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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
2009-015198-11
Secondary ID [2] 0 0
B1971014
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Meningitis, Meningococcal 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
Treatment: Other - rLP2086 vaccine
Treatment: Other - 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.


Treatment: Other: rLP2086 vaccine
120 mcg, 3 doses, at month 0, 2, and 6.

Treatment: Other: 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.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Study
Timepoint [1] 0 0
Vaccination 1 up to 6 months after Vaccination 3
Primary outcome [2] 0 0
Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1
Timepoint [2] 0 0
Within 30 days after Vaccination 1
Primary outcome [3] 0 0
Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2
Timepoint [3] 0 0
Within 30 days after Vaccination 2
Primary outcome [4] 0 0
Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3
Timepoint [4] 0 0
Within 30 days after Vaccination 3
Secondary outcome [1] 0 0
Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods
Timepoint [1] 0 0
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)
Secondary outcome [2] 0 0
Percentage of Participants With at Least One Medically Attended Adverse Event During Pre-specified Time Periods
Timepoint [2] 0 0
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)
Secondary outcome [3] 0 0
Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods
Timepoint [3] 0 0
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)
Secondary outcome [4] 0 0
Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods
Timepoint [4] 0 0
Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3)
Secondary outcome [5] 0 0
Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination
Timepoint [5] 0 0
Within 30 minutes after Vaccination 1, 2, 3
Secondary outcome [6] 0 0
Number of Days Participant Missed School or Work Due to Adverse Events (AEs)
Timepoint [6] 0 0
Vaccination 1 up to 1 month after Vaccination 3

Eligibility
Key inclusion criteria
* Healthy subjects aged 10 to 25 years.
Minimum age
10 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

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
1/11/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2014
Sample size
Target
Accrual to date
Final
5715
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
Australian Clinical Research Network - Maroubra
Recruitment hospital [2] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [3] 0 0
AusTrials Pty Ltd - Sherwood
Recruitment hospital [4] 0 0
Vaccinology and Immunology Research Trials Unit (VIRTU), Discipline of Paediatrics - North Adelaide
Recruitment hospital [5] 0 0
Telethon Institute for Child Health Research - Subiaco
Recruitment postcode(s) [1] 0 0
2035 - Maroubra
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4075 - Sherwood
Recruitment postcode(s) [4] 0 0
5006 - North Adelaide
Recruitment postcode(s) [5] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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United States of America
State/province [3] 0 0
Arkansas
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United States of America
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California
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Florida
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Indiana
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Iowa
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Kentucky
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Nebraska
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New York
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Ohio
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South Carolina
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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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Region Metropolitana
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Chile
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Santiago
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Czech Republic
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Jindrichuv Hradec
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Czech Republic
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Plzen
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Czech Republic
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Praha 2
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Czech Republic
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Tynec nad Sazavou
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Denmark
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Aarhus N
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Estonia
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Rakvere
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Estonia
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Tallinn
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Pori
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Tampere
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Turku
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Germany
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Hamburg
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Germany
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Wuerzburg
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Lithuania
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Kaunas
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Lithuania
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Vilnius
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Poland
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Debica
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Krakow
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Lubartow
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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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Sevilla
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Spain
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Valencia
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Sweden
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SE
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Sweden
State/province [46] 0 0
Umeå

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01352793
Trial related presentations / publications
Beeslaar J, Mather S, Absalon J, Eiden JJ, York LJ, Crowther G, Maansson R, Maguire JD, Peyrani P, Perez JL. Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older. Vaccine. 2022 Mar 15;40(12):1872-1878. doi: 10.1016/j.vaccine.2022.01.046. Epub 2022 Feb 11.
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01352793