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

NCT ID: NCT07086677

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

372 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-22

Study Completion Date

2027-09-23

Brief Summary

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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

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Conditions

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Streptococcus Pneumoniae

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PG4 vaccine with low dose adjuvant PA-001; dose schedule 1

Group Type EXPERIMENTAL

PG4 vaccine in Buffer 1 with low dose PA-001

Intervention Type BIOLOGICAL

Multivalent pneumococcal conjugate vaccine

PG4 vaccine with low dose adjuvant PA-001; dose schedule 2

Group Type EXPERIMENTAL

PG4 vaccine in Buffer 1 with low dose PA-001

Intervention Type BIOLOGICAL

Multivalent pneumococcal conjugate vaccine

PG4 vaccine with low dose adjuvant PA-002; dose schedule 1

Group Type EXPERIMENTAL

PG4 in Buffer 1 with low dose PA-002

Intervention Type BIOLOGICAL

Multivalent pneumococcal conjugate vaccine

PG4 vaccine with low dose adjuvant PA-002; dose schedule 2

Group Type EXPERIMENTAL

PG4 in Buffer 1 with low dose PA-002

Intervention Type BIOLOGICAL

Multivalent pneumococcal conjugate vaccine

PG4 vaccine with high dose adjuvant PA-001; dose schedule 1

Group Type EXPERIMENTAL

PG4 in Buffer 1 with high dose PA-001

Intervention Type BIOLOGICAL

Multivalent pneumococcal conjugate vaccine

PG4 vaccine with high dose adjuvant PA-001; dose schedule 2

Group Type EXPERIMENTAL

PG4 in Buffer 1 with high dose PA-001

Intervention Type BIOLOGICAL

Multivalent pneumococcal conjugate vaccine

PG4 vaccine with high dose adjuvant PA-002; dose schedule 1

Group Type EXPERIMENTAL

PG4 vaccine in Buffer 1 with high dose PA-002

Intervention Type BIOLOGICAL

Multivalent pneumococcal conjugate vaccine

PG4 vaccine with high dose adjuvant PA-002; dose schedule 2

Group Type EXPERIMENTAL

PG4 vaccine in Buffer 1 with high dose PA-002

Intervention Type BIOLOGICAL

Multivalent pneumococcal conjugate vaccine

PG4 vaccine; dose schedule 1

Group Type ACTIVE_COMPARATOR

PG4 vaccine in Buffer 2

Intervention Type BIOLOGICAL

Multivalent pneumococcal conjugate vaccine

Saline injection

Intervention Type BIOLOGICAL

Placebo

PG4 vaccine; dose schedule 2

Group Type ACTIVE_COMPARATOR

PG4 vaccine in Buffer 2

Intervention Type BIOLOGICAL

Multivalent pneumococcal conjugate vaccine

Saline injection

Intervention Type BIOLOGICAL

Placebo

20vPnC; dose schedule 1

Group Type ACTIVE_COMPARATOR

20-valent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

(20vPnC)

Saline injection

Intervention Type BIOLOGICAL

Placebo

20vPnC; dose schedule 2

Group Type ACTIVE_COMPARATOR

20-valent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

(20vPnC)

Saline injection

Intervention Type BIOLOGICAL

Placebo

Interventions

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PG4 vaccine in Buffer 1 with low dose PA-001

Multivalent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

PG4 in Buffer 1 with low dose PA-002

Multivalent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

PG4 in Buffer 1 with high dose PA-001

Multivalent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

PG4 vaccine in Buffer 1 with high dose PA-002

Multivalent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

PG4 vaccine in Buffer 2

Multivalent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

20-valent pneumococcal conjugate vaccine

(20vPnC)

Intervention Type BIOLOGICAL

Saline injection

Placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Exclusion Criteria

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

65 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Orange County Research Center

Lake Forest, California, United States

Site Status NOT_YET_RECRUITING

Indago Research & Health Center, Inc

Hialeah, Florida, United States

Site Status NOT_YET_RECRUITING

Johnson County Clinical Trials

Lenexa, Kansas, United States

Site Status RECRUITING

Velocity Clinical Research, Omaha

Omaha, Nebraska, United States

Site Status RECRUITING

CTI Clinical Research Center

Cincinnati, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Pfizer CT.gov Call Center

Role: CONTACT

1-800-718-1021

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C4931020

To obtain contact information for a study center near you, click here.

Other Identifiers

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C4931020

Identifier Type: -

Identifier Source: org_study_id

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