Phase 3, Adolescent Large Scale Safety Study

• Register: EUCTR
• Last refreshed on: 27 October 2014
• Main ID: EUCTR2009-015198-11-ES
• Date of registration: 12/01/2012
• Prospective Registration: No
• Primary sponsor: Pfizer Inc, 235 East 42nd Street, New York, NY 10017
• Public title: Phase 3, Adolescent Large Scale Safety Study
• Scientific title: 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
• Date of first enrolment: 15/07/2011
• Target sample size: 7500
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-015198-11
• Study type: Interventional clinical trial of medicinal product
• Study design: 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

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Canada, Chile, Czech Republic, Denmark, Estonia, Finland, Germany, Italy, Lithuania, Netherlands, Poland, Russian Federation, Spain, Sweden, United States

Contacts

• Name: Clinical Trials.gov Call Centre
• Affiliation: Pfizer Inc

• Name: Clinical Trials.gov Call Centre
• Affiliation: Pfizer Inc

Key inclusion & exclusion criteria

Inclusion criteria:
Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator?s study team before subjects are included in the study. 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 Germany: 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

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Bacterial Meningitis
MedDRA version: 14.1 Level: LLT Classification code 10004049 Term: Bacterial meningitis System Organ Class: 10021881 - Infections and infestations

Intervention(s)

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: NA
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 120-
INN or Proposed INN: MnB rLP2086 Subfamily B
CAS Number: NA
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 120-

Trade Name: Havrix Junio Monodose Vaccine
Pharmaceutical Form: Injection
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: EID50/dose 50% Embryo Infective Dose/dose
Concentration type: equal
Concentration number: 720-

Trade Name: Havrix Monodose Vaccine
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: EID50/dose 50% Embryo Infective Dose/dose
Concentration type: equal
Concentration number: 1140-

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-

Primary Outcome(s)

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 ?g rLP2086 vaccine and 85 control subjects).

Primary end point(s): The primary endpoints will be the safety related variables, as measured by adverse events (AEs), and serious adverse events (SAEs).

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.

Timepoint(s) of evaluation of this end point: 14 months after last subject last visit.

Secondary Outcome(s)

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 ?g 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.

Timepoint(s) of evaluation of this end point: 14 months after last subject last visit.

Secondary ID(s)

2009-015198-11-SE

B1971014

Source(s) of Monetary Support

Pfizer Inc