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The main purpose of this study is to evaluate safety and reactogenicity of the investigational pneumococcal vaccine (called Pn-MAPS30plus). PCV20 will be used as a comparator for this study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pn-MAPS30plus Group | Experimental | Participants receive three primary doses of Pn-MAPS30plus on Day 1, Day 61, Day 121 and a booster dose on Day 301. |
|
| PCV20 Group | Active Comparator | Participants receive three primary doses of PCV20 on Day 1, Day 61, Day 121 and a booster dose on Day 301. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pn-MAPS30plus | Biological | Pn-MAPS30plus vaccine will be administered intramuscularly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with solicited administration site adverse events (AEs) | The AEs considered are tenderness, redness, and swelling. | Day 1 to Day 7 |
| Number of participants with solicited systemic adverse events (AEs) | The AEs considered are fever, irritability, loss of appetite and somnolence (sleepiness/drowsiness). | Day 1 to Day 7 |
| Number of participants with unsolicited AEs | An unsolicited AE is 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. | Day 1 to Day 30 |
| Number of Participants with Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs Leading to Withdrawal | Day 1 up to trial end (Month 16) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| US GSK Clinical Trials Call Center | Contact | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
| EU GSK Clinical Trials Call Center | Contact | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
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Study Sponsor 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 asset(s) with development terminated 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.
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This is an observer-blind study.
| PCV20 | Combination Product | PCV20 vaccine will be administered intramuscularly. |
|
| ID | Term |
|---|---|
| D018410 | Pneumonia, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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