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Cancer Vaccine

Pneumococcal Vaccine for Infants

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 infants born at >36 weeks of gestation and 2 months of age at the time of consent
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up dose 1 to 1 month after dose 3
Awards & highlights

Summary

"This trial aims to test a new vaccine for infants to see if it is safe and can help the immune system fight off infections caused by a specific germ. Infants who are 2 months old,

Who is the study for?
This trial is for healthy male or female infants who are 2 months old, born at least 36 weeks into pregnancy. They must be considered healthy by the study doctor to participate.
What is being tested?
The trial is testing a new pneumococcal vaccine called PG4 against an existing one, Prevnar 20 (20vPnC). Infants will receive four doses and have their immune response measured through blood samples to see how well the vaccine works.
What are the potential side effects?
Possible side effects include unintentional reactions where the shot was given in the thigh muscle. Parents or guardians will report any observed side effects during clinic visits and phone calls.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My baby was born full-term and is now 2 months old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month after dose 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month after dose 4 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 AEs
Percentage of participants reporting adverse events (AEs)
Percentage of participants reporting local reactions within 7 days after each dose
+1 more
Secondary outcome measures
Pneumococcal immunoglobulin G (IgG) geometric mean concentrations (GMCs)

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Group 2 PG4Experimental Treatment1 Intervention
Multivalent Pneumococcal Vaccine
Group II: Group 1 PG4Experimental Treatment1 Intervention
Multivalent Pneumococcal Vaccine
Group III: Group 1 20-valent pneumococcal conjugate vaccine (20vPnC)Active Control1 Intervention
20-valent pneumococcal conjugate vaccine (20vPnC)
Group IV: Group 2 20-valent pneumococcal conjugate vaccine (20vPnC)Active Control1 Intervention
20-valent pneumococcal conjugate vaccine (20vPnC)

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,625 Previous Clinical Trials
14,283,794 Total Patients Enrolled
28 Trials studying Pneumococcal Diseases
107,853 Patients Enrolled for Pneumococcal Diseases
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,518 Previous Clinical Trials
11,458,370 Total Patients Enrolled
28 Trials studying Pneumococcal Diseases
107,853 Patients Enrolled for Pneumococcal Diseases
~267 spots leftby Jul 2026
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