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This study will evaluate the safety and immune response of a new formulation of pneumococcal vaccine, PnMAPS30plus, in healthy adults aged 50 to 64 years. Participants will receive a single dose of either the investigational vaccine or an approved pneumococcal vaccine (PCV20) and will be monitored for approximately six months. The study aims to determine if PnMAPS30plus is safe and well-tolerated and whether it helps the body produce antibodies that protect against pneumococcal disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Pn- MAPS30plus | Experimental | Participants receive a single dose of Pn-MAPS30plus vaccine at Day 1. |
|
| Group 2: PCV20 | Active Comparator | Participants receive a single dose of PCV20 (20-valent pneumococcal conjugate vaccine) at Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pn-MAPS30plus | Biological | Single dose of Pn-MAPS30plus received intramuscularly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Solicited Administration Site Adverse Events (AEs) | The solicited administration site AEs considered are pain, redness and swelling. | Day 1 to Day 7 |
| Number of Participants with Solicited Systemic AEs | The solicited systemic AEs considered are fever, headache, fatigue (tiredness), myalgia (muscle pain), and arthralgia (joint pain). | 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 Adverse Events (SAEs) | SAE is an AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or other situations that are considered serious per medical or scientific judgment. | From Day 1 to Day 181 (study end) |
| Number of Participants with Adverse Events of Special Interest (AESIs) | From Day 1 to Day 181 (study end) | |
| Number of Participants with AEs Leading to withdrawal from the study | From Day 1 to Day 181 (study end) | |
| Number of Participants with any Laboratory abnormalities | Day 8 compared to Screening Visit (up to Day -14) |
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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 | Single dose of PCV20 received intramuscularly. |
|
| Camberwell |
| Victoria |
| 3124 |
| Australia |
| D012141 |
| Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |