Trial to Assess Safety, Tolerability, and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A and B, Live Cold-adapted (CAIV-T) in Healthy Children (FluMist)
The study was designed to determine the number of doses of CAIV-T required to effectively immunize children and adolescents in the 6 to 17 year age group.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Prospective, Open-label, Phase II, Multi-center Study of the Safety, Tolerability and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A and B, Live Cold-adapted (CAIV-T) in Healthy Children, Aged 6 to 17 Years|
- The number of subjects achieving strain-specific hemagglutination inhibition (HAI) antibody seroconversion post Dose 1 [ Time Frame: Day 0, Day 35 post Dose 1 ] [ Designated as safety issue: No ]Immunogenicity was evaluated by comparison of pre and post-vaccination strain-specific titers of serum HAI antibody. Seroconversion was defined as a four-fold or greater rise in serum HAI antibody titer.
- The number of subjects achieving strain-specific HAI antibody seroconversion post Dose 1 [ Time Frame: Day 0, Day 35 post Dose 2 ] [ Designated as safety issue: No ]Immunogenicity was evaluated by comparison of pre and post-vaccination strain-specific titers of serum HAI antibody. Seroconversion was defined as a four-fold or greater rise in serum HAI antibody titer.
- The number of subjects reporting any reactogenicity event post dose [ Time Frame: Days 0-10 ] [ Designated as safety issue: Yes ]Reactogenicity events were predefined adverse events that could have occurred after vaccine administration. They included the following: fever (oral temperature >= 38C), cough, runny nose/nasal congestion, sore throat, irritability, headache, chills, vomiting, decreased activity, decreased appetite, and muscle aches.
- The number of subjects reporting any adverse event post dose [ Time Frame: Days 0-10 ] [ Designated as safety issue: Yes ]An adverse event (or adverse experience, AE) was defined as any untoward medical occurrence in a subject who was administered a study product.
- The number of subjects reporting serious adverse events post dose [ Time Frame: Days 0-42 ] [ Designated as safety issue: Yes ]An adverse event was considered serious (SAE) if it: resulted in death, regardless of cause; was life-threatening (subject was at risk of death as the event occurred); required inpatient hospitalization or prolonged existing hospitalization; resulted in persistent or significant disability/incapacity; or resulted in a congenital anomaly or birth defect (in the offspring of a vaccine recipient, where applicable).
|Study Start Date:||October 2000|
|Study Completion Date:||January 2001|
|Primary Completion Date:||January 2001 (Final data collection date for primary outcome measure)|
Experimental: Cold-adapted influenza vaccine trivalent (CAIV-T)
All subjects were scheduled to receive 2 doses of 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 the vaccine was formulated to contain approximately 1 x 10^7 TCID50 of each of three (two subtype A and one subtype B) reassortant 6:2 influenza strains, as described above, for a total of ~3 x 10^7 TCID50 per dose.
Other Name: FluMist
This was a phase II, prospective, open-label, multicenter, outpatient study designed to evaluate the safety, tolerability, and immunogenicity of one or two doses of CAIV-T in children and adolescents between 6 and 17 years of age. Subjects were allocated to one of three study groups according to age at the time of enrollment: study group one consisted of subjects between 6 and 9 years of age, group two of subjects 10 to 12 years of age, and group three of subjects 13 to 17 years of age.
Approximately 450 subjects (ie, 150 subjects per age group) participated in the study and were scheduled to receive two intranasal doses of CAIV-T separated by 35 ± 7 days in an open-label manner.
|University of Antwerp|
|Antwerp, Belgium, 2610|
|Leuven, Belgium, 3000|
|Oulu University Hospital|
|Oulu, Finland, 90220|
|Study Director:||Raburn Mallory, MD||MedImmune LLC|