drugset / Trial / NCT00644540

Immunogenicity and Safety Following a Single Dose of Influenza Vaccines in Healthy Children Who Received Either One or the Other Vaccine (an Adjuvanted Sub-unit Influenza Vaccine and a Non-adjuvanted Split Virion Influenza Vaccine) in the Previous V70P2 Study

NCT00644540 ↗

Phase 2 Completed 89 enrolled Novartis Vaccines
RandomizedParallel-groupSingle-blindPrevention

Summary

The purpose of this research is to evaluate the immunogenicity of a single dose of Influenza Vaccines (0.5mL or 0.25mL) in healthy children aged up to 35 months or 36 up to 48 months. To evaluate the safety and tolerability of a single 0.25mL IM of injection influenza vaccines in healthy children aged up to 35 months; to evaluate the safety and tolerability of a single 0.50mL IM injection of influenza vaccines in healthy children aged up to 48 months.

Timeline

Start
2007-11
Primary completion
2008-01
Completion
2008-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Adjuvanted Sub-unit Influenza Vaccine Vaccine 0.25 ml Intramuscular
Comparator Adjuvanted Sub-unit Influenza Vaccine Vaccine 0.5 ml Intramuscular
Comparator Non-adjuvanted Split Virion Influenza Vaccine Vaccine 0.25 ml Intramuscular
Comparator Non-adjuvanted Split Virion Influenza Vaccine Vaccine 0.5 ml Intramuscular

Indications