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Safety and Immunogenicity of 20vPnC in Toddlers With 2 Prior Doses of Prevenar 13

NCT05408429 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 356

Last updated 2024-09-19

Study results available
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Summary

The purpose of this study is to understand the safety and effects of a study vaccine (20vPnC) in toddlers who had 2 prior doses of Prevnar 13.

This study is being conducted in children who:

* are between 12 to 23 months of age;
* are healthy as determined by the study doctors;
* have received 2 doses of Prevnar 13 during the first year in life.

Participants in this study will receive either 1 dose or 2 doses of the study vaccine or 1 dose of Prevnar 13 as a shot in the muscle. During the study, participants will have to come to the study clinic to receive the vaccines and have blood sample collected. The study team will work with participants' parents or legal guardians to monitor any unwanted reactions to the vaccines. Participants are expected to take part in this study for about 1 or 3 months, for 1 dose or 2 dose schedules, respectively.

Conditions

  • Pneumococcal Disease

Interventions

BIOLOGICAL

20-valent pneumococcal conjugate vaccine

20-valent pneumococcal conjugate vaccine

BIOLOGICAL

13-valent pneumococcal conjugate vaccine

13-valent pneumococcal conjugate vaccine

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
23 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-24
Primary Completion
2023-06-01
Completion
2023-06-01

Countries

  • Hungary
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05408429 on ClinicalTrials.gov