At a glance
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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.
In Brief
A Phase 4 clinical trial evaluating Prevenar for Pneumococcal Infections. Completed, enrolled 505 participants across 5 sites.
Detailed 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.
Study Details
Timeline
Interventions
Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 4 doses starting from 121 to \< 212 days of age
Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 3 doses starting from 212 days to \< 12 months of age
Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 2 doses starting from 12 months to \< 24 months of age
Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 1 dose starting from 24 months to \< 72 months of age