A Phase II, Trial to Assess the Safety and Tolerability of Influenza Virus Vaccine, CAIV-T in Healthy Children and Adolescents Ages 6 to Less Than 18 Years.

PHASE2CompletedINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

June 30, 2003

Primary Completion Date

July 31, 2003

Study Completion Date

July 31, 2003

Conditions
Influenza
Interventions
BIOLOGICAL

Cold-adapted influenza vaccine trivalent (CAIV-T)

The total volume of 0.2 ml was administered intranasally with a spray applicator (approximately 0.1 ml into each nostril). Each dose of CAIV-T used in this study contained approximately 10\^7+/-0.5 fluorescent focus units (FFU) (equivalent to 10\^7+/-0.5 TCID50) of each of the following three influenza virus strains: Influenza Cold Adapted Virus Type H1N1, strain A/New Caledonia/20/99; Influenza Cold Adapted Virus Type H3N2, strain A/ Panama/2007/99; Influenza Cold Adapted Virus Type B, strain B/Hong Kong/ 330/01.

BIOLOGICAL

Placebo

The placebo consisted of physiologic normal saline.

Trial Locations (6)

Unknown

Catholic University Leuven, Leuven

Zamenhoflaan 12, Schoten

Universiteit Antwerpen, Wilrijk

Oddzial Dzieciecy Szpitala Powiatowete im, Trzebnica

CV 6 4DD

The Gables Medicentre, Coventry

KA 12 OAY

Townhead Surgery, Irvine, Ayshire

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

lead

MedImmune LLC

INDUSTRY

NCT00192179 - A Phase II, Trial to Assess the Safety and Tolerability of Influenza Virus Vaccine, CAIV-T in Healthy Children and Adolescents Ages 6 to Less Than 18 Years. | Biotech Hunter | Biotech Hunter