Clinical trial NCT05372575: A COHORT STUDY TO EVALUATE IMMUNOGENICITY FOR CHINESE CHILDREN AT THE TIME OF CLINICAL PNEUMONIA DIAGNOSIS
Official title: A COHORT STUDY TO EVALUATE IMMUNOGENICITY FOR CHILDREN AGED 5 MONTHS TO ≤60 MONTHS AT THE TIME OF CLINICAL PNEUMONIA DIAGNOSIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunogenicity, Vaccine
Keywords: Serum concentrations of anticapsular immunoglobulin G (IgG) and serum levels of opsonophagocytic activity (OPA) for the PCV13 pneumococcal serotypes
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-05-12
Enrollment: 300
Sex: ALL
Minimum age (years): 5
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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).

Primary outcomes:
measure: Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort
timeFrame: Day 1
measure: Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort
timeFrame: Day 1
measure: GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis
timeFrame: Day 1
measure: GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Children's Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: