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

Pfizer

Status and phase: Not yet enrolling; Phase 1

Conditions: Streptococcus Pneumoniae

Treatments: Biological: PG4 in Buffer 1 with low dose PA-002; Biological: 20-valent pneumococcal conjugate vaccine; Biological: PG4 vaccine in Buffer 1 with high dose PA-002; Biological: PG4 in Buffer 1 with high dose PA-001; Biological: Saline injection; Biological: PG4 vaccine in Buffer 2; Biological: PG4 vaccine in Buffer 1 with low dose PA-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT07086677

C4931020

Details and patient eligibility

About

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.

Enrollment: 372 estimated patients

Sex: All

Ages: 65 to 84 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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372 participants in 12 patient groups

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

Experimental group

Treatment:

Biological: PG4 vaccine in Buffer 1 with low dose PA-001

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

Experimental group

Treatment:

Biological: PG4 vaccine in Buffer 1 with low dose PA-001

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

Experimental group

Treatment:

Biological: PG4 in Buffer 1 with low dose PA-002

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

Experimental group

Treatment:

Biological: PG4 in Buffer 1 with low dose PA-002

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

Experimental group

Treatment:

Biological: PG4 in Buffer 1 with high dose PA-001

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

Experimental group

Treatment:

Biological: PG4 in Buffer 1 with high dose PA-001

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

Experimental group

Treatment:

Biological: PG4 vaccine in Buffer 1 with high dose PA-002

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

Experimental group

Treatment:

Biological: PG4 vaccine in Buffer 1 with high dose PA-002

PG4 vaccine; dose schedule 1

Active Comparator group

Treatment:

Biological: Saline injection

Biological: PG4 vaccine in Buffer 2

PG4 vaccine; dose schedule 2

Active Comparator group

Treatment:

Biological: Saline injection

Biological: PG4 vaccine in Buffer 2

20vPnC; dose schedule 1

Active Comparator group

Treatment:

Biological: Saline injection

Biological: 20-valent pneumococcal conjugate vaccine

20vPnC; dose schedule 2

Active Comparator group

Treatment:

Biological: Saline injection

Biological: 20-valent pneumococcal conjugate vaccine