Trials / Completed
CompletedNCT06531538
A Study to Learn About How a New Pneumococcal Vaccine Works in Children
A PHASE 2, RANDOMIZED, PARTIALLY DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE ADMINISTERED IN HEALTHY TODDLERS 12 THROUGH 15 MONTHS OF AGE
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 225 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 12 Months – 15 Months
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to learn about the safety, tolerability and immune effects of a pneumococcal vaccine in toddlers. Participants will take part in this study for approximately 6 or 8 months depending on which group they are assigned to. During this time participants will have 2 clinic visits and 1 phone visit for the 1-Dose group, or 3 clinic visits and 1 phone visit for the 2-Dose group. At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during some clinic visits.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PG4 | Multivalent pneumococcal conjugate vaccine. |
| BIOLOGICAL | 20-valent pneumococcal conjugate vaccine (20vPnC) | 20-valent pneumococcal conjugate vaccine (20vPnC) |
Timeline
- Start date
- 2024-07-30
- Primary completion
- 2026-02-09
- Completion
- 2026-02-09
- First posted
- 2024-08-01
- Last updated
- 2026-03-11
Locations
39 sites across 2 countries: United States, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06531538. Inclusion in this directory is not an endorsement.