Your session is about to expire
← Back to Search
Cancer Vaccine
Pneumococcal Vaccine for Pneumococcal Disease
Phase 1 & 2
Waitlist Available
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
Must not have
Known or suspected immunodeficiency or other conditions associated with immunosuppression
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
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 A newer version of the vaccine is designed to protect against 20 different types of bacteria.
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.
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.
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 belowSelect...
I am 18-49 years old and have never received a pneumococcal vaccine.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a condition that weakens my immune system.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreSecondary study objectives
Pneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Pneumococcal vaccines work by stimulating the immune system to recognize and fight Streptococcus pneumoniae bacteria, which cause pneumococcal diseases. These vaccines contain inactivated components of the bacteria, which trigger an immune response involving the production of antibodies.
This immune response provides long-term protection against severe infections such as pneumonia, meningitis, and bacteremia, reducing morbidity and mortality associated with these diseases.
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
PfizerLead Sponsor
4,669 Previous Clinical Trials
17,861,221 Total Patients Enrolled
1 Trials studying Pneumococcal Diseases
922 Patients Enrolled for Pneumococcal Diseases
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,553 Previous Clinical Trials
14,902,223 Total Patients Enrolled
1 Trials studying Pneumococcal Diseases
922 Patients Enrolled for Pneumococcal Diseases