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

Novartis

Status and phase: Completed; Phase 3

Conditions: Meningococcal Disease

Treatments: Biological: 4b - rMenB+OMV NZ and routine vaccines; Biological: 2b - rMenB+OMV NZ and routine vaccines; Biological: 2a - Routine and rMenB+OMV NZ vaccines; Biological: 1b - rMenB+OMV NZ and routine vaccines; Biological: 3a - rMenB+OMV NZ and routine vaccines; Biological: 1a - 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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00847145

2008-006301-17 (EudraCT Number)

V72P13E1

Details and patient eligibility

About

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

Enrollment: 2,249 patients

Sex: All

Ages: 365 to 394 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy 12-month-old toddlers (0/ +29 days) who completed Study V72P13

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 to enrollment.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,249 participants in 8 patient groups

12B12M (1a)

Experimental group

Description:

Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.

Treatment:

Biological: 1a - rMenB+OMV NZ and routine vaccines

12B13M (1b)

Experimental group

Description:

Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.

Treatment:

Biological: 1b - rMenB+OMV NZ and routine vaccines

12M13B15B (2a)

Experimental group

Description:

Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.

Treatment:

Biological: 2a - Routine and rMenB+OMV NZ vaccines

12M12B14B (2b)

Experimental group

Description:

Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.

Treatment:

Biological: 2b - rMenB+OMV NZ and routine vaccines

12B12M (3a)

Experimental group

Description:

Previously in the parent study subjects had received three doses of rMenB+OMV NZ at 2, 4 and 6 months of age respectively. These subjects had received one booster (fourth) dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.

Treatment:

Biological: 3a - rMenB+OMV NZ and routine vaccines

12B13M (3b)

Experimental group

Description:

Previously in the present study subjects had received three doses of rMenB+OMV NZ at 12 months of age respectively. These subjects one booster (fourth) dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.

Treatment:

Biological: 3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinations

12B12M_C (4a)

Experimental group

Description:

Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.

Treatment:

Biological: 4a- rMenB+OMV NZ and routine vaccines

12B13M_C (4b)

Experimental group

Description:

Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose o rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.

Treatment:

Biological: 4b - rMenB+OMV NZ and routine vaccines