Recruitment Status:
Pending
Project Description:
GSK is developing an investigational Respiratory Syncytial Virus (RSV) vaccine foradministration to pregnant women, with the aim of preventing medically assessed, RSV-associatedlower respiratory tract illnesses (LRTIs) in their infants by transfer of maternalantibodies. The vacc . . .
Primary Sponsor:
GlaxoSmithKline Philippines, Inc.
Study Type:
Interventional
Date of Registration:
15 February 2021
Date of FIrst Enrollment:
05 April 2021
Method of Allocation:
Randomized
FDA Clinical Trial Reference (CTR) Number:
2020-CT0584
Sources of Monetary or Material Support:
GlaxoSmithKline Biologicals
Primary Outcomes:
From birth (Visit 1-NB) to 6 months (Visit 4-NB), occurrencesof medically assessed, RSV-associated severe (includingvery severe) LRTIs according to the case definitions.
or
From birth (Visit 1-NB) to 6 months (Visit 4-NB), occurrencesof any medically assessed, RS . . .
Key Inclusion and Exclusion Criteria:
Maternal participants must satisfy all the following criteria at study entry:• Participants who, in the opinion of the investigator, can and will comply with therequirements of the protocol (e.g. completion of diaries, return for follow-up visits).• Participants who give wri . . .
Countries of Recruitment:
Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Colombia, Finland, France, India, Italy, Mexico, New Zealand, Panama, Philippines, Russia, South Africa, South Korea, Spain, Taiwan, Thailand, United Kingdom, United States
Health Condition(s) or Problem(s) Studied:
Respiratory Syncytial Virus (RSV)-associated Lower Respiratory Tract Illness (LRTI)