drugset / Trial / NCT02228980
Study of a Single Dose or Two Doses of a Trivalent Inactivated Influenza Vaccine Produced at Shenzhen, China
Non-randomizedParallel-groupOpen-labelPrevention
Summary
The main purpose of this trial is to describe the product profile in terms of immunogenicity and safety following administration of trivalent influenza vaccine (split-virion, inactivated) produced at Shenzhen (SP Shz TIV). Primary objective: * To describe in each group the immune response induced by a single dose (subjects aged ≥ 3 years) or by two doses (subjects aged 6 to 35 months) of SP Shz-TIV. Secondary objective: * To describe in each group the safety profile of the vaccine after a single dose (subjects aged ≥ 3 years) or after each and any dose administered (subjects aged 6-35 months).
Timeline
- Start
- 2014-09
- Primary completion
- 2014-12
- Completion
- 2015-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SP Shz TIV | Vaccine | 0.25 ml | Intramuscular |
| Subject | SP Shz TIV | Vaccine | 0.5 ml | Intramuscular |