Extension Study Evaluating Antibody Persistence and Safety, Tolerability and Immunogenicity of Booster Doses of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received One or Four Doses of the Same Vaccine

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01027351
• Date of registration: 04/12/2009
• Primary sponsor: Novartis Vaccines
• Public title: Extension Study Evaluating Antibody Persistence and Safety, Tolerability and Immunogenicity of Booster Doses of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received One or Four Doses of the Same Vaccine
• Scientific title: A Phase 2, Open-Label, Single-Center, Extension Study Evaluating Antibody Persistence Compared to Naïve Children and Safety, Tolerability and Immunogenicity of Booster Doses of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received One or Four Doses of the Novartis Vaccine as Infants in Study V72P6
• Date of first enrolment: January 2010
• Target sample size: 163
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01027351
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Countries of recruitment

United Kingdom

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy 40 to 44-months-old children, who participated and completed the study V72P6
(follow-on subjects)

- Healthy 40 to 44-months or 60 to 62-months-old children (naïve subjects)

Exclusion Criteria:

- Previous ascertained or suspected disease caused by N. meningitidis

- History of severe allergic reaction after previous vaccinations or hypersensitivity
to any vaccine component

- Any serious chronic or progressive disease

- Known or suspected impairment/alteration of the immune system

- Receipt of, or intent to immunize with another vaccine, within 30 days prior and
after vaccination with the investigational vaccines (within 14 days for licensed flu
vaccines)



Age minimum: 40 Months
Age maximum: 62 Months
Gender: Both

Health Condition(s) or Problem(s) studied

Meningococcal Disease

Intervention(s)

Biological: Serogroup B meningococcal Vaccine

Primary Outcome(s)

Bactericidal antibody persistence in children at 40 months of age who received 4 doses of rMenB+/-OMV NZ. Safety and tolerability [Time Frame: Individual subject participation either 3 months or 20 months]

Secondary Outcome(s)

Bactericidal Ab persistence at 40 mths of age after 1 dose of rMenB+/-OMV NZ.Bactericidal Ab response after 1 or 2 booster doses of rMenB+/-OMV NZ or 2 catch-up doses of rMenB+OMV NZ.Bactericidal Ab persistence in children at 60 mths. [Time Frame: Individual subject participation either 3 months or 20 months]

Secondary ID(s)

EUDRACT 2009-013054-33

V72P6E1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors