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

Phase 1

Completed

• Conditions: Pneumococcal Infection

• Registration Number: NCT01531322
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-12
• Study Start: 2011-10
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Study First Submitted QC: 2012-02-08
• Study First Posted: 2012-02-10
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-06
• Last Update Posted: 2018-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of participants reporting Adverse Events	Baseline to Month 1

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇳 Nanjing, Jiangsu, China