two 0.5mL intramuscular injections of an H5N1 influenza vaccineapart
Time Frame: administered 3 weeks apart
administered 3 weeks apart

Secondary Outcome Measures

Outcome Measure
Time Frame
safety and tolerability of, and magnitude of antibodies to one booster dose with a H5N1
Time Frame: 12 months after primary immunization
12 months after primary immunization
safety profile of a H5N1 compared to a seasonal flu vaccinepersistence of specific antibodies
Time Frame: 12 months after primary immunization
12 months after primary immunization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Vaccines

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

September 28, 2007

First Submitted That Met QC Criteria

September 28, 2007

First Posted (Estimate)

October 1, 2007

Study Record Updates

Last Update Posted (Estimate)

February 16, 2012

Last Update Submitted That Met QC Criteria

February 14, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V87P6
  • 2007-002480-27

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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