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 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Meningococcal Disease Meningococcal Meningitis	Biological: rMenB+OMV NZ with routine vaccinations Biological: rMenB+OMV NZ Biological: two doses of rMenB+OMV NZ	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	A Phase 2b, Open Label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of a Booster Dose of Novartis Meningococcal B Recombinant Vaccine Administered at 12, 18 or 24 Months of Age in Subjects Who Previously Received a Three-Dose Primary Series of the Novartis Meningococcal B Recombinant Vaccine as Infants in Study V72P12

Resource links provided by NLM:

MedlinePlus related topics: Fever Meningitis Meningococcal Infections

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Immunogenicity (SBA titer ), 1 month after booster vaccination at 12 or 18 or 24 months of age (primary immunization with 3 doses of rMenB+OMV NZ and routine concomitant vaccines at 2, 4 and 6 months of age) [ Time Frame: 1 month after booster ] [ Designated as safety issue: Yes ]
Safety and tolerability (body temperature, medically attended fever, use of antipyretics, AEs, solicited local and systemic reactions) of booster dose of rMenB+OMV NZ administered at 12 or 18 or 24 months of age [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Immunogenicity (SBA titer, SBA GMTs), 1 month after booster vaccination at 12 or 18 or 24 months of age (primary immunization with 3 doses of rMenB+OMV NZ at 2, 4 and 6 months of age without concomitant routine vaccines) [ Time Frame: 1 months after booster ] [ Designated as safety issue: Yes ]
Immunogenicity (SBA titer, SBA GMTs), 1 month after booster vaccination at 12 or 18 or 24 months of age (primary immunization with 3 doses of rMenB+OMV NZ and concomitant routine vaccines at 2, 3, 4 months of age) [ Time Frame: 1 months after booster ] [ Designated as safety issue: Yes ]
Bactericidal antibody persistence (SBA GMTs, SBA titer) in 12-, 18- and 24-month-old toddlers previously primed (primary immunization with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age) and in naïve toddlers as control [ Time Frame: 1 months after booster ] [ Designated as safety issue: Yes ]
Immunological memory (SBA GMT) 1 month after booster vaccination at 12 or 18 or 24 months of age AND after a single dose given to naïve subjects at 12 or 18 or 24 months of age [ Time Frame: 1 months after booster ] [ Designated as safety issue: Yes ]
Immunogenicity (SBA titer), safety and tolerability (body temperature, medically attended fever, use of antipyretics, AEs, solicited local and systemic reactions) of a two-dose catch-up regimen in unprimed toddlers aged 12, 18 or 24 months. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment:	1587
Study Start Date:	July 2009
Study Completion Date:	January 2012
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1a	Biological: rMenB+OMV NZ with routine vaccinations rMenB+OMV NZ with routine vaccinations at 2, 4, and 6 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 12 months of age
Experimental: 1b	Biological: rMenB+OMV NZ with routine vaccinations rMenB+OMV NZ with routine vaccinations at 2, 4, and 6 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 18 months of age
Experimental: 2a	Biological: rMenB+OMV NZ rMenB+OMV NZ at 2, 4, and 6 months of age and routine vaccinations at 3, 5 and 7 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 12 months of age
Experimental: 2b	Biological: rMenB+OMV NZ rMenB+OMV NZ at 2, 4, and 6 months of age and routine vaccinations at 3, 5 and 7 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 18 months of age
Experimental: 3a	Biological: rMenB+OMV NZ with routine vaccinations rMenB+OMV NZ with routine vaccinations at 2, 3 and 4 months of age; random allocation in a 1:1:1 ratio to receive 1 booster dose of rMenB+OMV NZ at 12 months of age
Experimental: 3b	Biological: rMenB+OMV NZ with routine vaccinations rMenB+OMV NZ with routine vaccinations at 2, 3 and 4 months of age; random allocation in a 1:1:1 ratio to receive 1 booster dose of rMenB+OMV NZ at 18 months of age
Experimental: 4	Biological: two doses of rMenB+OMV NZ two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age.
Experimental: 1c	Biological: rMenB+OMV NZ with routine vaccinations rMenB+OMV NZ with routine vaccinations at 2, 4, and 6 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 24 months of age
Experimental: 5	Biological: two doses of rMenB+OMV NZ two catch-up doses of rMenB+OMV NZ at 18 and 20 months of age
Experimental: 2c	Biological: rMenB+OMV NZ rMenB+OMV NZ at 2, 4, and 6 months of age and routine vaccinations at 3, 5 and 7 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 24 months of age
Experimental: 6	Biological: two doses of rMenB+OMV NZ two catch-up doses of rMenB+OMV NZ at 24 and 26 months of age
Experimental: 3c	Biological: rMenB+OMV NZ with routine vaccinations rMenB+OMV NZ with routine vaccinations at 2, 3 and 4 months of age; random allocation in a 1:1:1 ratio to receive 1 booster dose of rMenB+OMV NZ at 12 (Group 3a), 18 (Group 3b) or 24 (Group 3c) months of age

Eligibility

Ages Eligible for Study:	12 Months to 24 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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 to38 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00944034

Show 72 Study Locations

Sponsors and Collaborators

Novartis Vaccines

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:	NCT00944034 History of Changes
Other Study ID Numbers:	V72P12E1, 2009-011676-30
Study First Received:	July 21, 2009
Last Updated:	February 26, 2012
Health Authority:	United States: Food and Drug Administration Belgium: Federal Agency for Medicinal Products and Health Products Czech Republic: State Institute for Drug Control Germany: Federal Institute for Drugs and Medical Devices Italy: The Italian Medicines Agency Spain: Spanish Agency of Medicines United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:

Meningococcal meningitis
prevention
vaccination
toddler

Additional relevant MeSH terms:

Meningitis
Meningitis, Meningococcal
Meningococcal Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases

Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on May 19, 2013