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CompletedNCT05045144Updated Oct 5, 2023Results posted

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.

A Phase 3 interventional study of RSVPreF3(120 μg) and Flu Quadrivalent influenza vaccine (15 μg HA) in Respiratory Syncytial Virus Infections, sponsored by GlaxoSmithKline. Completed at 36 sites in 5 countries. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-05.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
1,586
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Respiratory Syncytial Virus Infections

Keywords

  • Respiratory Syncytial Virus Maternal vaccine
  • Flu Quadrivalent influenza vaccine
  • Lot-to-lot consistency
  • Immunogenicity
  • Safety
  • Reactogenicity
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 1,586 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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 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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,586 participants (actual)

Study arms

  • Experimental
    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.

    Combination Product: RSVPreF3(120 μg)

  • Experimental
    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.

    Combination Product: RSVPreF3(120 μg)

  • Experimental
    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.

    Combination Product: RSVPreF3(120 μg)

  • Experimental
    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.

    Combination Product: Flu Quadrivalent influenza vaccine (15 μg HA)

  • Active comparator
    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.

    Combination Product: Flu Quadrivalent influenza vaccine (15 μg HA) · Combination Product: Placebo

Interventions

  • Combination productRSVPreF3(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.

  • Combination productFlu Quadrivalent influenza vaccine (15 μg HA)

    A single dose of Flu Quadrivalent influenza (15 μg HA) vaccine was administrated intramuscular (IM).

  • Combination productPlacebo

    One dose of placebo, administered intramuscularly in the deltoid region of the right arm, at Day 1.

06

What researchers measure

Primary outcomes

  1. Percentage of Participants Reporting Solicited Administration Site Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group

    Assessed solicited administration site events include pain, erythema and swelling. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

    Time frame: From Day 1 to Day 7 (including Day 7)

  2. Percentage of Participants Reporting Solicited Systemic Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group

    Assessed solicited systemic events include fatigue, headache, gastrointestinal (GI) symptoms (nausea, vomiting, diarrhea, abdominal pain) and fever. The preferred location for measuring temperature was the oral cavity. Fever was defined as temperature equal to or above (≥) 38.0 °C/ 100.4°F. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

    Time frame: From Day 1 to Day 7 (including Day 7)

  3. Percentage of Participants Reporting Unsolicited Adverse Events (AEs) in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group

    An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

    Time frame: From Day 1 to Day 30 (including Day 30)

  4. Percentage of Participants Reporting Serious Adverse Events (SAEs) in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group

    An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or results i+F2n abnormal pregnancy outcomes. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

    Time frame: From Day 1 to Day 30 (including Day 30)

  5. Percentage of Participants Reporting SAEs in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group

    An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or results in abnormal pregnancy outcomes.This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

    Time frame: From first vaccination up to study end (Day 1 to Day 181)

  6. 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

    Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. RSV MAT IgG concentrations were expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EU/mL). As pre-specified in protocol, data reported in this outcome measure was presented only for individual RSV lot groups (RSV lot1, RSV lot2, RSV lot3), as the purpose was to analyze RSV MAT IgG ELISA concentrations, in order to demonstrate the lot-to-lot consistency of the vaccine lots.

    Time frame: At Day 31

  7. 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

    Flu D-QIV HI antibody titers against 3 influenza strains (A/Tasmania/503/2020 (H3N2) IVR-221; B/Washington/02/2019; B/Phuket/3073/2013) were expressed as geometric mean titers (GMTs), as assessed by HI assay. This objective analyzed the humoral immune response to the Flu D-QIV vaccine when given alone and co-administered with RSV MAT vaccine in terms of antibody titers against 3 influenza strains. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV+Flu Group and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

    Time frame: At Day 31

Secondary outcomes

  1. RSV A Neutralizing Antibody Titers for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31

    Serological assays for the determilnation of antibodies against RSV A were performed by neutralization assay. RSV A neutralizing antibody titers were expressed as geometric mean titers (GMTs), in serum dilution inducing 60% inhibition in plaque forming units (ED60). This objective analyzed the humoral immune response of RSV MAT vaccine when given alone and co-administered with Flu D-QIV in terms of RSV A neutralizing antibody. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups, since minimal differences were expected between participants who received different RSV lots of the vaccine.

    Time frame: At Day 1 and Day 31

  2. 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

    The SCR was defined as the percentage of participants with: a Day 1 (pre-vaccination) serum anti-HI titer \<1:10 and a Day 31 (post-vaccination) serum anti-HI titer ≥1:40, or a Day 1 (pre-vaccination) serum anti-HI titer ≥ 1:10 and a fold increase (post/pre) ≥ 4 at Day 31. The 3 influenza strains assessed were: A/Tasmania/503/2020 (H3N2) IVR-221; B/Washington/02/2019 and B/Phuket/3073/2013. This objective analyzed the seroconversion rate to the Flu D-QIV vaccine when given alone and co-administered with RSV MAT vaccine. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV+Flu group and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

    Time frame: At Day 31

  3. RSV B Neutralizing Antibody Titers for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31

    Serological assays for the determination of antibodies against RSV B were performed by neutralization assay. RSV B neutralizing antibody titers were expressed as GMTs, in ED60. This objective analyzed the humoral immune response of RSV MAT vaccine when given alone and co-administered with Flu D-QIV in terms of RSV B neutralizing antibody. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups, since minimal differences were expected between participants who received different RSV lots of the vaccine.

    Time frame: At Day 1 and Day 31

  4. RSV MAT IgG Concentrations for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31

    Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. RSV MAT IgG concentrations were expressed as GMCs, in EU/mL. This objective analyzed the humoral immune response of RSV MAT vaccine when given alone and co-administered with Flu D-QIV in terms of RSV MAT IgG concentrations. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups, since minimal differences were expected between participants who received different RSV lots of the vaccine.

    Time frame: At Day 1 and Day 31

  5. 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

    Flu D-QIV HI antibody titers against 3 influenza strains (A/Tasmania/503/2020 (H3N2) IVR-221;B/Washington/02/2019; B/Phuket/3073/2013) were expressed as geometric mean titers (GMTs), as assessed by HI assay. This objective analyzed the humoral immune response to the Flu D-QIV vaccine when given alone and co-administered with RSV MAT vaccine in terms of antibody titers against 3 influenza strains. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV+Flu Group and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

    Time frame: At Day 1 and Day 31

  6. 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

    SPR was measured by the percentage of participants achieving an HI antibody titer ≥1:40. This objective analyzed the seroprotection rate to the Flu D-QIV vaccine when given alone and co-administered with RSV MAT vaccine. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV+Flu Group and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

    Time frame: At Day 1 and Day 31

  7. RSV A Neutralizing Antibody Titers for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 1 and Day 31

    Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. RSV A neutralizing antibody titers were expressed as GMTs, in ED60. As pre-specified in protocol, data reported in this outcome measure was presented only for individual RSV lot groups (RSV lot1, RSV lot2, RSV lot3), as the purpose was to analyze the humoral immune response of RSV A neutralizing antibody titers, in order to demonstrate the lot-to-lot consistency of the vaccine lots.

    Time frame: At Day 1 and Day 31

  8. RSV B Neutralizing Antibody Titers for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 1 and Day 31

    Serological assays for the determination of antibodies against RSV B were performed by neutralization assay. RSV B neutralizing antibody titers were expressed as GMTs, in ED60. As pre-specified in protocol, data reported in this outcome measure was presented only for individual RSV lot groups (RSV lot1, RSV lot2, RSV lot3), as the purpose was to analyze the humoral immune response of RSV B neutralizing antibody titers, in order to demonstrate the lot-to-lot consistency of the vaccine lots.

    Time frame: At Day 1 and Day 31

  9. RSV MAT IgG Concentrations for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 1 and Day 31

    Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. RSV MAT IgG concentrations were expressed as GMCs, in EU/mL. As pre-specified in protocol, data reported in this outcome measure was presented only for individual RSV lot groups (RSV lot1, RSV lot2, RSV lot3), as the purpose was to analyze the RSV MAT IgG concentration, in order to demonstrate the lot-to-lot consistency of the vaccine lots.

    Time frame: At Day 1 and Day 31

07

Results

Posted Oct 5, 2023

Participant flow

Out of 1586 participants enrolled,47 participants did not receive vaccination as they did not meet the eligibility criteria or they were lost to follow up, therefore only 1539 participants were included in the Exposed Set and started the study.

Participant flow — Overall Study
MilestoneRSV lot1 GroupRSV lot2 GroupRSV lot3 GroupRSV+Flu Pooled GroupFlu+Placebo Group
Started220223218438440
Completed217220214433427
Not completed334513
Withdrew: Lost to follow-up323513
Withdrew: Withdrawal by subject01000
Withdrew: Migrated / moved from the study area00100

Outcome measures

PrimaryPercentage of Participants Reporting Solicited Administration Site Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group

Assessed solicited administration site events include pain, erythema and swelling. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

Time frame:
From Day 1 to Day 7 (including Day 7)
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting Solicited Administration Site Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group
Percentage of participantsRSV Pooled GroupRSV+Flu Pooled GroupFlu+Placebo Group
Pain53.6 (49.7 to 57.5)51.1 (46.4 to 55.9)34.4 (30 to 39)
Erythema4.4 (3 to 6.2)3.7 (2.1 to 5.9)0.5 (0.1 to 1.6)
Swelling4.5 (3.1 to 6.4)4.6 (2.8 to 7)0.9 (0.2 to 2.3)
PrimaryPercentage of Participants Reporting Solicited Systemic Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group

Assessed solicited systemic events include fatigue, headache, gastrointestinal (GI) symptoms (nausea, vomiting, diarrhea, abdominal pain) and fever. The preferred location for measuring temperature was the oral cavity. Fever was defined as temperature equal to or above (≥) 38.0 °C/ 100.4°F. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

Time frame:
From Day 1 to Day 7 (including Day 7)
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting Solicited Systemic Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group
Percentage of participantsRSV Pooled GroupRSV+Flu Pooled GroupFlu+Placebo Group
Fatigue52 (48.1 to 55.8)59.8 (55.1 to 64.4)51.9 (47.1 to 56.7)
Headache47.6 (43.7 to 51.5)51.4 (46.6 to 56.1)43.1 (38.4 to 47.8)
Nausea14.5 (11.9 to 17.5)15.3 (12.1 to 19)12.3 (9.4 to 15.7)
Vomiting2.3 (1.3 to 3.7)1.8 (0.8 to 3.6)2.3 (1.1 to 4.1)
Diarrhea12.1 (9.7 to 14.9)13 (10 to 16.5)17.1 (13.7 to 20.9)
Abdominal pain12 (9.6 to 14.7)13.5 (10.4 to 17)14.1 (11 to 17.7)
Temperature2.4 (1.4 to 3.9)3 (1.6 to 5)0.7 (0.1 to 2)
PrimaryPercentage of Participants Reporting Unsolicited Adverse Events (AEs) in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group

An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

Time frame:
From Day 1 to Day 30 (including Day 30)
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting Unsolicited Adverse Events (AEs) in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group
Percentage of participantsRSV Pooled GroupRSV+Flu Pooled GroupFlu+Placebo Group
Percentage of Participants Reporting Unsolicited Adverse Events (AEs) in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group26.6 (23.3 to 30.2)30.1 (25.9 to 34.7)25.7 (21.7 to 30)
PrimaryPercentage of Participants Reporting Serious Adverse Events (SAEs) in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group

An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or results i+F2n abnormal pregnancy outcomes. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

Time frame:
From Day 1 to Day 30 (including Day 30)
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting Serious Adverse Events (SAEs) in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group
Percentage of participantsRSV Pooled GroupRSV+Flu Pooled GroupFlu+Placebo Group
Percentage of Participants Reporting Serious Adverse Events (SAEs) in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group0.2 (0 to 0.8)0 (0 to 0.8)0.2 (0 to 1.3)
PrimaryPercentage of Participants Reporting SAEs in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group

An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or results in abnormal pregnancy outcomes.This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

Time frame:
From first vaccination up to study end (Day 1 to Day 181)
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting SAEs in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group
Percentage of participantsRSV Pooled GroupRSV+Flu Pooled GroupFlu+Placebo Group
Percentage of Participants Reporting SAEs in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group0.8 (0.2 to 1.8)0.9 (0.2 to 2.3)0.9 (0.2 to 2.3)
PrimaryRSV MAT Immunoglobulin G (IgG) Enzyme-Linked Immunosorbent Assay (ELISA) Concentrations for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 31

Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. RSV MAT IgG concentrations were expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EU/mL). As pre-specified in protocol, data reported in this outcome measure was presented only for individual RSV lot groups (RSV lot1, RSV lot2, RSV lot3), as the purpose was to analyze RSV MAT IgG ELISA concentrations, in order to demonstrate the lot-to-lot consistency of the vaccine lots.

Time frame:
At Day 31
Reported as:
Geometric mean · EU/mL
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
EU/mLRSV lot1 GroupRSV lot2 GroupRSV lot3 Group
RSV MAT Immunoglobulin G (IgG) Enzyme-Linked Immunosorbent Assay (ELISA) Concentrations for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 31102811.0 (95243.6 to 110979.6)100635.8 (92970.2 to 108933.4)108709.3 (101913.7 to 115958.0)
Statistical analysis
  • RSV lot1 Group vs RSV lot2 Group · GMC ratio · Gmc ratio: 1.02 · 95% CI 0.92 to 1.13
  • RSV lot1 Group vs RSV lot3 Group · GMC ratio · Gmc ratio: 0.95 · 95% CI 0.85 to 1.05
  • RSV lot2 Group vs RSV lot3 Group · GMC ratio · Gmc ratio: 0.93 · 95% CI 0.83 to 1.03
PrimaryFlu 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

Flu D-QIV HI antibody titers against 3 influenza strains (A/Tasmania/503/2020 (H3N2) IVR-221; B/Washington/02/2019; B/Phuket/3073/2013) were expressed as geometric mean titers (GMTs), as assessed by HI assay. This objective analyzed the humoral immune response to the Flu D-QIV vaccine when given alone and co-administered with RSV MAT vaccine in terms of antibody titers against 3 influenza strains. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV+Flu Group and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

Time frame:
At Day 31
Reported as:
Geometric mean · Titers
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
TitersRSV+Flu Pooled GroupFlu+Placebo Group
A/Tasmania/503/2020 (H3N2)301.6 (274.0 to 331.9)421.3 (383.4 to 463.0)
B/Washington/02/201930.7 (27.3 to 34.6)33.0 (29.3 to 37.2)
B/Phuket/3073/201356.2 (50.7 to 62.3)69.9 (62.6 to 77.9)
Statistical analysis
  • RSV+Flu Pooled Group vs Flu+Placebo Group · GMC ratio · Gmc ratio: 0.72 · 95% CI 0.63 to 0.82
  • RSV+Flu Pooled Group vs Flu+Placebo Group · GMC ratio · Gmc ratio: 0.93 · 95% CI 0.79 to 1.10
  • RSV+Flu Pooled Group vs Flu+Placebo Group · GMC ratio · Gmc ratio: 0.80 · 95% CI 0.69 to 0.93
SecondaryRSV A Neutralizing Antibody Titers for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31

Serological assays for the determilnation of antibodies against RSV A were performed by neutralization assay. RSV A neutralizing antibody titers were expressed as geometric mean titers (GMTs), in serum dilution inducing 60% inhibition in plaque forming units (ED60). This objective analyzed the humoral immune response of RSV MAT vaccine when given alone and co-administered with Flu D-QIV in terms of RSV A neutralizing antibody. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups, since minimal differences were expected between participants who received different RSV lots of the vaccine.

Time frame:
At Day 1 and Day 31
Reported as:
Geometric mean · Titers
RSV A Neutralizing Antibody Titers for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31
TitersRSV Pooled GroupRSV+Flu Pooled Group
Day 1721.6 (676.5 to 769.7)707.2 (653.4 to 765.5)
Day 318900.9 (8272.1 to 9577.5)7761.6 (7092.8 to 8493.6)
Statistical analysis
  • RSV Pooled Group vs RSV+Flu Pooled Group · GMC ratio · Gmc ratio: 0.87 · 95% CI 0.78 to 0.97
SecondarySeroconversion 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

The SCR was defined as the percentage of participants with: a Day 1 (pre-vaccination) serum anti-HI titer \<1:10 and a Day 31 (post-vaccination) serum anti-HI titer ≥1:40, or a Day 1 (pre-vaccination) serum anti-HI titer ≥ 1:10 and a fold increase (post/pre) ≥ 4 at Day 31. The 3 influenza strains assessed were: A/Tasmania/503/2020 (H3N2) IVR-221; B/Washington/02/2019 and B/Phuket/3073/2013. This objective analyzed the seroconversion rate to the Flu D-QIV vaccine when given alone and co-administered with RSV MAT vaccine. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV+Flu group and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

Time frame:
At Day 31
Reported as:
Number · Percentage of participants
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
Percentage of participantsRSV+Flu Pooled GroupFlu+Placebo Group
A/Tasmania/503/2020 (H3N2)42.5 (37.6 to 47.5)45.9 (41 to 50.9)
B/Washington/02/201925.4 (21.2 to 30)29.5 (25.1 to 34.2)
B/Phuket/3073/201331.4 (26.9 to 36.2)35.5 (30.8 to 40.4)
Statistical analysis
  • RSV+Flu Pooled Group vs Flu+Placebo Group · Miettinen and Nurminen · Difference of proportion: 3.44 · 95% CI -3.44 to 10.29
  • RSV+Flu Pooled Group vs Flu+Placebo Group · Miettinen and Nurminen · Difference of proportion: 4.15 · 95% CI -2.04 to 10.32
  • RSV+Flu Pooled Group vs Flu+Placebo Group · Miettinen and Nurminen · Difference of proportion: 4.08 · 95% CI -2.46 to 10.58
SecondaryRSV B Neutralizing Antibody Titers for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31

Serological assays for the determination of antibodies against RSV B were performed by neutralization assay. RSV B neutralizing antibody titers were expressed as GMTs, in ED60. This objective analyzed the humoral immune response of RSV MAT vaccine when given alone and co-administered with Flu D-QIV in terms of RSV B neutralizing antibody. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups, since minimal differences were expected between participants who received different RSV lots of the vaccine.

Time frame:
At Day 1 and Day 31
Reported as:
Geometric mean · Titers
RSV B Neutralizing Antibody Titers for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31
TitersRSV Pooled GroupRSV+Flu Pooled Group
Day 1967.4 (909.5 to 1028.9)940.1 (871 to 1014.6)
Day 3111030.5 (10344.5 to 11762)9162.3 (8483.3 to 9895.8)
SecondaryRSV MAT IgG Concentrations for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31

Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. RSV MAT IgG concentrations were expressed as GMCs, in EU/mL. This objective analyzed the humoral immune response of RSV MAT vaccine when given alone and co-administered with Flu D-QIV in terms of RSV MAT IgG concentrations. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups, since minimal differences were expected between participants who received different RSV lots of the vaccine.

Time frame:
At Day 1 and Day 31
Reported as:
Geometric mean · EU/mL
RSV MAT IgG Concentrations for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31
EU/mLRSV Pooled GroupRSV+Flu Pooled Group
Day 15522.7 (5285.7 to 5770.4)5772 (5455.8 to 6106.4)
Day 31104025.1 (99714.5 to 108522.2)83937 (79640.9 to 88464.9)
SecondaryFlu 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

Flu D-QIV HI antibody titers against 3 influenza strains (A/Tasmania/503/2020 (H3N2) IVR-221;B/Washington/02/2019; B/Phuket/3073/2013) were expressed as geometric mean titers (GMTs), as assessed by HI assay. This objective analyzed the humoral immune response to the Flu D-QIV vaccine when given alone and co-administered with RSV MAT vaccine in terms of antibody titers against 3 influenza strains. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV+Flu Group and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

Time frame:
At Day 1 and Day 31
Reported as:
Geometric mean · Titers
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
TitersRSV+Flu Pooled GroupFlu+Placebo Group
A/Tasmania/503/2020 (H3N2) , Day 192.2 (81.2 to 104.8)110.3 (97.2 to 125.1)
A/Tasmania/503/2020 (H3N2) , Day 31301.6 (274 to 331.9)421.3 (383.4 to 463)
B/Washington/02/2019 , Day 111.7 (10.6 to 13)10.3 (9.4 to 11.3)
B/Washington/02/2019 , Day 3130.7 (27.3 to 34.6)33 (29.3 to 37.2)
B/Phuket/3073/2013 , Day 121.2 (19 to 23.7)21.9 (19.6 to 24.5)
B/Phuket/3073/2013 , Day 3156.2 (50.7 to 62.3)69.9 (62.6 to 77.9)
SecondarySeroprotection 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

SPR was measured by the percentage of participants achieving an HI antibody titer ≥1:40. This objective analyzed the seroprotection rate to the Flu D-QIV vaccine when given alone and co-administered with RSV MAT vaccine. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV+Flu Group and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

Time frame:
At Day 1 and Day 31
Reported as:
Number · Percentage of participants
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
Percentage of participantsRSV+Flu Pooled GroupFlu+Placebo Group
A/Tasmania/503/2020 (H3N2) , Day 178.7 (74.5 to 82.4)82.8 (79 to 86.3)
A/Tasmania/503/2020 (H3N2) , Day 3198 (96.1 to 99.1)98.5 (96.8 to 99.5)
B/Washington/02/2019 , Day 119.7 (16.1 to 23.8)16.9 (13.5 to 20.8)
B/Washington/02/2019 , Day 3148 (43 to 53)48.8 (43.8 to 53.8)
B/Phuket/3073/2013 , Day 136.7 (32.2 to 41.4)39.8 (35.2 to 44.6)
B/Phuket/3073/2013 , Day 3174.4 (69.8 to 78.6)77.2 (72.8 to 81.2)
SecondaryRSV A Neutralizing Antibody Titers for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 1 and Day 31

Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. RSV A neutralizing antibody titers were expressed as GMTs, in ED60. As pre-specified in protocol, data reported in this outcome measure was presented only for individual RSV lot groups (RSV lot1, RSV lot2, RSV lot3), as the purpose was to analyze the humoral immune response of RSV A neutralizing antibody titers, in order to demonstrate the lot-to-lot consistency of the vaccine lots.

Time frame:
At Day 1 and Day 31
Reported as:
Geometric mean · Titers
RSV A Neutralizing Antibody Titers for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 1 and Day 31
TitersRSV lot1 GroupRSV lot2 GroupRSV lot3 Group
Day 1727.5 (652 to 811.6)758.4 (676.7 to 849.9)680.2 (607.4 to 761.7)
Day 318545.5 (7464.4 to 9783.2)8760.3 (7716.2 to 9945.8)9409.2 (8343.5 to 10611)
SecondaryRSV B Neutralizing Antibody Titers for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 1 and Day 31

Serological assays for the determination of antibodies against RSV B were performed by neutralization assay. RSV B neutralizing antibody titers were expressed as GMTs, in ED60. As pre-specified in protocol, data reported in this outcome measure was presented only for individual RSV lot groups (RSV lot1, RSV lot2, RSV lot3), as the purpose was to analyze the humoral immune response of RSV B neutralizing antibody titers, in order to demonstrate the lot-to-lot consistency of the vaccine lots.

Time frame:
At Day 1 and Day 31
Reported as:
Geometric mean · Titers
RSV B Neutralizing Antibody Titers for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 1 and Day 31
TitersRSV lot1 GroupRSV lot2 GroupRSV lot3 Group
Day 1895 (810.6 to 988.2)1030.3 (929.3 to 1142.3)979.7 (870.6 to 1102.4)
Day 3110457 (9258.5 to 11810.6)11107.2 (9984.4 to 12356.4)11543.3 (10377.6 to 12840.1)
SecondaryRSV MAT IgG Concentrations for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 1 and Day 31

Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. RSV MAT IgG concentrations were expressed as GMCs, in EU/mL. As pre-specified in protocol, data reported in this outcome measure was presented only for individual RSV lot groups (RSV lot1, RSV lot2, RSV lot3), as the purpose was to analyze the RSV MAT IgG concentration, in order to demonstrate the lot-to-lot consistency of the vaccine lots.

Time frame:
At Day 1 and Day 31
Reported as:
Geometric mean · EU/mL
RSV MAT IgG Concentrations for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 1 and Day 31
EU/mLRSV lot1 GroupRSV lot2 GroupRSV lot3 Group
Day 15691.9 (5276.8 to 6139.7)5613 (5197.8 to 6061.3)5270.1 (4883.6 to 5687.1)
Day 31102811 (95243.6 to 110979.6)100635.8 (92970.2 to 108933.4)108709.3 (101913.7 to 115958)

Adverse events

Collected over Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
RSV lot1 Group0/220 (0%)2/220 (0.9%)182/220 (82.7%)
RSV lot2 Group0/223 (0%)1/223 (0.4%)193/223 (86.5%)
RSV lot3 Group0/218 (0%)2/218 (0.9%)194/218 (89%)
RSV+Flu Pooled Group0/438 (0%)4/438 (0.9%)409/438 (93.4%)
Flu+Placebo Group0/440 (0%)4/440 (0.9%)396/440 (90%)
Most frequent serious events
Showing 10 of 15
Most frequent serious events
EventRSV lot1 GroupRSV lot2 GroupRSV lot3 GroupRSV+Flu Pooled GroupFlu+Placebo Group
Fibula fractureInjury, poisoning and procedural complications0/2200/2231/2180/4380/440
Cervical dysplasiaReproductive system and breast disorders0/2200/2231/2180/4380/440
Joint ankylosisMusculoskeletal and connective tissue disorders1/2200/2230/2180/4380/440
Suicidal ideationPsychiatric disorders1/2200/2230/2180/4380/440
Back painMusculoskeletal and connective tissue disorders0/2201/2230/2180/4380/440
Greater trochanteric pain syndromeMusculoskeletal and connective tissue disorders0/2201/2230/2180/4380/440
Intervertebral disc protrusionMusculoskeletal and connective tissue disorders0/2200/2230/2181/4380/440
OverdoseInjury, poisoning and procedural complications0/2200/2230/2181/4380/440
Suicide attemptPsychiatric disorders0/2200/2230/2181/4380/440
AppendicitisInfections and infestations0/2200/2230/2181/4380/440
Most frequent other events
Showing 10 of 172
Most frequent other events
EventRSV lot1 GroupRSV lot2 GroupRSV lot3 GroupRSV+Flu Pooled GroupFlu+Placebo Group
Administration site painGeneral disorders108/220131/223115/218360/438327/440
FatigueGeneral disorders110/220113/223121/218263/438230/440
HeadacheNervous system disorders110/220108/223108/218227/438196/440
DiarrhoeaGastrointestinal disorders29/22025/22328/21859/43877/440
NauseaGastrointestinal disorders34/22031/22332/21868/43854/440
Abdominal painGastrointestinal disorders25/22033/22325/21861/43863/440
Administration site swellingGeneral disorders9/22011/22310/21832/43814/440
Administration site erythemaGeneral disorders10/2209/22310/21818/4387/440
PyrexiaGeneral disorders6/2203/2238/21814/4383/440
NasopharyngitisInfections and infestations4/2204/2232/21813/43815/440

Baseline characteristics

Age, Continuous
Age, Continuous(YEARS)RSV lot1 GroupRSV lot2 GroupRSV lot3 GroupRSV+Flu Pooled GroupFlu+Placebo GroupTotal
Mean32.0 ± 9.631.4 ± 9.431.9 ± 9.332.0 ± 8.932.1 ± 8.931.9 ± 9.1
Sex: Female, Male
Sex: Female, Male(Participants)RSV lot1 GroupRSV lot2 GroupRSV lot3 GroupRSV+Flu Pooled GroupFlu+Placebo GroupTotal
Female2202232184384401539
Male000000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)RSV lot1 GroupRSV lot2 GroupRSV lot3 GroupRSV+Flu Pooled GroupFlu+Placebo GroupTotal
AMERICAN INDIAN OR ALASKA NATIVE24310726
ASIAN2225213843149
BLACK OR AFRICAN AMERICAN1236171755
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER000101
OTHER1433718
WHITE1831871853693661290
08

Study locations

36 sites
  • GSK Investigational Site
    West Palm Beach, Florida 33409, United States
  • GSK Investigational Site
    Stockbridge, Georgia 30281, United States
  • GSK Investigational Site
    Peoria, Illinois 61614, United States
  • GSK Investigational Site
    Springfield, Missouri 65802, United States
  • GSK Investigational Site
    Seattle, Washington 98105, United States
  • GSK Investigational Site
    Surrey, British Columbia V3S 2N6, Canada
  • GSK Investigational Site
    Vancouver, British Columbia V6Z 2T1, Canada
  • GSK Investigational Site
    Truro, Nova Scotia B2N 1L2, Canada
  • GSK Investigational Site
    London, Ontario N5W 6A2, Canada
  • GSK Investigational Site
    Sarnia, Ontario N7T 4X3, Canada
  • GSK Investigational Site
    Toronto, Ontario M9W 4L6, Canada
  • GSK Investigational Site
    Mirabel, Quebec J7J 2K8, Canada
  • GSK Investigational Site
    Pointe-Claire, Quebec H9R 4S3, Canada
  • GSK Investigational Site
    Sherbrooke, Quebec J1L 0H8, Canada
  • GSK Investigational Site
    St-Charles-Borromée, Quebec J6E 2B4, Canada
  • GSK Investigational Site
    Quebec, G1W 4R4, Canada
  • GSK Investigational Site
    Espoo, 02230, Finland
  • GSK Investigational Site
    Helsinki, 00100, Finland
  • GSK Investigational Site
    Helsinki, 00930, Finland
  • GSK Investigational Site
    Jarvenpaa, 04400, Finland
  • GSK Investigational Site
    Kokkola, 67100, Finland
  • GSK Investigational Site
    Pori, 28100, Finland
  • GSK Investigational Site
    Seinajoki, 60100, Finland
  • GSK Investigational Site
    Tampere, 33100, Finland
  • GSK Investigational Site
    Turku, 20520, Finland
  • GSK Investigational Site
    Gyeonggi-do, 15355, Korea, Republic of
  • GSK Investigational Site
    Seoul, 07441, Korea, Republic of
  • GSK Investigational Site
    Seoul, 08308, Korea, Republic of
  • GSK Investigational Site
    Alcorcón/Madrid, 28922, Spain
  • GSK Investigational Site
    Madrid, 28006, Spain
  • GSK Investigational Site
    Madrid, 28034, Spain
  • GSK Investigational Site
    Madrid, 28041, Spain
  • GSK Investigational Site
    Madrid, 28046, Spain
  • GSK Investigational Site
    Majadahonda (Madrid), 28222, Spain
  • GSK Investigational Site
    Santiago de Compostela, 15706, Spain
  • GSK Investigational Site
    Valencia, 46015, Spain
09

References and documents

Study documents

  • Study protocol · May 26, 2022
  • Statistical analysis plan · Jun 9, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.

Supporting information: Study protocol, Sap, Icf, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05045144
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Sep 16, 2021
Start date
Oct 26, 2021
Primary completion
Jun 6, 2022
Completion
Jun 6, 2022
Results posted
Oct 5, 2023
Last update
Oct 5, 2023

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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