Phase 3, Adolescent Large Scale Safety Study

• Register: EUCTR
• Last refreshed on: 10 November 2014
• Main ID: EUCTR2009-015198-11-EE
• Date of registration: 06/06/2011
• Prospective Registration: Yes
• 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, 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 =10 to <26 Years - B1971014
• Date of first enrolment: 18/07/2011
• Target sample size: 5700
• 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

Australia, Chile, Czech Republic, Denmark, Estonia, Finland, Germany, Lithuania, Poland, 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:
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 (and/or a parent/legally authorized representative) has been informed of all pertinent aspects of the study.
2. Parent/legally authorized representative and/or subject who are willing and able to comply with scheduled visits, laboratory tests, and other study procedures.
3. Male or female subjects aged =10 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. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study (through the follow-up telephone contact at month 12). A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active. Refer to Protocol Section 4.4 for further information.
7. Negative urine pregnancy test for all female subjects.
Are the trial subjects under 18? yes
Number of subjects for this age range: 3118
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2582
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. Previous vaccination with any meningococcal serogroup B vaccine.
2. Subjects who have received prior HAV vaccination.
3. Contraindication to vaccination with any HAV vaccine.
4. Subjects receiving any allergen immunotherapy with a non-licensed product or receiving allergen immunotherapy with a licensed product and not on stable maintenance doses.
5. Subjects who are scheduled to receive one or more doses of a human papillomavirus (HPV) vaccination as part of a 3-dose series during the period between Visit 1 and 28 days after the second study vaccination (Visit 3).
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, those receiving chronic systemic (oral, intravenous or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the United States with terminal complement deficiency are excluded from participation in this study. Please refer to the study reference manual (SRM) for additional details.
9. History of microbiologically 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 vaccines, 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.
17. Subjects who are investigational site staff members or relatives of those site staff members, or subjects who are Pfizer employees directly involved in the conduct of the trial or relatives of those Pfizer employees.


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: 16.0 Level: LLT Classification code 10004049 Term: Bacterial meningitis System Organ Class: 100000004862

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: N/a
Current Sponsor code: N/a
Other descriptive name: N/a
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 60-
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: 60-

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-

Primary Outcome(s)

Secondary Objective: To evaluate the safety profile of bivalent rLP2086 vaccine compared to a control (HAV/saline), as measured by AEs, SAEs, newly diagnosed chronic medical conditions, medically attended adverse events and immediate AEs.

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

Primary end point(s): - Percentage of subjects with at least one SAE occurring during the time period from the first study vaccination (Visit 1) through 6 months after last study vaccination (Visit 9).
- Percentage of subjects with at least one medically attended adverse event occurring during the time period within 30 days after each vaccination.

Main Objective: To evaluate the safety of bivalent rLP2086 vaccine compared to a control (hepatitis A virus [HAV] vaccine/saline), as assessed by serious adverse events (SAEs) and medically attended adverse events.

Secondary Outcome(s)

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

Secondary end point(s): Percentage of subjects with at least 1 SAE during the following time periods:
? 30 days after each vaccination
? 30 days after any vaccination
? During the vaccination phase [from the first study vaccination (visit 1) through 1 month after the last study vaccination (visit 8)]
? During the follow-up phase [from one month after the last study vaccination (visit 8) through 6 months after the third study vaccination (visit 9)]

Percentage of subjects with at least one medically attended adverse event occurring during the following time periods:
? 30 days after any vaccination
? During the vaccination phase [from the first study vaccination (visit 1) through 1 month after the last study vaccination (visit 8)]
? During the follow-up phase [from 1 month after the last study vaccination (visit 8) through 6 months after the third study vaccination (visit 9)]
? Throughout the study period [from the first study vaccination (visit 1) through 6 months after the third study vaccination (visit 9)]

Percentage of subjects with at least one newly diagnosed chronic medical condition occurring during the following time periods:
? 30 days after each vaccination
? 30 days after any vaccination
? During the vaccination phase [from the first study vaccination (visit 1) through 1 month after the last study vaccination (visit 8)]
? During the follow-up phase [from one month after the last study vaccination (visit 8) through 6 months after the third study vaccination (visit 9)]
? Throughout the study period [from the first study vaccination (visit 1) through 6 months after the third study vaccination (visit 9)]

Percentage of subjects with at least one adverse event occurring during the following time periods:
? 30 days after each vaccination
? 30 days after any vaccination
? During the vaccination phase [from the first study vaccination (visit 1) through 1 month after the last study vaccination (visit 8)]

Percentage of subjects reporting at least 1 immediate AE after each vaccination

Subject’s days missing school or work due to AEs during the vaccination phase (Visit 1 through Visit 8).

Secondary ID(s)

B1971014(6108A1-3003)

2009-015198-11-SE

Source(s) of Monetary Support

Pfizer Inc