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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 belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from 1 month before to 1 month after dose 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 1 month before to 1 month after dose 4
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 moreSecondary 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 moreSide effects data
From 2022 Phase 3 trial • 1511 Patients • NCT0437971388%
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.
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