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

Pneumococcal Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06182124
• Other study ID #: C4931001
• Status: Recruiting
• Phase: Phase 2
• Start date: December 20, 2023
• Est. completion date: November 13, 2025

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 in 2 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.

Participants will take part in this study for about 6 months for Stage 1 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: November 13, 2025
• Est. primary completion date: November 13, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female participants =18 to<50 years of age (Stage 1) and =50 years of age (Stage 2) 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 (Stage 2): 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

Related Conditions & MeSH terms

• Pneumococcal Disease
• Pneumococcal Infections

Intervention

Biological:
• Multivalent Pneumococcal Vaccine - Formulation 1
Multivalent pneumococcal conjugate vaccine. This is a possible candidate for continuation in Phase 2 (Stage 2).
• Multivalent Pneumococcal Vaccine - Formulation 2
Multivalent pneumococcal conjugate vaccine. This is a possible candidate for continuation in Phase 2 (Stage 2).
• 20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine (20vPnC)

Locations

Country	Name	City	State
United States	J. Lewis Research, Inc. / Foothill Family Clinic	Salt Lake City	Utah
United States	Clinical Trials of Texas, LLC	San Antonio	Texas
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	DM Clinical Research	Tomball	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants reporting prespecified local reactions within 7 days after vaccination	Prespecified local reactions (redness, swelling, and pain at the injection site) after vaccination	7 days
Primary	Percentage of participants reporting prespecified systemic events within 7 days after vaccination	Prespecified systemic events (fever, headache, fatigue, muscle pain, and joint pain) after vaccination	7 days
Primary	Percentage of participants reporting Adverse Events (AEs) within 1 month after vaccination	Adverse events occurring within 1 month after vaccination	1 month
Primary	Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination	SAEs occurring within 6 months after vaccination	6 months
Primary	Phase 2 (Stage 2) Only: Percentage of participants reporting related Serious Adverse Events (SAEs) through 12 months after vaccination	Related SAEs occurring through 12 months after vaccination	12 months
Secondary	Pneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs)	Pneumococcal OPA GMTs 1 month after vaccination	1 month after vaccination

External Links

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