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Cancer Vaccine

Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 2 for Pneumococcal Diseases

Phase 2

Recruiting

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Phase 1 (Stage 1): Adults 18 through 49 years of age with no history of ever receiving a pneumococcal vaccine (ie, pneumococcal vaccine-naïve)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial is testing a pneumococcal vaccine in adults to see if it is safe and helps boost the immune system against pneumococcal disease. The trial has two stages. In stage

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects from the vaccines may include pain at the injection site, fatigue, headache, muscle pain, joint pain, decreased appetite, chills or fever. These are common reactions similar to other vaccines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

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

+2 more

Secondary outcome measures

Pneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs)

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 2Experimental Treatment1 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).

Group II: Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 1Experimental Treatment1 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).

Group III: Phase 1 (Stage 1) and Phase 2 (Stage 2): 20-valent pneumococcal conjugate vaccine (20vPnC)Active Control1 Intervention

Participants to receive a single injection of 20vPnC.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,570 Previous Clinical Trials

10,915,306 Total Patients Enrolled

26 Trials studying Pneumococcal Diseases

106,639 Patients Enrolled for Pneumococcal Diseases

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,476 Previous Clinical Trials

8,091,521 Total Patients Enrolled

26 Trials studying Pneumococcal Diseases

106,639 Patients Enrolled for Pneumococcal Diseases

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being actively sought for this ongoing research study?

"Based on the information available on clinicaltrials.gov, this particular trial is currently not accepting new participants. The initial posting of the study was made on 12/15/2023 and it was last updated on 12/21/2023. However, there are currently 22 other trials actively seeking eligible candidates for enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study to Learn About the Safety and Immune Response of a New Pneumococcal Vaccine in Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06182124.

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