NCT00806195

Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

A Phase 3b, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 7,744 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 55 Days – 89 Days
• Healthy volunteers: Accepted

Summary

The primary objective of this phase 3b study is to evaluate the safety and tolerability of Novartis MenACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants

Conditions

• Meningitis
• Meningococcal Infection

Interventions

Type	Name	Description
BIOLOGICAL	MenACWY-CRM197	Four 0.5mL vaccinations of MenACWY-CRM197 conjugate vaccine was administered by intramuscular injection at 2, 4, 6 and 12 months of age.
BIOLOGICAL	DTaP (Diptheria, Tetanus, Pertussis) Vaccine	Four vaccinations of DTaP (Diptheria, Tetanus, Pertussis) was administered at 2, 4, 6, and 15 months of age.
BIOLOGICAL	Hib (Haemophilus influenza b) Vaccine	Four vaccinations of Hib (Haemophilus influenza b) vaccine was administered at 2, 4, 6 and 15 months of age.
BIOLOGICAL	IPV (Inactivated Polio Vaccine) Vaccine	Three vaccinations of IPV (Inactivated Polio Vaccine) was administered at 2, 4, and 6 months of age.
BIOLOGICAL	Pneumococcal conjugate Vaccine	Four vaccinations of Pneumococcal conjugate vaccine was administered at 2, 4, 6 and 12 months of age.
BIOLOGICAL	MMR (Measles, Mumps, and Rubella) Vaccine	One vaccination of MMR (Measles, Mumps, and Rubella) was administered at 12 months of age.
BIOLOGICAL	Varicella Vaccine	One vaccination of Varicella vaccine was administered at 12 months of age.
BIOLOGICAL	Hepatitis A Virus	One vaccination of Hepatitis A Virus vaccine was administered at 12 months of age.

Timeline

• Start date: 2008-12-01
• Primary completion: 2011-03-01
• Completion: 2011-11-01
• First posted: 2008-12-10
• Last updated: 2013-07-09
• Results posted: 2013-07-09

Locations

153 sites across 6 countries: United States, China, Costa Rica, Guatemala, Panama, Peru