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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00192270|
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : March 6, 2012
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Biological: CAIV-T||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||498 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2000|
|Primary Completion Date :||January 2001|
|Study Completion Date :||January 2001|
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
- The number of subjects achieving strain-specific hemagglutination inhibition (HAI) antibody seroconversion post Dose 1 [ Time Frame: Day 0, Day 35 post Dose 1 ]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 ]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 ]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 ]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 ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00192270
|University of Antwerp|
|Antwerp, Belgium, 2610|
|Leuven, Belgium, 3000|
|Oulu University Hospital|
|Oulu, Finland, 90220|
|Study Director:||Raburn Mallory, MD||MedImmune LLC|