Safety and Immunogenicity Testing of Influenza Vaccine in Healthy Children 2 Months and 6 Months of Age

April 12, 2016 updated by: Sanofi Pasteur, a Sanofi Company

Proof of Concept Study of the Safety and Immunogenicity of Influenza Virus Vaccine Fluzone® 2004-2005 Among Healthy Children 2 Months vs 6 Months of Age

Primary Objective:

To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule (described in the package insert for vaccine-naïve young children) to the investigational and control groups.

Observational Objective:

To describe the percentage of protective Hemagglutination Inhibition (HAI) antibody titers (following a 2-dose Fluzone® immunization series) to each of the 3 vaccine antigens among the investigational and control groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an observational and descriptive study that will provide preliminary comparative information about the safety and immunogenicity of Fluzone® vaccine among children aged 6 to 12 weeks (the investigational group, also referred to as the 2-month-old group) versus children aged 24 to 36 weeks (the control group, also referred to as the 6-month-old group). The study is not designed to achieve any preset statistical power, and no hypotheses will be tested.

Study Type

Interventional

Enrollment (Actual)

394

Phase

  • Phase 2
  • Phase 1

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

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • Georgia
      • Marietta, Georgia, United States, 30062
    • North Carolina
      • Durham, North Carolina, United States, 27705
    • Ohio
      • Akron, Ohio, United States, 44308
      • Dayton, Ohio, United States, 45404
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15241
    • Virginia
      • Norfolk, Virginia, United States, 23510
    • Washington
      • Seattle, Washington, United States, 98101

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

2 months to 9 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria :

  • Aged 42 to 84 days (6 to 12 weeks) or 24 to 36 weeks on the day of inclusion.
  • Born at full term of pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg.
  • Considered to be in good health on the basis of reported medical history and history-directed physical examination.
  • Available for the duration of the study.
  • Parent/guardian willing and able to provide informed consent.
  • Parent/guardian able to attend all scheduled visits and comply with all trial procedures.
  • Willingness to permit venipuncture or heel stick for purposes of collecting a blood sample.

Exclusion Criteria :

  • Reported allergy to egg proteins, chicken proteins or any other constituent of the vaccine.
  • Previous history of influenza vaccination or documented history of influenza infection.
  • Receipt of any vaccine in the 7 days prior to enrollment.
  • An acute illness with fever (rectal temperature ≥ 38.0 °C [or ≥ 100.4 °F]) in the 72 hours preceding enrollment in the trial (defer enrollment).
  • Known bleeding disorder.
  • Participation in any other clinical trial within 30 days prior to enrollment, or planned participation in another clinical trial prior to termination of the subject's participation in this study.
  • Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
  • Personal or immediate family history of congenital immune deficiency.
  • Developmental delay, neurologic disorder, or seizure disorder.
  • Chronic medical, congenital or developmental disorder that could interfere with trial conduct or completion.
  • Known HIV-positive or HBsAg-positive mother.
  • Known HIV, hepatitis B (HBsAg), or hepatitis C infection.
  • Blood or blood-derived products received in the past 2 months.
  • Prior history of Guillain-Barré syndrome.
  • Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.

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: Group 1
Participants aged 6 to 12 Weeks at enrollment
Biological: Influenza virus vaccine (2004-2005 Formulation)
0.25 mL, Intramuscular
Other Names:
  • Fluzone® Preservative-free
Experimental: Group 2
Participants aged 24 to 36 Weeks at enrollment
Biological: Influenza virus vaccine (2004-2005 Formulation)
0.25 mL, Intramuscular
Other Names:
  • Fluzone® Preservative-free

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation.
Time Frame: Day 0 to Day 7 post-vaccination
Solicited local (injection site) reactions: Tenderness, erythema (redness), and swelling Solicited systemic reactions: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Loss of Appetite, and Irritability.
Day 0 to Day 7 post-vaccination

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titer ≥ 40 Post-vaccination With Fluzone® (Seroprotection).
Time Frame: 21 days post-vaccination 2

Data presented for each of the three influenza vaccine virus antigens in the Fluzone® 2004-2005 pediatric formulation.

Seroprotection was defined as the percentage of participants with a reciprocal hemagglutination inhibition titers ≥ 40
21 days post-vaccination 2
Percentage of Participants With a Pre-vaccination Serum Hemagglutination Inhibition Antibody Titer of ≤ 10 That Had a Titer of ≥ 40 Post-vaccination With Fluzone® (Seroconversion).
Time Frame: 21 days post-vaccination 2
Seroconversion was defined as the percentage of participants with a pre-titer < 1:10 who demonstrated a ≥ 4-fold increases in titer from pre- to post-vaccination.
21 days post-vaccination 2
Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-vaccination With Fluzone® Vaccine.
Time Frame: 21 days post-vaccination 2
Data presented for each of the three influenza vaccine virus antigens in the Fluzone® 2004-2005 pediatric formulation.
21 days post-vaccination 2

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.

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

April 1, 2005

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

March 5, 2009

First Submitted That Met QC Criteria

March 5, 2009

First Posted (Estimate)

March 9, 2009

Study Record Updates

Last Update Posted (Estimate)

April 14, 2016

Last Update Submitted That Met QC Criteria

April 12, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRC27

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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