NCT01193335

Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants.

A Phase 4, Open-label Trial Describing The Safety, Tolerability, And Immunogenicity Of The 13 Valent Pneumococcal Conjugate Vaccine In Preterm Compared To Term Infants

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 42 Days – 98 Days
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to describe the safety, tolerability, and immunogenicity of a 2,3,4 and 12 month schedule of the 13-valent pneumococcal conjugate vaccine when given to preterm infants with concomitant vaccines, compared to infants born at term.There will be a follow-up phase to assess the persistence of the antibody response at 24 and 36 months of age.

Conditions

• 13-valent Pneumococcal Vaccine
• Premature Birth
• Immunization
• Safety

Interventions

Type	Name	Description
BIOLOGICAL	13-valent pneumococcal conjugate vaccine	13-valent pneumococcal conjugate vaccine will be administered at 2, 3, 4 and 12 months of age.
BIOLOGICAL	13-valent pneumococcal conjugate vaccine	13-valent pneumococcal conjugate vaccine will be administered at 2, 3, 4 and 12 months of age.

Timeline

• Start date: 2010-10-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2010-09-01
• Last updated: 2017-05-11
• Results posted: 2015-02-04

Locations

12 sites across 2 countries: Poland, Spain