A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Subjects
NCT ID: NCT01531322
Last Updated: 2018-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
72 participants
INTERVENTIONAL
2011-10-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Group 1
Adults aged 18 through 55 years (before the fifty sixth birthday)
13-valent Pneumococcal Conjugate Vaccine
suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
Group 2
Children aged 3 through 5 years (before the sixth birthday)
13-valent Pneumococcal Conjugate Vaccine
suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
Group 3
Infants aged approximately 2 months (42 to 98 days)
13-valent Pneumococcal Conjugate Vaccine
suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
Interventions
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13-valent Pneumococcal Conjugate Vaccine
suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
13-valent Pneumococcal Conjugate Vaccine
suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
13-valent Pneumococcal Conjugate Vaccine
suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
Eligibility Criteria
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Inclusion Criteria
* 18 through 55 years (before the fifty sixth birthday) for Group 1.
* 3 through 5 years (before the sixth birthday) for Group 2.
* 42 to 98 days for Group 3.
2. Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
Exclusion Criteria
* Previous anaphylactic reaction to any vaccine or vaccine-related component.
* Contraindication to vaccination with pneumococcal vaccine.
42 Days
55 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Huaian, Jiangsu, China
Pfizer Investigational Site
Nanjing, Jiangsu, China
Countries
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References
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Zhu F, Hu Y, Liang Q, Young M Jr, Zhou X, Chen Z, Liang JZ, Gruber WC, Scott DA. Safety and tolerability of 13-valent pneumococcal conjugate vaccine in healthy Chinese adults, children and infants. Ther Adv Drug Saf. 2015 Dec;6(6):206-11. doi: 10.1177/2042098615613985.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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6096A1-1000
Identifier Type: -
Identifier Source: secondary_id
B1851046
Identifier Type: -
Identifier Source: org_study_id
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