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Vaccine

New Pneumococcal Vaccine Ingredient for Pneumococcal Infections

Phase 1
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will study a new pneumococcal vaccine ingredient to see if it can prevent infections like meningitis, sepsis, ear infections and sinusitis. Healthy people over 50 and under 64 can join to help find out if the vaccine works.

Who is the study for?
This trial is for healthy adults aged 50 to 64 who haven't had a pneumococcal vaccine or any vaccines with extra ingredients in the last year. They should be able to use contraception if of childbearing potential and have stable health conditions.Check my eligibility
What is being tested?
The study tests a new pneumococcal vaccine ingredient (PF-07872411) aimed at boosting its effectiveness against infections like meningitis and sepsis. Participants will receive different doses of this ingredient or a control vaccine, to assess safety and efficacy over about 12 months.See study design
What are the potential side effects?
Participants may experience side effects from the vaccine which will be monitored through clinic visits and blood samples. Specific side effects are not listed but generally can include soreness at injection site, fever, fatigue, headache, muscle pain.

Timeline

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 Medically Attended Adverse Events (MAAEs) within 12 months after vaccination
Percentage of participants reporting Medically Attended Adverse Events (MAAEs) within 6 months after vaccination
+7 more
Secondary outcome measures
Pneumococcal opsonophagocytic activity (OPA) titers

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Low dose multivalent pneumococcal conjugate vaccine formulation BExperimental Treatment1 Intervention
Stage 2 - Participants will be randomized to receive a single injection.
Group II: Low dose multivalent pneumococcal conjugate vaccine formulation AExperimental Treatment1 Intervention
Stage 1 - Participants will be randomized to receive a single injection.
Group III: Standard dose multivalent pneumococcal conjugate vaccine controlActive Control1 Intervention
Control - Stages 1 and 2 - Participants will be randomized to receive a single injection.
Group IV: Low dose of multivalent pneumococcal conjugate vaccine controlActive Control1 Intervention
Primary control - Stages 1 and 2 - Participants will be randomized to receive a single injection.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,783 Total Patients Enrolled
26 Trials studying Pneumococcal Diseases
107,249 Patients Enrolled for Pneumococcal Diseases
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,092,951 Total Patients Enrolled
26 Trials studying Pneumococcal Diseases
107,249 Patients Enrolled for Pneumococcal Diseases

Media Library

PF-07872411 (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05831124 — Phase 1
Pneumococcal Diseases Clinical Trial 2023: PF-07872411 Highlights & Side Effects. Trial Name: NCT05831124 — Phase 1
PF-07872411 (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05831124 — Phase 1

Frequently Asked Questions

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

Does this research encompass elderly individuals in its demographic?

"This medical study will consider individuals that are at least 50 years of age, yet no older than 64."

Answered by AI

Is it possible to register for participation in this trial?

"Eligible patients for this trial must be aged 50 to 64 and diagnosed with pneumococcal diseases. It is estimated that around 150 participants are needed in total."

Answered by AI

Has the Low dose multivalent pneumococcal conjugate vaccine formulation B achieved regulatory approval from the FDA?

"Our internal analysis ranks the safety of Low dose multivalent pneumococcal conjugate vaccine formulation B a 1 due to its status as a Phase 1 trial with limited data regarding effectiveness and security."

Answered by AI

Are there any opportunities currently available to join this experiment?

"Data hosted on clinicaltrials.gov demonstrates that recruiting for this medical study is ongoing, with the listing first posted on April 19th 2023 and last updated on April 27th of the same year."

Answered by AI

How many participants is this research project accommodating?

"Indeed, clinicaltrials.gov reveals that this research is currently recruiting participants. This medical study was posted for the first time on April 19th 2023 and its details were most recently revised on April 27th of the same year. At present, a total of 150 patients must be enrolled between 3 trial sites."

Answered by AI
~13 spots leftby Jul 2024