A Clinical Trial on Safety in Pregnant Women and How Well the Infant is Protected Against RSV-associated Lower Respiratory Tract Infection When the Pregnant Woman Receives the Approved RSV Vaccine Compared to a Placebo.
Recruiting
Phase 3
Interventional Study
RSV Infections
RSV Immunisation
Preterm Labour
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 14 – 55
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 13,000 (estimated)
- Sponsor
- University of Witwatersrand, South Africa · Other
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About This Trial
Respiratory syncytial virus (RSV) is a virus that often affects children during childhood. Even though most cases of RSV are mild, it can cause serious disease and even death - especially in very young babies, babies born too early and those born with heart and lung problems. It is the most common cause for children under 5 years old to be hospitalised. In 2019, there were about 33 million RSV-inf…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Pregnant women considered to be legally competent, as per country legislation, to consent for trial participation for herself and her newborn
* At a gestational age in keeping with in-country approval of the vaccine administration, and not in active labour. Gestational age wil…
Contacts