← Eichor
Study identifier: NCT06955728 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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.

Condition: RSV Infections · RSV Immunisation · Preterm Labour  ·  Sponsor: University of Witwatersrand, South Africa

PhasePhase 3
Planned participants13000
Who can joinFemale, 14 Years to 55 Years
Healthy volunteersYes

About this study

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-infections in the lower respiratory tract (in the lungs and below the voice box) of which 3,6 million people were hospitalised and 26,300 passed away in hospital due to RSV. Almost half (50%) of deaths that are caused by RSV, happen in children younger than 6 months old and the majority (more than 95%) of these deaths happen to infants and children in low- and middle-income countries. A way that can help protect babies from becoming infected is through giving vaccines against the germ (RSV) that is targeted for prevention. There are currently no registered vaccines that can be given directly to babies however there is a lot of information available that shows that a vaccine can be safely giving to a mother while she is still pregnant. The mother then produces antibodies (protection cells) that is transferred to the baby before the baby is born, and the baby is protected from getting sick during the first few months of life. One of the vaccines that has been developed (ABRYSVO) has been used in many clinical trials in pregnant moms (and older people) to test if it is safe and will prot…

This description comes directly from the study's public registry record.

Talk to the study team

Lisa Nunes  ·  +27119834283  ·  lisa.nunes@wits-vida.org

Anthonet Koen  ·  +27119834283  ·  anthonet.koen@wits-vida.org

Always discuss trial participation with your own doctor first.

Locations (11)

Kintampo Health Research CentreKintampo, Bono East, GhanaNot Yet Recruiting
Dodowa Health Research CentreDodowa, Greater Accra Region, GhanaNot Yet Recruiting
Kenya Medical Research Institute Wellcome TrustKilifi, Kilifi County, KenyaNot Yet Recruiting
Kenya Medical Research Institute Centre for Global Health ResearchKisumu, Nyanza, KenyaRecruiting
Wits RHI Shandukani CRSHillbrow, Gauteng, South AfricaRecruiting
VIDA Nkanyezi Research UnitJohannesburg, Gauteng, South AfricaRecruiting
Setshaba Research CentreSoshanguve, Gauteng, South AfricaRecruiting
Wits Vaccines & Infectious Diseases Analytics (VIDA) Research unitSoweto, Gauteng, South AfricaRecruiting
Enhancing Care FoundationDurban, KwaZulu-Natal, South AfricaRecruiting
MRC Unit on Child and Adolescent HealthRondebosch, Western Cape, South AfricaRecruiting
MRC Unit The Gambia at London School of Hygiene & Tropical MedicineBasse Santa Su, Upper River Division, The GambiaRecruiting

Follow this study

Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.

We email about this public record only. Unsubscribe anytime with one click. Never medical advice.

Is this your study? This page was generated automatically from the public registry record. Sponsors can claim it — free — to add branding and verified contact routing. Claim this page →

This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.

Source record: clinicaltrials.gov/study/NCT06955728