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This clinical study is designed to evaluate an investigational pneumococcal vaccine named Pn-MAPS30plus. The vaccine is designed to stimulate the immune system to produce antibodies against various serotypes of the S. pneumoniae bacteria, potentially aiding the body in fighting infection upon exposure. Pn-MAPS30plus aims to broaden protection by covering more serotypes than currently licensed pneumococcal vaccines. The study's purpose is to determine whether the vaccine is safe, well-tolerated, and effective in inducing immune responses against S. pneumoniae.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pn-MAPS30plus Group | Experimental | Participants receive a single dose of Pn-MAPS30plus on Day 1. |
|
| PCV20 Group | Active Comparator | Participants receive a single dose of PCV20 on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pn-MAPS30plus | Biological | The Pn-MAPS30plus vaccine will be administered intramuscularly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Each Solicited Administration Site (Local) Event | Day 1 (post-vaccination) to Day 7 | |
| Number of Participants with Each Solicited Systemic Event | Day 1 (post-vaccination) to Day 7 | |
| Number of Participants with Any Unsolicited Adverse Events (AEs) | Day 1 (post-vaccination) 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 6) | |
| Number of Participants with Hematological and Biochemical Laboratory Abnormalities | On Day 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Norwood | South Australia | 5067 | Australia | ||
| GSK Investigational Site |
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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| ID | Term |
|---|---|
| D018410 | Pneumonia, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D011014 | Pneumonia |
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This trial will be conducted in an observer-blind manner.
| PCV20 | Combination Product | The PCV20 vaccine will be administered intramuscularly. |
|
| Bayswater |
| Victoria |
| 3153 |
| Australia |
| GSK Investigational Site | Camberwell | Victoria | 3124 | Australia |
| GSK Investigational Site | East Melbourne | Victoria | 3002 | Australia |
| D012141 |
| Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |