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

Pfizer Inc.0 个研究点开始时间: 2022年3月24日最近更新: 2022年3月28日

适应症

试验速览

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•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

•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).

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