NCT01000311

A Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months

A Phase 3, Randomized, Open Label, Controlled Multicenter Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 529 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 55 Days – 89 Days
• Healthy volunteers: Accepted

Summary

This Phase 3 study is designed to demonstrate the safety and immunogenicity of MenACWY and non-interference of concomitant routine vaccines by MenACWY in an infant age group.

Conditions

• Meningococcal Disease

Interventions

Type	Name	Description
BIOLOGICAL	MenACWY-CRM	One dose (0.5 mL) of MenACWY conjugate vaccine supplied as an extemporaneous mixing just before injection of the lyophilized component (MenA) reconstituted with the liquid component (MenCWY) was administered at 2, 4, 6 and 12 months of age as IM injections in the anterolateral area of the thigh.
BIOLOGICAL	DTaP-IPV/Hib	IM injections of 3 doses of 0.5 mL each of DTaP-IPV/Hib supplied in prefilled vial were administered at 2, 4 and 6 months of age in the anterolateral area of the thigh.
BIOLOGICAL	HBV	IM injections of 3 doses of 0.5 mL each of HBV supplied in prefilled vial were administered at 2, 4 and 6 months of age in the anterolateral area of the thigh.
BIOLOGICAL	PCV	IM injections of 4 doses of 0.5 mL each of PCV supplied in prefilled vial were administered at 2, 4, 6 and 12 months of age in the anterolateral area of the thigh.
BIOLOGICAL	MMR	Subcutaneous (SC) injection of 1 dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 12 months of age in the anterolateral area of the thigh.

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2009-10-23
• Last updated: 2014-04-21
• Results posted: 2014-03-26

Locations

46 sites across 3 countries: United States, Australia, Canada