A Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Infants In China

Summary

This study is primarily designed to evaluate the IgG immune responses to the 13 pneumococcal serotypes induced by 13vPnC compared with the immune responses induced by 7vPnC when measured 1 month after the infant series, and to evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local reactions, systemic events and adverse events.

Timeline

Start

2012-09

Primary completion

2014-04

Completion

2014-04

Publications

• Zhu F, Hu Y, Li J, Ye Q, Young MM Jr, Liang JZ, Gruber WC, Giardina PC, Scott DA. Immunogenicity and Safety of the 13-Valent Pneumococcal Conjugate Vaccine Administered in a 3 + 1 versus 2 + 1 Dose Schedule Among Infants in China. Pediatr Infect Dis J. 2019 Nov;38(11):1150-1158. doi: 10.1097/INF.0000000000002458.
• Zhu F, Hu Y, Li J, Ye Q, Young MM Jr, Zhou X, Chen Z, Yan B, Liang JZ, Gruber WC, Giardina PC, Scott DA. Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine Compared With 7-valent Pneumococcal Conjugate Vaccine Among Healthy Infants in China. Pediatr Infect Dis J. 2016 Sep;35(9):999-1010. doi: 10.1097/INF.0000000000001248.

Drugs

Indications