Trials / Completed
CompletedNCT00192257
Trial to Compare the Safety, Tolerability and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Influenza Virus in Children With Asthma
A Prospective, Randomized, Open-Label, Controlled Trial to Compare the Safety, Tolerability and Efficacy of Influenza Virus Vaccine, Trivalent, Type A&B, Live, Cold-Adapted (CAIV-T) With Influenza Virus Vaccine, Trivalent, Inactivated (TIV) in Children With Asthma Aged 6 Years to 17 Years
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2,229 (planned)
- Sponsor
- MedImmune LLC · Industry
- Sex
- All
- Age
- 6 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
\- Trial to assess asthma exacerbation through to the end of the study; and to demonstrate that the efficacy over one season against culture-confirmed influenza-illness; and finally to assess the safety and tolerability of CAIV-T in children with asthma.
Detailed description
\- To assess asthma exacerbation, being defined as acute wheezing illness associated with hospitalization, unscheduled clinic visits, or new prescriptions from study vaccination through to the end of the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CAIV-T and TIV |
Timeline
- Start date
- 2002-10-01
- Completion
- 2003-05-01
- First posted
- 2005-09-19
- Last updated
- 2006-10-03
Locations
2 sites across 1 country: Belgium
Source: ClinicalTrials.gov record NCT00192257. Inclusion in this directory is not an endorsement.