Pneumococcal Vaccine for Pneumococcal Disease

Recruiting at17 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Pfizer

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing different versions of a pneumococcal vaccine to see if they are safe and effective. It involves adults aged 18-49 in the initial phase and adults aged 50 and older in the later phase. The vaccine helps the immune system fight off pneumococcal bacteria. A newer version of the vaccine is designed to protect against 20 different types of bacteria.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

This trial is for healthy adults to test a new pneumococcal vaccine. Stage 1 includes those aged 18-49, while Stage 2 includes individuals 50 and older. Participants must be willing to give blood samples and report any side effects during clinic visits over a period of up to one year.

Inclusion Criteria

I am an adult considered fit for the study and have had stable health conditions for the last 12 weeks.

I agree to use contraception for 28 days after the study, or I cannot have children.

I am 18-49 years old and have never received a pneumococcal vaccine.

Exclusion Criteria

I plan to receive a pneumococcal vaccine.

I haven't had nonlive vaccines in 14 days or live vaccines in 28 days.

History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component in pneumococcal conjugate vaccines and any other diphtheria toxoid-containing vaccine

Treatment Details

Interventions

• 20-valent pneumococcal conjugate vaccine (20vPnC) (Cancer Vaccine)
• Multivalent Pneumococcal Vaccine - Formulation 1 (Cancer Vaccine)
• Multivalent Pneumococcal Vaccine - Formulation 2 (Cancer Vaccine)

Trial Overview The study tests two different formulations of a new pneumococcal vaccine against an existing vaccine (20vPnC, Prevnar 20). Each participant receives one shot in the upper arm muscle and is monitored for immune response and safety.

Participant Groups

Group I: Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 2 Experimental Treatment 1 Intervention

Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 2. This is a possible candidate for continuation in Phase 2 (Stage 2) and Phase 2(Stage 3).

Group II: Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 1 Experimental Treatment 1 Intervention

Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 1. This is a possible candidate for continuation in Phase 2 (Stage 2) and Phase 2(Stage 3).

Group III: Phase 2 (Stage 3): a licensed pneumococcal comparator vaccine Active Control 1 Intervention

Participants to receive a single injection of a licensed pneumococcal comparator vaccine.

Group IV: Phase 1 (Stage 1) and Phase 2 (Stage 2): 20-valent pneumococcal conjugate vaccine (20vPnC) Active Control 1 Intervention

Participants to receive a single injection of 20vPnC.

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University