A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Infants and Young Children
NCT03574389
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Evidence of a personally signed and dated ICD indicating that the parent(s)/legal guardian has been informed of all pertinent aspects of the study.
- Aged 6 weeks (42 days) to <6 years at the time of consent.
- Healthy infants and children as determined by medical history, physical examination, and judgment of the investigator.
- Participation in other studies involving investigational drug(s)/vaccine(s) since
birth (Cohort 1 only) or in the 6 months prior to study entry (Cohorts 2, 3, and 4)
and/or during study participation.
- Other acute or chronic medical or psychiatric condition, including recent laboratory
abnormality, that may increase the risk associated with study participation or
investigational product administration 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.
- Vaccination with licensed or investigational pneumococcal vaccine.
- Previous vaccination with licensed or investigational Hib vaccine.
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Descriptive Information | |||||||
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Brief Title ICMJE | A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Infants and Young Children | ||||||
Official Title ICMJE | A PHASE 3 OPEN-LABEL TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN INFANTS AND YOUNG CHILDREN IN CHINA WHO ARE NAIVE TO PNEUMOCOCCAL VACCINATION | ||||||
Brief Summary | The purpose of this study is to assess the safety and immunogenicity of 13-valent Pneumococcal conjugate vaccine in Chinese infant and young children. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention | ||||||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE | 936 | ||||||
Original Estimated Enrollment ICMJE | 656 | ||||||
Estimated Study Completion Date ICMJE | December 31, 2023 | ||||||
Estimated Primary Completion Date | October 27, 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 42 Days to 5 Years (Child) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03574389 | ||||||
Other Study ID Numbers ICMJE | B1851178 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | March 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |