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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-501988-40-00 | Other Identifier | EU CTR number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Co-administration Group | Experimental | Participants received both respiratory syncytial virus prefusion protein 3 older adult (RSVPreF3 OA) vaccine and 20-valent pneumococcal conjugate vaccine (PCV20) on Day 1. |
|
| Control Group | Active Comparator | Participants received PCV20 vaccine on Day 1 and RSVPreF3 OA vaccine on Day 31. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSVPreF3 OA investigational vaccine | Biological | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Day 31 |
| 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. | 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 in ED60. | At Day 31 for Co-administration Group and at Day 61 for Control Group |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
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Inclusion Criteria:
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.
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Guntersville | Alabama | 35976 | United States | ||
| GSK Investigational Site |
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 tohttps://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.
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.
This study was conducted in adult participants aged 60 years and older, in 38 study sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Co-administration Group | Participants received both respiratory syncytial virus prefusion protein 3 older adult (RSVPreF3 OA) vaccine and 20-valent pneumococcal conjugate vaccine (PCV20) on Day 1. |
| 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 | Jun 23, 2023 | May 6, 2025 |
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|
| PCV20 | Biological | 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 |
|
|
| 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. | 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) |
| 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. | 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) |
| 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. | 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) |
| 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. | 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) |
| 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. | 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]) |
| 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. | 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]) |
| Phoenix |
| Arizona |
| 85023 |
| United States |
| GSK Investigational Site | Huntington Beach | California | 92647 | United States |
| GSK Investigational Site | Modesto | California | 95350 | United States |
| GSK Investigational Site | Hamden | Connecticut | 06517 | United States |
| GSK Investigational Site | Clearwater | Florida | 33756 | United States |
| GSK Investigational Site | DeLand | Florida | 32720 | United States |
| GSK Investigational Site | Jupiter | Florida | 33458 | United States |
| GSK Investigational Site | Largo | Florida | 33777 | United States |
| GSK Investigational Site | Orlando | Florida | 32801 | United States |
| GSK Investigational Site | West Des Moines | Iowa | 50266 | United States |
| GSK Investigational Site | New Orleans | Louisiana | 70115 | United States |
| GSK Investigational Site | Troy | Michigan | 48085 | United States |
| GSK Investigational Site | St Louis | Missouri | 63110 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45212 | United States |
| GSK Investigational Site | North Charleston | South Carolina | 29405 | United States |
| GSK Investigational Site | Dallas | Texas | 75251 | United States |
| GSK Investigational Site | Frisco | Texas | 75033 | United States |
| GSK Investigational Site | Mesquite | Texas | 75149 | United States |
| GSK Investigational Site | Plano | Texas | 75024 | United States |
| GSK Investigational Site | Antwerp | 2000 | Belgium |
| GSK Investigational Site | Ghent | 9000 | Belgium |
| GSK Investigational Site | Kluisbergen | 9690 | Belgium |
| GSK Investigational Site | Mechelen | 2800 | Belgium |
| GSK Investigational Site | Namur | 5000 | Belgium |
| GSK Investigational Site | Wetteren | 9230 | Belgium |
| GSK Investigational Site | Krakow | 31-501 | Poland |
| GSK Investigational Site | Lodz | 91-363 | Poland |
| GSK Investigational Site | Lublin | 20-362 | Poland |
| GSK Investigational Site | Pu?awy | 24-100 | Poland |
| GSK Investigational Site | Staszów | 28-200 | Poland |
| GSK Investigational Site | Warsaw | 00-215 | Poland |
| GSK Investigational Site | Warsaw | 02-677 | Poland |
| GSK Investigational Site | Warsaw | 03-291 | Poland |
| GSK Investigational Site | Wroclaw | 53-673 | Poland |
| GSK Investigational Site | Barcelona | 08023 | Spain |
| GSK Investigational Site | Barcelona | 8025 | Spain |
| GSK Investigational Site | Valencia | 46020 | Spain |
Participants received PCV20 vaccine on Day 1 and RSVPreF3 OA vaccine on Day 31.
| COMPLETED |
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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 RSVPreF3 OA vaccine and PCV20 on Day 1. |
| BG001 | Control Group | Participants received PCV20 vaccine on Day 1 and RSVPreF3 OA vaccine on Day 31. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | The "All Other Races" category (i.e., American Indian or Alaska Native and Asian) where 0\ | Count of Participants | Participants |
|
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 31 |
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| 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. | 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. | 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 in ED60. | PPS for RSVPreF3 OA. Only the participants with RSV-B data at the specified timepoints were included in the analysis. | 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 | 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. | PPS for RSVPreF3 OA. Only the participants with RSV-A data at the specified timepoints were included in the 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 Day 31 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 increase of the within participant ratios of the post-vaccination titer over the pre-vaccination titer. Neutralizing titers were measured with neutralization assay. | PPS for RSVPreF3 OA. Only the participants with RSV-B data at the specified timepoints were included in the 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 Day 31 for Control Group) |
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| 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. | 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. | Posted | Count of Participants | Participants | 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) |
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| 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. | Exposed set. Only those participants with solicited systemic AEs were included in this analysis. | Posted | Count of Participants | Participants | 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) |
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| 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. | Exposed set. | Posted | Count of Participants | Participants | 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) |
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| 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. | Exposed set. | Posted | Count of Participants | Participants | 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]) |
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| 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. | Exposed set. | Posted | Count of Participants | Participants | 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]) |
|
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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.
Solicited and unsolicited events were reported per participant 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.
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| 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 RSVPreF3 OA vaccine and PCV20 on Day 1. | 0 | 553 | 9 | 553 | 410 | 553 |
| EG001 | Control Group | Participants received PCV20 vaccine on Day 1 and RSVPreF3 OA vaccine on Day 31. | 2 | 557 | 14 | 557 | 423 | 557 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Vertigo positional | Ear and labyrinth disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Death | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Fracture displacement | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Breast cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Breast cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Tumour rupture | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
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| Ureterolithiasis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
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| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardiovascular disorder | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ear congestion | Ear and labyrinth disorders | MedDRA 27.0 | Systematic Assessment |
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| Graves' disease | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
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| Orbital haematoma | Eye disorders | MedDRA 27.0 | Systematic Assessment |
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| Swelling of eyelid | Eye disorders | MedDRA 27.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Frequent bowel movements | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Periodontal inflammation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Axillary pain | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Chills | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Swelling | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
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| Acarodermatitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Arthritis infective | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Clostridium difficile infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Infective tenosynovitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Influenza | 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 externa | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Tooth abscess | 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 |
| |
| Varicella zoster virus infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Tooth dislocation | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Fibrin D dimer increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertonic bladder | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysphonia | 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 |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal 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 |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular 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 full 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 23, 2024 | May 6, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| Male |
|
| All Other Races |
|
| White |
|
| Multiple |
|
| Other |
|
| Strep pneumoniae - serotype 3 |
|
|
| Strep pneumoniae - serotype 4 |
|
|
| Strep pneumoniae - serotype 5 |
|
|
| Strep pneumoniae - serotype 6A |
|
|
| Strep pneumoniae - serotype 6B |
|
|
| Strep pneumoniae - serotype 7F |
|
|
| Strep pneumoniae - serotype 8 |
|
|
| Strep pneumoniae - serotype 9V |
|
|
| Strep pneumoniae - serotype 10A |
|
|
| Strep pneumoniae - serotype 11A |
|
|
| Strep pneumoniae - serotype 12F |
|
|
| Strep pneumoniae - serotype 14 |
|
|
| Strep pneumoniae - serotype 15B |
|
|
| Strep pneumoniae - serotype 18C |
|
|
| Strep pneumoniae - serotype 19A |
|
|
| Strep pneumoniae - serotype 19F |
|
|
| Strep pneumoniae - serotype 22F |
|
|
| Strep pneumoniae - serotype 23F |
|
|
| Strep pneumoniae - serotype 33F |
|
|
| Strep pneumoniae - serotype 3 | GMT ratio | 1.31 | 2-Sided | 95 | 1.12 | 1.54 | The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate. | Non-Inferiority | NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was <=2. |
| Strep pneumoniae - serotype 4 | GMT ratio | 1.34 | 2-Sided | 95 | 1.13 | 1.58 | The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate. | Non-Inferiority | NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was <=2. |
| Strep pneumoniae - serotype 5 | GMT ratio | 1.36 | 2-Sided | 95 | 1.08 | 1.71 | The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate. | Non-Inferiority | NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was <=2. |
| Strep pneumoniae - serotype 6A | GMT ratio | 1.37 | 2-Sided | 95 | 1.12 | 1.69 | The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate. | Non-Inferiority | NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was <=2. |
| Strep pneumoniae - serotype 6B | GMT ratio | 1.41 | 2-Sided | 95 | 1.17 | 1.70 | The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate. | Non-Inferiority | NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was <=2. |
| Strep pneumoniae - serotype 7F | GMT ratio | 1.34 | 2-Sided | 95 | 1.16 | 1.55 | The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate. | Non-Inferiority | NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was <=2. |
| Strep pneumoniae - serotype 8 | GMT ratio | 1.38 | 2-Sided | 95 | 1.17 | 1.64 | The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate. | Non-Inferiority | NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was <=2. |
| Strep pneumoniae - serotype 9V | GMT ratio | 1.24 | 2-Sided | 95 | 1.05 | 1.47 | The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate. | Non-Inferiority | NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was <=2. |
| Strep pneumoniae - serotype 10A | GMT ratio | 1.22 | 2-Sided | 95 | 1.03 | 1.44 | The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate. | Non-Inferiority | NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was <=2. |
| Strep pneumoniae - serotype 11A | GMT ratio | 1.18 | 2-Sided | 95 | 0.98 | 1.42 | The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate. | Non-Inferiority | NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was <=2. |
| Strep pneumoniae - serotype 12F | GMT ratio | 1.20 | 2-Sided | 95 | 0.99 | 1.46 | The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate. | Non-Inferiority | NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was <=2. |
| Strep pneumoniae - serotype 14 | GMT ratio | 1.42 | 2-Sided | 95 | 1.21 | 1.67 | The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate. | Non-Inferiority | NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was <=2. |
| Strep pneumoniae - serotype 15B | GMT ratio | 1.46 | 2-Sided | 95 | 1.22 | 1.76 | The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate. | Non-Inferiority | NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was <=2. |
| Strep pneumoniae - serotype 18C | GMT ratio | 1.29 | 2-Sided | 95 | 1.07 | 1.55 | The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate. | Non-Inferiority | NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was <=2. |
| Strep pneumoniae - serotype 19A | GMT ratio | 1.39 | 2-Sided | 95 | 1.20 | 1.61 | The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate. | Non-Inferiority | NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was <=2. |
| Strep pneumoniae - serotype 19F | GMT ratio | 1.33 | 2-Sided | 95 | 1.12 | 1.57 | The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate. | Non-Inferiority | NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was <=2. |
| Strep pneumoniae - serotype 22F | GMT ratio | 1.34 | 2-Sided | 95 | 1.12 | 1.60 | The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate. | Non-Inferiority | NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was <=2. |
| Strep pneumoniae - serotype 23F | GMT ratio | 1.36 | 2-Sided | 95 | 1.09 | 1.71 | The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate. | Non-Inferiority | NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was <=2. |
| Strep pneumoniae - serotype 33F | GMT ratio | 1.40 | 2-Sided | 95 | 1.20 | 1.64 | The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate. | Non-Inferiority | NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was <=2. |
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| Participants |
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