A Study To Assess The Safety And Effectiveness Of Prevenar In Chinese Children Who Have Not Previously Received A Vaccine Against Pneumococcal Bacteria
- Conditions
- Pneumococcal InfectionsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2014-004178-40-Outside-EU/EEA
- Lead Sponsor
- Pfizer, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 506
1. Evidence of a personally signed and dated informed consent document indicating that the parent/legal guardian has been informed of all pertinent aspects of the study.
2. Parent/legal guardian willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
3. Chinese male or female subject.
4. Aged 121 days to less than (<) 72 months at the time of enrollment.
5. Healthy subject 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: 506
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. Previous vaccination with licensed or investigational pneumococcal vaccine.
2. Previous anaphylactic reaction to any vaccine or vaccine-related component.
3. Contraindication to vaccination with pneumococcal vaccine.
4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
5. Known or suspected immune deficiency or suppression.
6. History of culture-proven invasive disease caused by Streptococcus pneumoniae.
7. Receipt of blood products or gamma-globulin within 12 weeks before the first dose of Prevenar until the blood draw approximately 1 month after the last dose of Prevenar.
8. Major known congenital malformation or serious chronic disorder.
9. Significant neurological disorder or history of seizure (including febrile seizure for
groups 1, 2, and 3), or significant stable or evolving disorders such as cerebral palsy,
encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving
syndromes due to birth trauma, such as Erb’s palsy.
10. Other severe acute or chronic medical or psychiatric condition or 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.
11. Receipt of any investigational drugs or medical devices within 28 days before the first
dose of Prevenar until the blood draw approximately 1 month after the last dose of
Prevenar.
12. Direct descendent (child or grandchild) of any study personnel or Pfizer employee.
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