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A COHORT STUDY TO EVALUATE IMMUNOGENICITY FOR CHINESE CHILDREN AT THE TIME OF CLINICAL PNEUMONIA DIAGNOSIS

NCT05372575 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-10-03

Study results available
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Summary

This is a PAC study after PCV13 launch in China. Based on recommendation from China Agency, Pfizer was required to conduct a descriptive immunogenicity study to measure the antibody levels at the time of disease onset.

Conditions

  • Immunogenicity, Vaccine

Interventions

BIOLOGICAL

PCV13 PAC study

To test the serotype-specific IgG geometric mean concentration (GMC) and MOPA geometric mean titers (GMT) for each of the pneumococcal serotypes measured at the time of diagnosis of clinical pneumonia.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Months
Max Age
60 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-15
Primary Completion
2021-12-14
Completion
2021-12-14

Countries

  • China

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 NCT05372575 on ClinicalTrials.gov