Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered as Booster Dose at 12, 18 or 24 Months of Age in Toddlers (12-24 Months) Primed With a Three-Dose Immunization Series as Infants in Study V72P12

Novartis

Status and phase

Completed

Phase 3

Phase 2

Conditions

Meningococcal Meningitis

Meningococcal Disease

Treatments

Biological: two doses of rMenB+OMV NZ

Biological: rMenB+OMV NZ

Biological: rMenB+OMV NZ with routine vaccinations

Study type

Interventional

Funder types

Industry

Identifiers

NCT00944034

2009-011676-30

V72P12E1

Details and patient eligibility

About

This extension study V72P12E1 will investigate the safety, tolerability and immunogenicity of a fourth (booster) dose of rMenB+OMV NZ at 12, 18 and 24 months of age in subjects previously primed with rMenB+OMV NZ according to two different three-dose immunization schedules in infancy (2, 4 and 6 or 2, 3 and 4 months of age in the parent study V72P12). The study will also explore the bactericidal antibody persistence at 12, 18 and 24 months of age, following the two different immunization schedules, in order to identify the optimal timing for boosting. Two catch-up rMenB+OMV NZ doses will be given to unprimed, naïve toddlers at 12 (subjects enrolled in the control group of V72P12), 18 and 24 months of age (two new cohort of subjects enrolled). These subjects will generate data for assessing the safety and immunogenicity of a two-dose catch-up regimen at these ages, but will also serve as controls for a descriptive comparison of antibody persistence and booster responses for the other groups.

Enrollment

1,588 patients

Sex

All

Ages

12 to 24 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Follow-on participants of V72P12:

Healthy toddlers who completed Study V72P12, aged:

12 months or older - Groups 1a, 2a, 3a, 4
18 months (0/ +29 days window) - Groups 1b, 2b, 3b
24 months (0/ +29 days window) - Groups 1c, 2c, 3c

Naive subjects newly enrolled:

Group 5: healthy 18-month-old toddlers (0/ +29 days window)
Group 6: healthy 24-month-old toddlers (0/ +29 days window)

Exclusion criteria

History of any meningococcal B vaccine administration (only for groups 5 and 6);
Previous ascertained or suspected disease caused by N. meningitidis;
History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
Significant acute or chronic infection within the previous 7 days or axillary temperature major or equal to 38 degrees within the previous day
Antibiotics within 6 days prior to enrollment;
Any serious chronic or progressive disease;
Known or suspected impairment or alteration of the immune system;
Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,588 participants in 12 patient groups

B+R246_12

Experimental group

Description:

Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.

Treatment:

Biological: rMenB+OMV NZ with routine vaccinations

B+R246_18

Experimental group

Description:

Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.

Treatment:

Biological: rMenB+OMV NZ with routine vaccinations

B+R246_24

Experimental group

Description:

Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.

Treatment:

Biological: rMenB+OMV NZ with routine vaccinations

B246_12

Experimental group

Description:

Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.

Treatment:

Biological: rMenB+OMV NZ

B246_18

Experimental group

Description:

Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.

Treatment:

Biological: rMenB+OMV NZ

B246_24

Experimental group

Description:

Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.

Treatment:

Biological: rMenB+OMV NZ

B+R234_12

Experimental group

Description:

Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.

Treatment:

Biological: rMenB+OMV NZ with routine vaccinations

B+R234_18

Experimental group

Description:

Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.

Treatment:

Biological: rMenB+OMV NZ with routine vaccinations

B+R234_24

Experimental group

Description:

Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.

Treatment:

Biological: rMenB+OMV NZ with routine vaccinations

B12 14

Experimental group

Description:

Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.

Treatment:

Biological: two doses of rMenB+OMV NZ

B18 20

Experimental group

Description:

Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.