Back to resultsA Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Subjects
Primary Purpose
Pneumococcal Infection
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
13-valent Pneumococcal Conjugate Vaccine
13-valent Pneumococcal Conjugate Vaccine
13-valent Pneumococcal Conjugate Vaccine
Sponsored by
About this trial
This is an interventional basic science trial for Pneumococcal Infection focused on measuring 13vPnC, Healthy subjects, China
Eligibility Criteria
Inclusion Criteria:
Age at the time of enrollment is:
- 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.
- Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
Exclusion Criteria:
- Previous vaccination with licensed or investigational pneumococcal vaccine.
- Previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination with pneumococcal vaccine.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group 1
Group 2
Group 3
Arm Description
Adults aged 18 through 55 years (before the fifty sixth birthday)
Children aged 3 through 5 years (before the sixth birthday)
Infants aged approximately 2 months (42 to 98 days)
Outcomes
Primary Outcome Measures
Number of participants reporting Adverse Events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01531322
Brief Title
A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Subjects
Official Title
A Phase 1 Open-label Study to Assess the Safety and Tolerability of a Single Dose of 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Adults, Children and Infants
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will assess the safety and tolerability of a single dose of 13-valent Pneumococcal Conjugate Vaccine for approximately 1 month after vaccination sequentially in healthy Chinese adults aged 18 through 55 years, followed by children aged 3 through 5 years, and then infants aged approximately 2 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Infection
Keywords
13vPnC, Healthy subjects, China
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Adults aged 18 through 55 years (before the fifty sixth birthday)
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Children aged 3 through 5 years (before the sixth birthday)
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Infants aged approximately 2 months (42 to 98 days)
Intervention Type
Biological
Intervention Name(s)
13-valent Pneumococcal Conjugate Vaccine
Intervention Description
suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
Intervention Type
Biological
Intervention Name(s)
13-valent Pneumococcal Conjugate Vaccine
Intervention Description
suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
Intervention Type
Biological
Intervention Name(s)
13-valent Pneumococcal Conjugate Vaccine
Intervention Description
suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
Primary Outcome Measure Information:
Title
Number of participants reporting Adverse Events
Time Frame
Baseline to Month 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
42 Days
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age at the time of enrollment is:
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.
Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
Exclusion Criteria:
Previous vaccination with licensed or investigational pneumococcal vaccine.
Previous anaphylactic reaction to any vaccine or vaccine-related component.
Contraindication to vaccination with pneumococcal vaccine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Huaian
State/Province
Jiangsu
ZIP/Postal Code
223300
Country
China
Facility Name
Pfizer Investigational Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
26668712
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1851046&StudyName=A%20Study%20Assessing%2013-valent%20Pneumococcal%20Conjugate%20Vaccine%20in%20Healthy%20Chinese%20Subjects
Description
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Learn more about this trial
A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Subjects
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