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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/NCT01352793
Registration number
NCT01352793
Ethics application status
Date submitted
11/05/2011
Date registered
12/05/2011
Date last updated
11/03/2015
Titles & IDs
Public title
A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years
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Scientific title
A Phase 3, Randomized, Active-controlled, Observer-blinded Trial To Assess The Safety And Tolerability Of A Meningococcal Serogroup B Bivalent Recombinant Lipoprotein (rlp2086) Vaccine Given In Healthy Subjects Aged Greater Than Or Equal To 10 To Less Than 26 Years
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Secondary ID [1]
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2009-015198-11
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Secondary ID [2]
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B1971014
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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 - rLP2086 vaccine
Other interventions - control
Experimental: rLP2086 vaccine - rLP2086 vaccine
Other: control - The control treatment will be HAVRIX vaccine at month 0 and 6 and a normal saline injection at month 2.
Other interventions: rLP2086 vaccine
120 mcg, 3 doses, at month 0, 2, and 6.
Other interventions: control
HAVRIX: 720 EL.U. or 1440 EL.Ul, 2 doses, at month 0 and 6. Placebo: normal saline injection, 1 dose, at month 2.
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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 One Serious Adverse Event (SAE) Throughout the Study
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Assessment method [1]
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An adverse event (AE) was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.
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Timepoint [1]
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Vaccination 1 up to 6 months after Vaccination 3
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Primary outcome [2]
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Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1
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Assessment method [2]
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A medically attended AE was defined as a non-serious AE that required medical attention.
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Timepoint [2]
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Within 30 days after Vaccination 1
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Primary outcome [3]
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Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2
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Assessment method [3]
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A medically attended AE was defined as a non-serious AE that required medical attention.
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Timepoint [3]
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Within 30 days after Vaccination 2
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Primary outcome [4]
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Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3
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Assessment method [4]
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A medically attended AE was defined as a non-serious AE that required medical attention.
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Timepoint [4]
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Within 30 days after Vaccination 3
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Secondary outcome [1]
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Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods
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Assessment method [1]
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An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
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Timepoint [1]
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Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3)
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Secondary outcome [2]
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Percentage of Participants With at Least One Medically Attended Adverse Event During Pre-specified Time Periods
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Assessment method [2]
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A medically attended AE was defined as a non-serious AE that required medical attention.
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Timepoint [2]
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Within 30 days after any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3); throughout study (Vaccination 1 up to 6 months after Vaccination 3)
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Secondary outcome [3]
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Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods
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Assessment method [3]
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A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Newly diagnosed chronic medical condition did not include illnesses considered to be temporary conditions. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
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Timepoint [3]
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Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase(Vaccination 1 up to 1 month after Vaccination 3); follow-up phase(1 month up to 6 months after Vaccination 3); throughout study(Vaccination 1 up to 6 months after Vaccination 3)
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Secondary outcome [4]
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Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods
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Assessment method [4]
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An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
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Timepoint [4]
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Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3)
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Secondary outcome [5]
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Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination
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Assessment method [5]
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An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Any AE that occurred within the first 30 minutes after the administration of study vaccine (bivalent rLP2086, HAV vaccine or saline) was classified as an immediate AE. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
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Timepoint [5]
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Within 30 minutes after Vaccination 1, 2, 3
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Secondary outcome [6]
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Number of Days Participant Missed School or Work Due to Adverse Events (AEs)
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Assessment method [6]
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Timepoint [6]
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Vaccination 1 up to 1 month after Vaccination 3
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Eligibility
Key inclusion criteria
- Healthy subjects aged 10 to 25 years.
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Minimum age
10
Years
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Maximum age
25
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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
- Previous vaccination with Hepatitis A virus vaccine
- Previous vaccination with investigational meningococcal B vaccine
- History of culture-proven N. meningitidis serogroup B disease
- Any neuroinflammatory or autoimmune condition
- Any immune defect that would prevent an effective response to the study vaccine
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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?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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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
1/11/2012
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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
1/09/2014
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Sample size
Target
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Accrual to date
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Final
5715
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
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Recruitment hospital [1]
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Australian Clinical Research Network - Maroubra
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Recruitment hospital [2]
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The Children's Hospital at Westmead - Westmead
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Recruitment hospital [3]
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AusTrials Pty Ltd - Sherwood
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Recruitment hospital [4]
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Vaccinology and Immunology Research Trials Unit (VIRTU), Discipline of Paediatrics - North Adelaide
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Recruitment hospital [5]
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Telethon Institute for Child Health Research - Subiaco
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Recruitment postcode(s) [1]
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2035 - Maroubra
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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4075 - Sherwood
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Recruitment postcode(s) [4]
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5006 - North Adelaide
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Recruitment postcode(s) [5]
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6008 - Subiaco
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Recruitment outside Australia
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United States of America
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State/province [1]
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Alabama
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Arizona
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Arkansas
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California
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Florida
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Indiana
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Iowa
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Ohio
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Tennessee
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Texas
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Utah
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Virginia
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Chile
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Araucania
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Chile
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Chile
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Santiago
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Jindrichuv Hradec
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Plzen
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Aarhus N
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Pori
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Tampere
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Germany
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Debica
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Lubartow
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Oborniki Slaskie
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Poznan
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Torun
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Trzebnica
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Wroclaw
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Spain
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Sevilla
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Spain
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Valencia
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SE
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Sweden
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Umeå
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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
A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to
receive 120 µg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will
receive HAVRIX vaccine at month 0 and 6 and saline at month 2.
All subjects will be followed for 6 months after the last vaccination to assess safety and
tolerability.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01352793
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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 public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01352793
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