Phase 3
N=1,539
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.
Respiratory Syncytial Virus Infections
Bottom Line
View on ClinicalTrials.gov: NCT05045144 ↗Enrolled (actual)
1,539
Serious AEs
0.8%
Results posted
Oct 2023
Primary outcome: Primary: Percentage of Participants Reporting Solicited Administration Site Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group — 53.6; 51.1; 34.4; 4.4 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- RSVPreF3(120 μg) (Combination_product); Flu Quadrivalent influenza vaccine (15 μg HA) (Combination_product); Placebo (Combination_product)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Reporting Solicited Administration Site Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group |
53.6; 51.1; 34.4; 4.4; 3.7; 0.5 | — |
| PRIMARY Percentage of Participants Reporting Solicited Systemic Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group |
52; 59.8; 51.9; 47.6; 51.4; 43.1 | — |
| PRIMARY Percentage of Participants Reporting Unsolicited Adverse Events (AEs) in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group |
26.6; 30.1; 25.7 | — |
| PRIMARY Percentage of Participants Reporting Serious Adverse Events (SAEs) in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group |
0.2; 0; 0.2 | — |
| PRIMARY Percentage of Participants Reporting SAEs in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group |
0.8; 0.9; 0.9 | — |
| PRIMARY RSV MAT Immunoglobulin G (IgG) Enzyme-Linked Immunosorbent Assay (ELISA) Concentrations for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 31 |
102811.0; 100635.8; 108709.3 | — |
| PRIMARY Flu D-QIV Haemagglutinin Inhibition (HI) Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 31 |
301.6; 421.3; 30.7; 33.0; 56.2; 69.9 | — |
| SECONDARY RSV A Neutralizing Antibody Titers for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31 |
721.6; 707.2; 8900.9; 7761.6 | — |
| SECONDARY Seroconversion Rate (SCR) to Flu D-QIV HI Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 31 |
42.5; 45.9; 25.4; 29.5; 31.4; 35.5 | — |
| SECONDARY RSV B Neutralizing Antibody Titers for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31 |
967.4; 940.1; 11030.5; 9162.3 | — |
| SECONDARY RSV MAT IgG Concentrations for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31 |
5522.7; 5772; 104025.1; 83937 | — |
| SECONDARY Flu D-QIV HI Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 1 and Day 31 |
92.2; 110.3; 301.6; 421.3; 11.7; 10.3 | — |
| SECONDARY Seroprotection Rate (SPR) to Flu D-QIV HI Antibody Titers for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 1 and Day 31 |
78.7; 82.8; 98; 98.5; 19.7; 16.9 | — |
| SECONDARY RSV A Neutralizing Antibody Titers for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 1 and Day 31 |
727.5; 758.4; 680.2; 8545.5; 8760.3; 9409.2 | — |
| SECONDARY RSV B Neutralizing Antibody Titers for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 1 and Day 31 |
895; 1030.3; 979.7; 10457; 11107.2; 11543.3 | — |
| SECONDARY RSV MAT IgG Concentrations for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 1 and Day 31 |
5691.9; 5613; 5270.1; 102811; 100635.8; 108709.3 | — |
Summary
The purpose of this study is to evaluate the clinical lot-to-lot consistency of the respiratory syncytial virus (RSV) maternal (RSV MAT) vaccine administered to healthy non-pregnant women 18-49 years of age (YOA). In addition, this study will evaluate immunogenicity, safety and reactogenicity from co-administration of RSV MAT vaccine and GSK's quadrivalent seasonal influenza (Flu D-QIV) vaccine.
Eligibility Criteria
Inclusion Criteria
- Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- 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
Medical conditions
- 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 pr
Data sourced from ClinicalTrials.gov (NCT05045144). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.