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

NCT ID: NCT05372575

Last Updated: 2023-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-15
• Study Completion Date: 2021-12-14

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PCV13 group and non PCV13 group

This study plan to recruit those young patients who have or not have got PCV13 vaccine before study start

Group Type: OTHER

PCV13 PAC study

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Evidence of a personally signed and dated informed consent document indicating that the parent(s)/legal guardian has been informed of all pertinent aspects of the study.

2. Subjects whose caregiver is willing and able to comply with scheduled visits, laboratory tests, and other study procedures.

3. A diagnosis of clinical pneumonia per SCH standard of care.

4. 5 months to ≤60 months of age at the time of consent.

5. Vaccination history (ie, vaccine book or picture of vaccine book) is available for confirmation.

Exclusion Criteria

1. Infant or child who is a family member of:

• Investigator site staff members directly involved in the conduct of the study;
• Site staff members otherwise supervised by the investigator;
• Pfizer employees directly involved in the conduct of the study.

2. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

3. Blood draw is counter indicated.

4. Previous participation in this study within 30 days.

5. Previous vaccination with licensed or investigational pneumococcal vaccine. This excludes previous vaccination with 13vPnC as per the approved recommendations in China.

6. Received blood, blood fractions, plasma, or immunoglobulins within 3 months of the study blood draw.

7. Hospital acquired pneumonia (ie, onset >48 hours after hospitalization).

• Minimum Eligible Age: 5 Months
• Maximum Eligible Age: 60 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Children's Hospital of Soochow University

Suzhou, Jiangsu, China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=B1851196

To obtain contact information for a study center near you, click here.

Other Identifiers

2022-000845-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B1851196

Identifier Type: -

Identifier Source: org_study_id