Respiratory Syncytial Virus Infections
Conditions
Keywords
Respiratory syncytial virus, Vaccine, Older adult, Immunogenicity, Safety
Brief summary
The purpose of this study is to assess the ability of RSVPreF3 OA investigational vaccine to generate an immune response when given in combination with PCV20 and its safety in older adults, aged ≥60 years of age.
Interventions
BIOLOGICALRSVPreF3 OA investigational vaccine
One dose of RSVPreF3 OA vaccine given intramuscularly in participant's non-dominant arm on Day 1 (in the Coad group) or Day 31(in the Control group).
BIOLOGICALPCV20
One dose of the 20-valent pneumococcal conjugate vaccine (PCV20) given intramuscularly in participant's dominant arm (Coad group) or non-dominant arm (Control group) on Day 1
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* A male or female ≥60 years of age at the time of the first study intervention administration. * 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, are allowed to participate in this study if considered by the investigator as medically stable.
Exclusion criteria
* Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination. * History of any reaction or hypersensitivity likely to be exacerbated by the study interventions, in particular any history of severe allergic reaction to any vaccine containing diphtheria toxoid, or pneumococcal polysaccharide 23-valent vaccine (PPSV23). * Participants considered by investigator as suffering from serious or unstable chronic illness. * 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 active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol. * 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. * History of previous vaccination with any licensed or investigational pneumococcal conjugate vaccine, or planned receipt through study participation. * History of previous vaccination with any licensed or investigational pneumococcal polysaccharide vaccine in the last 5 years from enrollment, or planned receipt through study participation. * Previous vaccination with any 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 and ending 30 days after the last study intervention administration, 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. In the case of COVID 19 and inactivated/subunit influenza vaccines, this time window can be decreased to 14 days before and after each study intervention administration. In case of COVID-19 vaccine administration within 14 to 30 days window, the administration of COVID-19 vaccine should be in accordance with local government recommendations. * Planned or actual administration of adjuvanted quadrivalent influenza vaccine or live 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. Note: In case an emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by the public health authorities outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor or designee is notified accordingly. * Administration of long-acting immune-modifying drugs or planned administration at any time during the study period. * Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the 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 and topical 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 (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 EoS. * Participation of any study personnel or their immediate dependents, family, or household members.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | At Day 31 | The OP titers were measured with multiplexed opsonophagocytosis assay and the results were expressed as GMT for each of the pneumococcal vaccine serotype. |
| Adjusted GMTs of Respiratory Syncytial Virus-A (RSV-A) Neutralizing Titers [Estimated Dilution 60 (ED60)] at 1 Month After the RSVPreF3 OA Vaccination | 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 in ED60. |
| Adjusted GMTs of RSV-B Neutralizing Titers (ED60) at 1 Month After the RSVPreF3 OA Vaccination | 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 in ED60. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number 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 Day 1 for Co-Administration Group and at Days 1 and 31 for Control group) | The solicited systemic events after vaccination include fever (pyrexia), headache, fatigue, myalgia and arthralgia. Fever is defined as body temperature \>=38 degree Celsius; preferred location for measuring the temperature is oral. |
| Number of Participants With Unsolicited AEs | Within 30 days (the day of vaccination and 29 subsequent days) after each vaccine administration (vaccines administered at Day 1 for Co-Administration Group and at Days 1 and 31 for Control group) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the administration of a study vaccine, which does not necessarily have a causal relationship with study vaccine. An unsolicited AE is an AE that is 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 are communicated by participant/participant's caregiver(s) who have signed the informed consent. Unsolicited AEs include both serious adverse events (SAEs) and non-serious AEs. |
| Mean Geometric Increase (MGI) of RSV-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 Day 31 for Control Group) | The MGI was defined as the geometric mean increase of the within participant ratios of the post-vaccination titer over the pre-vaccination titer. Neutralizing titers were measured with neutralization assay. |
| Number of Participants With Potential Immune-mediated Diseases (pIMDs) | Throughout the study period (from Day 1 up to 6 months after the last dose administration [last dose given at Day 1 for Co-administration Group and Day 31 for Control Group]) | The pIMD is a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. |
| Number of Participants With SAEs | Throughout the study period (from Day 1 up to 6 months after the last dose administration [last dose given at Day 1 for Co-administration Group and Day 31 for Control Group]) | An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. |
| 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 Day 31 for Control Group) | The MGI was defined as the geometric mean increase of the within participant ratios of the post-vaccination titer over the pre-vaccination titer. Neutralizing titers were measured with neutralization assay. |
| Number 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 Day 1 for Co-Administration Group and at Days 1 and 31 for Control group) | The solicited administration site events after vaccination include pain, erythema/redness, and swelling. |
Countries
Belgium, Poland, Spain, United States
Participant flow
Recruitment details
This study was conducted in adult participants aged 60 years and older, in 38 study sites.
Pre-assignment details
Out of 1113 participants, a total of 1110 were eligible and were randomized in a 1:1 ratio to either co-administration group or control group at Day 1.
Participants by arm
| Arm | Count |
|---|---|
| Co-administration Group Participants received both RSVPreF3 OA vaccine and PCV20 on Day 1. | 553 |
| Control Group Participants received PCV20 vaccine on Day 1 and RSVPreF3 OA vaccine on Day 31. | 557 |
| Total | 1,110 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 2 |
| Overall Study | Lost to Follow-up | 8 | 13 |
| Overall Study | Migrated / moved from the study area | 1 | 1 |
| Overall Study | Other | 0 | 3 |
| Overall Study | Withdrawal by participant, not due to an adverse event | 5 | 7 |
Baseline characteristics
| Characteristic | Co-administration Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 69.6 years STANDARD_DEVIATION 7.28 | 69.6 years STANDARD_DEVIATION 7.41 | 69.6 years STANDARD_DEVIATION 7.35 |
| Race/Ethnicity, Customized All Other Races | 7 Participants | 7 Participants | 14 Participants |
| Race/Ethnicity, Customized Black or African American | 64 Participants | 54 Participants | 118 Participants |
| Race/Ethnicity, Customized Multiple | 2 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized Other | 4 Participants | 4 Participants | 8 Participants |
| Race/Ethnicity, Customized White | 476 Participants | 488 Participants | 964 Participants |
| Sex: Female, Male Female | 316 Participants | 315 Participants | 631 Participants |
| Sex: Female, Male Male | 237 Participants | 242 Participants | 479 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 553 | 2 / 557 |
| other Total, other adverse events | 410 / 553 | 423 / 557 |
| serious Total, serious adverse events | 9 / 553 | 14 / 557 |
Outcome results
Primary
Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination
The OP titers were measured with multiplexed opsonophagocytosis assay and the results were expressed as GMT for each of the pneumococcal vaccine serotype.
Time frame: At Day 31
Population: Per protocol set (PPS) for PCV20 included all eligible participants in the exposed set who: received the PVC20 vaccine, had immunogenicity results for OP titers, complied with blood draw interval, without intercurrent medical conditions and without prohibited concomitant medication/vaccination and who did not meet any of the criteria for elimination up to blood sample collection. Only participants with data available at the specified timepoint were included in the analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Co-administration Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 1 | 74.7 Titers |
| Co-administration Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 3 | 88.5 Titers |
| Co-administration Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 4 | 1220.9 Titers |
| Co-administration Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 5 | 191.0 Titers |
| Co-administration Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 6A | 1790.0 Titers |
| Co-administration Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 6B | 2121.6 Titers |
| Co-administration Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 7F | 2411.3 Titers |
| Co-administration Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 8 | 522.9 Titers |
| Co-administration Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 9V | 937.0 Titers |
| Co-administration Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 10A | 6033.4 Titers |
| Co-administration Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 11A | 798.0 Titers |
| Co-administration Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 12F | 1608.4 Titers |
| Co-administration Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 14 | 2322.3 Titers |
| Co-administration Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 15B | 4336.4 Titers |
| Co-administration Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 18C | 1148.6 Titers |
| Co-administration Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 19A | 1392.3 Titers |
| Co-administration Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 19F | 525.6 Titers |
| Co-administration Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 22F | 5492.3 Titers |
| Co-administration Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 23F | 729.7 Titers |
| Co-administration Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 33F | 14902.8 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 22F | 7351.5 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 1 | 110.8 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 11A | 944.2 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 3 | 116.2 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 19A | 1933.8 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 4 | 1634.1 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 12F | 1932.4 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 5 | 260.3 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 33F | 20920.9 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 6A | 2458.3 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 14 | 3301.4 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 6B | 2996.9 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 19F | 696.7 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 7F | 3225.1 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 15B | 6350.2 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 8 | 723.0 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 23F | 995.0 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 9V | 1161.0 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 18C | 1480.0 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination | Strep pneumoniae - serotype 10A | 7349.4 Titers |
Comparison: Strep pneumoniae - serotype 195% CI: [1.22, 1.81]
Comparison: Strep pneumoniae - serotype 395% CI: [1.12, 1.54]
Comparison: Strep pneumoniae - serotype 495% CI: [1.13, 1.58]
Comparison: Strep pneumoniae - serotype 595% CI: [1.08, 1.71]
Comparison: Strep pneumoniae - serotype 6A95% CI: [1.12, 1.69]
Comparison: Strep pneumoniae - serotype 6B95% CI: [1.17, 1.7]
Comparison: Strep pneumoniae - serotype 7F95% CI: [1.16, 1.55]
Comparison: Strep pneumoniae - serotype 895% CI: [1.17, 1.64]
Comparison: Strep pneumoniae - serotype 9V95% CI: [1.05, 1.47]
Comparison: Strep pneumoniae - serotype 10A95% CI: [1.03, 1.44]
Comparison: Strep pneumoniae - serotype 11A95% CI: [0.98, 1.42]
Comparison: Strep pneumoniae - serotype 12F95% CI: [0.99, 1.46]
Comparison: Strep pneumoniae - serotype 1495% CI: [1.21, 1.67]
Comparison: Strep pneumoniae - serotype 15B95% CI: [1.22, 1.76]
Comparison: Strep pneumoniae - serotype 18C95% CI: [1.07, 1.55]
Comparison: Strep pneumoniae - serotype 19A95% CI: [1.2, 1.61]
Comparison: Strep pneumoniae - serotype 19F95% CI: [1.12, 1.57]
Comparison: Strep pneumoniae - serotype 22F95% CI: [1.12, 1.6]
Comparison: Strep pneumoniae - serotype 23F95% CI: [1.09, 1.71]
Comparison: Strep pneumoniae - serotype 33F95% CI: [1.2, 1.64]
Primary
Adjusted GMTs 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 in ED60.
Time frame: At Day 31 for Co-administration Group and at Day 61 for Control Group
Population: PPS 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 blood draw interval, without intercurrent medical conditions and without prohibited concomitant medication/vaccination and who did not meet any of the criteria for elimination up to blood sample collection. Only the participants with RSV-A data at the specified timepoints were included in the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Co-administration Group | Adjusted GMTs of Respiratory Syncytial Virus-A (RSV-A) Neutralizing Titers [Estimated Dilution 60 (ED60)] at 1 Month After the RSVPreF3 OA Vaccination | 8338.2 Titers |
| Control Group | Adjusted GMTs of Respiratory Syncytial Virus-A (RSV-A) Neutralizing Titers [Estimated Dilution 60 (ED60)] at 1 Month After the RSVPreF3 OA Vaccination | 8872.7 Titers |
Comparison: RSV-A95% CI: [0.94, 1.2]
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 in ED60.
Time frame: At Day 31 for Co-administration Group and at Day 61 for Control Group
Population: PPS for RSVPreF3 OA. Only the participants with RSV-B data at the specified timepoints were included in the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Co-administration Group | Adjusted GMTs of RSV-B Neutralizing Titers (ED60) at 1 Month After the RSVPreF3 OA Vaccination | 9477.5 Titers |
| Control Group | Adjusted GMTs of RSV-B Neutralizing Titers (ED60) at 1 Month After the RSVPreF3 OA Vaccination | 9497.6 Titers |
Comparison: RSV-B95% CI: [0.89, 1.13]
Secondary
Mean Geometric Increase (MGI) of RSV-A Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination
The MGI was defined as the geometric mean increase 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 Day 31 for Control Group)
Population: PPS for RSVPreF3 OA. Only the participants with RSV-A data at the specified timepoints were included in the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Co-administration Group | Mean Geometric Increase (MGI) of RSV-A Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination | 8.3 Ratio |
| Control Group | Mean Geometric Increase (MGI) of RSV-A Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination | 9.3 Ratio |
Secondary
MGI of RSV-B Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination
The MGI was defined as the geometric mean increase 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 Day 31 for Control Group)
Population: PPS for RSVPreF3 OA. Only the participants with RSV-B data at the specified timepoints were included in the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Co-administration Group | MGI of RSV-B Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination | 9.4 Ratio |
| Control Group | MGI of RSV-B Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination | 9.1 Ratio |
Secondary
Number of Participants With Potential Immune-mediated Diseases (pIMDs)
The pIMD is a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Time frame: Throughout the study period (from Day 1 up to 6 months after the last dose administration [last dose given at Day 1 for Co-administration Group and Day 31 for Control Group])
Population: Exposed set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Co-administration Group | Number of Participants With Potential Immune-mediated Diseases (pIMDs) | 2 Participants |
| Control Group | Number of Participants With Potential Immune-mediated Diseases (pIMDs) | 1 Participants |
Secondary
Number of Participants With SAEs
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Time frame: Throughout the study period (from Day 1 up to 6 months after the last dose administration [last dose given at Day 1 for Co-administration Group and Day 31 for Control Group])
Population: Exposed set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Co-administration Group | Number of Participants With SAEs | 9 Participants |
| Control Group | Number of Participants With SAEs | 14 Participants |
Secondary
Number of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration
The solicited administration site events after vaccination include 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 Day 1 for Co-Administration Group and at Days 1 and 31 for Control group)
Population: Exposed set included all participants in the Enrolled set who received at least 1 study intervention. Only those participants with solicited administration site AEs were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Co-administration Group | Number of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration | Pain at injection site, PCV20 dose, given at Day 1 | 283 Participants |
| Co-administration Group | Number of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration | Pain at injection site, RSV dose, given at Day 1 | 290 Participants |
| Co-administration Group | Number of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration | Erythema at injection site, PCV20 dose, given at Day 1 | 24 Participants |
| Co-administration Group | Number of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration | Erythema at injection site, RSV dose, given at Day 1 | 54 Participants |
| Co-administration Group | Number of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration | Swelling at injection site, PCV20 dose, given at Day 1 | 17 Participants |
| Co-administration Group | Number of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration | Swelling at injection site, RSV dose, given at Day 1 | 26 Participants |
| Control Group | Number of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration | Swelling at injection site, PCV20 dose, given at Day 1 | 17 Participants |
| Control Group | Number of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration | Pain at injection site, PCV20 dose, given at Day 1 | 208 Participants |
| Control Group | Number of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration | Erythema at injection site, RSV dose, given at Day 31 | 33 Participants |
| Control Group | Number of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration | Pain at injection site, RSV dose, given at Day 31 | 225 Participants |
| Control Group | Number of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration | Swelling at injection site, RSV dose, given at Day 31 | 21 Participants |
| Control Group | Number of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration | Erythema at injection site, PCV20 dose, given at Day 1 | 21 Participants |
Secondary
Number of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration
The solicited systemic events after vaccination include fever (pyrexia), headache, fatigue, myalgia and arthralgia. Fever is defined as body temperature \>=38 degree Celsius; preferred location for measuring the temperature is oral.
Time frame: Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Day 1 for Co-Administration Group and at Days 1 and 31 for Control group)
Population: Exposed set. Only those participants with solicited systemic AEs were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Co-administration Group | Number of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration | Myalgia, Dosing at Day 1 | 176 Participants |
| Co-administration Group | Number of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration | Fatigue, Dosing at Day 1 | 198 Participants |
| Co-administration Group | Number of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration | Arthralgia, Dosing at Day 1 | 80 Participants |
| Co-administration Group | Number of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration | Fever, Dosing at Day 1 | 16 Participants |
| Co-administration Group | Number of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration | Headache, Dosing at Day 1 | 144 Participants |
| Control Group | Number of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration | Fatigue, Dosing at Day 1 | 152 Participants |
| Control Group | Number of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration | Fatigue, Dosing at Day 31 | 144 Participants |
| Control Group | Number of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration | Myalgia, Dosing at Day 31 | 108 Participants |
| Control Group | Number of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration | Arthralgia, Dosing at Day 1 | 41 Participants |
| Control Group | Number of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration | Myalgia, Dosing at Day 1 | 89 Participants |
| Control Group | Number of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration | Arthralgia, Dosing at Day 31 | 67 Participants |
| Control Group | Number of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration | Fever, Dosing at Day 1 | 4 Participants |
| Control Group | Number of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration | Fever, Dosing at Day 31 | 8 Participants |
| Control Group | Number of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration | Headache, Dosing at Day 1 | 83 Participants |
| Control Group | Number of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration | Headache, Dosing at Day 31 | 97 Participants |
Secondary
Number of Participants With Unsolicited AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the administration of a study vaccine, which does not necessarily have a causal relationship with study vaccine. An unsolicited AE is an AE that is 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 are communicated by participant/participant's caregiver(s) who have signed the informed consent. Unsolicited AEs include both serious adverse events (SAEs) and non-serious AEs.
Time frame: Within 30 days (the day of vaccination and 29 subsequent days) after each vaccine administration (vaccines administered at Day 1 for Co-Administration Group and at Days 1 and 31 for Control group)
Population: Exposed set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Co-administration Group | Number of Participants With Unsolicited AEs | 60 Participants |
| Control Group | Number of Participants With Unsolicited AEs | 98 Participants |