# Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster or as a Two-dose Catch-up to Healthy Toddlers

> **NCT00847145** · PHASE3 · COMPLETED · sponsor: **Novartis Vaccines** · enrollment: 2249 (actual)

## Conditions studied

- Meningococcal Disease

## Interventions

- **BIOLOGICAL:** 1a - rMenB+OMV NZ and routine vaccines
- **BIOLOGICAL:** 1b - rMenB+OMV NZ and routine vaccines
- **BIOLOGICAL:** 2a - Routine and rMenB+OMV NZ vaccines
- **BIOLOGICAL:** 2b - rMenB+OMV NZ and routine vaccines
- **BIOLOGICAL:** 3a - rMenB+OMV NZ and routine vaccines
- **BIOLOGICAL:** 3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinations
- **BIOLOGICAL:** 4a- rMenB+OMV NZ and routine vaccines
- **BIOLOGICAL:** 4b - rMenB+OMV NZ and routine vaccines

## Key facts

- **NCT ID:** NCT00847145
- **Lead sponsor:** Novartis Vaccines
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2009-02
- **Primary completion:** 2010-08
- **Final completion:** 2010-08
- **Target enrollment:** 2249 (ACTUAL)
- **Last updated:** 2015-03-03


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00847145

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00847145, "Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster or as a Two-dose Catch-up to Healthy Toddlers". Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/clinical/NCT00847145. Licensed CC0.

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