Phase 3
N=530
A Study on Safety and Immune Response of Investigational RSV OA Vaccine in Combination With Herpes Zoster Vaccine in Healthy Adults
Respiratory Syncytial Viruses · Respiratory Syncytial Virus Infections
Bottom Line
View on ClinicalTrials.gov: NCT05966090 ↗Enrolled (actual)
530
Serious AEs
3.6%
Results posted
Apr 2025
Primary outcome: Primary: Adjusted Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies at 1 Month Post-second Dose of HZ/su Vaccination — 49326.9; 61192.7 mIU/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- RSVPreF3 OA investigational vaccine (Biological); HZ/su vaccine (Biological)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies at 1 Month Post-second Dose of HZ/su Vaccination |
49326.9; 61192.7 | — |
| PRIMARY 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 |
8426.8; 9628.7 | — |
| PRIMARY Adjusted GMTs of RSV-B Neutralizing Titers (ED60) at 1 Month After the RSVPreF3 OA Vaccination |
10354.2; 10143.4 | — |
| SECONDARY Percentage of Participants With Seropositivity at Pre-vaccination and 1 Month Post-second Dose of HZ/su Vaccination |
98.5; 97.3; 100.0; 100.0 | — |
| SECONDARY GMC of Anti-glycoprotein Antibodies at Pre-vaccination and 1 Month Post-second Dose of HZ/su Vaccination |
1739.4; 1492.2; 50235.2; 61204.7 | — |
| SECONDARY Mean Geometric Increase (MGI) of Anti-glycoprotein Antibodies at Pre-vaccination and 1 Month Post-second Dose of HZ/su Vaccination |
28.24; 43.24 | — |
| SECONDARY Vaccine Response Rate (VRR) at 1 Month Post-second Dose of HZ/su Vaccination |
92.9; 96.5 | — |
| SECONDARY GMT of RSV-A Neutralizing Titers (ED60) at Pre-vaccination and 1 Month After the RSVPreF3 OA Vaccination |
1005.4; 961.2; 8553.3; 9689.4 | — |
| SECONDARY MGI of Respiratory Syncytial Virus-A Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination |
8.55; 9.91 | — |
| SECONDARY GMT of RSV-B Neutralizing Titers (ED60) at Pre-vaccination and 1 Month After the RSVPreF3 OA Vaccination |
1148.8; 1167.9; 10521.3; 10352.2 | — |
| SECONDARY MGI of RSV-B Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination |
9.01; 8.69 | — |
| SECONDARY Percentage of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration |
67.6; 59.8; 63.1; 49.6; 57.3; 63.4 | — |
| SECONDARY Percentage of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration |
8.9; 6.2; 3.3; 3.0; 7.4; 37.2 | — |
| SECONDARY Percentage of Participants With Unsolicited Adverse Events |
23.4; 30.2 | — |
| SECONDARY Percentage of Participants With Serious Adverse Events (SAEs) |
4.9; 2.3 | — |
| SECONDARY Percentage of Participants With Potential Immune-mediated Diseases (pIMDs) |
0.4; 0.8 | — |
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.
Eligibility Criteria
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
- 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 vacc
Data sourced from ClinicalTrials.gov (NCT05966090). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.