A Phase III Study to Assess the Lot-to-lot Consistency of GSK's Investigational RSV Maternal Vaccine and the Immune Response and Safety of RSV Maternal Vaccine When Given Alone or Co-administered With GSK's Influenza D-QIV Vaccine in Healthy Non-pregnant Women.
NCT ID: NCT05045144
Last Updated: 2023-10-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1586 participants
INTERVENTIONAL
2021-10-26
2022-06-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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RSV lot1 Group
Participants randomized to the RSV lot1 Group received one dose of RSV MAT Lot 1 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care.
RSVPreF3(120 μg)
A single dose of RSVPreF3(120 μg) combined with Sodium Chloride (NaCl) was administrated intramuscular (IM). There were used 3 different lots of RSVPreF3(120 μg), one for each individual group (RSV lot1 Group, RSV lot2 Group and RSV lot3 Group) considered under RSV pooled Group.
RSV lot2 Group
Participants randomized to the RSV lot2 Group received one dose of RSV MAT Lot 2 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care.
RSVPreF3(120 μg)
A single dose of RSVPreF3(120 μg) combined with Sodium Chloride (NaCl) was administrated intramuscular (IM). There were used 3 different lots of RSVPreF3(120 μg), one for each individual group (RSV lot1 Group, RSV lot2 Group and RSV lot3 Group) considered under RSV pooled Group.
RSV lot3 Group
Participants randomized to the RSV lot3 Group received one dose of RSV MAT Lot 3 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care.
RSVPreF3(120 μg)
A single dose of RSVPreF3(120 μg) combined with Sodium Chloride (NaCl) was administrated intramuscular (IM). There were used 3 different lots of RSVPreF3(120 μg), one for each individual group (RSV lot1 Group, RSV lot2 Group and RSV lot3 Group) considered under RSV pooled Group.
RSV+Flu pooled Group
Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181).
The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines.
Flu Quadrivalent influenza vaccine (15 μg HA)
A single dose of Flu Quadrivalent influenza (15 μg HA) vaccine was administrated intramuscular (IM).
Flu+Placebo Group
Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181).
This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group.
Flu Quadrivalent influenza vaccine (15 μg HA)
A single dose of Flu Quadrivalent influenza (15 μg HA) vaccine was administrated intramuscular (IM).
Placebo
One dose of placebo, administered intramuscularly in the deltoid region of the right arm, at Day 1.
Interventions
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RSVPreF3(120 μg)
A single dose of RSVPreF3(120 μg) combined with Sodium Chloride (NaCl) was administrated intramuscular (IM). There were used 3 different lots of RSVPreF3(120 μg), one for each individual group (RSV lot1 Group, RSV lot2 Group and RSV lot3 Group) considered under RSV pooled Group.
Flu Quadrivalent influenza vaccine (15 μg HA)
A single dose of Flu Quadrivalent influenza (15 μg HA) vaccine was administrated intramuscular (IM).
Placebo
One dose of placebo, administered intramuscularly in the deltoid region of the right arm, at Day 1.
Eligibility Criteria
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Inclusion Criteria
* Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any study specific procedure.
* Healthy female participants; as established by medical history and clinical examination, aged 18 to 49 years at the time of the first study intervention administration.
* Female participants of childbearing potential may be enrolled in the study, if the participant:
* has practiced adequate contraception for 1 month prior to study intervention administration, and
* has a negative pregnancy test on the day of study intervention administration, and
* has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the study intervention administration.
* No local condition precluding injection in both left and right deltoid muscles.
Exclusion Criteria
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions;
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination;
* Current autoimmune disorder, for which the participant has received immune-modifying therapy within 6 months, before study vaccination;
* Hypersensitivity to latex;
* Acute or chronic clinically significant abnormality or poorly controlled pre-existent co-morbidities or any other clinical conditions, as determined by physical examination or medical history that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study;
* Significant or uncontrolled psychiatric illness;
* Recurrent history or uncontrolled neurological disorders or seizures;
* Documented HIV-positive participant;
* Body mass index \> 40 kg/m\^2;
* Any clinically significant\* hematological parameter and/or biochemical laboratory abnormality.
\*The investigator should use his/her clinical judgment to decide which abnormalities are clinically significant.
* Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
Prior/Concomitant therapy
* Use of any investigational or non-registered product other than the study intervention(s) during the period starting 30 days before study intervention (Day -29 to Day 1), or planned use during the study period;
* Administration of long-acting immune-modifying drugs at any time during the study period;
* Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the study intervention or planned administration during the study period;
* Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first study intervention dose(s). For corticosteroids, this will mean prednisone 5 mg/day, or equivalent. Inhaled and topical steroids are allowed;
* Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after the vaccination dose;
* Administration of a seasonal influenza vaccine during the 6 months preceding entry into the study;
* Previous experimental vaccination against RSV.
Prior/Concurrent clinical study experience Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product;
Other exclusions
* Pregnant or lactating female;
* Female planning to become pregnant or planning to discontinue contraceptive precautions;
* Alcoholism or substance use disorder within the past 24 months based on the presence of two or more of the following abuse criteria: hazardous use, social/interpersonal problems related to use, neglected major roles to use, withdrawal tolerance, use of larger amounts or longer, repeated attempts to quit or control use, much time spent using, physical or psychological problems related to use, activities given up to use, craving;
* Any study personnel or their immediate dependents, family, or household members.
18 Years
49 Years
FEMALE
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
West Palm Beach, Florida, United States
GSK Investigational Site
Stockbridge, Georgia, United States
GSK Investigational Site
Peoria, Illinois, United States
GSK Investigational Site
Springfield, Missouri, United States
GSK Investigational Site
Seattle, Washington, United States
GSK Investigational Site
Surrey, British Columbia, Canada
GSK Investigational Site
Vancouver, British Columbia, Canada
GSK Investigational Site
Truro, Nova Scotia, Canada
GSK Investigational Site
London, Ontario, Canada
GSK Investigational Site
Sarnia, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Mirabel, Quebec, Canada
GSK Investigational Site
Pointe-Claire, Quebec, Canada
GSK Investigational Site
Québec, Quebec, Canada
GSK Investigational Site
Saint-Charles-Borromée, Quebec, Canada
GSK Investigational Site
Sherbrooke, Quebec, Canada
GSK Investigational Site
Espoo, , Finland
GSK Investigational Site
Helsinki, , Finland
GSK Investigational Site
Helsinki, , Finland
GSK Investigational Site
Järvenpää, , Finland
GSK Investigational Site
Kokkola, , Finland
GSK Investigational Site
Pori, , Finland
GSK Investigational Site
Seinäjoki, , Finland
GSK Investigational Site
Tampere, , Finland
GSK Investigational Site
Turku, , Finland
GSK Investigational Site
Gyeonggi-do, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Alcorcón/Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Majadahonda (Madrid), , Spain
GSK Investigational Site
Santiago de Compostela, , Spain
GSK Investigational Site
Valencia, , Spain
Countries
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References
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Chime N, Anspach B, Jain V, Laajalahti O, Ollinger T, Yaplee D, Kim JH. Phase 3 Study Assessing Lot-to-Lot Consistency of Respiratory Syncytial Virus Prefusion Protein F3 Vaccine and Its Immune Response, Safety, and Reactogenicity When Co-administered With Quadrivalent Influenza Vaccine. J Infect Dis. 2025 Feb 4;231(1):e144-e153. doi: 10.1093/infdis/jiae342.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2021-000357-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
214709
Identifier Type: -
Identifier Source: org_study_id
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