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

NCT00858468 | Completed Phase 1 Results

• 1 other identifier: GRC27
• Study Type: interventional
• Target: 394
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Influenza

Keywords

Influenza; Influenza vaccine

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation.

  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 Outcomes (3)

• Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titer ≥ 40 Post-vaccination With Fluzone® (Seroprotection).

  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).

  21 days post-vaccination 2

• Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-vaccination With Fluzone® Vaccine.

  21 days post-vaccination 2

Study Arms (2)

Group 1

EXPERIMENTAL

Participants aged 6 to 12 Weeks at enrollment

Biological: Influenza virus vaccine (2004-2005 Formulation)

Group 2

EXPERIMENTAL

Participants aged 24 to 36 Weeks at enrollment

Biological: Influenza virus vaccine (2004-2005 Formulation)

Interventions

Influenza virus vaccine (2004-2005 Formulation) BIOLOGICAL

0.25 mL, Intramuscular

Also known as: Fluzone® Preservative-free

Group 1

Eligibility Criteria

• Age: 2 Months - 9 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (8)

Unknown Facility

Little Rock, Arkansas, 72205, United States

Location

Unknown Facility

Marietta, Georgia, 30062, United States

Location

Unknown Facility

Durham, North Carolina, 27705, United States

Location

Unknown Facility

Akron, Ohio, 44308, United States

Location

Unknown Facility

Dayton, Ohio, 45404, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15241, United States

Location

Unknown Facility

Norfolk, Virginia, 23510, United States

Location

Unknown Facility

Seattle, Washington, 98101, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2009
• First Posted: March 9, 2009
• Study Start: April 1, 2005
• Primary Completion: June 1, 2006
• Study Completion: December 1, 2006
• Last Updated: April 14, 2016
• Results First Posted: July 31, 2009

Record last verified: 2016-04

Locations

US (8)