Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
This study has been completed.
Sponsor:
Novartis Vaccines
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
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Purpose
This study is aimed to explore safety and immunogenicity of two formulations of a Meningococcal B Vaccine when administered to healthy infants.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Biological: Serogroup B meningococcal Vaccine |
Phase 2 |
| 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 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 147 |
| Study Start Date: | September 2006 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
"rMenB "Routine vaccinations + Novartis rMenB vaccine 2, 4, 6, and 12 months (rMenB)
|
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.
|
|
Experimental: Group 2
"rMenB + OMV" Routine vaccinations + Novartis rMenB vaccine + OMV NZ 2, 4, 6, and 12 months (rMenB+ OMV)
|
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.
|
|
Experimental: Group 3
"Routine" Routine vaccinations + Novartis rMenB vaccine12 months (rMenB)
|
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.
|
|
Experimental: Group 4
"Routine+OMV" Routine vaccinations + Novartis rMenB vaccine + OMV NZ 12 months (rMenB + OMV)
|
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.
|
Eligibility| Ages Eligible for Study: | 55 Days to 89 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00381615
Locations
| United Kingdom | |
| Gloucester, United Kingdom, GLI 3NN | |
| London, United Kingdom, NW9 5EQ | |
| Oxford, United Kingdom, OX3 7LJ | |
Sponsors and Collaborators
Novartis Vaccines
Investigators
| Study Chair: | Novartis Vaccines - Information Services | Novartis |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Vaccines ) |
| ClinicalTrials.gov Identifier: | NCT00381615 History of Changes |
| Other Study ID Numbers: | V72P6 |
| Study First Received: | September 27, 2006 |
| Last Updated: | January 4, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Novartis:
|
Meningococcal disease prevention vaccination |
ClinicalTrials.gov processed this record on May 23, 2013