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

Study Overview
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Brief Summary
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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.

Official Title
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A COHORT STUDY TO EVALUATE IMMUNOGENICITY FOR CHILDREN AGED 5 MONTHS TO ≤60 MONTHS AT THE TIME OF CLINICAL PNEUMONIA DIAGNOSIS

Conditions
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Immunogenicity, Vaccine

Intervention / Treatment
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* Biological: PCV13 PAC study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Subjects whose caregiver is willing and able to comply with scheduled visits, laboratory tests, and other study procedures. A diagnosis of clinical pneumonia per SCH standard of care. 5 months to ≤60 months of age at the time of consent. Vaccination history (ie, vaccine book or picture of vaccine book) is available for confirmation. Exclusion Criteria: 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. 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. Blood draw is counter indicated. Previous participation in this study within 30 days. Previous vaccination with licensed or investigational pneumococcal vaccine. This excludes previous vaccination with 13vPnC as per the approved recommendations in China. Received blood, blood fractions, plasma, or immunoglobulins within 3 months of the study blood draw. Hospital acquired pneumonia (ie, onset >48 hours after hospitalization).

Ages Eligible for Study
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Minimum Age: 5 Months
Maximum Age: 60 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PCV13 group and non PCV13 group<br>This study plan to recruit those young patients who have or not have got PCV13 vaccine before study start | Biological: PCV13 PAC study<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort | Approximately 5 mL of blood sample was collected within 24 hours of enrollment. Blood must have been drawn from peripheral veins (eg, arm, foot, or scalp veins). Serum concentrations of anticapsular IgG were determined by enzyme-linked immunosorbent assay (ELISA) for each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in all participants with a collected blood sample. | Day 1 | 
| Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort | Approximately 5 mL of blood sample was collected within 24 hours of enrollment. Blood must have been drawn from peripheral veins (eg, arm, foot, or scalp veins). Serum levels of MOPA for each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all 13vPnC cohort participants with adequate blood volume. In the Non-13vPnC cohort, a sample of participants with adequate blood volume was selected, to be equal to the number of the 13vPnC Cohort included for MOPA testing. Titer was expressed as reciprocal of the highest serum dilution. | Day 1 | 
| GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis | Approximately 5 mL of blood sample was collected within 24 hours of enrollment. Blood must have been drawn from peripheral veins (eg, arm, foot, or scalp veins). Serum concentrations of anticapsular IgG were determined by ELISA for each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in all participants with a collected blood sample. For each cohort, participants were assigned to 2 subgroups: Participant in whom a 13vPnC VT strain had been isolated from the respiratory tract, and participant from whom a 13vPnC VT strain had not been isolated from the respiratory tract (VT carrier versus without VT carrier). | Day 1 | 
| GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis | Approximately 5 mL of blood sample was collected within 24 hours of enrollment. Blood must have been drawn from peripheral veins (eg, arm, foot, or scalp veins). Serum levels of MOPA for each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all 13vPnC cohort participants with adequate blood volume. In the Non-13vPnC cohort, a sample of participants with adequate blood volume was selected, to be equal to the number of the 13vPnC Cohort included for MOPA testing. For each cohort, participants were assigned to 2 subgroups: Participant in whom a 13vPnC VT strain had been isolated from the respiratory tract, and participant from whom a 13vPnC VT strain had not been isolated from the respiratory tract (VT carrier versus without VT carrier). Titer was expressed as reciprocal of the highest serum dilution. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Serum concentrations of anticapsular immunoglobulin G (IgG) and serum levels of opsonophagocytic activity (OPA) for the PCV13 pneumococcal serotypes