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

Novartis

Status and phase: Completed; Phase 2

Conditions: Meningococcal Disease

Treatments: Biological: rMenB+OMV NZ; Biological: rMenB

Study type: Interventional

Funder types: Industry

Identifiers

NCT01026974

V72P9E1

EUDRACT 2009-013075-21

Details and patient eligibility

About

The proposed study V72P9E1 is an Extension Study of V72P9. The objectives of this extension study will be to explore antibody persistence in children at approximately 40 months of age and to evaluate the safety, tolerability and immunogenicity of a booster dose of rMenB±OMV NZ administered to subjects at approximately 40 months of age. Antibody persistence will be subsequently measured at 18-20 months after these booster doses when the subjects are 60 months of age. Two groups of naïve subjects, aged approximately 40 and 60 months, will be recruited in the study to serve as a baseline comparator for assessing antibody persistence at these ages. These subjects will receive a two-dose catch-up regimen with rMenB+OMV NZ. Subjects who are enrolled at 40 months of age are offered DTaP/IPV and MMR vaccinations , if they have not already received these vaccines prior to enrollment.

Enrollment: 120 patients

Sex: All

Ages: 40 to 62 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy 40 to 44-months-old children, who participated and completed the study V72P9 (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)

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

4rMenB

Experimental group

Description:

Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study (NCT00433914) and one booster dose of rMenB vaccine at 40 months of age in the present study.

Treatment:

Biological: rMenB

4rMenB+OMV NZ

Experimental group

Description:

Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8months; 2 months after and at 12 months) in parent study (NCT00433914) and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.

Treatment:

Biological: rMenB+OMV NZ

Naive_4042

Experimental group

Description:

Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.

Treatment:

Biological: rMenB+OMV NZ

Naive_6062

Experimental group

Description:

Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.

Treatment:

Biological: rMenB+OMV NZ