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Cancer Vaccine

Pneumococcal Vaccine for Children

Phase 2
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female toddlers aged ≥12 to ≤15 months at the time of consent
Be younger than 18 years old
Must not have
Previous vaccination with any licensed or investigational pneumococcal vaccine (other than 20vPnC) or planned receipt during study participation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days after each dose
Awards & highlights

Summary

This trial aims to understand how safe and well-tolerated a pneumococcal vaccine is in toddlers, as well as its effects on the immune system. Participants will be involved for about 6

Who is the study for?
This trial is for toddlers who need to be healthy with no history of pneumococcal disease or prior vaccination against it. They should not have any known allergies to vaccine components and must be able to attend multiple clinic visits.
What is being tested?
The study is testing a new pneumococcal vaccine called PG4, also known as the 20-valent pneumococcal conjugate vaccine (20vPnC). It aims to understand its safety and how well it can stimulate an immune response in children.
What are the potential side effects?
Possible side effects include reactions at the injection site like pain or swelling, fever, irritability, decreased appetite, and fatigue. Blood tests may also cause temporary discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child is between 12 and 15 months old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not had, nor plan to get, any pneumococcal vaccine other than 20vPnC during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days after each dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days after each dose for reporting.

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 the last assigned 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 each dose
+1 more
Secondary study objectives
Pneumococcal serotype specific IgG concentrations

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: PG4 2-Dose GroupExperimental Treatment1 Intervention
Participants to receive two injections of Multivalent Pneumococcal Vaccine
Group II: PG4 1-Dose GroupExperimental Treatment1 Intervention
Participants to receive a single injection of Multivalent Pneumococcal Vaccine
Group III: 20-valent pneumococcal conjugate vaccine (20vPnC)Active Control1 Intervention
Participants to receive a single injection of 20-valent pneumococcal conjugate vaccine (20vPnC).

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,625 Previous Clinical Trials
14,283,894 Total Patients Enrolled
28 Trials studying Pneumococcal Diseases
107,953 Patients Enrolled for Pneumococcal Diseases
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,518 Previous Clinical Trials
11,458,470 Total Patients Enrolled
28 Trials studying Pneumococcal Diseases
107,953 Patients Enrolled for Pneumococcal Diseases
~200 spots leftby Sep 2025
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