NCT00626327

Safety and Immune Response of Novartis MenACWY-CRM Conjugate Vaccine When Given to Healthy Toddlers

A Phase 3, Open-Label, Randomized, Multi-Center Study to Evaluate the Safety and Immunogenicity of MMRV Vaccine When Administered Concomitantly With Novartis Meningococcal ACWY Conjugate Vaccine to Healthy Toddlers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,630 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 7 Months – 1 Year
• Healthy volunteers: Accepted

Summary

Safety immune response of Novartis MenACWY-CRM conjugate vaccine when given to healthy toddlers

Conditions

• Meningococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	MenACWY-CRM + MMRV	One injection of MenACWY-CRM vaccine at 7-9 months of age; the second injection of MenACWY-CRM vaccine concomitantly administered with MMRV (Measles, Mumps, Rubella and Varicella) vaccine at 12 months of age.
BIOLOGICAL	MMRV	one injection of MMRV (Measles, Mumps, Rubella and Varicella) vaccine at 12 months of age
BIOLOGICAL	MenACWY-CRM	Two injections of MenACWY-CRM at 7-9 months and 12 months of age; one injection of MMRV (Measles, Mumps, Rubella and Varicella) at 13.5 months of age

Timeline

• Start date: 2008-02-01
• Primary completion: 2010-07-01
• Completion: 2010-10-01
• First posted: 2008-02-29
• Last updated: 2013-04-19
• Results posted: 2013-03-15

Locations

90 sites across 1 country: United States