Safety and Immunogenicity of Fluzone® Vaccine in Children Who Received 2 Doses of the 2005-2006 Fluzone Formulation.

NCT00390884 | Completed Phase 4 Results

• 1 other identifier: GRC29
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 5

Brief Summary

To compare the groups with respect to influenza immune responses following Dose 1 of Fluzone vaccine (2006-2007 formulation).

Conditions

Influenza

Keywords

Fluzone®; Influenza; Influenza virus infection; Influenza vaccine

Outcome Measures

Primary Outcomes (1)

• Percentage of Seroprotected Participants Post-vaccination With Fluzone®

  Seroprotection was defined as a Post-vaccination Hemagglutination Inhibition titer of greater than or equal to 1:40.

  Day 28 Post-vaccination

Secondary Outcomes (1)

• Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone®

  Day 28 Post-vaccination

Other Outcomes (1)

• Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®

  Days 0-7 Post-vaccination

Study Arms (2)

Fluzone®-Primed Group

EXPERIMENTAL

Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28, NCT00242424), will receive 2 doses of Fluzone® Pediatric 2006-2007 formulation.

Biological: Influenza Virus Vaccine, Fluzone®

Fluzone®-Naive Group

EXPERIMENTAL

Participants had never received Influenza vaccine and had received two doses of placebo in the fall of 2005 (Study GRC28, NCT00242424), will receive 2 doses of Fluzone® Pediatric 2006-2007 formulation.

Biological: Influenza Virus Vaccine, Fluzone®

Interventions

Influenza Virus Vaccine, Fluzone® BIOLOGICAL

0.25 mL, Intramuscular

Also known as: Fluzone®

Fluzone®-Primed Group

Eligibility Criteria

• Age: 11 Months - 14 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Previously enrolled in study GRC28 and received 2 vaccinations of the assigned lot.
• Considered to be in good health on the basis of reported medical history and history-directed physical evaluation.
• Available for the duration of the study.
• Parent/legal representative willing and able to provide informed consent.
• Parent/legal representative able to attend all scheduled visits and comply with all trial procedures.
• Parent/legal representative willing to permit venipuncture for purposes of collecting a blood sample.

You may not qualify if:

• Receipt of any vaccine within the past 7 days (subjects may be deferred until after the seven days has passed.)
• Reported allergy to egg proteins, chicken proteins or any other constituent of the vaccine.
• Ever received any influenza vaccine, other than at Visits 1 and 2 of study GRC28, or known to have ever been diagnosed with laboratory-confirmed influenza.
• An acute illness with fever (rectal temperature ≥ 100.4°F \[38.0°C\]) in the 72 hours preceding enrollment in the trial (defer enrollment).
• Known bleeding disorder.
• Participation in any other interventional clinical trial within 30 days prior to enrollment, or planned participation in another interventional clinical trial prior to termination of the subject's participation in the 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, in the opinion of the investigator, could interfere with trial conduct or completion.
• Known Human Immunodeficiency Virus (HIV)-positive mother or Hepatitis B surface antigen (HBsAg)-positive mother.
• Known HIV, Hepatitis B, or Hepatitis C infection.
• Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other immunomodulator therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting \< 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
• Prior personal history of Guillain-Barré syndrome.
• Any condition that, 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 (5)

Unknown Facility

Layton, Utah, 84041, United States

Location

Unknown Facility

Pleasant Grove, Utah, 84062, United States

Location

Unknown Facility

Provo, Utah, 84604, United States

Location

Unknown Facility

Salt Lake City, Utah, 84107, United States

Location

Unknown Facility

South Jordan, Utah, 84095, 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 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2006
• First Posted: October 23, 2006
• Study Start: October 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: September 1, 2008
• Last Updated: April 14, 2016
• Results First Posted: December 31, 2009

Record last verified: 2016-04

Locations

US (5)