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

Pfizer

Status: Completed

Conditions: Immunogenicity, Vaccine

Treatments: Biological: PCV13 PAC study

Study type: Interventional

Funder types: Industry

Identifiers

NCT05372575

2022-000845-34 (EudraCT Number)

B1851196

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 5 to 60 months old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

PCV13 group and non PCV13 group

Other group

Description:

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

Treatment:

Biological: PCV13 PAC study