NCT00657709

Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

A Phase 3, Partially Blinded, Randomized, Multi-Center, Controlled Study to Evaluate Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,630 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 55 Days – 89 Days
• Healthy volunteers: Accepted

Summary

The proposed study was aimed to assess the immunogenicity, safety, tolerability and lot to lot consistency of 3 lots of Novartis Meningococcal B vaccine when given concomitantly with routine infant vaccines.

Conditions

• Serogroup B Meningococcal Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1)	One dose of rMenB Lot concomitantly with the routinely administered infant vaccines
BIOLOGICAL	Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2)	One dose of rMenB concomitantly with the routinely administered infant vaccines
BIOLOGICAL	Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)	One dose of rMenB concomitantly with the routinely administered infant vaccines
BIOLOGICAL	Infanrix Hexa	Routine vaccination
BIOLOGICAL	Menjugate	One dose of the routinely administered infant vaccines + MenC vaccine
BIOLOGICAL	Prevenar	Routine vaccination

Timeline

• Start date: 2008-03-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2008-04-14
• Last updated: 2017-10-10
• Results posted: 2015-04-10

Locations

66 sites across 5 countries: Austria, Czechia, Finland, Germany, Italy