A Phase 1, Observer-Blind, Randomized, Active Controlled Trial to Evaluate the Safety and Immunogenicity of An Investigational Pneumococcal Vaccine in Adults 50 To 64 Years of Age

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Biological, Combination product
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 64
Healthy Volunteers: t
View:

• Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.

• Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any trial-specific procedure.

• Healthy male and female participants between and including 50 through 64 YOA at the time of Informed consent form (ICF) signature.

• Female participants of childbearing potential may be enrolled if they practice adequate contraception and have a negative pregnancy test prior to study intervention administration.

Locations
Other Locations
Australia
GSK Investigational Site
RECRUITING
Bayswater
GSK Investigational Site
RECRUITING
Camberwell
GSK Investigational Site
RECRUITING
East Melbourne
GSK Investigational Site
RECRUITING
Norwood
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date: 2025-08-12
Estimated Completion Date: 2026-06-18
Participants
Target number of participants: 120
Treatments
Experimental: Pn-MAPS30plus Group
Participants receive a single dose of Pn-MAPS30plus on Day 1.
Active_comparator: PCV20 Group
Participants receive a single dose of PCV20 on Day 1.
Related Therapeutic Areas
Sponsors
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov

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