A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01531322
First received: August 12, 2011
Last updated: February 15, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Pneumococcal Infection
Biological: 13-valent Pneumococcal Conjugate Vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of participants reporting Adverse Events [ Time Frame: Baseline to Month 1 ] [ Designated as safety issue: Yes ]

Enrollment: 72
Study Start Date: October 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Adults aged 18 through 55 years (before the fifty sixth birthday)
Biological: 13-valent Pneumococcal Conjugate Vaccine
suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
Experimental: Group 2
Children aged 3 through 5 years (before the sixth birthday)
Biological: 13-valent Pneumococcal Conjugate Vaccine
suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
Experimental: Group 3
Infants aged approximately 2 months (42 to 98 days)
Biological: 13-valent Pneumococcal Conjugate Vaccine
suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose

  Eligibility

Ages Eligible for Study:   42 Days to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531322

Locations
China, Jiangsu
Pfizer Investigational Site
Huaian, Jiangsu, China, 223300
Pfizer Investigational Site
Nanjing, Jiangsu, China, 210009
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01531322     History of Changes
Other Study ID Numbers: B1851046, 6096A1-1000
Study First Received: August 12, 2011
Last Updated: February 15, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Pfizer:
13vPnC
Healthy subjects
China

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 17, 2014