NCT00488683

B Cell Response to a Primary and a Booster Course of the Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants

A Phase II, Single Center, Open-label, Randomized Study to Investigate Meningococcal Serogroup A, C, W-135 and Y Saccharide Specific B Cell Response to a Primary and a Booster Course of the Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 56 Days – 83 Days
• Healthy volunteers: Accepted

Summary

This study is aimed to assess whether the frequency of meningococcal serogroup A, C, W-135 and Y specific memory B Cells, measured 1 month after a primary vaccination series of Novartis MenACWY vaccine, predicts the specific serum bactericidal activity using human complement (hSBA) of (respectively) serogroup A, C, W-135 and Y at 12 months of age

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-, and 12-months as IM injections in the anterolateral area of the right thigh.
BIOLOGICAL	DTaP-Hib-IPV	IM injections of 3 doses of 0.5 mL each of DTaP-Hib-IPV supplied in prefilled vial were administered at 2-, 3-, and 4-months in the anterolateral area of the left thigh.
BIOLOGICAL	PCV	IM injections of 3 doses of 0.5 mL each of PCV supplied in pre-filled syringe were administered at 2-, 4-, and 12-months (Groups 2 and 3) or 13-months (Group 1) in the anterolateral area of the left thigh.
BIOLOGICAL	MMR	IM injection of one dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 13 months in the anterolateral area of the left thigh.
BIOLOGICAL	Hib	IM injection of one dose 0.5 mL of Hib supplied in pre-filled syringe was administered at 13 months in the anterolateral area of the right thigh.

Timeline

• Start date: 2007-07-01
• Primary completion: 2009-05-01
• Completion: 2009-06-01
• First posted: 2007-06-20
• Last updated: 2014-10-01
• Results posted: 2014-08-15

Locations

1 site across 1 country: United Kingdom