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A Phase II, Observer-Blind, Randomized, Multi-center Study to Evaluate the Safety and Immunogenicity of Two 0.25 mL or 0.5 mL Doses of Investigational Vaccine and Active Influenza Vaccine in Healthy Children Aged 6 to <60 Months
This a multicenter phase II trial will evaluate safety and immunogenicity of two 0.25 mL or 0.5 mL doses of investigational influenza vaccine and active control influenza vaccine in healthy children aged 6 to \<60 months.
Details
| Lead sponsor | Novartis |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 360 |
| Start date | 2008-01 |
| Completion | 2008-10 |
Conditions
- Influenza
Interventions
- Influenza Trivalent Inactivated vaccines Novartis
- Influenza Trivalent Inactivated vaccines
Primary outcomes
- To evaluate the safety and tolerability of one and two doses of investigational vaccines or active control influenza vaccine in unprimed healthy children aged 6 months to <36 months. — 211 days
Countries
Guatemala