Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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30 March 2015 |
Main ID: |
EUCTR2009-015198-11-DK |
Date of registration:
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15/08/2011 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Phase 3, Adolescent Large Scale Safety Study
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Scientific title:
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A Phase 3, Randomized, Placebo and Active-Control, Observer-Blind Trial to Assess the Safety, Tolerability and Immunogenicity of a Meningococcal Serogroup B Recombinant Lipoprotein (rLP2086) Vaccine Given in Healthy Subjects Aged =11 to <26 Years - B1971014 |
Date of first enrolment:
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15/09/2011 |
Target sample size:
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7500 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-015198-11 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: yes
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Countries of recruitment
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Argentina
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Australia
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Belgium
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Brazil
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Canada
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Chile
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Czech Republic
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Denmark
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Estonia
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Finland
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Germany
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Italy
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Lithuania
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Netherlands
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Poland
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Russian Federation
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Spain
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Sweden
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Turkey
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United States
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Contacts
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Name:
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Clinical Trials.gov Call Centre
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Address:
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235 E 42nd Street
NY 10017
New York
United Kingdom |
Telephone:
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001 8007181021 |
Email:
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ClinicalTrials.govCallCentre@pfizer.com |
Affiliation:
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Pfizer Inc |
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Name:
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Clinical Trials.gov Call Centre
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Address:
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235 E 42nd Street
NY 10017
New York
United Kingdom |
Telephone:
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001 8007181021 |
Email:
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ClinicalTrials.govCallCentre@pfizer.com |
Affiliation:
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Pfizer Inc |
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Key inclusion & exclusion criteria
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Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
1. Evidence of a personally signed and dated informed consent document indicating that
the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
3. Male or female subjects aged =11 and <26 years at time of enrollment.
4. Available for the entire study period and can be reached by telephone.
5. Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
6. Parent/legal guardian and/or subject must be able and willing to complete all relevant study procedures during study participation.
7. All male and female subjects must agree to practice a form of effective contraception,
such as barrier contraception (ie, condom plus spermicide, a female condom, diaphragm, cervical cap or intrauterine device), implants, injectables, combined oral contraceptives or sexual abstinence prior to entering into the study, for the duration of the vaccination period and for 28 days after the last study vaccination. For Denmark: The phrase “sexual abstinence” is not applicable, with the understanding that all male and female subjects of childbearing potential must practice an effective form of contraception during the study.
8. Negative urine pregnancy test for female subjects. Are the trial subjects under 18? yes Number of subjects for this age range: 4103 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 3397 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria: Subjects presenting with any of the following will not be included in the study:
1. Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
2. Subject is a direct descendant (e.g. child, grandchild or other family member) of study
site personnel.
3. Previous vaccination with any meningococcal serogroup B vaccine.
4. Subjects who have received prior HAV vaccination.
5. Contraindication to vaccination with any HAV vaccine.
6. A previous anaphylactic reaction to any vaccine or vaccine-related component.
7. Bleeding diathesis or condition associated with prolonged bleeding time that would
contraindicate intramuscular injection.
8. A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function or those receiving immunosuppressive therapy. Subjects with terminal complement deficiency may be included. Please refer to the SRM additional details.
9. History of culture-proven disease caused by Neisseria meningitidis or Neisseria gonorrhoea.
10. Significant neurological disorder or history of seizure (excluding simple febrile seizure).
11. Receipt of any blood products, including immunoglobulin within 6 months before the
first study vaccination.
12. Current participation in another investigational study. Participation in purely
observational studies is acceptable.
13. Received any investigational drugs or devices within 28 days before administration of
the first study vaccination.
14. Any neuroinflammatory and autoimmune condition, including but not limited to transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
15. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
16. Subject is pregnant or breastfeeding.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Bacterial Meningitis MedDRA version: 14.0
Level: LLT
Classification code 10004049
Term: Bacterial meningitis
System Organ Class: 10021881 - Infections and infestations
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Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
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Intervention(s)
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Product Name: MnB rLP2086 Vaccine Product Code: MnB rLP2086 (PF-05212366) Pharmaceutical Form: Suspension for injection INN or Proposed INN: MnB rLP2086 Subfamily A CAS Number: N/a Current Sponsor code: N/a Other descriptive name: N/a Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 120- INN or Proposed INN: MnB rLP2086 Subfamily B CAS Number: N/a Current Sponsor code: N/a Other descriptive name: N/a Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 120-
Trade Name: Havrix Junior Monodose Vaccine Pharmaceutical Form: Injection INN or Proposed INN: N/a CAS Number: N/a Current Sponsor code: N/a Other descriptive name: N/a Concentration unit: ELISA unit/ml enzyme-linked immunosorbent assay unit/millitre Concentration type: equal Concentration number: 720-
Trade Name: Havrix Monodose Vaccine Pharmaceutical Form: Suspension for injection INN or Proposed INN: N/a CAS Number: N/a Current Sponsor code: N/a Other descriptive name: N/a Concentration unit: ELISA unit/ml enzyme-linked immunosorbent assay unit/millitre Concentration type: equal Concentration number: 1440-
Product Name: Sterile saline solution (0.9%) Pharmaceutical Form: Solution for injection INN or Proposed INN: N/a CAS Number: N/a Current Sponsor code: N/a Other descriptive name: N/a Concentration unit: ml millilitre(s) Concentration type: equal Concentration number: 0.5-
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Primary Outcome(s)
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Main Objective: To evaluate the safety profile of rLP2086 vaccine, as measured by adverse events (AEs), during the 6-month vaccination period and 6-month postdose 3 follow-up.
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Primary end point(s): The primary endpoints will be the safety related variables, as measured by adverse events (AEs), and serious adverse events (SAEs).
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Secondary Objective: To describe the immune response induced by the rLP2086 vaccine as measured by serum bactericidal assays using human complement (hSBAs) performed with MnB strains expressing LP2086 subfamily A and B proteins, measured 1 month after study vaccinations 2 and 3 in a subset of 255 randomly assigned subjects (170 recipients of 120 µg rLP2086 vaccine and 85 control subjects).
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Timepoint(s) of evaluation of this end point: 14 months after last subject last visit.
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Secondary Outcome(s)
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Secondary end point(s): The secondary endpoints will only be applied to the subset of 255 randomly assigned subjects aged 11 to 18 years (170 recipients of 120 µg rLP2086 vaccine and 85 control subjects) who have hSBA tests.
? hSBA titers, as measured by GMTs, for each of the 2 primary strains at each blood draw visit (visits 1, 4 and 6).
? The proportion of subjects with an rLP2086-specific hSBA titer =1:4 for each of the 2 primary strains, measured prior to the first vaccination with rLP2086, 1 month after the second vaccination with rLP2086 vaccine and 1 month after the third vaccination with rLP2086 vaccine.
? The proportion of subjects with an rLP2086-specific hSBA titer =1:4, =1:8, =1:16, =1:32, =1:64, and =1:128 for each of the 2 primary strains at each blood sampling time point.
?The proportion of subjects achieving = 4 fold-rise on rLP2086-specific hSBA titer for each of the 2 primary strains, from prior to the first vaccination (visit 1) to 1 month after the second vaccination with rLP2086 vaccine and from prior to the first vaccination (visit 1) to 1 month after the third vaccination with rLP2086 vaccine.
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Timepoint(s) of evaluation of this end point: 14 months after last subject last visit.
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Secondary ID(s)
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2009-015198-11-SE
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B1971014(6108A1-3003)
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Source(s) of Monetary Support
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Pfizer Inc
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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