Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Vaccines )

ClinicalTrials.gov Identifier:

NCT00381615

First received: September 27, 2006

Last updated: January 4, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 27, 2006

Last Updated Date

January 4, 2012

Start Date ^ICMJE

September 2006

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety, tolerability and Immunogenicity as measured by serum bactericidal activity of the two vaccines [ Time Frame: at one month after completion of immunization schedule ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Safety, tolerabilty and Immunogenicity as measured by serum bactericidal activity of the two vaccines at one month after completion of immunization schedule

Change History

Complete list of historical versions of study NCT00381615 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety, tolerability and Immunogenicity as measured by serum bactericidal activity of the two vaccines at other time points [ Time Frame: 6 months after completion of the immunization schedule ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Safety, tolerabilty and Immunogenicity as measured by serum bactericidal activity of the two vaccines at other time points (i.e.6 months after completion of the immunization schedule)

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title ^ICMJE

A Phase 2, Open Label, Multi-Centre, Controlled, Randomized Study of the Safety, Tolerability and Immunogenicity of Two Different Formulations of Novartis Meningococcal B Vaccine When Administered to Healthy Infants

Brief Summary

This study is aimed to explore safety and immunogenicity of two formulations of a Meningococcal B Vaccine when administered to healthy infants.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Biological: Serogroup B meningococcal Vaccine

In this study, healthy infants aged 2 months at enrollment time were randomized in a 2:2:1:1 ratio to receive either 4 doses of Novartis Meningococcal Recombinant Vaccine +/- OMV according to a 2, 4, 6, 12-month schedule or a single dose of Novartis Meningococcal Recombinant Vaccine +/- OMV at 12 months of age. Novartis Meningococcal Recombinant Vaccine +/- OMV is supplied in a pre-filled syringe, 0.5 mL dose.

Study Arm (s)

Experimental: Group 1
"rMenB "Routine vaccinations + Novartis rMenB vaccine 2, 4, 6, and 12 months (rMenB)

Intervention: Biological: Serogroup B meningococcal Vaccine
Experimental: Group 2
"rMenB + OMV" Routine vaccinations + Novartis rMenB vaccine + OMV NZ 2, 4, 6, and 12 months (rMenB+ OMV)

Intervention: Biological: Serogroup B meningococcal Vaccine
Experimental: Group 3
"Routine" Routine vaccinations + Novartis rMenB vaccine12 months (rMenB)

Intervention: Biological: Serogroup B meningococcal Vaccine
Experimental: Group 4
"Routine+OMV" Routine vaccinations + Novartis rMenB vaccine + OMV NZ 12 months (rMenB + OMV)

Intervention: Biological: Serogroup B meningococcal Vaccine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

147

Completion Date

August 2008

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

healthy 2-month old infants (55-89 days, inclusive)

Exclusion Criteria:

previous receipt of any meningococcal B vaccine
previous ascertained or suspected disease caused by N. meningitidis
history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component
any present or suspected serious acute or chronic disease
known or suspected autoimmune disease or impairment /alteration of immune function

Gender

Both

Ages

55 Days to 89 Days

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00381615

Other Study ID Numbers ^ICMJE

V72P6

Has Data Monitoring Committee

Responsible Party

Novartis ( Novartis Vaccines )

Study Sponsor ^ICMJE

Novartis Vaccines

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Novartis Vaccines - Information Services

Novartis

Information Provided By

Novartis

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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