Safety and Immunogenicity of Inactivated Influenza Virus Vaccine Among Healthy Children 6-12 Weeks of Age (GRC28)

This study has been completed.
Sponsor:
Collaborator:
Sanofi Pasteur, a Sanofi Company
Information provided by:
Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT00242424
First received: October 19, 2005
Last updated: January 27, 2009
Last verified: January 2009
  Purpose

Study of the safety and immunogenicity (antibody producing capability) comparing inactivated influenza vaccine to placebo given to infants at 2 and 3 months of age. Infants will receive inactivated influenza vaccine at the same time as other vaccines on the routine immunization schedule. Infants will be randomized at enrollment to receive inactivated influenza vaccine or placebo at a 2:1 ratio. This study is double-blind, randomized, and placebo-controlled.


Condition Intervention Phase
Inactivated Influenza Vaccine
Biological: 2005-2006 trivalent inactivated influenza vaccine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of Fluzone Influenza Virus Vaccine (2005-2006 Formulation) Among Healthy Children 6 to 12 Weeks of Age

Resource links provided by NLM:


Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:
  • To demonstrate the safety of Fluzone vaccine administered to 2-month old children [ Time Frame: within 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 1375
Study Start Date: September 2005
Study Completion Date: September 2007
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
0.25 ml normal saline placebo given as injection to infants at 2 and 3 months of age
Biological: 2005-2006 trivalent inactivated influenza vaccine
Children enrolled at 6-12 weeks to receive first dose, 0.25 ml of trivalent inactivated influenza vaccine, 2005-6 pediatric Fluzone formulation (sanofi pastuer), with concomitant routine pediatric vaccines. Second dose administered 4 weeks later.
Experimental: 2
2005-6 Fluzone, pediatric formulation of trivalent inactivated influenza vaccine (sanofi pasteur) administered to infants at 2 and 3 months of age
Biological: 2005-2006 trivalent inactivated influenza vaccine
Children enrolled at 6-12 weeks to receive first dose, 0.25 ml of trivalent inactivated influenza vaccine, 2005-6 pediatric Fluzone formulation (sanofi pastuer), with concomitant routine pediatric vaccines. Second dose administered 4 weeks later.

Detailed Description:

Methods: A double-blind, randomized, placebo-controlled trial was conducted in 1375 healthy US infants 6-12 weeks of age. Subjects received either 2 doses of trivalent inactivated influenza vaccine (TIV, Fluzone®, sanofi pasteur 2005-6 pediatric formulation) (N=915) or placebo (N=460) 1 month apart, along with indicated concomitant vaccines. Solicited adverse events were collected for 7 days following each vaccination, unsolicited adverse events for 28 days, and serious adverse events for 6 months. Hemagglutination inhibition antibodies to all 3 vaccine strains were measured following the second TIV/placebo dose.

Results: No significant differences were seen between TIV and placebo groups for any safety outcomes. Fever ≥38oC rectal within 3 days of vaccination was seen in 11.2% vs 11.7% of TIV vs placebo recipients. Serious adverse events within 28 days of vaccine/placebo were reported in 1.9% of TIV and 1.5% of placebo recipients; only one (hypersensitivity reaction in a TIV recipient) was considered vaccine-related. Significantly increased antibody responses (p<0.001) were seen against all 3 strains in TIV recipients by titer ≥ 1:40 or geometric mean titer (GMT) (p<0.001). Altogether, 50% of infants had antibody titers ≥ 1:40 for H1N1, 86% for H3N2, and 11% for B compared with 7%, 10%, and 0.3% in the placebo group. The reciprocal GMT for influenza recipients was 33, 95, and 11 for H1N1, H3N2, and B vs. 7, 9, and 5 for placebo recipients. Over 90% of infants who received TIV had antibody ≥ 1:40 for at least one vaccine strain and 49.6% for 2 strains, vs. 16.4% and 0.9% in the placebo group.

Conclusions: TIV administered to young infants beginning at 6-12 weeks of age is safe and immunogenic.

  Eligibility

Ages Eligible for Study:   42 Days to 84 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 42 to 84 days on the day of inclusion
  • Full term (born at >=36 weeks with birth weight >=2.5 kg
  • Considered to be in good health
  • Parental consent obtained and available
  • Available for the study duration (6 months)

Exclusion Criteria:

  • Reported allergy to egg proteins, chicken proteins
  • Previous history of influenza vaccination or disease
  • Receipt of any vaccine other than Hepatitis B prior to enrollment
  • Acute illness with rectal temperature >= 38.0 (defer enrollment)
  • Known bleeding disorder
  • Participation in other interventional clinical trial within 30 days prior to enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00242424

Locations
United States, Washington
Seattle Children's Hospital and Regional Medical Center
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Seattle Children's Hospital
Sanofi Pasteur, a Sanofi Company
Investigators
Study Chair: Janet A Englund, MD Seattle Children's Hospital
  More Information

Publications:
Englund JA, Walter EB, Black S, et al. Safety and Immunogenicity of Fluzone Trivalent Inactivated Influenza Vaccine (TIV) in Infants 6-12 Weeks of Age. Presented at Infectious Disease Society of America (IDSA), Toronto, Oct. 14, 2006

Responsible Party: Janet Englund, MD, Seattle Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00242424     History of Changes
Other Study ID Numbers: 05065501
Study First Received: October 19, 2005
Last Updated: January 27, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Seattle Children's Hospital:
influenza vaccine
infants
safety
immunogenicity

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 22, 2014