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

October 19, 2005
January 27, 2009
September 2005
September 2006   (final data collection date for primary outcome measure)
To demonstrate the safety of Fluzone vaccine administered to 2-month old children [ Time Frame: within 6 months ] [ Designated as safety issue: Yes ]
To demonstrate the safety of Fluzone vaccine administered to 2-month old children
Complete list of historical versions of study NCT00242424 on ClinicalTrials.gov Archive Site
Not Provided
There are no secondary endpoints, but other observational objectives that will be evaluated include immunogenicity of trivalent inactivated influenza vaccines in infants administered inactivated influenza vaccine at 2 and 3 months of age, and serological
Not Provided
Not Provided
 
Safety and Immunogenicity of Inactivated Influenza Virus Vaccine Among Healthy Children 6-12 Weeks of Age
Safety and Immunogenicity of Fluzone Influenza Virus Vaccine (2005-2006 Formulation) Among Healthy Children 6 to 12 Weeks of Age

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Inactivated Influenza Vaccine
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.
  • Placebo Comparator: 1
    0.25 ml normal saline placebo given as injection to infants at 2 and 3 months of age
    Intervention: Biological: 2005-2006 trivalent inactivated influenza vaccine
  • Experimental: 2
    2005-6 Fluzone, pediatric formulation of trivalent inactivated influenza vaccine (sanofi pasteur) administered to infants at 2 and 3 months of age
    Intervention: Biological: 2005-2006 trivalent inactivated influenza vaccine
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1375
September 2007
September 2006   (final data collection date for primary outcome measure)

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
Both
42 Days to 84 Days
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00242424
05065501
No
Janet Englund, MD, Seattle Children's Hospital Research Institute
Seattle Children's Hospital
Sanofi Pasteur, a Sanofi Company
Study Chair: Janet A Englund, MD Seattle Children's Hospital
Seattle Children's Hospital
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP