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A Study to Learn About a Type of Pneumococcal Vaccine With a New Ingredient (PF-07872411) Intended to Enhance the Effects of the Vaccine Which is Given to Adults

NCT05831124 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-07-29

No results posted yet for this study

Summary

The purpose of this clinical trial is to learn about a pneumococcal vaccine with a new ingredient (PF-07872411) intended to enhance the effects of the vaccine. This pneumococcal vaccine with the new ingredient may prevent the diseases caused by pneumococcal bacteria like meningitis, sepsis, ear infections and sinusitis.

Meningitis is an infection in which the tissue around the brain and spine is swollen.

Sepsis is a very serious infection in your blood caused by a germ (a bacteria). Sinusitis is when your sinuses (the air-filled spaces inside your nose and head), are infected.

This study is seeking for healthy participants who:

* are above 50 years of age and less than 64 years of age.
* have not taken any vaccine for pneumococcal diseases before.
* have not taken any vaccines with additional ingredients within 1 year before administration of the study vaccine.

All participants will receive a single study vaccine shot in the upper arm muscle at the study clinic. The study will compare the experiences of people receiving the vaccine with a new ingredient in the vaccine to those without the new ingredient. This will be done by comparing 2 different dose levels of the new ingredient. It will also be compared against people who receive the vaccine without the new ingredient and at different dose levels. This will help the study team establish if the vaccine with a new ingredient is safe and effective.

Participants will take part in this study for about 12 months. During this time participants will have up to 6 clinic visits. 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 visits.

Some participants will need to have blood taken for laboratory tests before they can be judged to be eligible to be included in the study.

Conditions

  • Pneumococcal Disease

Interventions

OTHER

Low dose multivalent pneumococcal conjugate vaccine formulation A

Biological

OTHER

Low dose multivalent pneumococcal conjugate vaccine formulation B

Biological

BIOLOGICAL

Low dose of multivalent pneumococcal conjugate vaccine control

low dose multivalent pneumococcal conjugate vaccine

BIOLOGICAL

Standard dose multivalent pneumococcal conjugate vaccine control

multivalent pneumococcal conjugate vaccine

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-19
Primary Completion
2024-06-26
Completion
2024-06-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05831124 on ClinicalTrials.gov