A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Subjects
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
2 other identifiers
interventional
72
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2011
Shorter than P25 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFirst Posted
Study publicly available on registry
February 10, 2012
CompletedSeptember 7, 2018
September 1, 2018
3 months
August 12, 2011
September 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants reporting Adverse Events
Baseline to Month 1
Study Arms (3)
Group 1
EXPERIMENTALAdults aged 18 through 55 years (before the fifty sixth birthday)
Group 2
EXPERIMENTALChildren aged 3 through 5 years (before the sixth birthday)
Group 3
EXPERIMENTALInfants aged approximately 2 months (42 to 98 days)
Interventions
suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
Eligibility Criteria
You may qualify if:
- Age at the time of enrollment is:
- through 55 years (before the fifty sixth birthday) for Group 1.
- through 5 years (before the sixth birthday) for Group 2.
- to 98 days for Group 3.
- Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
You may not qualify if:
- Previous vaccination with licensed or investigational pneumococcal vaccine.
- Previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination with pneumococcal vaccine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (2)
Pfizer Investigational Site
Huaian, Jiangsu, 223300, China
Pfizer Investigational Site
Nanjing, Jiangsu, 210009, China
Related Publications (1)
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.
PMID: 26668712DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2011
First Posted
February 10, 2012
Study Start
October 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
September 7, 2018
Record last verified: 2018-09