A Phase III, Open-label, Randomized, Controlled, Multi-country Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With Herpes Zoster Recombinant Subunit (HZ/su) Vaccine in Adults Aged 50 Years and Older
Overview
- Phase
- Phase 3
- Intervention
- RSVPreF3 OA investigational vaccine
- Conditions
- Respiratory Syncytial Viruses
- Sponsor
- GlaxoSmithKline
- Enrollment
- 530
- Locations
- 1
- Primary Endpoint
- Adjusted Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies at 1 Month Post-second Dose of HZ/su Vaccination
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
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.
Arms & Interventions
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.
Intervention: RSVPreF3 OA investigational vaccine
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.
Intervention: HZ/su vaccine
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.
Intervention: RSVPreF3 OA investigational vaccine
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.
Intervention: HZ/su vaccine
Outcomes
Primary Outcomes
Adjusted Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies at 1 Month Post-second Dose of HZ/su Vaccination
Time Frame: At 1 month post-second dose of HZ/su vaccination (Day 91)
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).
Adjusted GMTs of RSV-B Neutralizing Titers (ED60) at 1 Month After the RSVPreF3 OA Vaccination
Time Frame: At Day 31 for Co-administration Group and at Day 61 for Control Group
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.
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
Time Frame: At Day 31 for Co-administration Group and at Day 61 for Control Group
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.
Secondary Outcomes
- Percentage of Participants With Unsolicited Adverse Events(Within 30 days (the day of vaccination and 29 subsequent days) after vaccine administration)
- Percentage of Participants With Serious Adverse Events (SAEs)(From first dose of study vaccine administration (Day 1) up to 6 months after last dose of study vaccine administration, approximately 241 days)
- Percentage of Participants With Potential Immune-mediated Diseases (pIMDs)(From first dose of study vaccine administration (Day 1) up to 6 months after last dose of study vaccine administration, approximately 241 days)
- Percentage of Participants With Seropositivity at Pre-vaccination and 1 Month Post-second Dose of HZ/su Vaccination(Pre-vaccination (Day 1) and 1 month post-second dose of HZ/su vaccination (Day 91))
- GMC of Anti-glycoprotein Antibodies at Pre-vaccination and 1 Month Post-second Dose of HZ/su Vaccination(Pre-vaccination (Day 1) and 1 month post-second dose of HZ/su vaccination (Day 91))
- Mean Geometric Increase (MGI) of Anti-glycoprotein Antibodies at Pre-vaccination and 1 Month Post-second Dose of HZ/su Vaccination(At 1 month post-second dose of HZ/su vaccination (Day 91) compared to Pre-vaccination (Day 1))
- Vaccine Response Rate (VRR) at 1 Month Post-second Dose of HZ/su Vaccination(At 1 month post-second dose of HZ/su vaccination (Day 91))
- GMT of RSV-A Neutralizing Titers (ED60) at Pre-vaccination and 1 Month After the RSVPreF3 OA Vaccination(At pre-vaccination (Day 1) and Day 31 for Co-administration Group and at pre-vaccination (Day 1) and Day 61 for Control Group)
- MGI of Respiratory Syncytial Virus-A Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination(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))
- GMT of RSV-B Neutralizing Titers (ED60) at Pre-vaccination and 1 Month After the RSVPreF3 OA Vaccination(At pre-vaccination (Day 1) and Day 31 for Co-administration Group and at pre-vaccination (Day 1) and Day 61 for Control Group)
- MGI of RSV-B Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination(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))
- Percentage of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration(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))
- Percentage of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration(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))