WHO ICTRP trial
A Study to Evaluate the Efficacy of Maternal Immunization with RSV F Vaccine in…
EUCTR2016-002302-39-GB · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2016-002302-39-GB |
|---|---|
| Public title | A Study to Evaluate the Efficacy of Maternal Immunization with RSV F Vaccine in Preventing RSV Lower Respiratory Tract Infection in Young Infants |
| Scientific title | A Phase 3, Randomized, Observer-Blind, Placebo-Controlled, Group-Sequential Study to Determine the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) F Nanoparticle Vaccine with Aluminum in Healthy Third-trimester Pregnant Women; and Safety and Efficacy of Maternally Transferred… |
| Primary sponsor | Novavax, Inc. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | United States;Philippines;Mexico;Argentina;Spain;Australia;Chile;South Africa;New Zealand;United Kingdom;India |
| Conditions | Respiratory syncytial virus (RSV) is the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide. In industrialized countries, nearly all children have been infected with RSV by 2 years of age… |
| Interventions | Product Name: Adjuvanted RSV F Vaccine Pharmaceutical Form: Solution for injection INN or Proposed INN: RESPIRATORY SYNCYTIAL VIRUS FUSION PROTEIN Other descriptive name: RESPIRATORY SYNCYTIAL VIRUS FUSION PROTEIN Concentration unit: µg… |
| Registration date | Jul 21, 2016 |
| Target size | 8618 |
| Secondary IDs | RSV-M-301;NCT02624947 |
| Registry page | clinicaltrialsregister.eu |
At a glance
- No Results available
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: