NCT01531322

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 42 Days – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pneumococcal Infection

Interventions

Type	Name	Description
BIOLOGICAL	13-valent Pneumococcal Conjugate Vaccine	suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
BIOLOGICAL	13-valent Pneumococcal Conjugate Vaccine	suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
BIOLOGICAL	13-valent Pneumococcal Conjugate Vaccine	suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2012-02-10
• Last updated: 2018-09-07

Locations

2 sites across 1 country: China