Pneumococcal Infections
Conditions
Interventions
Trade Name: Prevenar 13/Prevnar 13
Product Name: 13-valent pneumococcal conjugate vaccine
Pharmaceutical Form: Injection
INN or Proposed INN: pneumococcal saccharide conjugated vaccine, adsorbed
Othe
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Evidence of a personally signed and dated informed consent document indicating thatthe 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. Residents of Suzhou municipal districts (Gusu, New and high-tech, Wuzhong, Xiangcheng, Industrial Park). 4. A diagnosis of clinical pneumonia per SCH standard of care. 5. 5 months to =60 months of age at the time of consent. 6. Vaccination history (ie, vaccine book or picture of vaccine book) is available for confirmation. a. For the 13vPnC cohort: Participants should have received at least 2 doses of 13vPnC prior to hospitalization. There must be a minimum of 2 weeks between the second 13vPnC dose and enrollment. b. For the unvaccinated cohort: Children did not receive any dose of 13vPnC in the past Are the trial subjects under 18? yes Number of subjects for this age range: 300 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Infant or child who is a family member of: a. Investigator site staff members directly involved in the conduct of the study; b. Site staff members otherwise supervised by the investigator; c. 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the antibody levels as measured by IgG and MOPA by 13vPnC vaccination status and vaccine-type (VT) carriage status, among children 5 months to <60 months of age with diagnosis of clinical pneumonia per local standard. ;Secondary Objective: Not applicable;Primary end point(s): 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;Timepoint(s) of evaluation of this end point: Time of Pneumonia diagnosis | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
China
Contacts
Public ContactClinicalTrials.gov call center
Pfizer Inc
Outcome results
None listed