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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Co-administration Group | Experimental | 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. |
|
| Control Group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSVPreF3 OA investigational vaccine | Biological | One dose of RSVPreF3 OA investigational vaccine given intramuscularly on Day 1 (Coadministration group) or Day 31 (Control group). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At 1 month post-second dose of HZ/su vaccination (Day 91) |
| 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. | At Day 31 for Co-administration Group and at Day 61 for Control Group |
| 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. | At Day 31 for Co-administration Group and at Day 61 for Control Group |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Pre-vaccination (Day 1) and 1 month post-second dose of HZ/su vaccination (Day 91) |
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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:
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 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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Daphne | Alabama | 36526 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42054374 | Derived | Roussy JF, Dennis P, Gupta AK, Wallace G, Abitbol A, Aggarwal N, Surber JG, Lee T, Smith BA, Gerard C, Hailemariam HA, David MP, Jastorff AM, Van der Wielen M. Immunogenicity and Safety of the Adjuvanted Respiratory Syncytial Virus Prefusion F Protein-Based Vaccine When Co-administered With the Adjuvanted Recombinant Herpes Zoster Subunit Vaccine in Adults >/= 50 Years of Age. Clin Infect Dis. 2026 Apr 29:ciag208. doi: 10.1093/cid/ciag208. Online ahead of print. |
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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.
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
A total of 530 eligible participants were randomized in a 1:1 ratio to either co-administration group or control group at Day 1.
This study was conducted in adult participants aged 50 years and older, in 20 study sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 17, 2023 | Feb 18, 2025 |
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|
| HZ/su vaccine | Biological | Two doses of HZ/su vaccine given intramuscularly on Day 1 and Day 61. |
|
|
| 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. | 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 | 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. | 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 | 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). | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | The solicited administration site events after vaccination included pain, erythema/redness, and swelling. | 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 | The solicited systemic events after vaccination included arthralgia, fatigue, fever (pyrexia), headache, myalgia, shivering/chills, and gastrointestinal symptoms (nausea, vomiting, diarrhea, and abdominal pain). | 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 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. | Within 30 days (the day of vaccination and 29 subsequent days) after vaccine administration |
| 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. | 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) | 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. | From first dose of study vaccine administration (Day 1) up to 6 months after last dose of study vaccine administration, approximately 241 days |
| 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 | Québec | Quebec | G1N 4V3 | Canada |
| GSK Investigational Site | Québec | Quebec | G6W 0M5 | Canada |
| GSK Investigational Site | Québec | Quebec | H9R 4S3 | Canada |
| GSK Investigational Site | Québec | Quebec | J7J 2K8 | 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 | Québec | G1N 4V3 | Canada |
| GSK Investigational Site | Québec | G6W 0M5 | Canada |
| GSK Investigational Site | Québec | H9R 4S3 | Canada |
| GSK Investigational Site | Québec | 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 |
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. |
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| NOT COMPLETED |
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Exposed set included all participants in the enrolled set who received at least 1 study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Co-administration Group | Participants received both HZ/su vaccine and RSVPreF3 OA vaccine on Day 1 followed by second dose of HZ/su vaccine on Day 61. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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). | Per protocol set for HZ/su included all eligible participants in the exposed set who: received 2 doses of HZ/su vaccine, had immunogenicity results for anti-gE antibody concentrations, complied with the blood draw interval, without intercurrent medical conditions and without prohibited concomitant medication/vaccination, did not met any of the criteria for elimination up to blood sample collection. Participants with data available at the time of analysis were reported in this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At 1 month post-second dose of HZ/su vaccination (Day 91) |
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| 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 | 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. | Per protocol set for RSVPreF3 OA included all eligible participants in the exposed set who: received the RSVPreF3 OA vaccine, had immunogenicity results for RSV neutralizing titers, complied with the blood draw interval, without intercurrent medical conditions and without prohibited concomitant medication/vaccination and who did not met any of the criteria for elimination up to blood sample collection.Participants with data available at the time of analysis were reported in this outcome measure | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 31 for Co-administration Group and at Day 61 for Control Group |
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| Primary | 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. | Per protocol set for RSVPreF3 OA. Participants with data available at the time of analysis were reported in this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 31 for Co-administration Group and at Day 61 for Control Group |
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| Secondary | 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). | Per protocol set for HZ/su. Only those participants with available data at specified timepoints were included in this analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | Pre-vaccination (Day 1) and 1 month post-second dose of HZ/su vaccination (Day 91) |
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| Secondary | 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. | Per protocol set for HZ/su. Only those participants with available data at specified timepoints were included in this analysis. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | Pre-vaccination (Day 1) and 1 month post-second dose of HZ/su vaccination (Day 91) |
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| Secondary | 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. | Per protocol set for HZ/su. Only those participants with available data at specified timepoints were included in this analysis. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | At 1 month post-second dose of HZ/su vaccination (Day 91) compared to Pre-vaccination (Day 1) |
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| Secondary | 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). | Per protocol set for HZ/su. Only those participants with available data at specified timepoint were included in this analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 1 month post-second dose of HZ/su vaccination (Day 91) |
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| Secondary | 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. | Per protocol set for RSVPreF3 OA. Only those participants with available data at specified timepoints were included in this analysis. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At pre-vaccination (Day 1) and Day 31 for Co-administration Group and at pre-vaccination (Day 1) and Day 61 for Control Group |
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| Secondary | 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. | Per protocol set for RSVPreF3 OA. Only those participants with available data at specified timepoints were included in this analysis. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | 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) |
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| Secondary | 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. | Per protocol set for RSVPreF3 OA. Only those participants with available data at specified timepoints were included in this analysis. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At pre-vaccination (Day 1) and Day 31 for Co-administration Group and at pre-vaccination (Day 1) and Day 61 for Control Group |
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| Secondary | 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. | Per protocol set for RSVPreF3 OA. Only those participants with available data at specified timepoints were included in this analysis. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | 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) |
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| Secondary | 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. | Exposed set included all participants in the enrolled set who received at least 1 study intervention. Only those participants with solicited AEs were included in this analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | 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) |
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| Secondary | 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). | Exposed set. Only those participants with solicited AEs were included in this analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | 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) |
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| Secondary | 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. | Exposed set. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 30 days (the day of vaccination and 29 subsequent days) after vaccine administration |
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| Secondary | 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. | Exposed set. | Posted | Number | 95% Confidence Interval | Percentage of participants | From first dose of study vaccine administration (Day 1) up to 6 months after last dose of study vaccine administration, approximately 241 days |
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| Secondary | 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. | Exposed set. | Posted | Number | 95% Confidence Interval | Percentage of participants | From first dose of study vaccine administration (Day 1) up to 6 months after last dose of study vaccine administration, approximately 241 days |
|
|
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).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Co-administration Group | Participants received both HZ/su vaccine and RSVPreF3 OA vaccine on Day 1 followed by second dose of HZ/su vaccine on Day 61. | 0 | 265 | 13 | 265 | 240 | 265 |
| EG001 | 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. | 0 | 265 | 6 | 265 | 235 | 265 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Invasive breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Endometrial cancer stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Schizoaffective disorder | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Superficial vein thrombosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Aortic valve incompetence | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Eustachian tube dysfunction | Ear and labyrinth disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Macular oedema | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperaesthesia teeth | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pancreatic cyst | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Injection site lymphadenopathy | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Injection site warmth | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vaccination site reaction | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Allergy to vaccine | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bacterial vaginosis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gastritis viral | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Infected dermal cyst | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Wound infection staphylococcal | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Bladder injury | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Scar | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Skin injury | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Body temperature decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Fibrin D dimer increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| N-terminal prohormone brain natriuretic peptide increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Troponin T increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Axillary mass | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Colorectal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Generalised anxiety disorder | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Breast cyst | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Breast mass | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Penile cyst | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Uterine pain | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Panniculitis | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 25, 2024 | Feb 18, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| D007239 | Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
Non - Inferiority (NI) was to be demonstrated if the upper limit of the 2 sided 95% confidence interval (CI) of the GMC ratio between the Control group (at Day 91) versus Co-administration group (at Day 91) for anti-gE Ab 1-month after the second HZ/su vaccine dose was <=1.5.
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