A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Investigational Unadjuvanted RSV Maternal Vaccine Compared to Placebo When Administered to Healthy Non-pregnant Women.
Status: Completed
Location: See all (11) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The purpose of this study is to evaluate different dose levels of the investigational RSV maternal vaccine (GSK3888550A) based on safety/reactogenicity and immune response data. As this is the first time the investigational RSV maternal vaccine (GSK3888550A) is being been used in humans, this study will be performed in healthy non-pregnant women 18-45 years of age before testing in pregnant women.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:
• Subjects who the investigator believes will comply with the requirements of the protocol (e.g. completion of the diary cards/questionnaires, return for follow-up visits, have regular contact to allow evaluation during the study);
• Written informed consent obtained from the subject;
• Healthy female subjects; as established by medical history and clinical examination, aged 18 to 45 years at the time of the vaccination;
• Female subjects of childbearing potential may be enrolled in the study, if the subject:
‣ has practiced adequate contraception for 30 days prior to vaccination, and
⁃ has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception until 90 days after vaccination
Locations
United States
Kansas
GSK Investigational Site
Lenexa
New York
GSK Investigational Site
Rochester
Other Locations
Finland
GSK Investigational Site
Helsinki
GSK Investigational Site
Tampere
GSK Investigational Site
Turku
GSK Investigational Site
Turku
Germany
GSK Investigational Site
Goch
GSK Investigational Site
Hamburg
GSK Investigational Site
Hannover
GSK Investigational Site
Mainz
GSK Investigational Site
Wuerzburg
Time Frame
Start Date:2018-10-30
Completion Date:2019-09-02
Participants
Target number of participants:502
Treatments
Experimental: RSV MAT formulation 1 Group
Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Experimental: RSV MAT formulation 2 Group
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Experimental: RSV MAT formulation 3 Group
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
Placebo_comparator: Control Group
Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm