CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,249 enrolled
Drug / intervention
1a - rMenB+OMV NZ and routine vaccines +7 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00847145
NCT00847145Phase 3Completed
CompareCT.gov

A Phase 3, Open Label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster at 12 Months of Age or as a Two-dose Catch-up to Healthy Toddlers Who Participated in Study V72P13

Novartis Vaccines·interventional·Posted Feb 19, 2009·Updated Mar 3, 2015

In Brief

A Phase 3 clinical trial evaluating 1a - rMenB+OMV NZ and routine vaccines, 1b - rMenB+OMV NZ and routine vaccines, and 6 other interventions for Meningococcal Disease. Completed, enrolled 2,249 participants across 59 sites in 5 countries.

Detailed Summary

The proposed study is an Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster at 12 Months of Age or as a Two-dose Catch-up to Healthy Toddlers

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Disease
CountriesAustria, Czechia, Finland, Germany, Italy
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 19, 2009
Enrollment StartFeb 1, 2009
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 17.4 years ago

Interventions

1a - rMenB+OMV NZ and routine vaccinesbiological

One dose of rMenB vaccine and routine vaccine at study month 12.

1b - rMenB+OMV NZ and routine vaccinesbiological

One dose of rMenB vaccine at study month 12 and routine vaccine at study month 13.

2a - Routine and rMenB+OMV NZ vaccinesbiological

One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15.

2b - rMenB+OMV NZ and routine vaccinesbiological

Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12.

3a - rMenB+OMV NZ and routine vaccinesbiological

One dose of rMenB vaccine and one dose of routine vaccine at study month 12.

3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinationsbiological

One dose of rMenB vaccine at study month 12 and one dose of routine vaccine study month 13.

4a- rMenB+OMV NZ and routine vaccinesbiological

One dose of rMenB vaccine and one dose of routine vaccine at study month 12.

4b - rMenB+OMV NZ and routine vaccinesbiological

One dose of rMenB vaccine and one dose of routine vaccine at study month 12.