NCT01964716

13vPnC Multidose Vial Safety, Tolerability and Immunogenicity Study in Healthy Infants.

A Phase 3, Randomized, Open-label Trial To Evaluate The Safety, Tolerability And Immunogenicity Of 13-valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials Given With Routine Pediatric Vaccinations In Healthy Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 42 Days – 70 Days
• Healthy volunteers: Accepted

Summary

This study will compare the immune responses of the infants who have been given 13vPnC in the mutidose vial formulation to the immune reponses of the infants who have been given 13vPnC in the single-dose syringe formulation. It will also evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in all infants who are vaccinated.

Conditions

• Pneumococcal Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	13-valent pneumococcal conjugate vaccine	Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (multidose vial formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.
BIOLOGICAL	13-valent pneumococcal conjugate vaccine	Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (single-dose syringe formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2013-10-17
• Last updated: 2015-03-13
• Results posted: 2015-03-13

Locations

2 sites across 1 country: The Gambia