A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese infants and young childre
- Conditions
- Pneumococcal InfectionsTherapeutic area: Not possible to specify
- Registration Number
- EUCTR2019-000926-23-Outside-EU/EEA
- Lead Sponsor
- Pfizer, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- Not specified
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
Are the trial subjects under 18? yes
Number of subjects for this age range: 936
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
-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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method