NCT01218451

NeisVac-C Single Prime Study in Infants

A Phase 3b, Randomized, Open Label, Feasibility Study of a Single Priming Dose of Meningococcal Group C Conjugate Vaccine (NeisVac-C) in Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 956 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 8 Weeks – 11 Weeks
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the feasibility of a single priming dose of NeisVac-C in infants (at either 4 or 6 months of age), as determined by immune response.

Conditions

• Neisseria Meningitidis

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal group C polysaccharide conjugate vaccine	0.5 mL dose, subcutaneous administration in right anterolateral thigh
BIOLOGICAL	Pneumococcal 13-valent conjugate vaccine	0.5 mL dose, subcutaneous administration in right anterolateral thigh
BIOLOGICAL	Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine	0.5 mL dose, subcutaneous administration in right anterolateral thigh

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-01-01
• Completion: 2012-06-01
• First posted: 2010-10-11
• Last updated: 2015-05-21

Locations

24 sites across 2 countries: Poland, Spain