A Study to Learn About How a New Pneumococcal Vaccine Works in Adults

Not Applicable

Recruiting

• Conditions: Streptococcus Pneumoniae
• Interventions: Biological: PG4 vaccine in Buffer 1 with low dose PA-001; Biological: PG4 in Buffer 1 with low dose PA-002; Biological: PG4 in Buffer 1 with high dose PA-001; Biological: PG4 vaccine in Buffer 1 with high dose PA-002; Biological: PG4 vaccine in Buffer 2; Biological: 20-valent pneumococcal conjugate vaccine; Biological: Saline injection

• Registration Number: NCT07086677
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to learn about the safety and tolerability of a pneumococcal vaccine in adults.

Participants will receive either:

* an experimental PG4 vaccine

* a PG4 vaccine comparator

* a standard 20vPnC vaccine comparator

* placebo. A placebo does not have any medicine in it but looks just like the study medicine.

Participants will take part in this study for up to 18 months depending on which group they are assigned to. During this time, the participants will receive up to two doses of study vaccine or comparator and take part in follow-up visits.

At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during clinic visits.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-18
• Study First Submitted QC: 2025-07-18
• Study Start: 2025-07-22
• Study First Posted: 2025-07-25
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-05
• Last Update Posted: 2025-08-11
• Primary Completion: 2027-09-23
• Study Completion: 2027-09-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 372

Inclusion Criteria

• Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
• Participants either with no history of ever receiving a pneumococcal vaccine or who have received a pneumococcal vaccine more than 5 years prior to vaccination in this study

Key

Exclusion Criteria

• Participants with a history of microbiologically proven invasive disease caused by S pneumoniae.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PG4 vaccine with low dose adjuvant PA-001; dose schedule 1	PG4 vaccine in Buffer 1 with low dose PA-001	-
PG4 vaccine with low dose adjuvant PA-001; dose schedule 2	PG4 vaccine in Buffer 1 with low dose PA-001	-
PG4 vaccine with low dose adjuvant PA-002; dose schedule 1	PG4 in Buffer 1 with low dose PA-002	-
PG4 vaccine with low dose adjuvant PA-002; dose schedule 2	PG4 in Buffer 1 with low dose PA-002	-
PG4 vaccine with high dose adjuvant PA-001; dose schedule 1	PG4 in Buffer 1 with high dose PA-001	-
PG4 vaccine with high dose adjuvant PA-001; dose schedule 2	PG4 in Buffer 1 with high dose PA-001	-
PG4 vaccine with high dose adjuvant PA-002; dose schedule 1	PG4 vaccine in Buffer 1 with high dose PA-002	-
PG4 vaccine with high dose adjuvant PA-002; dose schedule 2	PG4 vaccine in Buffer 1 with high dose PA-002	-
PG4 vaccine; dose schedule 1	PG4 vaccine in Buffer 2	-
PG4 vaccine; dose schedule 1	Saline injection	-
PG4 vaccine; dose schedule 2	PG4 vaccine in Buffer 2	-
PG4 vaccine; dose schedule 2	Saline injection	-
20vPnC; dose schedule 1	20-valent pneumococcal conjugate vaccine	-
20vPnC; dose schedule 1	Saline injection	-
20vPnC; dose schedule 2	20-valent pneumococcal conjugate vaccine	-
20vPnC; dose schedule 2	Saline injection	-

Primary Outcome Measures

Name	Time	Method
Percentage of participants reporting prespecified local reactions after each dose.	Within 7 days after each study intervention.	Prespecified local reactions (redness, swelling, and pain at the injection site) occurring within 7 days of each dose administered in the study.
Percentage of participants reporting prespecified systemic reactions after each dose.	Within 7 days after each study intervention.	Prespecified systemic reactions (fever, vomiting, diarrhea, headache, fatigue, muscle pain, and joint pain) occurring within 7 days of each dose administered in the study.
Percentage of participants reporting adverse events.	From signing of the ICD to 1 month after last study intervention.	Adverse Events (AEs) occurring from Dose 1 through 1 month after the last vaccination
Percentage of participants reporting serious adverse events.	From signing of the ICD to 12 months after the last study intervention.	Serious Adverse Events (SAEs) occurring from Dose 1 through 12 months after the last vaccination.
Percentage of participants with abnormal hematology and chemistry laboratory values.	Within 2 weeks after each study intervention.	Any abnormal hematology or chemistry laboratory values as compared to baseline within 2 weeks after each study intervention.

Trial Locations

Locations (5)

Orange County Research Center; 🇺🇸 Lake Forest, California, United States

Indago Research & Health Center, Inc; 🇺🇸 Hialeah, Florida, United States

Johnson County Clinical Trials; 🇺🇸 Lenexa, Kansas, United States

Velocity Clinical Research, Omaha; 🇺🇸 Omaha, Nebraska, United States

CTI Clinical Research Center; 🇺🇸 Cincinnati, Ohio, United States