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

Novartis

Status and phase: Completed; Phase 2

Conditions: Meningococcal Disease

Treatments: Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine.; Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine, without Outer Membrane Vesicles (OMV)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01027351

V72P6E1

EUDRACT 2009-013054-33

Details and patient eligibility

About

The proposed study V72P6E1 is an Extension Study of V72P6 (NCT00381615). The objectives of this extension study will be to explore antibody persistence at approximately 40 months of age and to evaluate the safety, tolerability and immunogenicity of booster doses 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: 163 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 V72P6 (NCT00381615; 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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163 participants in 6 patient groups

5rMenB

Experimental group

Description:

Subjects who had received four doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, without Outer Membrane Vesicles (OMV) (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of the same vaccine, at 40 months of age in the present study.

Treatment:

Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine, without Outer Membrane Vesicles (OMV)

5rMenB+OMV NZ

Experimental group

Description:

Subjects who had received four doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of the same vaccine, at 40 months of age in the present study.

Treatment:

Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine.

3rMenB

Experimental group

Description:

Subjects who had previously received one dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine without OMV (at 12 months of age) were administered two doses of the same vaccine, at 40 and 42 months of age in the present study.

Treatment:

Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine, without Outer Membrane Vesicles (OMV)

3rMenB+OMV NZ

Experimental group

Description:

Subjects who had previously received one dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine (at 12 months of age) were administered two doses of the same vaccine, at 40 and 42 months of age in the present study.

Treatment:

Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine.

Naive_4042

Experimental group

Description:

Vaccine-naive subjects who received two catch-up doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 40 and 42 months of age in the present study.

Treatment:

Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine.

Naive_6062

Experimental group

Description:

Vaccine-naive subjects who received two catch-up doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 60 and 62 months of age in the present study.

Treatment:

Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine.