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Vaccine

20-valent pneumococcal conjugate vaccine for Pneumococcal Diseases

Phase 3
Waitlist Available
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.
Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 1 month before to 1 month after dose 4
Awards & highlights

Study Summary

This trial found that the 4-dose series of the 20-valent pneumococcal conjugate vaccine was safe and immunogenic in healthy infants.

Eligible Conditions
  • Pneumococcal Diseases

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 1 month before to 1 month after dose 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 1 month before to 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 With AEs From Dose 4 to 1 Month After Dose 4
Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3
Percentage of Participants With Local Reaction Within 7 Days After Dose 2
+12 more
Secondary outcome measures
GMRs of Prespecified Antibody Levels to Specific Concomitant Vaccine Antigen (Mumps) 1 Month After Dose 4
GMRs of Prespecified Antibody Levels to Specific Concomitant Vaccine Antigen (Varicella) 1 Month After Dose 4
GMRs of Prespecified Antibody Levels to Specific Concomitant Vaccine Antigens (Rubella) 1 Month After Dose 4
+9 more

Side effects data

From 2022 Phase 3 trial • 1511 Patients • NCT04379713
88%
Irritability (IRRITABILITY)
81%
Hypersomnia (INCREASED SLEEP)
61%
Injection site pain (PAIN)
55%
Decreased appetite (DECREASED APPETITE)
46%
Injection site erythema (REDNESS)
37%
Injection site swelling (SWELLING)
34%
Pyrexia (FEVER)
6%
Upper respiratory tract infection
1%
Bronchiolitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
20vPnC
13vPnC

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 20-valent pneumococcal conjugate vaccineExperimental Treatment1 Intervention
Pneumococcal conjugate vaccine
Group II: 13-valent pneumococcal conjugate vaccineActive Control1 Intervention
Pneumococcal conjugate vaccine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
20-valent pneumococcal conjugate vaccine
2022
Completed Phase 3
~6190

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,561 Previous Clinical Trials
10,904,986 Total Patients Enrolled
26 Trials studying Pneumococcal Diseases
105,342 Patients Enrolled for Pneumococcal Diseases
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,471 Previous Clinical Trials
8,086,401 Total Patients Enrolled
26 Trials studying Pneumococcal Diseases
105,342 Patients Enrolled for Pneumococcal Diseases

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~413 spots leftby Mar 2025