drugset / Trial / NCT01040078
Novel Influenza A/H1N1 Split- Virion Vaccine in Healthy Children Aged 6 to 35 Month
RandomizedSingle-groupDouble-blindPrevention
Summary
The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration.
Timeline
- Start
- 2009-12
- Primary completion
- 2010-02
- Completion
- 2010-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | H1N1 Influenza vaccine | Vaccine | 7.5 ug | Intramuscular |
| Subject | H1N1 Influenza vaccine | Vaccine | 15 ug | Intramuscular |
| Comparator | Quadrivalent influenza vaccine | Vaccine | 0.5 ml | Intramuscular |