NCT02494999

A Phase III Clinical Trial of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants

A Randomized, Double-blind, Parallel-Controlled Phase III Clinical Trial of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,200 (actual)
• Sponsor: Jiangsu Province Centers for Disease Control and Prevention · Network
• Sex: All
• Age: 42 Days – 77 Days
• Healthy volunteers: Accepted

Summary

In order to evaluate immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine produced by Beijing Minhai Biotechnology Co., Ltd., a randomized, double-blind, parallel-controlled phase III clinical trial is planned to conduct in healthy infants aged 2 months in China.

Detailed description

There will be two arms. 1200 healthy infants aged 2 months will be randomly assigned (1:1) to receive an experimental vaccine or a comparator vaccine in Month 0,2 and 4 (primary vaccination). All of them will receive a fourth dose as booster vaccination in Month 10.

Conditions

• Pneumonia

Interventions

Type	Name	Description
BIOLOGICAL	13-valent pneumococcal conjugate vaccine	0.5ml vaccine produced by Beijing Minhai Biotechnology Co., Ltd.,three doses with 2 month interval, a booster dose 10 months after the first dose
BIOLOGICAL	Prevnar 13	0.5ml vaccine produced by Wyeth,three doses with 2 month interval, a booster dose 10 months after the first dose

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-12-01
• Completion: 2019-10-01
• First posted: 2015-07-13
• Last updated: 2020-05-13

Locations

4 sites across 1 country: China