NCT01692886

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

A Phase 3, Randomized, Active-controlled Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13vPnC Vaccine Compared With a 7vPnC in Healthy Infants in China

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,674 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 42 Days – 77 Days
• Healthy volunteers: Accepted

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.

Conditions

• Pneumococcal Infection

Interventions

Type	Name	Description
BIOLOGICAL	7-valent Pneumococcal Conjugate Vaccine	suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 4-Month Visit, 5-Month Visit, and 12-Month Visit, respectively
BIOLOGICAL	13-valent Pnumococcal Conjugate vaccine	suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 4-Month Visit, 5-Month Visit, and 12-Month Visit, respectively
BIOLOGICAL	13-valent Pnumococcal Conjugate vaccine	suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 2-Month Visit, 4-Month Visit, 6-Month Visit, and 12-Month Visit, respectively
BIOLOGICAL	13-valent Pnumococcal Conjugate vaccine	suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 5-Month Visit, and 12-Month Visit, respectively

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2012-09-25
• Last updated: 2014-07-16

Locations

4 sites across 1 country: China