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OpenTrials
Completed

NCT Number: NCT06182124

A Study to Learn About the Safety and Immune Response of a New Pneumococcal Vaccine in Adults

The purpose of this study is to learn about the safety and immune effects of a pneumococcal vaccine in adults. This vaccine can possibly provide protection against further pneumococcal disease.

This study will happen in 4 stages: Stage 1 is seeking participants who are between 18 years to 49 years of age. The participants will receive 1 of 2 pneumococcal vaccine candidates (different formulations) or 20vPnC (Prevnar 20) as a single shot given into the upper arm muscle.

Stage 2 will begin after participants have completed Stage 1, and a pneumococcal vaccine candidate has been decided.

Stage 2 is seeking participants who are adults 50 years of age and older. The participants will receive the chosen pneumococcal vaccine candidate from Stage 1 or 20vPnC (Prevnar 20). The vaccines will be given as a single shot into the upper arm muscle.

Stage 3 is seeking participants who are adults 50 years of age and older. The participants will receive the chosen pneumococcal vaccine candidate from Stage 1 or a licensed pneumococcal comparator vaccine. The vaccines will be given as a single shot into the upper arm muscle.

Stage 4 is seeking participants who are adults 50 years of age and older. The participants will receive either one of three pneumococcal vaccine candidates or one of two licensed pneumococcal comparator vaccines. The vaccines will be given as a single shot into the upper arm muscle.

Participants will take part in this study for about 6 months for Stage 1, Stage 3, and Stage 4 and 12 months for Stage 2. During this time participants will have from 2 to 4 clinic visits and 1 phone visit. At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during these clinic visits.

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Key information

Conditions

Pneumococcal Disease Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Pneumococcal Infections Streptococcal Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Alliance for Multispecialty Research, LLC, Doral, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female participants ≥18 to<50 years of age (Stage 1) and ≥50 years of age (Stage 2, Stage 3, and Stage 4) at the time of consent
  • Adults determined by clinical assessment to be eligible for the study, including adults with preexisting stable disease within 12 weeks before receipt of study intervention
  • Participants willing to use acceptable contraception for at least 28 days after study intervention; female participants not of childbearing potential; male participants unable to father children
  • Phase 1 (Stage 1): Adults 18 through 49 years of age with no history of ever receiving a pneumococcal vaccine (ie, pneumococcal vaccine-naïve)
  • Phase 2 (Stages 2, 3, and 4): Adults ≥50 through 64 years of age with no history of ever receiving a pneumococcal vaccine (ie, pneumococcal vaccine-naïve) and adults 65 years of age and older with either no history of ever receiving a pneumococcal vaccine or who received PPSV23 >5 years prior to the first vaccination in this study (ie, experienced)

Exclusion criteria

  • 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
  • Serious chronic disorder that in the investigator's opinion would make the participant inappropriate for entry into the study
  • Medical or psychiatric condition (recent or active suicidal ideation/behavior or laboratory abnormality) that may increase risk of study participation or make participant inappropriate for the study
  • Known or suspected immunodeficiency or other conditions associated with immunosuppression
  • Planned receipt of any licensed or investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation
  • Receipt of any inactivated or otherwise nonlive vaccine within 14 days or any live vaccine within 28 days before administration of study intervention

Treatment and study plan

Multivalent Pneumococcal Vaccine - Formulation 1

Biological

Multivalent pneumococcal conjugate vaccine. This is a possible candidate for continuation in Phase 2 (Stages 2, 3, and 4).

Multivalent Pneumococcal Vaccine - Formulation 2

Biological

Multivalent pneumococcal conjugate vaccine. This is a possible candidate for continuation in Phase 2 (Stages 2, 3, and 4).

20-valent pneumococcal conjugate vaccine (20vPnC)

Biological

20-valent pneumococcal conjugate vaccine (20vPnC)

Other names: Prevnar 20

Licensed pneumococcal comparator vaccine

Biological

A licensed pneumococcal comparator vaccine

Multivalent Pneumococcal Vaccine - Formulation 3

Biological

Multivalent pneumococcal conjugate vaccine

Multivalent Pneumococcal Vaccine - Formulation 4

Biological

Multivalent pneumococcal conjugate vaccine

Primary outcomes

  1. Percentage of participants reporting prespecified local reactions within 7 days after vaccination

    Time frame: 7 days

    Prespecified local reactions (redness, swelling, and pain at the injection site) after vaccination

  2. Percentage of participants reporting prespecified systemic events within 7 days after vaccination

    Time frame: 7 days

    Prespecified systemic events (fever, headache, fatigue, muscle pain, and joint pain) after vaccination

  3. Percentage of participants reporting Adverse Events (AEs) within 1 month after vaccination

    Time frame: 1 month

    Adverse events occurring within 1 month after vaccination

  4. Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination

    Time frame: 6 months

    SAEs occurring within 6 months after vaccination

  5. Phase 2 (Stage 2) Only: Percentage of participants reporting related Serious Adverse Events (SAEs) through 12 months after vaccination

    Time frame: 12 months

    Related SAEs occurring through 12 months after vaccination

Secondary outcomes

  1. Phase 1 (Stage 1) and Phase 2 (Stage 2) Only: Pneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs)

    Time frame: 1 month after vaccination

    Pneumococcal OPA GMTs 1 month after vaccination

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 1/2, RANDOMIZED, DOUBLE-BLIND TRIAL OF THE SAFETY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS 18 YEARS OF AGE AND OLDER

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 26, 2023
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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