E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Not possible to specify |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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). |
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E.5 End points |
E.5.1 | 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 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Time of Pneumonia diagnosis |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
Will this trial be conducted at a single site globally?
| Yes |
E.8.4 | Will this trial be conducted at multiple sites globally? | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial months | 28 |