drugset / Trial / NCT01964989
Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to Approved Flu Vaccine in Children.
RandomizedParallel-groupQuadruple-blindPrevention
Summary
Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to \<72 Months of Age. The study was conducted during the 2013/2014 and 2014/2015 northern hemisphere influenza season.
Timeline
- Start
- 2013-11
- Primary completion
- 2015-10
- Completion
- 2016-08
Publications
- Esposito S, Fling J, Chokephaibulkit K, de Bruijn M, Oberye J, Zhang B, Vossen J, Heijnen E, Smolenov I. Immunogenicity and Safety of an MF59-adjuvanted Quadrivalent Seasonal Influenza Vaccine in Young Children at High Risk of Influenza-associated Complications: A Phase III, Randomized, Observer-blind, Multicenter Clinical Trial. Pediatr Infect Dis J. 2020 Aug;39(8):e185-e191. doi: 10.1097/INF.0000000000002727.
- Vesikari T, Kirstein J, Devota Go G, Leav B, Ruzycky ME, Isakov L, de Bruijn M, Oberye J, Heijnen E. Efficacy, immunogenicity, and safety evaluation of an MF59-adjuvanted quadrivalent influenza virus vaccine compared with non-adjuvanted influenza vaccine in children: a multicentre, randomised controlled, observer-blinded, phase 3 trial. Lancet Respir Med. 2018 May;6(5):345-356. doi: 10.1016/S2213-2600(18)30108-5. Epub 2018 Apr 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine | Vaccine | 0.25 ml | Intramuscular |
| Subject | Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine | Vaccine | 0.5 ml | Intramuscular |
| Comparator | Non-adjuvanted Trivalent Influenza Vaccine | Vaccine | 0.25 ml | Intramuscular |
| Comparator | Non-adjuvanted Trivalent Influenza Vaccine | Vaccine | 0.5 ml | Intramuscular |
| Comparator | Quadrivalent influenza vaccine | Vaccine | 0.25 ml | Intramuscular |
| Comparator | Quadrivalent influenza vaccine | Vaccine | 0.5 ml | Intramuscular |