Trials / Active Not Recruiting
Active Not RecruitingNCT07086677
A Study to Learn About How a New Pneumococcal Vaccine Works in Adults
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN STUDY TO DESCRIBE THE SAFETY AND TOLERABILITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 380 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 65 Years – 84 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to learn about the safety and tolerability of a pneumococcal vaccine in adults. Participants will receive either: * an experimental PG4 vaccine * a PG4 vaccine comparator * a standard 20vPnC vaccine comparator * placebo. A placebo does not have any medicine in it but looks just like the study medicine. Participants will take part in this study for up to 18 months depending on which group they are assigned to. During this time, the participants will receive up to two doses of study vaccine or comparator and take part in follow-up 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 clinic visits.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PG4 vaccine in Buffer 1 with low dose PA-001 | Multivalent pneumococcal conjugate vaccine |
| BIOLOGICAL | PG4 in Buffer 1 with low dose PA-002 | Multivalent pneumococcal conjugate vaccine |
| BIOLOGICAL | PG4 in Buffer 1 with high dose PA-001 | Multivalent pneumococcal conjugate vaccine |
| BIOLOGICAL | PG4 vaccine in Buffer 1 with high dose PA-002 | Multivalent pneumococcal conjugate vaccine |
| BIOLOGICAL | PG4 vaccine in Buffer 2 | Multivalent pneumococcal conjugate vaccine |
| BIOLOGICAL | 20-valent pneumococcal conjugate vaccine | (20vPnC) |
| BIOLOGICAL | Saline injection | Placebo |
Timeline
- Start date
- 2025-07-22
- Primary completion
- 2027-10-21
- Completion
- 2027-10-21
- First posted
- 2025-07-25
- Last updated
- 2026-04-08
Locations
19 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07086677. Inclusion in this directory is not an endorsement.