A Phase III, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Reactogenicity and Immune Response of a Single Intramuscular Dose of Unadjuvanted RSV Maternal Vaccine, in High Risk Pregnant Women Aged 15 to 49 Years and Infants Born to the Vaccinated Mothers
ClinicalTrials.gov processed this data on January 11, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
TERMINATED - HAS RESULTS(See Contacts and Locations)
Verified January 2024 by GlaxoSmithKline
Sponsor
GlaxoSmithKlineInformation Provided by (Responsible Party)
GlaxoSmithKlineClinicaltrials.gov Identifier
NCT04980391Other Study ID Numbers: 214725
First Submitted: July 20, 2021
First Posted: July 28, 2021
Results First Posted: February 6, 2024
Last Update Posted: February 6, 2024
Last Verified: January 2024
History of Changes
Listing a study on this site does not mean it has been evaluated by the U.S. Federal Government. The safety and scientific validity of a study listed on ClinicalTrials.gov is the responsibility of the study sponsor and investigators. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
ClinicalTrials.gov, a resource provided by the U.S. National Library of Medicine (NLM), is a registry and results information database of clinical research studies sponsored or funded by a broad range of public and private organizations around the world. Not all studies listed on ClinicalTrials.gov are funded by the National Institutes of Health (NIH) or other agencies of the U.S. Federal Government. Not all listed studies are regulated and/or reviewed by the U.S. Food and Drug Administration or other governmental entities.
Information on ClinicalTrials.gov is provided by study sponsors and investigators, and they are responsible for ensuring that the studies follow all applicable laws and regulations. NLM staff do not verify the scientific validity or relevance of the submitted information beyond a limited quality control review for apparent errors, deficiencies, or inconsistencies.
Choosing to participate in a study is an important personal decision. Before you participate in a study, discuss all options with your health care provider and other trusted advisors. For more information about participating in clinical studies, see Learn About Clinical Studies, which includes questions that you might want to ask before deciding to participate in a study.
For more information about using the information on ClinicalTrials.gov, please also see Terms and Conditions.
See also the Web Policies and Notices for the NIH web site.
Tracking Information | |
---|---|
First Submitted Date | July 20, 2021 |
First Posted Date | July 28, 2021 |
Results First Submitted Date | November 28, 2023 |
Results First Posted Date | February 6, 2024 |
Last Update Posted Date | February 6, 2024 |
Study Start Date | August 3, 2021 |
Actual Primary Completion Date | May 30, 2023 |
Current Primary Outcome Measures(submitted: January 11, 2024) |
|
Change History | Complete list of historical versions of study NCT04980391 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures |
|
Current Other Outcome Measures | Not Provided |
Descriptive Information | |
---|---|
Brief Title | A Study on the Safety and Immune Response to an Unadjuvanted RSV Maternal Vaccine, in High Risk Pregnant Women Aged 15 to 49 Years and Infants Born to the Vaccinated Mothers |
Official Title | A Phase III, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Reactogenicity and Immune Response of a Single Intramuscular Dose of Unadjuvanted RSV Maternal Vaccine, in High Risk Pregnant Women Aged 15 to 49 Years and Infants Born to the Vaccinated Mothers |
Brief Summary | The purpose of this study was to evaluate the safety, reactogenicity and immune response of a single intramuscular dose of the respiratory syncytial virus (RSV) maternal vaccine compared to placebo, when administered in the second or third trimester of pregnancy in women, 15 to 49 years of age (YOA), with high risk pregnancies and in the infants born to the vaccinated mothers. Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in the study. Ongoing study participants at that time continued to be monitored as part of the study. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: RandomizedInterventional Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Prevention |
Target Follow-Up Duration | Not Provided |
Biospecimen | Not Provided |
Sampling Method | Not Provided |
Study Population | Not Provided |
Condition |
|
Intervention | Biological: RSV MAT Single dose of the RSV MAT vaccine reconstituted with NaCl solution, administered intramuscularly in the non-dominant arm, at Day 1. |
Study Groups/Cohorts | Experimental: RSV_MAT GroupMaternal participants randomized to the RSV_MAT Group received a single dose of the RSV MAT vaccine administered, between 24 and 36 weeks of gestation, at Day 1 in this study. Intervention:
Placebo Comparator: Control GroupMaternal participants randomized to the Control Group received a single dose of Placebo administered, between 24 and 36 weeks of gestation, at Day 1 in this study. Intervention:
No Intervention: RSV_MAT Group-InfantThis group consisted of infants born to mothers (from RSV_MAT Group-Mother) who received a single dose of RSV MAT vaccine during pregnancy. No Intervention: Control Group-InfantThis group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy. |
Publications * | Not Provided |
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
Recruitment Information | |
---|---|
Recruitment Status | Terminated |
Actual Enrollment(submitted: January 11, 2024) | 384 |
Actual Study Completion Date | May 30, 2023 |
Actual Primary Study Completion Date | May 30, 2023 |
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
|
Sex/Gender | Sexes Eligible for Study: Female |
Ages | 15 Years to 49 Years (Child, Adult) |
Accepts Healthy Volunteers | Yes |
Contacts | Contact information is only displayed when the study is recruiting subjects |
Listed Location Countries | United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, Brazil, Brazil, Brazil, Canada, Canada, Canada, Finland, India, India, Italy, Italy, Italy, Panama, Panama, South Africa, Spain, Spain, Spain, Spain, Spain, Spain |
Administrative Information | |
---|---|
NCT Number | NCT04980391 |
Other Study ID Numbers | 214725 |
Has Data Monitoring Committee | Yes |
U.S FDA-regulated Product | Studies a U.S. FDA-regulated Drug Product: Yes Studies a U.S. FDA-regulated Device Product: No Product Manufactured in and Exported from the U.S.: No |
IPD Sharing Statement | Plan to Share IPD: Yes |
Responsible Party | GlaxoSmithKline, GlaxoSmithKline |
Study Sponsor | GlaxoSmithKline |
Collaborators | Not Provided |
Investigators | |
PRS Account | GlaxoSmithKline |
Verification Date | January 2024 |