Dose-Ranging Study to Evaluate a 25-Valent Pneumococcal C... | NCT06077656

NCT06077656

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Canadian Center for Vaccinology	OTHER
Vaccine Evaluation Center, Canada	OTHER
PATH	OTHER

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation A administered by intramuscular injection on Day 1	Biological: IVT PCV-25 Formulation A
Group B	Experimental	Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation B administered by intramuscular injection on Day 1	Biological: IVT PCV-25 Formulation B
Group C	Experimental	Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation C administered by intramuscular injection on Day 1	Biological: IVT PCV-25 Formulation C
Group D	Active Comparator	Participants will receive a single 0.5mL dose of PCV 20 administered by intramuscular injection on Day 1	Biological: PCV 20

Name	Type	Description	Arm Group Labels	Other Names
IVT PCV-25 Formulation A	Biological	25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and low dose adjuvant	Group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Solicited Local Adverse Events (AEs)	Number and severity of solicited local AEs (redness, swelling, and pain at the injection site) by group	7 days post-vaccination (Day 8)
Solicited Systemic AEs	Number and severity of solicited systemic AEs within 7 days after vaccination by group	7 days post-vaccination (Day 8)
Unsolicited AEs	Number and severity of unsolicited AEs within 28 days after vaccination by group	28 days post-vaccination (Day 29)
Severe Adverse Events (SAEs)	Number of SAEs within 6 months after vaccination by group	6 months post-vaccination (Day 169)

Secondary Outcomes

Measure	Description	Time Frame
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group	Geometric mean concentrations (GMC) of serotype-specific IgG at Day 1 and Day 29 by group	Baseline (Day 1) and 28 days post-vaccination (Day 29)
Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy adults who are 18 through 49 years old on the day of randomization (Day 1).
Participant must provide voluntary written informed consent to participate in the study.
Participant must be able to comprehend and comply with study requirements and procedures and be willing and able to return for all scheduled follow-up visits.
Adult female participants who are not surgically sterile must have a negative pregnancy test at screening and negative pregnancy test prior to vaccination and must agree to employ a highly effective method to avoid pregnancy through Day 57 of the study.

Exclusion Criteria:

Use of any investigational medicinal product within 90 days prior to randomization or planned use of such a product during the period of study participation.
Adults who have previously been vaccinated against S. pneumoniae.
History of microbiologically confirmed invasive disease caused by S. pneumoniae.
History of allergic disease (including angioedema) or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines, including PEG.
Any abnormal vital sign deemed clinically relevant by the PI.
Acute illness at time of randomization (moderate or severe) and/or fever (body temperature of ≥ 38.0°C)
History of any non-study vaccine administration within 14 days of study vaccine administration.
No planned vaccines until after Day 29 (Visit 3).
Chronic administration (defined as more than 14 consecutive days) of immunosuppressant or other immune modifying drugs prior to the administration of the study vaccine (and within the 6 months prior to administration of the study vaccine), including the use of glucocorticoids. The use of topical and inhaled glucocorticoids will be permitted.
Administration of immunoglobulins and/or any blood products within the 6 months prior to administration of the study vaccine or anticipation of such administration during the study period.
Any medical or social condition that in the opinion of the PI , may interfere with the study objectives, pose a risk to the participant, or prevent the participant from completing the study follow-up.
Any screening laboratory test result outside the normal range and with toxicity score ≥ 2, unless allowed by study team.
A positive serologic test for human immunodeficiency virus (HIV)-1 or HIV-2 (HIV 1/2 Ab), hepatitis B (HBsAg) or hepatitis C (HCV Ab).
History of malignancy, excluding non-melanoma skin and cervical carcinoma in situ.
Recent history (within the past year) or signs of alcohol or substance abuse.
History of major psychiatric disorder.
Female adult participants who are pregnant or breastfeeding.
Participant is an employee of, or direct descendant (child or grandchild) of any person employed by the Sponsor, PATH, the Contract Research Organization (CRO), the PI.

Name	Affiliation	Role
Sybil Tasker, MD, MPH, FIDSA	Inventprise Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Inventprise Clinical Site		Vancouver	British Columbia	V5Z 4H4	Canada
Inventprise Clinical Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41576705	Derived	Langley JM, Sadarangani M, Ockenhouse C, Barreto L, Ye L, Tang Y, Breeze JL, Feser J, Hosken NA, Andi-Lolo I, Tasker SA, Halperin SA; Canadian Immunization Research Network. Safety and immunogenicity of a 25-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive healthy adults: Results from 2 randomised, controlled clinical trials. Vaccine. 2026 Mar 7;75:128236. doi: 10.1016/j.vaccine.2026.128236. Epub 2026 Jan 22.

See Also Links

Label	URL
Safety and immunogenicity of a 25-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive healthy adults: Results from 2 randomised, controlled clinical trials	View source

Arm/Group Information

ID	Title	Description
FG000	Group A: IVT PCV-25 Formulation A	Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation A administered by intramuscular injection on Day 1 IVT PCV-25 Formulation A: 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and low dose adjuvant
FG001	Group B: IVT PCV-25 Formulation B	Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation B administered by intramuscular injection on Day 1 IVT PCV-25 Formulation B: 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and high dose adjuvant
FG002	Group C: IVT PCV-25 Formulation C	Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation C administered by intramuscular injection on Day 1 IVT PCV-25 Formulation C: 25 valent pneumococcal conjugate vaccine containing high dose polysaccharide and high dose adjuvant
FG003	Group D: PCV-20	Participants will receive a single 0.5mL dose of PCV 20 administered by intramuscular injection on Day 1 PCV 20: 20 valent pneumococcal conjugate vaccine

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Group A: IVT PCV-25 Formulation A	Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation A administered by intramuscular injection on Day 1 IVT PCV-25 Formulation A: 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and low dose adjuvant
BG001

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Solicited Local Adverse Events (AEs)

Number and severity of solicited local AEs (redness, swelling, and pain at the injection site) by group

Safety population (One participant was missing the Memory Aid so the denominator for safety outcomes is 219 in this specific safety endpoint)

Posted

Number

events

7 days post-vaccination (Day 8)

ID	Title	Description
OG000	Group A: IVT PCV-25 Formulation A	Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation A administered by intramuscular injection on Day 1 IVT PCV-25 Formulation A: 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and low dose adjuvant
OG001	Group B: IVT PCV-25 Formulation B

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Group A: IVT PCV-25 Formulation A	Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation A administered by intramuscular injection on Day 1 IVT PCV-25 Formulation A: 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and low dose adjuvant

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 6, 2024	Aug 26, 2025	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Apr 11, 2024	Aug 26, 2025	SAP_001.pdf