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 - Full Text View

Purpose

The proposed study V72P9E1 is an Extension Study of V72P9. 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 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.

Condition	Intervention	Phase
Meningococcal Disease	Biological: Serogroup B meningococcal vaccine	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	A Phase 2, Open-Label, Single-Center, Extension Study Evaluating Antibody Persistence Compared to Naïve Children and Safety, Tolerability and Immunogenicity of a Booster Dose of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received a Three-Dose Series of the Novartis Vaccine as Infants in Study V72P9

Resource links provided by NLM:

MedlinePlus related topics: Meningococcal Infections

Drug Information available for: Lactitol Meningococcal Vaccines

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Bactericidal antibody persistence in children at 40 months of age who received 3 doses of rMenB+/-OMV NZ . Safety and tolerability. [ Time Frame: Individual subject participation either 3 months or 20 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Bactericidal antibody response after a booster dose of rMenB+/-OMV NZ or 2 catch-up doses of rMenB+OMV NZ . Bactericidal antibody persistence in children at 60 months. [ Time Frame: Individual subject participation either 3 months or 20 months ] [ Designated as safety issue: Yes ]

Enrollment:	120
Study Start Date:	February 2010
Study Completion Date:	May 2012
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1	Biological: Serogroup B meningococcal vaccine Subjects will be assigned to a study group based on the group assignment in the parent study (follow-on subjects) or on their age (naïve subjects). They will received one booster doses of the same vaccine they had received in the parent trial (rMenB or rMenB+OMV NZ) or two catch-up doses of rMenB+OMV NZ. To test the antibody response and persistence they will have 2, 3 or 4 blood draws, depending on the study group.
Experimental: Arm 2	Biological: Serogroup B meningococcal vaccine Subjects will be assigned to a study group based on the group assignment in the parent study (follow-on subjects) or on their age (naïve subjects). They will received one booster doses of the same vaccine they had received in the parent trial (rMenB or rMenB+OMV NZ) or two catch-up doses of rMenB+OMV NZ. To test the antibody response and persistence they will have 2, 3 or 4 blood draws, depending on the study group.
Experimental: Arm 3	Biological: Serogroup B meningococcal vaccine Subjects will be assigned to a study group based on the group assignment in the parent study (follow-on subjects) or on their age (naïve subjects). They will received one booster doses of the same vaccine they had received in the parent trial (rMenB or rMenB+OMV NZ) or two catch-up doses of rMenB+OMV NZ. To test the antibody response and persistence they will have 2, 3 or 4 blood draws, depending on the study group.
Experimental: Arm 4	Biological: Serogroup B meningococcal vaccine Subjects will be assigned to a study group based on the group assignment in the parent study (follow-on subjects) or on their age (naïve subjects). They will received one booster doses of the same vaccine they had received in the parent trial (rMenB or rMenB+OMV NZ) or two catch-up doses of rMenB+OMV NZ. To test the antibody response and persistence they will have 2, 3 or 4 blood draws, depending on the study group.

Eligibility

Ages Eligible for Study:	40 Months to 62 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01026974

Locations

United Kingdom
Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital
Oxford, United Kingdom, OX3 7LJ

Sponsors and Collaborators

Novartis Vaccines

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:	NCT01026974 History of Changes
Other Study ID Numbers:	V72P9E1, EUDRACT 2009-013075-21
Study First Received:	December 4, 2009
Last Updated:	June 27, 2012
Health Authority:	United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:

Children
Pre-school
Meningococcal disease
Prevention
Vaccination

Additional relevant MeSH terms:

Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013