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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01423084




Registration number
NCT01423084
Ethics application status
Date submitted
23/08/2011
Date registered
25/08/2011
Date last updated
20/02/2015

Titles & IDs
Public title
Safety and Immunogenicity of Novartis Meningococcal B Vaccine Formulated With OMV Manufactured at Two Different Sites, in Healthy Adolescents Aged 11-17 Years
Scientific 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
Secondary ID [1] 0 0
V72_41
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Meningococcal Disease 0 0
Meningococcal Meningitis 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Serogroup B meningococcal vaccine

Experimental: MenB Lot 1 - MenB vaccine Lot 1: 2 doses administered 1 month apart

Active Comparator: MenB Lot 2 - MenB vaccine Lot 2: 2 doses administered 1 month apart


Other interventions: 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 two 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

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against 3 Neisseria.Meningitidis (N. Meningitidis) Serogroup B Reference Strains. - 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 Enzyme-linked Immunosorbent Assay (ELISA) GMCs for vaccine antigen 287-953. The equivalence interval will be (0.5, 2.0).
Timepoint [1] 0 0
One month after the second vaccination (day 61)
Primary outcome [2] 0 0
ELISA Geometric Mean Concentration (GMCs) Against Vaccine Antigen 287-953 - The immune response of two different lots of rMenB+OMV NZ is evaluated in terms of ELISA GMCs against vaccine antigen 287-953.
Timepoint [2] 0 0
One month after the second vaccination (day 61)
Secondary outcome [1] 0 0
Percentage of Subjects in Each Lot With hSBA = 1:5 - The percentage of subjects in each lot with hSBA = 1:5 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
Timepoint [1] 0 0
One month after the second vaccination (day 61)
Secondary outcome [2] 0 0
Geometric Mean Ratio (GMR) of GMTs Against Each of N. Meningitidis Serogroup B Reference Strains. - The immune response of two different lots of rMenB+OMV NZ against each of N. meningitidis serogroup B test strains is evaluated in terms of GMR between GMTs (1month after the second vaccination vs baseline).
Timepoint [2] 0 0
One month after the second vaccination (day 61)
Secondary outcome [3] 0 0
Geometric Mean Ratio (GMR) of ELISA Geometric Mean Concentration (GMCs) Against Antigen 287-953 - The immune response of two different lots of rMenB+OMV NZ against antigen 287-953 is evaluated in terms of GMRs between ELISA GMCs (day 61 vs baseline).
Timepoint [3] 0 0
One month after the second vaccination (day 61)
Secondary outcome [4] 0 0
hSBA GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45. - The immunogenicity of two different lots of rMenB+OMV NZ is evaluated in terms of hSBA GMT against 3 N. Meningitidis serogroup B reference strains at two weeks after last vaccination.
Timepoint [4] 0 0
Two weeks after the second vaccination (day 45)
Secondary outcome [5] 0 0
GMRs of GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45. - The immunogenicity of two different lots of rMenB+OMV NZ is evaluated in terms of GMRs of GMT against 3 N.
meningitidis serogroup B reference strains at two weeks after last vaccination.
Timepoint [5] 0 0
Two weeks after the second vaccination (day 45)
Secondary outcome [6] 0 0
Percentage of Subjects With hSBA =1:5 Against Each of N. Meningitidis Serogroup B Reference Strains at Day 45. - The immune response of two different lots of rMenB+OMV NZ against each of N. Meningitidis serogroup B reference strains is evaluated in terms of percentages of subjects with hSBA =1:5 two weeks after the last vaccination.
Timepoint [6] 0 0
Two weeks after the second vaccination (day 45)
Secondary outcome [7] 0 0
ELISA GMCs Against Vaccine Antigen 287-953 at Day 45. - The immune response of two different lots of rMenB+OMV NZ is evaluated in terms of ELISA GMCs against vaccine antigen 287-953.
Timepoint [7] 0 0
Two weeks after the second vaccination (day 45)
Secondary outcome [8] 0 0
GMR of ELISA GMCs Against Antigen 287-953 at Day 45. - The immune response of two different lots of rMenB+OMV NZ against antigen 287-953 is evaluated in terms of GMRs between ELISA GMCs (day 45 vs baseline).
Timepoint [8] 0 0
Two weeks after the second vaccination (day 45)
Secondary outcome [9] 0 0
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) - Number of subjects reporting solicited local and systemic Adverse Events and other indicators of reactogenicity after any vaccination.
Timepoint [9] 0 0
From day 1 to day 7 after any vaccination
Secondary outcome [10] 0 0
Number of Subjects Reporting Unsolicited AEs - Number of subjects reporting any Unsolicited AEs after any vaccination.
Timepoint [10] 0 0
From day 1 to day 7 after any vaccination.
Secondary outcome [11] 0 0
Number of Subjects Reporting SAEs and AE Leading to Withdrawal - Number of subjects reporting any Serious AEs (SAEs), medically attended AEs and AEs that result in a subject's withdrawal from the study after any vaccination.
Timepoint [11] 0 0
Throughout the study period.

Eligibility
Key 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.
Minimum age
11 Years
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Children's Hospital - Herston
Recruitment hospital [2] 0 0
AusTrials Pty Ltd-Suites 6, 10 & 11, Peninsula Specialist Centre - Kippa-Ring
Recruitment hospital [3] 0 0
AusTrials Pty Ltd-Suite 5, Level 1, 14 Primrose Street - Sherwood
Recruitment hospital [4] 0 0
Women's and Children's Hospital, 72 King William Road - North Adelaide
Recruitment hospital [5] 0 0
Murdoch Children's Research Institute-Level 5, 207 Bouverie St-University of Melbourne - Melbourne
Recruitment hospital [6] 0 0
Telethon Institute for Child Heath Research-cnr - Hamilton Street and Roberts Road-Subiaco
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
4021 - Kippa-Ring
Recruitment postcode(s) [3] 0 0
4075 - Sherwood
Recruitment postcode(s) [4] 0 0
5006 - North Adelaide
Recruitment postcode(s) [5] 0 0
3010 - Melbourne
Recruitment postcode(s) [6] 0 0
6008 - Hamilton Street and Roberts Road-Subiaco
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
British Columbia
Country [2] 0 0
Canada
State/province [2] 0 0
Nova Scotia
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Novartis Vaccines
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01423084
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications