NCT01193582

A Study To Assess The Safety And Effectiveness Of Prevenar In Chinese Children Who Have Not Previously Received A Vaccine Against Pneumococcal Bacteria

A Phase 4, Open-label Trial to Assess the Safety, Tolerability and Immunogenicity of Prevenar in Older Infants and Young Children in China Who Are Naive to Previous Pneumococcal Vaccination.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 505 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 121 Days – 72 Months
• Healthy volunteers: Accepted

Summary

A vaccine called Prevenar is already approved for use in China for vaccination of children younger than 6 years old against infections caused by Streptococcus pneumoniae. This study is to measure the amount of antibodies (antibodies help people fight off diseases) Chinese children aged between 121 days and 6 years (72 months) produce when given Prevenar. The study will also provide more data on how safe and well tolerated Prevenar is in Chinese children.

Conditions

• Pneumococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	Prevenar	Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 4 doses starting from 121 to \< 212 days of age
BIOLOGICAL	Prevenar	Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 3 doses starting from 212 days to \< 12 months of age
BIOLOGICAL	Prevenar	Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 2 doses starting from 12 months to \< 24 months of age
BIOLOGICAL	Prevenar	Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 1 dose starting from 24 months to \< 72 months of age

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2010-09-02
• Last updated: 2013-11-20
• Results posted: 2013-11-20

Locations

5 sites across 1 country: China