NCT01139021

One Year Antibody Persistence After a Fourth Dose Boost or Two Catch-Up Doses of Novartis Meningococcal B Recombinant Vaccine Administered Starting From 12 Months of Age and Response to a Third Dose Boost or Two Catch-Up Doses Starting at 24 Months of Age

A Phase 3, Open-Label, Multi-Center, Extension Study of V72P13E1 to Assess Antibody Persistence at One Year After a Fourth Dose Boost or Two Catch-Up Doses of Novartis Meningococcal B Recombinant Vaccine Administered Starting at 12 Months of Age and to Evaluate the Response to a Third Dose Boost or Two Catch-Up Doses Starting at 24 Months of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 508 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 23 Months – 27 Months
• Healthy volunteers: Accepted

Summary

One year antibody persistence after the fourth dose boost or two catch-up doses administered starting from 12 months of age and to evaluate the response to a a third dose boost or two catch-up dose starting at 24 months of age.

Conditions

• Meningococcal Disease

Interventions

Type	Name	Description
BIOLOGICAL	rMenB+OMV NZ	Subjects will be assigned to a study group based on the group assignment in the parent study (follow-on subjects). In addition, one group of naïve age-matched subjects will be recruited at the same study sites. Subjects who had received 4 doses of rMenB+OMV NZ will have one visit including one blood draw. Subjects who had received two catch-up doses in V72P13E1 will receive a third dose boost and will have 3 blood samples drawn. Naïve subjects will receive two catch-up doses and have 3 blood samples drawn.

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-11-01
• Completion: 2011-09-01
• First posted: 2010-06-08
• Last updated: 2015-04-10
• Results posted: 2015-04-10

Locations

19 sites across 2 countries: Czechia, Finland