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CompletedNCT04841577Updated Sep 3, 2024Results posted

A Study on the Immune Response and Safety Elicited by a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Influenza in Adults Aged 60 Years and Above

A Phase 3 interventional study of RSVPreF3 OA investigational vaccine and FLU-QIV in Respiratory Syncytial Virus Infections, sponsored by GlaxoSmithKline. Completed at 14 sites in 3 countries. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-03.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
976
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study summary

The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when co-administered with the seasonal quadrivalent influenza vaccine (FLU-QIV) in adults aged 60 years and above compared to separate administration of the vaccines.

02

Conditions studied

  • Respiratory Syncytial Virus Infections
03

In context

Respiratory Syncytial Virus Infections

293 studies on the registry are indexed under Respiratory Syncytial Virus Infections; 45 are open to participants now.

This study's enrollment of 976 is above the median of 90 across 213 interventional studies indexed under Respiratory Syncytial Virus Infections.

Browse Respiratory Syncytial Virus Infections 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
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol A male or female ≥60 YOA at the time of the first study intervention administration.
  • Participants living in the general community or in an assisted-living facility that provides minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.
  • Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure.
  • Participants who are medically stable in the opinion of the investigator at the time of first vaccination. Participants with chronic stable medical conditions with or without specific treatment are allowed to participate in this study if considered by the investigator as medically stable.

Exclusion criteria

Exclusion Criteria:

Medical conditions

  • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy based on medical history and physical examination.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
  • Hypersensitivity to latex.
  • History of GBS, anaphylaxis, febrile seizures, Bell's palsy and narcolepsy.
  • Serious or unstable chronic illness.
  • Any history of dementia or any medical condition that moderately or severely impairs cognition.
  • Recurrent or un-controlled neurological disorders or seizures. Participants with medically-controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol (e.g. completion of diary cards, attend regular phone calls/study site visits).
  • Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study
  • Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.

Prior/Concomitant therapy

  • Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study interventions during the period beginning 30 days before the first dose of study vaccines and ending 30 days after the last vaccine administration, or planned use during the study period.
  • Administration of an influenza vaccine during the 6 months preceding the study FLU-QIV administration.
  • Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first study intervention administration and ending 30 days after the last study intervention administration.

Note: In case an emergency mass vaccination for an unforeseen public health threat is recommended and/or organized by the public health authorities, outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly.

  • Previous vaccination with an RSV vaccine.
  • Administration of long-acting immune-modifying drugs or planned administration at any time during the study period).
  • Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the first dose of study vaccine or planned administration during the study period.
  • Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the first study vaccination or planned administration during the study period. For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Inhaled and topical steroids are allowed.

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 intervention (drug/invasive medical device).

Other exclusions

  • History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
  • Planned move during the study conduct that prohibits participation until 1 month post-last vaccine administration.
  • Bedridden participants.
  • Participation of 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
None (open label)
Enrollment
976 participants (actual)

Study arms

  • Experimental
    Co-Ad Group

    Participants received 1 dose of RSV_PreF3 Older Adult (OA) investigational vaccine and 1 dose of FLU-QIV at Day 1 and were followed up until the study end.

    Biological: RSVPreF3 OA investigational vaccine · Biological: FLU-QIV

  • Active comparator
    Control Group

    Participants received 1 dose of FLU-QIV at Day 1 and 1 dose of RSV_PreF3 OA investigational vaccine at Day 31 and were followed up until the study end.

    Biological: RSVPreF3 OA investigational vaccine · Biological: FLU-QIV

Interventions

  • BiologicalRSVPreF3 OA investigational vaccine

    RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.

  • BiologicalFLU-QIV

    FLU-QIV administered intramuscularly in the deltoid region of the dominant (Co-Ad Group) arm or the non-dominant (Control Group) arm.

06

What researchers measure

Primary outcomes

  1. RSV-A Neutralization Antibody Titers Expressed as Geometric Mean Titers (GMTs)

    The serum neutralization assay is a functional assay that measures the ability of serum antibodies to neutralize RSV-A entry and replication in a host cell line. The serum neutralizing antibody titer is expressed in ED60 (Estimated Dilution 60) and corresponds to the inverse of the interpolated serum dilution that yields a 60% reduction of the signal compared to a control without serum.

    Time frame: At 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group)

  2. Hemagglutinin Inhibition (HI) Antibody Titers for Each of the FLU Vaccine Strains Expressed as Group GMTs

    HI antibody titers were assessed for each of the Flu vaccine strains, namely Flu A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria). The serum HI antibody titers are expressed in 1/Dilution (DIL) where DIL corresponds to the highest dilution that shows complete HI.

    Time frame: 1 month after the FLU vaccine dose (at Day 31)

Secondary outcomes

  1. Secondary: HI Seroconversion Status for Each of the Flu Vaccine Strains Expressed as Seroconversion Rate (SCR)

    SCR for HI antibody response was defined as the percentage of vaccinees who have either a HI pre-dose titer \< 1:10 and a post-dose titer \>= 1:40 or a pre-dose titer \>= 1:10 and at least a four-fold increase in post-dose titer. HI antibody titers were assessed for each of the Flu vaccine strains, namely Flu A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria).

    Time frame: 1 month after the FLU vaccine dose (at Day 31)

  2. RSV-A Neutralization Antibody Titers Expressed as Mean Geometric Increase (MGI)

    MGI was defined as the geometric mean of the within participant ratios of the post dose titer over the pre-dose titer.

    Time frame: 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group)

  3. RSV-B Neutralization Antibody Titers Expressed as Geometric Mean Titers (GMT)

    The serum neutralization assay is a functional assay that measures the ability of serum antibodies to neutralize RSV-B entry and replication in a host cell line. The serum neutralizing antibody titer is expressed in ED60 (Estimated Dilution 60) and corresponds to the inverse of the interpolated serum dilution that yields a 60% reduction of the signal compared to a control without serum.

    Time frame: 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group)

  4. RSV-B Neutralization Antibody Titers Expressed as MGI

    MGI was defined as the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer.

    Time frame: 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group)

  5. HI Antibody Titers for Each of the FLU Vaccine Strains Expressed as GMTs

    HI antibody titers were assessed for each of the Flu vaccine strains, namely A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria). The serum HI antibody titers are expressed in 1/DIL where DIL corresponds to the highest dilution that shows complete HI.

    Time frame: At baseline (at Day 1) and 1 month after the FLU vaccine dose (at Day 31)

  6. HI Seroprotection Status for Each of the FLU Vaccine Strains Expressed as Seroprotection Rate (SPR)

    SPR for HI antibody response was defined as percentage of vaccinees with a serum HI titer \>= 1:40 that usually is accepted as indicating protection. HI antibody titers were assessed for each of the Flu vaccine strains, namely A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria).

    Time frame: At baseline (at Day 1) and 1 month after the FLU vaccine dose (at Day 31)

  7. HI Antibody Titers for Each of the FLU Vaccine Strains Expressed as MGI

    MGI was defined as the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer. HI antibody were assessed for each of the FLUvaccine strain, namely A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria).

    Time frame: 1 month after the FLU vaccine dose (at Day 31)

  8. Percentage of Participants With Solicited Administration Site Events

    Solicited administration site adverse events(AEs) assessed were erythema, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade.

    Time frame: Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination

  9. Percentage of Participants With Solicited Systemic Events

    Solicited systemic events assessed were arthralgia, fatigue, fever \[defined as temperature equal to or above (\>=) 38 degrees Celsius (C)/100.4 degrees Fahrenheit (F)\], headache and myalgia. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination.

    Time frame: Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination

  10. Percentage of Participants Reporting at Least One Unsolicited Adverse Event

    An unsolicited AEs is any AE reported in addition to those solicited during the clinical study and that was not included in a list of solicited events using a Participant Diary. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. Unsolicited AEs include serious, non-serious AEs and potential immune-mediated diseases (pIMDs). Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

    Time frame: Within 30 days (the day of vaccination and 29 subsequent days) after each vaccination

  11. Percentage of Participants Reporting at Least One Serious Adverse Event (SAE)

    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. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.

    Time frame: From Day 1 up to study end (6 months after last vaccination)

  12. Percentage of Participants Reporting at Least One Potential Immune-mediated Disease (pIMD)

    pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

    Time frame: From Day 1 up to study end (6 months after last vaccination)

07

Results

Posted Oct 18, 2022

Participant flow

Participant flow — Overall Study
MilestoneCo-Ad GroupControl Group
Started442443
Completed429417
Not completed1326
Withdrew: Adverse event510
Withdrew: Lost to follow-up87
Withdrew: Consent withdrawal, not due to a (s)ae08
Withdrew: Other01

Outcome measures

PrimaryRSV-A Neutralization Antibody Titers Expressed as Geometric Mean Titers (GMTs)

The serum neutralization assay is a functional assay that measures the ability of serum antibodies to neutralize RSV-A entry and replication in a host cell line. The serum neutralizing antibody titer is expressed in ED60 (Estimated Dilution 60) and corresponds to the inverse of the interpolated serum dilution that yields a 60% reduction of the signal compared to a control without serum.

Time frame:
At 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group)
Reported as:
Geometric mean · Titers (ED 60)
RSV-A Neutralization Antibody Titers Expressed as Geometric Mean Titers (GMTs)
Titers (ED 60)Co-Ad GroupControl Group
RSV-A Neutralization Antibody Titers Expressed as Geometric Mean Titers (GMTs)10060.5 (9126 to 11090.7)12255 (11160.4 to 13456.9)
Statistical analysis
  • Co-Ad Group vs Control Group · Adjusted group gmt ratio: 1.27 · 95% CI 1.12 to 1.44
PrimaryHemagglutinin Inhibition (HI) Antibody Titers for Each of the FLU Vaccine Strains Expressed as Group GMTs

HI antibody titers were assessed for each of the Flu vaccine strains, namely Flu A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria). The serum HI antibody titers are expressed in 1/Dilution (DIL) where DIL corresponds to the highest dilution that shows complete HI.

Time frame:
1 month after the FLU vaccine dose (at Day 31)
Reported as:
Geometric mean · Titers (1/DIL)
Hemagglutinin Inhibition (HI) Antibody Titers for Each of the FLU Vaccine Strains Expressed as Group GMTs
Titers (1/DIL)Co-Ad GroupControl Group
Flu A/Hong Kong/2671/2019 H3N2295.2 (263.6 to 330.6)346.8 (306.6 to 392.3)
Flu A/Victoria/2570/2019 H1N1267.1 (235.6 to 302.8)325.4 (282.5 to 374.9)
Flu B/Phuket/3073/2013 Yamagata28.9 (26 to 32.1)34.8 (31.1 to 39.0)
Flu B/Washington/02/2019 Victoria41.6 (37.1 to 46.6)47.9 (41.9 to 54.8)
Statistical analysis
  • Co-Ad Group vs Control Group · Adjusted geometric mean titer ratio: 1.17 · 95% CI 1.02 to 1.35
  • Co-Ad Group vs Control Group · Adjusted geometric mean titer ratio: 1.22 · 95% CI 1.03 to 1.44
  • Co-Ad Group vs Control Group · Adjusted geometric mean titer ratio: 1.17 · 95% CI 1.04 to 1.32
  • Co-Ad Group vs Control Group · Adjusted geometric mean titer ratio: 1.10 · 95% CI 0.95 to 1.26
SecondarySecondary: HI Seroconversion Status for Each of the Flu Vaccine Strains Expressed as Seroconversion Rate (SCR)

SCR for HI antibody response was defined as the percentage of vaccinees who have either a HI pre-dose titer \< 1:10 and a post-dose titer \>= 1:40 or a pre-dose titer \>= 1:10 and at least a four-fold increase in post-dose titer. HI antibody titers were assessed for each of the Flu vaccine strains, namely Flu A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria).

Time frame:
1 month after the FLU vaccine dose (at Day 31)
Reported as:
Number · Percentage of participants
Secondary: HI Seroconversion Status for Each of the Flu Vaccine Strains Expressed as Seroconversion Rate (SCR)
Percentage of participantsCo-Ad GroupControl Group
Flu A/Hong Kong/2671/2019 H3N254.3 (49.5 to 59.1)56.9 (52.0 to 61.8)
Flu A/Victoria/2570/2019 H1N178.9 (74.7 to 82.7)83.5 (79.5 to 86.9)
Flu B/Phuket/3073/2013 Yamagata28.8 (24.6 to 33.4)32.8 (28.3 to 37.6)
Flu B/Washington/02/2019 Victoria35.6 (31.1 to 40.3)36 (31.4 to 40.9)
Statistical analysis
  • Co-Ad Group vs Control Group · Miettinen and Nurminen · Difference in percentage: 2.60 · 95% CI -4.13 to 9.30
  • Co-Ad Group vs Control Group · Miettinen and Nurminen · Difference in percentage: 4.53 · 95% CI -0.77 to 9.83
  • Co-Ad Group vs Control Group · Miettinen and Nurminen · Difference in percentage: 4.04 · 95% CI -2.21 to 10.28
  • Co-Ad Group vs Control Group · Miettinen and Nurminen · Difference in percentage: 0.41 · 95% CI -6.07 to 6.90
SecondaryRSV-A Neutralization Antibody Titers Expressed as Mean Geometric Increase (MGI)

MGI was defined as the geometric mean of the within participant ratios of the post dose titer over the pre-dose titer.

Time frame:
1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group)
Reported as:
Geometric mean · Ratio
RSV-A Neutralization Antibody Titers Expressed as Mean Geometric Increase (MGI)
RatioCo-Ad GroupControl Group
RSV-A Neutralization Antibody Titers Expressed as Mean Geometric Increase (MGI)9.61 (8.7 to 10.61)12.95 (11.75 to 14.28)
SecondaryRSV-B Neutralization Antibody Titers Expressed as Geometric Mean Titers (GMT)

The serum neutralization assay is a functional assay that measures the ability of serum antibodies to neutralize RSV-B entry and replication in a host cell line. The serum neutralizing antibody titer is expressed in ED60 (Estimated Dilution 60) and corresponds to the inverse of the interpolated serum dilution that yields a 60% reduction of the signal compared to a control without serum.

Time frame:
1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group)
Reported as:
Geometric mean · Titers (ED 60)
RSV-B Neutralization Antibody Titers Expressed as Geometric Mean Titers (GMT)
Titers (ED 60)Co-Ad GroupControl Group
RSV-B Neutralization Antibody Titers Expressed as Geometric Mean Titers (GMT)10518.6 (9302 to 11894.3)14349.7 (12640.6 to 16289.9)
Statistical analysis
  • Co-Ad Group vs Control Group · Adjusted group gmt ratio: 1.28 · 95% CI 1.09 to 1.51
SecondaryRSV-B Neutralization Antibody Titers Expressed as MGI

MGI was defined as the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer.

Time frame:
1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group)
Reported as:
Geometric mean · Ratio
RSV-B Neutralization Antibody Titers Expressed as MGI
RatioCo-Ad GroupControl Group
RSV-B Neutralization Antibody Titers Expressed as MGI7.67 (6.76 to 8.72)9.28 (8.06 to 10.69)
SecondaryHI Antibody Titers for Each of the FLU Vaccine Strains Expressed as GMTs

HI antibody titers were assessed for each of the Flu vaccine strains, namely A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria). The serum HI antibody titers are expressed in 1/DIL where DIL corresponds to the highest dilution that shows complete HI.

Time frame:
At baseline (at Day 1) and 1 month after the FLU vaccine dose (at Day 31)
Reported as:
Geometric mean · Titers (1/DIL)
HI Antibody Titers for Each of the FLU Vaccine Strains Expressed as GMTs
Titers (1/DIL)Co-Ad GroupControl Group
Flu A/Hong Kong/2671/2019 H3N2, Day 161.4 (53.8 to 69.9)63.3 (55.7 to 71.9)
Flu A/Hong Kong/2671/2019 H3N2, Day 31295.2 (263.6 to 330.6)346.8 (306.6 to 392.3)
Flu A/Victoria/2570/2019 H1N1, Day 120 (18 to 22.3)19.9 (17.8 to 22.2)
Flu A/Victoria/2570/2019 H1N1, Day 31267.1 (235.6 to 302.8)325.4 (282.5 to 374.9)
Flu B/Phuket/3073/2013 Yamagata, Day 110.4 (9.5 to 11.3)10.8 (9.9 to 11.7)
Flu B/Phuket/3073/2013 Yamagata, Day 3128.9 (26 to 32.1)34.8 (31.1 to 39)
Flu B/Washington/02/2019 Victoria, Day 112.2 (11.1 to 13.4)13.5 (12.2 to 15.1)
Flu B/Washington/02/2019 Victoria, Day 3141.6 (37.1 to 46.6)47.9 (41.9 to 54.8)
SecondaryHI Seroprotection Status for Each of the FLU Vaccine Strains Expressed as Seroprotection Rate (SPR)

SPR for HI antibody response was defined as percentage of vaccinees with a serum HI titer \>= 1:40 that usually is accepted as indicating protection. HI antibody titers were assessed for each of the Flu vaccine strains, namely A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria).

Time frame:
At baseline (at Day 1) and 1 month after the FLU vaccine dose (at Day 31)
Reported as:
Number · Percentage of participants
HI Seroprotection Status for Each of the FLU Vaccine Strains Expressed as Seroprotection Rate (SPR)
Percentage of participantsCo-Ad GroupControl Group
Flu A/Hong Kong/2671/2019 H3N2, Day 170.8 (66.3 to 75)70.3 (65.7 to 74.5)
Flu A/Hong Kong/2671/2019 H3N2, Day 3197.4 (95.4 to 98.7)97.1 (95 to 98.5)
Flu A/Victoria/2570/2019 H1N1, Day 135.4 (30.9 to 40.1)34.6 (30.1 to 39.2)
Flu A/Victoria/2570/2019 H1N1, Day 3194.6 (92 to 96.6)93.4 (90.6 to 95.6)
Flu B/Phuket/3073/2013 Yamagata, Day 114.3 (11.1 to 17.9)14.9 (11.7 to 18.6)
Flu B/Phuket/3073/2013 Yamagata, Day 3147.8 (43 to 52.6)54.3 (49.3 to 59.2)
Flu B/Washington/02/2019 Victoria, Day 120 (16.3 to 24.1)23.6 (19.7 to 27.8)
Flu B/Washington/02/2019 Victoria, Day 3159.3 (54.4 to 64)61.3 (56.4 to 66)
SecondaryHI Antibody Titers for Each of the FLU Vaccine Strains Expressed as MGI

MGI was defined as the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer. HI antibody were assessed for each of the FLUvaccine strain, namely A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria).

Time frame:
1 month after the FLU vaccine dose (at Day 31)
Reported as:
Geometric mean · Ratio
HI Antibody Titers for Each of the FLU Vaccine Strains Expressed as MGI
RatioCo-Ad GroupControl Group
Flu A/Hong Kong/2671/2019 H3N24.81 (4.22 to 5.48)5.50 (4.81 to 6.29)
Flu A/Victoria/2570/2019 H1N113.36 (11.58 to 15.42)16.25 (14.08 to 18.76)
Flu B/Phuket/3073/2013 Yamagata HI2.82 (2.55 to 3.12)3.22 (2.90 to 3.58)
Flu B/Washington/02/2019 Victoria3.43 (3.06 to 3.85)3.60 (3.18 to 4.08)
SecondaryPercentage of Participants With Solicited Administration Site Events

Solicited administration site adverse events(AEs) assessed were erythema, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade.

Time frame:
Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination
Reported as:
Number · Percentage of participants
Percentage of Participants With Solicited Administration Site Events
Percentage of participantsCo-Ad GroupControl Group
Erythema against Flu Dose given at Day 11.1 (0.4 to 2.6)0.5 (0.1 to 1.6)
Erythema against RSV Dose given at Day 14.1 (2.5 to 6.4)—
Erythema against RSV Dose given at Day 31—2.1 (1 to 4)
Pain against Flu Dose given at Day 128.3 (24.1 to 32.8)20.5 (16.9 to 24.6)
Pain against RSV Dose given at Day 147.9 (43.2 to 52.7)—
Pain against RSV Dose give at Day 31—39.1 (34.4 to 44)
Swelling against Flu Dose given at Day 11.4 (0.5 to 3)0.7 (0.1 to 2)
Swelling against RSV Dose given at Day 13.2 (1.8 to 5.3)—
Swelling against RSV Dose given at Day 31—1 (0.3 to 2.4)
SecondaryPercentage of Participants With Solicited Systemic Events

Solicited systemic events assessed were arthralgia, fatigue, fever \[defined as temperature equal to or above (\>=) 38 degrees Celsius (C)/100.4 degrees Fahrenheit (F)\], headache and myalgia. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination.

Time frame:
Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination
Reported as:
Number · Percentage of participants
Percentage of Participants With Solicited Systemic Events
Percentage of participantsCo-Ad GroupControl Group
Arthralgia, Dosing at Day 116.2 (12.9 to 20)4.8 (3 to 7.2)
Arthralgia, Dosing at Day 31—11.2 (8.4 to 14.6)
Fatigue, Dosing at Day 122.4 (18.6 to 26.6)12.8 (9.8 to 16.3)
Fatigue, Dosing at Day 31—17.9 (14.3 to 21.9)
Fever, Dosing at Day 12.5 (1.3 to 4.4)0.7 (0.1 to 2)
Fever, Dosing at Day 31—1 (0.3 to 2.4)
Headache, Dosing at Day 121.7 (17.9 to 25.8)12.8 (9.8 to 16.3)
Headache, Dosing at Day 31—16.2 (12.8 to 20.1)
Myalgia, Dosing at Day 122.1 (18.3 to 26.3)9.4 (6.8 to 12.5)
Myalgia, Dosing at Day 31—19.6 (15.9 to 23.7)
SecondaryPercentage of Participants Reporting at Least One Unsolicited Adverse Event

An unsolicited AEs is any AE reported in addition to those solicited during the clinical study and that was not included in a list of solicited events using a Participant Diary. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. Unsolicited AEs include serious, non-serious AEs and potential immune-mediated diseases (pIMDs). Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Time frame:
Within 30 days (the day of vaccination and 29 subsequent days) after each vaccination
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting at Least One Unsolicited Adverse Event
Percentage of participantsCo-Ad GroupControl Group
Percentage of Participants Reporting at Least One Unsolicited Adverse Event18.8 (15.2 to 22.7)23.7 (19.8 to 27.9)
SecondaryPercentage of Participants Reporting at Least One Serious Adverse Event (SAE)

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. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.

Time frame:
From Day 1 up to study end (6 months after last vaccination)
Reported as:
Number · Percentage of Participants
Percentage of Participants Reporting at Least One Serious Adverse Event (SAE)
Percentage of ParticipantsCo-Ad GroupControl Group
Percentage of Participants Reporting at Least One Serious Adverse Event (SAE)3.4 (1.9 to 5.5)4.5 (2.8 to 6.9)
SecondaryPercentage of Participants Reporting at Least One Potential Immune-mediated Disease (pIMD)

pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

Time frame:
From Day 1 up to study end (6 months after last vaccination)
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting at Least One Potential Immune-mediated Disease (pIMD)
Percentage of participantsCo-Ad GroupControl Group
Percentage of Participants Reporting at Least One Potential Immune-mediated Disease (pIMD)1.1 (0.4 to 2.6)0.2 (0 to 1.3)

Adverse events

Collected over Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Co-Ad Group4/442 (0.9%)15/442 (3.4%)290/442 (65.6%)
Control Group8/443 (1.8%)20/443 (4.5%)276/443 (62.3%)
Most frequent serious events
Showing 10 of 30
Most frequent serious events
EventCo-Ad GroupControl Group
DeathGeneral disorders4/4428/443
COVID-19Infections and infestations2/4423/443
Suspected COVID-19Infections and infestations1/4423/443
Acute disseminated encephalomyelitisNervous system disorders2/4420/443
AnaemiaBlood and lymphatic system disorders1/4420/443
Cardiac failure congestiveCardiac disorders1/4420/443
DiverticulitisInfections and infestations1/4420/443
COVID-19 pneumoniaInfections and infestations1/4420/443
Urinary tract infectionInfections and infestations1/4420/443
Subdural haematomaInjury, poisoning and procedural complications1/4420/443
Most frequent other events
Showing 10 of 134
Most frequent other events
EventCo-Ad GroupControl Group
Injection site painGeneral disorders236/442192/443
FatigueGeneral disorders100/442106/443
HeadacheNervous system disorders99/442103/443
MyalgiaMusculoskeletal and connective tissue disorders98/442100/443
ArthralgiaMusculoskeletal and connective tissue disorders73/44260/443
Injection site erythemaGeneral disorders21/44211/443
Injection site swellingGeneral disorders16/4428/443
PyrexiaGeneral disorders14/4426/443
Upper respiratory tract infectionInfections and infestations4/44210/443
CoughRespiratory, thoracic and mediastinal disorders9/4423/443

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Co-Ad GroupControl GroupTotal
Mean68.4 ± 6.968.6 ± 6.968.5 ± 6.9
Sex: Female, Male
Sex: Female, Male(Participants)Co-Ad GroupControl GroupTotal
Female228228456
Male214215429
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Co-Ad GroupControl GroupTotal
Asian459
Black Or African American7270142
Maori7512
Mixed Race218227445
Native Hawaiian Or Other Pacific Islander213
Other, Not Specified202
White137135272
08

Study locations

14 sites
  • GSK Investigational Site
    Auckland, 1010, New Zealand
  • GSK Investigational Site
    Auckland, 1701, New Zealand
  • GSK Investigational Site
    Christchurch, 8011, New Zealand
  • GSK Investigational Site
    Havelock North, 4130, New Zealand
  • GSK Investigational Site
    Paraparaumu, 5032, New Zealand
  • GSK Investigational Site
    Tauranga, 3001, New Zealand
  • GSK Investigational Site
    Wellington, 6242, New Zealand
  • GSK Investigational Site
    Ciudad de Panama, 7099, Panama
  • GSK Investigational Site
    Panama, 0801, Panama
  • GSK Investigational Site
    Panama, 1001, Panama
  • GSK Investigational Site
    Panama, 7002, Panama
  • GSK Investigational Site
    Panama, 7219, Panama
  • GSK Investigational Site
    Boksburg, Gauteng 1459, South Africa
  • GSK Investigational Site
    Middelburg, Mpumalanga 1055, South Africa
09

References and documents

Publications

  • Chandler R, Montenegro N, Llorach C, Aguirre LN, Germain S, Kuriyakose SO, Lambert A, Descamps D, Olivier A, Hulstrom V. Immunogenicity, Reactogenicity, and Safety of AS01E-adjuvanted RSV Prefusion F Protein-based Candidate Vaccine (RSVPreF3 OA) When Co-administered With a Seasonal Quadrivalent Influenza Vaccine in Older Adults: Results of a Phase 3, Open-Label, Randomized Controlled Trial. Clin Infect Dis. 2024 Jan 8:ciad786. doi: 10.1093/cid/ciad786. Online ahead of print. PubMed 38189778 ↗

Study documents

  • Study protocol · Nov 27, 2020
  • Statistical analysis plan · Apr 16, 2021

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

Individual participant data

Plan to share: Yes — GSK will assess requests from qualified researchers for anonymized individual patient-level data (IPD) and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf

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 Sep 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04841577
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Apr 12, 2021
Start date
Apr 27, 2021
Primary completion
Sep 22, 2021
Completion
Feb 8, 2022
Results posted
Oct 18, 2022
Last update
Sep 3, 2024

Oversight

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

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