Safety and Immunogenicity of Novartis Meningococcal B Vaccine Formulated With OMV Manufactured at Two Different Sites, in Healthy Adolescents Aged 11-17 Years
This study has been completed.
Sponsor:
Novartis
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01423084
First received: August 23, 2011
Last updated: January 12, 2012
Last verified: January 2012
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Purpose
The primary objective of this study is to demonstrate the equivalence of rMenB+OMV NZ lot 1 to rMenB+OMV NZ lot 2 when administered to adolescents, as measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs) against 3 N. meningitidis serogroup B reference strains (H44/76, 5/99, and NZ98/254) and as measured by ELISA geometric mean concentrations (GMCs) against vaccine antigen 287-953, approximately 30 days after a primary vaccination course of two doses administered one month apart.
| Condition | Intervention | Phase |
|---|---|---|
|
Meningococcal Disease Meningococcal Meningitis |
Biological: Serogroup B meningococcal vaccine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | A Phase 3, Randomized, Comparative, Multicenter Observer-Blind Study Evaluating the Safety and Immunogenicity of Novartis Meningococcal B Vaccine Formulated With OMV Manufactured at Two Different Sites, in Healthy Adolescents Aged 11-17 Years |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Consistency of two lots of rMenB+OMV NZ [ Time Frame: one month after the second vaccination ] [ Designated as safety issue: No ]Consistency of the immune response of the two lots of rMenB+OMV NZ will be assessed at one month after the second vaccination based on the ratio of the vaccine lot hSBA GMTs for each of three serogroup B reference strains (H44/76, 5/99, and NZ98/254) and based on the ratio of ELISA GMCs for vaccine antigen 287-953. The equivalence interval will be (0.5, 2.0).
Secondary Outcome Measures:
- Percentage of subjects in each lot with hSBA ≥ 5 [ Time Frame: one month after the second vaccination ] [ Designated as safety issue: No ]The percentage of subjects in each lot with hSBA ≥ 5 at one month after the second vaccination for each of the three reference strains (H44/76, 5/99, and NZ98/254) for each vaccine group
- Geometric mean titer (GMT) of human Serum Bactericidal Assay (hSBA) and geometric mean ratio (GMR) [ Time Frame: at 1 month and 2 weeks after the second vaccination ] [ Designated as safety issue: No ]The hSBA GMT increase (post-vaccination to pre-vaccination geometric mean ratio [GMR]) and associated two-sided 95% CI at each time point for each of the three N. meningitidis serogroup B reference strains and for each vaccine group.
- ELISA Geometric Mean concentration (GMC) [ Time Frame: at 1 month and 2 weeks after the second vaccination ] [ Designated as safety issue: No ]The ELISA GMC increase (post-vaccination to pre-vaccination GMR) and associated two-sided 95% CI at each time point for vaccine antigen 287-953 and for each vaccine group
- Percentage of subjects with hSBA GMT in a subset for B strains [ Time Frame: at two weeks after second vaccination ] [ Designated as safety issue: No ]The hSBA GMT and associated two-sided 95% CI at two weeks after the second vaccination in a subset of approximately 160 subjects (approximately 80 per lot) for each of three N. meningitidis serogroup B reference strains (H44/76, 5/99, and NZ98/254) and for each vaccine group.
- ELISA GMC in a subset against antigen 287-953 [ Time Frame: at two weeks after the second vaccination ] [ Designated as safety issue: No ]The ELISA GMC and associated two-sided 95% CI at two weeks after the second vaccination in a subset of approximately 160 subjects (approximately 80 per lot) for vaccine antigen 287-953 for each vaccine group.
- Percentage of subjects with hSBA ≥ 5 in a subset against B strain [ Time Frame: at 2 weeks after the second vaccination ] [ Designated as safety issue: No ]The percentage of subjects with hSBA ≥ 5 at 2 weeks after the second vaccination in a subset of approximately 160 subjects (80 per lot) for each N. meningitidis serogroup B reference strain and vaccine group.
- Number of subjects with solicited local and systemic reactions [ Time Frame: 7 days post vaccination ] [ Designated as safety issue: Yes ]Local (i.e., injection site pain, erythema, swelling, induration) and systemic (i.e., fever [axillary temperature ≥ 38.0 °C], nausea, fatigue, myalgia, arthralgia, headache) reactions will be assessed for 7 days (including the day of vaccination) post each vaccination. SAEs, medically attended AEs and AEs that result in a subject's withdrawal from the study will be collected throughout the study period.
| Enrollment: | 344 |
| Study Start Date: | August 2011 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: MenB Lot 1
MenB vaccine Lot 1: 2 doses administered 1 month apart
|
Biological: Serogroup B meningococcal vaccine
All subjects will receive two rMenB+OMV NZ vaccinations one month apart and will be followed for a total of 2 months. Subjects will be randomized to 1 of 2 treatment arms to receive either two doses of rMenB+OMV NZ vaccine Lot 1 or 2 doses of rMenB+OMV NZ Lot 2. A total of 2 blood samples will be collected (at the first vaccination and 1 month after the 2nd vaccination). An additional blood draw will be collected in a subset of approximately 160 subjects (approximately 80 subjects in Group 1 and approximately 80 subjects in Group 2) at 2 weeks after the second vaccination |
|
Active Comparator: MenB Lot 2
MenB vaccine Lot 2: 2 doses administered 1 month apart
|
Biological: Serogroup B meningococcal vaccine
All subjects will receive two rMenB+OMV NZ vaccinations one month apart and will be followed for a total of 2 months. Subjects will be randomized to 1 of 2 treatment arms to receive either two doses of rMenB+OMV NZ vaccine Lot 1 or 2 doses of rMenB+OMV NZ Lot 2. A total of 2 blood samples will be collected (at the first vaccination and 1 month after the 2nd vaccination). An additional blood draw will be collected in a subset of approximately 160 subjects (approximately 80 subjects in Group 1 and approximately 80 subjects in Group 2) at 2 weeks after the second vaccination |
Detailed Description:
Novartis will consider this study a success if, at one month following the second vaccination, the two-sided 95% CI of the ratio of the hSBA GMTs for each of 3 serogroup B reference strains (H44/76, 5/99, and NZ98/254) and the two-sided 95% CI of the ratio of the ELISA GMCs against vaccine antigen 287-953 are contained within the interval (0.5, 2.0).
Eligibility| Ages Eligible for Study: | 11 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Male and female subjects (11-17 years of age inclusive) who have given their written assent and whose parents or legal guardians have given written informed consent at the time of enrollment
- who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period)
- in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
Exclusion Criteria:
- History of any serogroup B meningococcal vaccination
- Current or previous, confirmed or suspected disease caused by N. meningitidis
- Exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment
- Significant acute or chronic infection within the previous 7 days or fever (defined as axillary temperature ≥ 38.0 °C) within the previous day
- Antibiotic use within 3 days (72 hours) prior to enrollment
- Pregnancy or nursing (breastfeeding) mothers
- Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the 2 months duration of the study. If sexually active the subject must have been using one of the accepted birth control methods for at least 30 days prior to study entry
- Any serious chronic or progressive disease, Known or suspected impairment/alteration of the immune system
- Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days
- History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01423084
Locations
| Australia, Queensland | |
| Royal Children's Hospital | |
| Herston, Queensland, Australia, 4029 | |
| AusTrials Pty Ltd-Suites 6, 10 & 11, Peninsula Specialist Centre | |
| Kippa-Ring, Queensland, Australia, 4021 | |
| AusTrials Pty Ltd-Suite 5, Level 1, 14 Primrose Street | |
| Sherwood, Queensland, Australia, 4075 | |
| Australia, South Australia | |
| Women's and Children's Hospital | |
| 72 King William Road-North Adelaide, South Australia, Australia, 5006 | |
| Australia, Victoria | |
| Murdoch Children's Research Institute-Level 5 | |
| 207 Bouverie St-University of Melbourne, Victoria, Australia, 3010 | |
| Australia, Western Australia | |
| Telethon Institute for Child Heath Research-cnr | |
| Hamilton Street and Roberts Road-Subiaco, Western Australia, Australia, 6008 | |
| Canada, British Columbia | |
| TASC Research Services | |
| 1-15243 91st Avenue-Surrey, British Columbia, Canada, V3R 8P8 | |
| Canada, Nova Scotia | |
| Colchester Regional Hospital Colchester Research Group | |
| 68 Robie Street Truro, Nova Scotia, Canada, B2N 1L2 | |
| Canada, Ontario | |
| Albion Finch Medical Centre | |
| 1620 Albion Road, Suite 106-Etobicoke, Ontario, Canada, M9V 4B4 | |
| SKDS Research Inc | |
| 221-679 Davis Dr.Newmarket, Ontario, Canada, L3Y 5G8 | |
| Medicor Research Inc | |
| 359 Riverside, Suite 200 -Sudbury, Ontario, Canada, P3E 1H5 | |
| Devonshire Clinical Research INC | |
| 423 Devonshire Ave., Suite 301-Woodstock, Ontario, Canada, N4S 5P5 | |
| Garfield Hartley MD | |
| 790 Bay Street, Suite 540 Toronto, Ontario, Canada, M5G 1N8 | |
Sponsors and Collaborators
Novartis
Novartis Vaccines
More Information
No publications provided
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT01423084 History of Changes |
| Other Study ID Numbers: | V72_41 |
| Study First Received: | August 23, 2011 |
| Last Updated: | January 12, 2012 |
| Health Authority: | Canada: Health Canada Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by Novartis:
|
Meningococcal Meningitis prevention, vaccination adolescents |
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 23, 2013