Safety and Immunogenicity of Pneumococcal Conjugate Formulations in Healthy Adults 18 Through 49 Years of Age

Sponsor

Pfizer (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05489328

Collaborator

(none)

405

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of the study is to describe the safety and immunogenicity of Pneumococcal Conjugate Formulations in healthy adults 18 through 49 years of age.

Condition or Disease	Intervention/Treatment	Phase
Pneumococcal Disease	Other: Candidate-1 Other: Candidate-2 Other: Candidate-3 Other: Candidate-4 Other: Candidate-5 Other: Candidate-6 Other: Candidate Control Biological: 13vPnC Biological: PCV15	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

405 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel AssignmentParallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

A PHASE 1, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF PNEUMOCOCCAL CONJUGATE FORMULATIONS IN HEALTHY ADULTS 18 THROUGH 49 YEARS OF AGE

Anticipated Study Start Date :

Aug 15, 2022

Anticipated Primary Completion Date :

Oct 14, 2022

Anticipated Study Completion Date :

Oct 14, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Candidate-1 Participants to receive a single injection of Candidate-1.	Other: Candidate-1 Biological
Experimental: Candidate-2 Participants to receive a single injection of Candidate-2.	Other: Candidate-2 Biological
Experimental: Candidate-3 Participants to receive a single injection of Candidate-3.	Other: Candidate-3 Biological
Experimental: Candidate-4 Participants to receive a single injection of Candidate-4.	Other: Candidate-4 Biological
Experimental: Candidate-5 Participants to receive a single injection of Candidate-5.	Other: Candidate-5 Biological
Experimental: Candidate-6 Participants to receive a single injection of Candidate-6.	Other: Candidate-6 Biological
Active Comparator: Candidate Control Participants to receive a single injection of Candidate Control.	Other: Candidate Control Biological
Other: 13-valent pneumococcal conjugate vaccine (13vPnC) Participants to receive a single injection of 13vPnC.	Biological: 13vPnC 13-valent pneumococcal conjugate vaccine
Other: 15-valent pneumococcal conjugate vaccine (PCV15) Participants to receive a single injection of PCV15.	Biological: PCV15 15-valent pneumococcal conjugate vaccine

Outcome Measures

Primary Outcome Measures

Percentage of participants reporting prompted local reactions within 7 days after study intervention administration [7 days]
Prompted local reactions (redness, swelling, pain at the injection site) after study intervention administration
Percentage of participants reporting prompted systemic events within 7 days after study intervention administration [7 days]
Prompted systemic events (fever, headache, fatigue, muscle pain, joint pain) after study intervention administration
Percentage of participants reporting Adverse Events (AEs) within 1 month after study intervention administration [1 month]
Adverse events occurring within 1 month after study intervention administration
Percentage of participants reporting Serious Adverse Events (SAEs) within 1 month after study intervention administration [1 month]
SAEs occurring within 1 month after study intervention administration

Secondary Outcome Measures

Pneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs) [1 month after study intervention administration]
Pneumococcal OPA GMTs 1 month after study intervention administration

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 49 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male or female participants ≥18 and ≤49 years of age 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

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
Previous vaccination with 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT05489328

Other Study ID Numbers:

C4801001

First Posted:

Aug 5, 2022

Last Update Posted:

Aug 5, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pneumococcal Infections

Study Results

No Results Posted as of Aug 5, 2022