Safety and Immunogenicity of 2 Formulations of an Intramuscular A/H5N1 Pandemic Influenza Vaccine in Children

January 10, 2014 updated by: Sanofi Pasteur, a Sanofi Company

This is an open, randomized, multicenter clinical trial.

Objectives:

  • To describe the safety profiles during the 21 days following each primary and booster injection.
  • To describe the immune response 21 days after each primary and booster injection of each formulation.
  • To describe the antibody persistence after the first vaccination

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

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

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 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria :

All subjects:

  • Able to attend all scheduled visits and to comply with all trial procedures.

Children/Adolescents aged ≥ 2 years to < 18 years:

  • Aged ≥ 2 years to < 18 years on the day of inclusion.
  • Informed Consent Form signed by one parent or another legal representative and by an independent witness if the parent/legal representative is illiterate.
  • For a female, inability to bear a child or negative urine pregnancy test (as applicable).
  • For a female of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination and at least 4 weeks after the last vaccination (as applicable).

Infants/toddlers aged ≥ 6 months to < 2 years:

  • Aged ≥ 6 months to < 2 years on the day of inclusion.
  • Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2 kg.
  • Informed Consent Form signed by one parent/legally acceptable representative and an independent witness if the parent/legally acceptable representative is illiterate.
  • Subject who completed vaccination according to the national immunization schedule.

Exclusion Criteria :

All subjects:

  • Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
  • Planned participation in another clinical trial during the present trial period.
  • Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy.
  • Systemic hypersensitivity to any of the vaccine components or history of life threatening reaction to the trial vaccine or a vaccine containing the same substances (egg proteins, chick proteins, thimerosal, aluminum, neomycin, formaldehyde, and octoxinol 9).
  • Chronic illness at a stage that could interfere with trial conduct or completion.
  • Blood or blood-derived products received in the past 3 months.
  • Any vaccination in the 4 weeks preceding the first trial vaccination.
  • Vaccination planned in the 4 weeks following any trial vaccination.
  • History of the H5N1 infection (confirmed either clinically, serologically or virologically).
  • Known HIV, Hepatitis B (HBsAg) or Hepatitis C seropositivity.
  • Previous vaccination with an avian flu vaccine.
  • Subject at high risk of the H5N1 infection during the trial.
  • Thrombocytopenia or bleeding disorder contraindicating IM vaccination.
  • Febrile illness (rectal equivalent temperature ≥ 38.0°C) on the day of inclusion.

Children/Adolescents aged ≥ 2 years to < 18 years:

  • Breast-feeding mothers.
  • Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures (if applicable, depending on the subject's age).

Infants/toddlers aged ≥ 6 months to < 2 years:

  • History of seizures.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group 1
Subjects aged 9 to 17 years
Biological: A/H5N1 Inactivated, split-virion pandemic influenza vaccine
0.5 mL, Intramuscular
Experimental: Study Group 2
Subjects aged 3 to 8 years
Biological: A/H5N1 Inactivated, split virion pandemic influenza vaccine
0.5 mL, Intramuscular
Biological: A/H5N1 Inactivated, split virion pandemic influenza vaccine
0.25 mL, Intramuscular
Experimental: Study Group 3
Subjects aged 6 to 35 months
Biological: A/H5N1 Inactivated, split virion pandemic influenza vaccine
0.5 mL, Intramuscular
Biological: A/H5N1 Inactivated, split virion pandemic influenza vaccine
0.25 mL, Intramuscular

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To describe safety following administration of A/H5N1 inactivated split virion pandemic influenza vaccine.
Time Frame: 21 Days post-vaccination
21 Days post-vaccination

Collaborators and Investigators

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

Sponsor

Sanofi Pasteur, a Sanofi Company

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

Helpful Links

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

June 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

June 26, 2007

First Submitted That Met QC Criteria

June 26, 2007

First Posted (Estimate)

June 27, 2007

Study Record Updates

Last Update Posted (Estimate)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 10, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GPA04

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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