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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00808028
Registration number
NCT00808028
Ethics application status
Date submitted
12/12/2008
Date registered
15/12/2008
Date last updated
14/04/2015
Titles & IDs
Public title
A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents
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Scientific title
A Randomized, Single-blind, Placebo-controlled, Phase 2 Trial Of The Safety, Immunogenicity, And Tolerability Of Meningococcal Serogroup B (Mnb) Rlp2086 Vaccine At Doses Of 60 Mug, 120 Mug, And 200 Mug In Healthy Adolescents Aged 11 To 18 Years
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Secondary ID [1]
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B1971005
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Secondary ID [2]
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6108A1-2001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Meningitis, Meningococcal
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Condition category
Condition code
Infection
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Other infectious diseases
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Infection
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Studies of infection and infectious agents
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - meningococcal B rLP2086 vaccine.
Other interventions - meningococcal B rLP2086 vaccine.
Other interventions - meningococcal B rLP2086 vaccine.
Other interventions - normal saline (placebo)
Experimental: 1 - dose level 1 rLP2086 vaccine
Experimental: 2 - dose level 2 rLP2086 vaccine
Experimental: 3 - dose level 3 rLP2086 vaccine
Placebo Comparator: 4 - normal saline (placebo)
Other interventions: meningococcal B rLP2086 vaccine.
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
Other interventions: meningococcal B rLP2086 vaccine.
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
Other interventions: meningococcal B rLP2086 vaccine.
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
Other interventions: normal saline (placebo)
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2
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Assessment method [1]
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Timepoint [1]
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Before vaccination 1 up to 1 month after vaccination 2
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Primary outcome [2]
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Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3
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Assessment method [2]
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Timepoint [2]
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Before vaccination 1 up to 1 month after vaccination 3
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Primary outcome [3]
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Percentage of Participants With Atleast One Adverse Event (AE): Stage 1
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Assessment method [3]
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Timepoint [3]
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Vaccination 1 upto 1 Month after vaccination 3
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Primary outcome [4]
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Percentage of Participants With Atleast One Adverse Event (AE): Stage 2
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Assessment method [4]
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Timepoint [4]
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6 month after vaccination 3 up to 48 months
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Secondary outcome [1]
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Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level
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Assessment method [1]
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Timepoint [1]
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1 month before vaccination 1, 1 month after vaccination 2, 3
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Eligibility
Key inclusion criteria
- Healthy male or female subjects between the ages of >=11 and <=18 years at the time of
enrollment.
- Negative urine pregnancy test for all female subjects.
- Parent/legal guardian or subject under supervision of the parent/legal guardian must
be able to complete all relevant study procedures during study participation.
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Minimum age
11
Years
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Maximum age
18
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- History of any invasive meningococcal disease.
- A previous anaphylactic or severe vaccine-associated adverse reaction.
- Any clinically significant chronic disease.
- A known or suspected disease of the immune system or those receiving immunosuppressive
therapy, including systemic corticosteroids. Topical, inhaled or intra-articular
corticosteroids are allowed.
- Participation in another investigational study in the 1-month (30-day) period before
study visit 1 and during the conduct of the study.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2014
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Sample size
Target
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Accrual to date
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Final
538
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
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Recruitment hospital [1]
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Queensland Paediatric Infectious Diseases (QPID) Laboratory - Herston
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Recruitment hospital [2]
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Department of Paediatrics, Women's & Children's Hospital - North Adelaide
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Recruitment hospital [3]
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Royal Children's Hospital - Carlton
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Recruitment hospital [4]
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Children's Clinical Research Facility, Vaccine Trials Group (VTG), - Subiaco
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Recruitment postcode(s) [1]
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4029 - Herston
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Recruitment postcode(s) [2]
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5006 - North Adelaide
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Recruitment postcode(s) [3]
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3053 - Carlton
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Recruitment postcode(s) [4]
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6008 - Subiaco
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Recruitment outside Australia
Country [1]
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Poland
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Debica
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Poland
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Krakow
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Poland
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Leczna
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Lodz
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Lubartow
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Lublin
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Melno
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Oborniki Slaskie
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Poznan
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Siemianowice Slaskie
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Torun
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Trzebnica
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Wroclaw
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Spain
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La Coruna
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Spain
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Madrid
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Spain
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Pontevedra
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Spain
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Almeria
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Spain
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Barcelona
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Spain
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Valencia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the safety and immunogenicity of an investigational
meningococcal B rLP2086 vaccine in adolescents aged 11 to 18 years old.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00808028
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00808028
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