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

NCT ID: NCT00242424

Last Updated: 2009-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 1375 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2007-09-30

Brief Summary

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.

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.

Conditions

Inactivated Influenza Vaccine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

1

0.25 ml normal saline placebo given as injection to infants at 2 and 3 months of age

Group Type: PLACEBO_COMPARATOR

2005-2006 trivalent inactivated influenza vaccine

Intervention Type: BIOLOGICAL

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.

2

2005-6 Fluzone, pediatric formulation of trivalent inactivated influenza vaccine (sanofi pasteur) administered to infants at 2 and 3 months of age

Group Type: EXPERIMENTAL

2005-2006 trivalent inactivated influenza vaccine

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 42 Days
• Maximum Eligible Age: 84 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: collaborator

Seattle Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seattle Children's Hospital Research Institute

Principal Investigators

Janet A Englund, MD

Role: STUDY_CHAIR

Seattle Children's Hospital

Locations

Seattle Children's Hospital and Regional Medical Center

Seattle, Washington, United States

Countries

United States

References

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

Reference Type: RESULT

Other Identifiers

05065501

Identifier Type: -

Identifier Source: org_study_id