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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07105722




Registration number
NCT07105722
Ethics application status
Date submitted
4/08/2025
Date registered
6/08/2025
Date last updated
2/09/2025

Titles & IDs
Public title
A Trial to Evaluate the Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults 50 To 64 Years of Age
Scientific title
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
Secondary ID [1] 0 0
221544
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumonia, Bacterial 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Pn-MAPS30plus
Other interventions - PCV20

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.


Treatment: Other: Pn-MAPS30plus
The Pn-MAPS30plus vaccine will be administered intramuscularly.

Other interventions: PCV20
The PCV20 vaccine will be administered intramuscularly.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Each Solicited Administration Site (Local) Event
Timepoint [1] 0 0
Day 1 (post-vaccination) to Day 7
Primary outcome [2] 0 0
Number of Participants with Each Solicited Systemic Event
Timepoint [2] 0 0
Day 1 (post-vaccination) to Day 7
Primary outcome [3] 0 0
Number of Participants with Any Unsolicited Adverse Events (AEs)
Timepoint [3] 0 0
Day 1 (post-vaccination) to Day 30
Primary outcome [4] 0 0
Number of Participants with Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs Leading to Withdrawal
Timepoint [4] 0 0
Day 1 up to trial end (Month 6)
Primary outcome [5] 0 0
Number of Participants with Hematological and Biochemical Laboratory Abnormalities
Timepoint [5] 0 0
On Day 8

Eligibility
Key inclusion criteria
1. Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
2. Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any trial-specific procedure.
3. Healthy male and female participants between and including 50 through 64 YOA at the time of Informed consent form (ICF) signature.
4. Female participants of childbearing potential may be enrolled if they practice adequate contraception and have a negative pregnancy test prior to study intervention administration.
Minimum age
50 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of microbiologically proven Invasive Pneumococcal Disease (IPD) caused by S. pneumoniae within the past 3 years.
2. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
3. Any confirmed or suspected immunosuppressive or immunodeficient condition.
4. Hypersensitivity to latex.
5. Clinical conditions representing a contraindication to intramuscular vaccination, and blood collection.
6. Documented history of Human immunodeficiency virus (HIV)-positive participant.
7. Acute or unstable chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, or metabolic conditions as determined by the investigator.
8. Recurrent history of uncontrolled neurological or any neuroinflammatory disorders.
9. Any behavioural or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with trial participation.
10. History of potential immune-mediated disorders (pIMDs).
11. Any other clinical condition that, might pose additional risk to the participant.
12. Use of any investigational or non-registered product other than the study interventions during the period beginning 30 days before the study intervention administration.
13. History of previous vaccination with any pneumococcal vaccine.
14. Receipt of blood or plasma products or immunoglobulins, from 90 days before study intervention administration, or planned receipt within 30 days of study intervention administration.
15. Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the trial.
16. Pregnant or lactating female participant.
17. History of chronic alcohol consumption and/or drug abuse, based on investigator judgment.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/08/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
18/06/2026
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Norwood
Recruitment hospital [2] 0 0
GSK Investigational Site - Camberwell
Recruitment postcode(s) [1] 0 0
5067 - Norwood
Recruitment postcode(s) [2] 0 0
3124 - Camberwell

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US GSK Clinical Trials Call Center
Address 0 0
Country 0 0
Phone 0 0
877-379-3718
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07105722