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CompletedNCT05966090RSV-OA=ADJ-020Updated Apr 1, 2025Results posted

A Study on Safety and Immune Response of Investigational RSV OA Vaccine in Combination With Herpes Zoster Vaccine in Healthy Adults

A Phase 3 interventional study of RSVPreF3 OA investigational vaccine and HZ/su vaccine in Respiratory Syncytial Viruses and Respiratory Syncytial Virus Infections, sponsored by GlaxoSmithKline. Completed at 27 sites in 2 countries. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-01.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
530
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study summary

To assess the ability of RSVPreF3 OA investigational vaccine to generate an immune response when given in combination with HZ/su vaccine and its safety in older adults, aged >=50 years of age.

02

Conditions studied

  • Respiratory Syncytial Viruses
  • Respiratory Syncytial Virus Infections

Keywords

  • Respiratory syncytial virus
  • Infection
  • Vaccine
  • Older adult
  • Immunogenicity
  • Safety
03

In context

Herpes Zoster

360 studies on the registry are indexed under Herpes Zoster; 60 are open to participants now.

This study's enrollment of 530 is above the median of 250 across 299 interventional studies indexed under Herpes Zoster.

Browse Herpes Zoster 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
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • A male or female participant ≥50 YOA at the time of the first study intervention administration.
  • Female participants of non-childbearing potential may be enrolled in the study.

  • Female participants of childbearing potential may be enrolled in the study, if the participant:

    • has practiced adequate contraception from 1 month prior to study intervention administration.
    • has a negative pregnancy test on the day of and prior to study intervention administration.
    • has agreed to continue effective contraception until the end of the study.
  • Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol. Written or witnessed informed consent obtained from the participant prior to any study specific procedure being performed.
  • 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.
  • Participants who are medically stable in the opinion of the investigator at the time of first study intervention administration. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes mellitus, hypertension, or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable.

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • Any confirmed or suspected autoimmune disorders, 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 study interventions, in particular any history of severe allergic reaction to any vaccine component.
  • History of Guillain-Barré syndrome.
  • Any history of dementia or any medical condition that moderately or severely impairs cognition.
  • Recurrent or uncontrolled neurological disorders or seizures. Participants with medically controlled 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.
  • 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.
  • Clinically suspected or polymerase chain reaction (PCR)-confirmed ongoing episode of herpes zoster.
  • History of previous vaccination with any licensed or investigational recombinant adjuvanted zoster vaccine (HZ/su vaccine; Shingrix) before the study start or planned receipt through study participation.
  • History of previous vaccination with any licensed or investigational live herpes zoster vaccine (Zostavax) in the last 2 years from enrollment, or planned receipt through study participation.
  • Previous vaccination with licensed or investigational RSV vaccine.
  • 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 interventions, or their planned use during the study period.

  • 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.

    o In the case of COVID-19 and inactivated/subunit/split influenza vaccines, this time window can be decreased to 14 days before and after each study intervention administration provided COVID-19 vaccine use is in line with local governmental recommendations.

  • Planned or actual administration of adjuvanted quadrivalent influenza vaccine influenza 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.
  • Administration of long-acting immune-modifying drugs during the period starting 180 days before the administration of first dose of study interventions or planned administration at any time during the study period (e.g., infliximab).
  • Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the administration of first dose of study interventions 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 intervention dose or planned administration during the study period. For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Inhaled, topical or intra-articular steroids are allowed.
  • 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 (IMP) (drug or invasive medical device).
  • 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.Bedridden participants.
  • Planned move during the study conduct that prohibits participation until study end.
  • 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
530 participants (actual)

Study arms

  • Experimental
    Co-administration Group

    Participants received both herpes zoster recombinant subunit (HZ/su) vaccine and respiratory syncytial virus prefusion protein 3 older adult (RSVPreF3 OA) vaccine on Day 1 followed by second dose of HZ/su vaccine on Day 61.

    Biological: RSVPreF3 OA investigational vaccine · Biological: HZ/su vaccine

  • Active comparator
    Control Group

    Participants received HZ/su vaccine on Day 1 and RSVPreF3 OA vaccine on Day 31 followed by second dose of HZ/su vaccine on Day 61.

    Biological: RSVPreF3 OA investigational vaccine · Biological: HZ/su vaccine

Interventions

  • BiologicalRSVPreF3 OA investigational vaccine

    One dose of RSVPreF3 OA investigational vaccine given intramuscularly on Day 1 (Coadministration group) or Day 31 (Control group).

    Also known as: Respiratory Syncytial Virus PreFusion protein 3 Older Adults vaccine

  • BiologicalHZ/su vaccine

    Two doses of HZ/su vaccine given intramuscularly on Day 1 and Day 61.

    Also known as: Herpes Zoster recombinant subunit vaccine, Shingrix

06

What researchers measure

Primary outcomes

  1. Adjusted Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies at 1 Month Post-second Dose of HZ/su Vaccination

    Anti-gE antibodies were measured with enzyme linked immunosorbent assay (ELISA) and the results were expressed as GMC, in milli international units per milliliter (mIU/mL).

    Time frame: At 1 month post-second dose of HZ/su vaccination (Day 91)

  2. Adjusted Geometric Mean Titers (GMT) of Respiratory Syncytial Virus-A (RSV-A) Neutralizing Titers [Estimated Dilution 60 (ED60)] at 1 Month After the RSVPreF3 OA Vaccination

    Neutralizing titers were measured with neutralization assay and the results were expressed as GMT. The ED60 was defined as the dose that produced an effect in 60% of the population.

    Time frame: At Day 31 for Co-administration Group and at Day 61 for Control Group

  3. Adjusted GMTs of RSV-B Neutralizing Titers (ED60) at 1 Month After the RSVPreF3 OA Vaccination

    Neutralizing titers were measured with neutralization assay and the results were expressed as GMT. The ED60 was defined as the dose that produced an effect in 60% of the population.

    Time frame: At Day 31 for Co-administration Group and at Day 61 for Control Group

Secondary outcomes

  1. Percentage of Participants With Seropositivity at Pre-vaccination and 1 Month Post-second Dose of HZ/su Vaccination

    Seropositivity was defined as the percentage of participants whose antibody concentration was greater than or equal to the assay cut-off value (97 mIU/mL).

    Time frame: Pre-vaccination (Day 1) and 1 month post-second dose of HZ/su vaccination (Day 91)

  2. GMC of Anti-glycoprotein Antibodies at Pre-vaccination and 1 Month Post-second Dose of HZ/su Vaccination

    Anti-gE antibodies were measured with ELISA and the results were expressed as GMC.

    Time frame: Pre-vaccination (Day 1) and 1 month post-second dose of HZ/su vaccination (Day 91)

  3. Mean Geometric Increase (MGI) of Anti-glycoprotein Antibodies at Pre-vaccination and 1 Month Post-second Dose of HZ/su Vaccination

    The MGI was defined as the geometric mean of the within participant ratios of the post-vaccination titer over the pre-vaccination titer. Anti-gE antibodies were measured with ELISA.

    Time frame: At 1 month post-second dose of HZ/su vaccination (Day 91) compared to Pre-vaccination (Day 1)

  4. Vaccine Response Rate (VRR) at 1 Month Post-second Dose of HZ/su Vaccination

    The VRR was defined as the percentage of participants who had at least: a 4-fold increase post-vaccination anti-gE antibody concentration as compared to (over) the pre-vaccination anti-gE antibody concentration (for participants who were seropositive at pre-vaccination); or, a 4-fold increase post-vaccination anti-gE antibody concentration as compared to (over) the anti-gE antibody cut-off value for seropositivity (97 mIU/mL) (for participants who were seronegative at pre-vaccination).

    Time frame: At 1 month post-second dose of HZ/su vaccination (Day 91)

  5. GMT of RSV-A Neutralizing Titers (ED60) at Pre-vaccination and 1 Month After the RSVPreF3 OA Vaccination

    Neutralizing titers were measured with neutralization assay and the results were expressed as GMT. The ED60 was defined as the dose that produced an effect in 60% of the population.

    Time frame: At pre-vaccination (Day 1) and Day 31 for Co-administration Group and at pre-vaccination (Day 1) and Day 61 for Control Group

  6. MGI of Respiratory Syncytial Virus-A Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination

    The MGI was defined as the geometric mean of the within participant ratios of the post-vaccination titer over the pre-vaccination titer. Neutralizing titers were measured with neutralization assay.

    Time frame: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for Co-administration Group and Day 61 for Control Group) compared to Pre-vaccination (Day 1 for Co-administration Group and Control Group)

  7. GMT of RSV-B Neutralizing Titers (ED60) at Pre-vaccination and 1 Month After the RSVPreF3 OA Vaccination

    Neutralizing titers were measured with neutralization assay and the results were expressed as GMT. The ED60 was defined as the dose that produced an effect in 60% of the population.

    Time frame: At pre-vaccination (Day 1) and Day 31 for Co-administration Group and at pre-vaccination (Day 1) and Day 61 for Control Group

  8. MGI of RSV-B Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination

    The MGI was defined as the geometric mean of the within participant ratios of the post-vaccination titer over the pre-vaccination titer. Neutralizing titers were measured with neutralization assay.

    Time frame: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for Co-administration Group and Day 61 for Control Group) compared to Pre-vaccination (Day 1 for Co-administration Group and Control Group)

  9. Percentage of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration

    The solicited administration site events after vaccination included pain, erythema/redness, and swelling.

    Time frame: Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Days 1 and 61 for Co-Administration Group and at Days 1, 31 and 61 for Control group)

  10. Percentage of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration

    The solicited systemic events after vaccination included arthralgia, fatigue, fever (pyrexia), headache, myalgia, shivering/chills, and gastrointestinal symptoms (nausea, vomiting, diarrhea, and abdominal pain).

    Time frame: Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Days 1 and 61 for Co-Administration Group and at Days 1, 31 and 61 for Control group)

  11. Percentage of Participants With Unsolicited Adverse Events

    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study vaccine, which does not necessarily have a causal relationship with study vaccine. An unsolicited AE was an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs must had been communicated by participant/participant's caregiver(s) who had signed the informed consent. Unsolicited AEs included both serious and non-serious AEs.

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

  12. Percentage of Participants With Serious Adverse Events (SAEs)

    An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.

    Time frame: From first dose of study vaccine administration (Day 1) up to 6 months after last dose of study vaccine administration, approximately 241 days

  13. Percentage of Participants With Potential Immune-mediated Diseases (pIMDs)

    The pIMD was a subset of adverse events of special interest that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

    Time frame: From first dose of study vaccine administration (Day 1) up to 6 months after last dose of study vaccine administration, approximately 241 days

07

Results

Posted Apr 1, 2025

Participant flow

This study was conducted in adult participants aged 50 years and older, in 20 study sites.

Participant flow — Overall Study
MilestoneCo-administration GroupControl Group
Started265265
Completed256255
Not completed910
Withdrew: Lost to follow-up66
Withdrew: Adverse event11
Withdrew: Withdrawal by subject11
Withdrew: Protocol-specified withdrawal criterion met01
Withdrew: Other11

Outcome measures

PrimaryAdjusted Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies at 1 Month Post-second Dose of HZ/su Vaccination

Anti-gE antibodies were measured with enzyme linked immunosorbent assay (ELISA) and the results were expressed as GMC, in milli international units per milliliter (mIU/mL).

Time frame:
At 1 month post-second dose of HZ/su vaccination (Day 91)
Reported as:
Geometric mean · mIU/mL
Adjusted Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies at 1 Month Post-second Dose of HZ/su Vaccination
mIU/mLCo-administration GroupControl Group
Adjusted Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies at 1 Month Post-second Dose of HZ/su Vaccination49326.9 (44948.5 to 54131.7)61192.7 (55306.4 to 67705.5)
Statistical analysis
  • Co-administration Group vs Control Group · Ratio: 1.24 · 95% CI 1.08 to 1.42The analysis of covariance (ANCOVA) model, for logarithm-transformed concentration, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as a covariate.
PrimaryAdjusted Geometric Mean Titers (GMT) of Respiratory Syncytial Virus-A (RSV-A) Neutralizing Titers [Estimated Dilution 60 (ED60)] at 1 Month After the RSVPreF3 OA Vaccination

Neutralizing titers were measured with neutralization assay and the results were expressed as GMT. The ED60 was defined as the dose that produced an effect in 60% of the population.

Time frame:
At Day 31 for Co-administration Group and at Day 61 for Control Group
Reported as:
Geometric mean · Titers
Adjusted Geometric Mean Titers (GMT) of Respiratory Syncytial Virus-A (RSV-A) Neutralizing Titers [Estimated Dilution 60 (ED60)] at 1 Month After the RSVPreF3 OA Vaccination
TitersCo-administration GroupControl Group
Adjusted Geometric Mean Titers (GMT) of Respiratory Syncytial Virus-A (RSV-A) Neutralizing Titers [Estimated Dilution 60 (ED60)] at 1 Month After the RSVPreF3 OA Vaccination8426.8 (7504.2 to 9462.7)9628.7 (8532.7 to 10865.4)
Statistical analysis
  • Co-administration Group vs Control Group · Ratio: 1.14 · 95% CI 0.97 to 1.35The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as a covariate.
PrimaryAdjusted GMTs of RSV-B Neutralizing Titers (ED60) at 1 Month After the RSVPreF3 OA Vaccination

Neutralizing titers were measured with neutralization assay and the results were expressed as GMT. The ED60 was defined as the dose that produced an effect in 60% of the population.

Time frame:
At Day 31 for Co-administration Group and at Day 61 for Control Group
Reported as:
Geometric mean · Titers
Adjusted GMTs of RSV-B Neutralizing Titers (ED60) at 1 Month After the RSVPreF3 OA Vaccination
TitersCo-administration GroupControl Group
Adjusted GMTs of RSV-B Neutralizing Titers (ED60) at 1 Month After the RSVPreF3 OA Vaccination10354.2 (9288.4 to 11542.3)10143.4 (9057.5 to 11359.4)
Statistical analysis
  • Co-administration Group vs Control Group · Ratio: 0.98 · 95% CI 0.84 to 1.15The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as a covariate.
SecondaryPercentage of Participants With Seropositivity at Pre-vaccination and 1 Month Post-second Dose of HZ/su Vaccination

Seropositivity was defined as the percentage of participants whose antibody concentration was greater than or equal to the assay cut-off value (97 mIU/mL).

Time frame:
Pre-vaccination (Day 1) and 1 month post-second dose of HZ/su vaccination (Day 91)
Reported as:
Number · Percentage of participants
Percentage of Participants With Seropositivity at Pre-vaccination and 1 Month Post-second Dose of HZ/su Vaccination
Percentage of participantsCo-administration GroupControl Group
Pre-vaccination (Day 1)98.5 (96.1 to 99.6)97.3 (94.6 to 98.9)
1 month post-second dose of HZ/su vaccination (Day 91)100.0 (98.2 to 100.0)100.0 (97.9 to 100.0)
SecondaryGMC of Anti-glycoprotein Antibodies at Pre-vaccination and 1 Month Post-second Dose of HZ/su Vaccination

Anti-gE antibodies were measured with ELISA and the results were expressed as GMC.

Time frame:
Pre-vaccination (Day 1) and 1 month post-second dose of HZ/su vaccination (Day 91)
Reported as:
Geometric mean · mIU/mL
GMC of Anti-glycoprotein Antibodies at Pre-vaccination and 1 Month Post-second Dose of HZ/su Vaccination
mIU/mLCo-administration GroupControl Group
Pre-vaccination (Day 1)1739.4 (1503.4 to 2012.5)1492.2 (1278.5 to 1741.5)
1 month post-second dose of HZ/su vaccination (Day 91)50235.2 (46013.4 to 54844.4)61204.7 (54959.6 to 68159.4)
SecondaryMean Geometric Increase (MGI) of Anti-glycoprotein Antibodies at Pre-vaccination and 1 Month Post-second Dose of HZ/su Vaccination

The MGI was defined as the geometric mean of the within participant ratios of the post-vaccination titer over the pre-vaccination titer. Anti-gE antibodies were measured with ELISA.

Time frame:
At 1 month post-second dose of HZ/su vaccination (Day 91) compared to Pre-vaccination (Day 1)
Reported as:
Geometric mean · Ratio
Mean Geometric Increase (MGI) of Anti-glycoprotein Antibodies at Pre-vaccination and 1 Month Post-second Dose of HZ/su Vaccination
RatioCo-administration GroupControl Group
Mean Geometric Increase (MGI) of Anti-glycoprotein Antibodies at Pre-vaccination and 1 Month Post-second Dose of HZ/su Vaccination28.24 (23.66 to 33.71)43.24 (34.97 to 53.47)
SecondaryVaccine Response Rate (VRR) at 1 Month Post-second Dose of HZ/su Vaccination

The VRR was defined as the percentage of participants who had at least: a 4-fold increase post-vaccination anti-gE antibody concentration as compared to (over) the pre-vaccination anti-gE antibody concentration (for participants who were seropositive at pre-vaccination); or, a 4-fold increase post-vaccination anti-gE antibody concentration as compared to (over) the anti-gE antibody cut-off value for seropositivity (97 mIU/mL) (for participants who were seronegative at pre-vaccination).

Time frame:
At 1 month post-second dose of HZ/su vaccination (Day 91)
Reported as:
Number · Percentage of participants
Vaccine Response Rate (VRR) at 1 Month Post-second Dose of HZ/su Vaccination
Percentage of participantsCo-administration GroupControl Group
Vaccine Response Rate (VRR) at 1 Month Post-second Dose of HZ/su Vaccination92.9 (88.4 to 96.1)96.5 (92.5 to 98.7)
SecondaryGMT of RSV-A Neutralizing Titers (ED60) at Pre-vaccination and 1 Month After the RSVPreF3 OA Vaccination

Neutralizing titers were measured with neutralization assay and the results were expressed as GMT. The ED60 was defined as the dose that produced an effect in 60% of the population.

Time frame:
At pre-vaccination (Day 1) and Day 31 for Co-administration Group and at pre-vaccination (Day 1) and Day 61 for Control Group
Reported as:
Geometric mean · Titers
GMT of RSV-A Neutralizing Titers (ED60) at Pre-vaccination and 1 Month After the RSVPreF3 OA Vaccination
TitersCo-administration GroupControl Group
Pre-vaccination (Day 1)1005.4 (909.1 to 1111.9)961.2 (860.8 to 1073.4)
Day 318553.3 (7568.7 to 9666.1)—
Day 61—9689.4 (8561.7 to 10965.7)
SecondaryMGI of Respiratory Syncytial Virus-A Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination

The MGI was defined as the geometric mean of the within participant ratios of the post-vaccination titer over the pre-vaccination titer. Neutralizing titers were measured with neutralization assay.

Time frame:
At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for Co-administration Group and Day 61 for Control Group) compared to Pre-vaccination (Day 1 for Co-administration Group and Control Group)
Reported as:
Geometric mean · Ratio
MGI of Respiratory Syncytial Virus-A Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination
RatioCo-administration GroupControl Group
MGI of Respiratory Syncytial Virus-A Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination8.55 (7.44 to 9.82)9.91 (8.55 to 11.49)
SecondaryGMT of RSV-B Neutralizing Titers (ED60) at Pre-vaccination and 1 Month After the RSVPreF3 OA Vaccination

Neutralizing titers were measured with neutralization assay and the results were expressed as GMT. The ED60 was defined as the dose that produced an effect in 60% of the population.

Time frame:
At pre-vaccination (Day 1) and Day 31 for Co-administration Group and at pre-vaccination (Day 1) and Day 61 for Control Group
Reported as:
Geometric mean · Titers
GMT of RSV-B Neutralizing Titers (ED60) at Pre-vaccination and 1 Month After the RSVPreF3 OA Vaccination
TitersCo-administration GroupControl Group
Pre-vaccination (Day 1)1148.8 (1042.2 to 1266.3)1167.9 (1033.5 to 1319.8)
Day 3110521.3 (9411.3 to 11762.2)—
Day 61—10352.2 (9122.8 to 11747.3)
SecondaryMGI of RSV-B Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination

The MGI was defined as the geometric mean of the within participant ratios of the post-vaccination titer over the pre-vaccination titer. Neutralizing titers were measured with neutralization assay.

Time frame:
At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for Co-administration Group and Day 61 for Control Group) compared to Pre-vaccination (Day 1 for Co-administration Group and Control Group)
Reported as:
Geometric mean · Ratio
MGI of RSV-B Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination
RatioCo-administration GroupControl Group
MGI of RSV-B Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination9.01 (7.93 to 10.24)8.69 (7.50 to 10.07)
SecondaryPercentage of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration

The solicited administration site events after vaccination included pain, erythema/redness, and swelling.

Time frame:
Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Days 1 and 61 for Co-Administration Group and at Days 1, 31 and 61 for Control group)
Reported as:
Number · Percentage of participants
Percentage of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration
Percentage of participantsCo-administration GroupControl Group
Pain at injection site, HZ/su dose 1, given at Day 167.6 (61.4 to 73.3)59.8 (53.4 to 65.9)
Pain at injection site, RSV dose, given at Day 163.1 (56.8 to 69.1)—
Pain at injection site, RSV dose, given at Day 31—49.6 (43.0 to 56.1)
Pain at injection site, HZ/su dose 2, given at Day 6157.3 (50.6 to 63.9)63.4 (56.9 to 69.6)
Erythema at injection site, HZ/su dose 1, given at Day 114.6 (10.5 to 19.6)13.1 (9.2 to 18.0)
Erythema at injection site, RSV dose, given at Day 17.9 (4.9 to 12.0)—
Erythema at injection site, RSV dose, given at Day 31—7.6 (4.6 to 11.8)
Erythema at injection site, HZ/su dose 2, given at Day 6116.0 (11.5 to 21.5)11.9 (8.1 to 16.8)
Swelling at injection site, HZ/su dose 1, given at Day 18.7 (5.5 to 12.9)8.8 (5.6 to 13.0)
Swelling at injection site, RSV dose, given at Day 16.0 (3.4 to 9.6)—
Swelling at injection site, RSV dose, given at Day 31—5.5 (3.0 to 9.2)
Swelling at injection site, HZ/su dose 2, given at Day 618.9 (5.5 to 13.4)8.5 (5.3 to 12.8)
SecondaryPercentage of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration

The solicited systemic events after vaccination included arthralgia, fatigue, fever (pyrexia), headache, myalgia, shivering/chills, and gastrointestinal symptoms (nausea, vomiting, diarrhea, and abdominal pain).

Time frame:
Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Days 1 and 61 for Co-Administration Group and at Days 1, 31 and 61 for Control group)
Reported as:
Number · Percentage of participants
Percentage of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration
Percentage of participantsCo-administration GroupControl Group
Fever, Dosing at Day 18.9 (5.7 to 13.1)6.2 (3.6 to 9.8)
Fever, Dosing at Day 31—3.3 (1.4 to 6.3)
Fever, Dosing at Day 613.0 (1.2 to 6.2)7.4 (4.4 to 11.5)
Headache, Dosing at Day 137.2 (31.3 to 43.4)30.0 (24.5 to 36.0)
Headache, Dosing at Day 31—22.9 (17.8 to 28.6)
Headache, Dosing at Day 6130.9 (25.0 to 37.3)33.3 (27.4 to 39.6)
Fatigue, Dosing at Day 148.8 (42.6 to 55.1)36.2 (30.3 to 42.3)
Fatigue, Dosing at Day 31—31.8 (26.1 to 38.1)
Fatigue, Dosing at Day 6139.6 (33.2 to 46.2)46.5 (40.1 to 53.0)
Myalgia, Dosing at Day 151.9 (45.7 to 58.2)40.4 (34.4 to 46.6)
Myalgia, Dosing at Day 31—26.9 (21.5 to 33.0)
Myalgia, Dosing at Day 6137.0 (30.7 to 43.5)41.6 (35.3 to 48.0)
Arthralgia, Dosing at Day 124.0 (18.9 to 29.7)16.2 (11.9 to 21.2)
Arthralgia, Dosing at Day 31—12.7 (8.8 to 17.5)
Arthralgia, Dosing at Day 6120.9 (15.8 to 26.7)21.0 (16.0 to 26.7)
Chills, Dosing at Day 122.9 (17.9 to 28.5)12.7 (8.9 to 17.4)
Chills, Dosing at Day 31—13.1 (9.1 to 17.9)
Chills, Dosing at Day 6123.0 (17.8 to 29.0)25.9 (20.5 to 31.9)
Gastrointestinal Symptoms, Dosing at Day 115.9 (11.7 to 20.9)15.0 (10.9 to 19.9)
Gastrointestinal Symptoms, Dosing at Day 31—11.4 (7.7 to 16.1)
Gastrointestinal Symptoms, Dosing at Day 619.1 (5.7 to 13.6)12.3 (8.5 to 17.2)
SecondaryPercentage of Participants With Unsolicited Adverse Events

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study vaccine, which does not necessarily have a causal relationship with study vaccine. An unsolicited AE was an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs must had been communicated by participant/participant's caregiver(s) who had signed the informed consent. Unsolicited AEs included both serious and non-serious AEs.

Time frame:
Within 30 days (the day of vaccination and 29 subsequent days) after vaccine administration
Reported as:
Number · Percentage of participants
Percentage of Participants With Unsolicited Adverse Events
Percentage of participantsCo-administration GroupControl Group
Percentage of Participants With Unsolicited Adverse Events23.4 (18.4 to 29.0)30.2 (24.7 to 36.1)
SecondaryPercentage of Participants With Serious Adverse Events (SAEs)

An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.

Time frame:
From first dose of study vaccine administration (Day 1) up to 6 months after last dose of study vaccine administration, approximately 241 days
Reported as:
Number · Percentage of participants
Percentage of Participants With Serious Adverse Events (SAEs)
Percentage of participantsCo-administration GroupControl Group
Percentage of Participants With Serious Adverse Events (SAEs)4.9 (2.6 to 8.2)2.3 (0.8 to 4.9)
SecondaryPercentage of Participants With Potential Immune-mediated Diseases (pIMDs)

The pIMD was a subset of adverse events of special interest that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

Time frame:
From first dose of study vaccine administration (Day 1) up to 6 months after last dose of study vaccine administration, approximately 241 days
Reported as:
Number · Percentage of participants
Percentage of Participants With Potential Immune-mediated Diseases (pIMDs)
Percentage of participantsCo-administration GroupControl Group
Percentage of Participants With Potential Immune-mediated Diseases (pIMDs)0.4 (0.0 to 2.1)0.8 (0.1 to 2.7)

Adverse events

Collected over Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination (approximately up to 241 days).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Co-administration Group0/265 (0%)13/265 (4.9%)240/265 (90.6%)
Control Group0/265 (0%)6/265 (2.3%)235/265 (88.7%)
Most frequent serious events
Showing 10 of 25
Most frequent serious events
EventCo-administration GroupControl Group
Transitional cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)2/2650/265
Iron deficiency anaemiaBlood and lymphatic system disorders1/2650/265
AnaemiaBlood and lymphatic system disorders0/2651/265
Arteriosclerosis coronary arteryCardiac disorders0/2651/265
Myocardial infarctionCardiac disorders1/2650/265
Atrial fibrillationCardiac disorders1/2650/265
Gastrointestinal haemorrhageGastrointestinal disorders0/2651/265
AppendicitisInfections and infestations0/2651/265
Pneumonia influenzalInfections and infestations1/2650/265
CystitisInfections and infestations1/2650/265
Most frequent other events
Showing 10 of 135
Most frequent other events
EventCo-administration GroupControl Group
Injection site painGeneral disorders204/265197/265
FatigueGeneral disorders149/265156/265
MyalgiaMusculoskeletal and connective tissue disorders153/265155/265
HeadacheNervous system disorders119/265138/265
ChillsGeneral disorders85/26590/265
ArthralgiaMusculoskeletal and connective tissue disorders86/26578/265
Injection site erythemaGeneral disorders59/26557/265
DiarrhoeaGastrointestinal disorders30/26543/265
Injection site swellingGeneral disorders38/26540/265
PyrexiaGeneral disorders29/26540/265

Baseline characteristics

Exposed set included all participants in the enrolled set who received at least 1 study intervention.

Age, Continuous
Age, Continuous(years)Co-administration GroupControl GroupTotal
Mean63.9 ± 8.5663.9 ± 8.7363.9 ± 8.64
Sex: Female, Male
Sex: Female, Male(Participants)Co-administration GroupControl GroupTotal
Female146146292
Male119119238
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Co-administration GroupControl GroupTotal
Hispanic or Latino283058
Not Hispanic or Latino237235472
Unknown or Not Reported000
08

Study locations

27 sites
  • GSK Investigational Site
    Daphne, Alabama 36526, United States
  • GSK Investigational Site
    Tempe, Arizona 85281, United States
  • GSK Investigational Site
    Corte Madera, California 94925, United States
  • GSK Investigational Site
    Aurora, Colorado 80012, United States
  • GSK Investigational Site
    North Miami Beach, Florida 33162, United States
  • GSK Investigational Site
    West Palm Beach, Florida 33409, United States
  • GSK Investigational Site
    Columbus, Georgia 31904-8946, United States
  • GSK Investigational Site
    Versailles, Kentucky 40383, United States
  • GSK Investigational Site
    New Orleans, Louisiana 70115, United States
  • GSK Investigational Site
    Fort Worth, Texas 76104, United States
  • GSK Investigational Site
    San Antonio, Texas 78229, United States
  • GSK Investigational Site
    Brampton, Ontario L6T 0G1, Canada
  • GSK Investigational Site
    Guelph, Ontario N1H 1B1, Canada
  • GSK Investigational Site
    Toronto, Ontario M4G 3E8, Canada
  • GSK Investigational Site
    Toronto, Ontario M9V 4B4, Canada
  • GSK Investigational Site
    Sherbrooke, Quebec J1L 0H8, Canada
  • GSK Investigational Site
    Brampton, L6T 0G1, Canada
  • GSK Investigational Site
    Guelph, N1H 1B1, Canada
  • GSK Investigational Site
    Quebec, G1N 4V3, Canada
  • GSK Investigational Site
    Quebec, G6W 0M5, Canada
  • GSK Investigational Site
    Quebec, H9R 4S3, Canada
  • GSK Investigational Site
    Quebec, J7J 2K8, Canada
  • GSK Investigational Site
    Sarnia, N7T 4X3, Canada
  • GSK Investigational Site
    Sherbrooke, J1L 0H8, Canada
  • GSK Investigational Site
    Toronto, M3H 5S4, Canada
  • GSK Investigational Site
    Toronto, M4G 3E8, Canada
  • GSK Investigational Site
    Toronto, M9V 4B4, Canada
09

References and documents

Study documents

  • Study protocol · Apr 17, 2023
  • Statistical analysis plan · Jul 25, 2024

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 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 Apr 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05966090
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jul 28, 2023
Start date
Jul 28, 2023
Primary completion
Feb 19, 2024
Completion
Jul 29, 2024
Results posted
Apr 1, 2025
Last update
Apr 1, 2025

Oversight

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

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