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	Vaccine: 2005-2006 trivalent inactivated influenza vaccine	Phase II

Further study details as provided by Children''''s Hospital and Regional Medical Center, Seattle:

Primary Outcomes: To demonstrate the safety of Fluzone vaccine administered to 2-month old children
Secondary Outcomes: 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
Expected Total Enrollment:  1380

Ages Eligible for Study:  42 Days   -   84 Days,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00242424

Fred Ruben, MD      570-839-5633    fred.ruben@sanofipasteur.com
Diane Maus, RN      570-839-4498    dane.maus@sanofipasteur.com

Washington
      Seattle Children''''s Hospital and Regional Medical Center, Seattle,  Washington,  98105,  United States

Study chairs or principal investigators

Janet A Englund, MD,  Study Chair,  Children''''s Hospital and Regional Medical Center, Seattle, WA   

Study ID Numbers:  05065501
Last Updated:  December 8, 2005
Record first received:  October 19, 2005
ClinicalTrials.gov Identifier:  NCT00242424
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10