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

Completed · Phase 2/Phase 3

Conditions studied: Inactivated Influenza Vaccine

In brief

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.

Key facts

Study ID

NCT00242424

Run by

Seattle Children's Hospital

People needed

1375

Starts

2005-09-01

Expected to finish

2007-09-01

Last updated by the study team

2009-01-28

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Seattle Children's Hospital and Regional Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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