A Large Global Study to Investigate the Safety of an experimental vaccine against meningococcal type B disease in Adolescents and Young Adults

• Register: EUCTR
• Last refreshed on: 27 October 2014
• Main ID: EUCTR2009-015198-11-LT
• Date of registration: 02/06/2011
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc.
• Public title: A Large Global Study to Investigate the Safety of an experimental vaccine against meningococcal type B disease in Adolescents and Young Adults
• Scientific title: A Phase 3, Randomized, Active-Control, 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: 14/10/2011
• 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, treatment plan, 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 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 vaccin.
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

Prevention of Bacterial Meningitis
MedDRA version: 17.0 Level: LLT Classification code 10051594 Term: Infectious disease prophylaxis NOS System Organ Class: 100000004865

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

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: 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: Inactivated hepatitis A virus
CAS Number: N/a
Current Sponsor code: N/a
Other descriptive name: Inactivated hepatitis A virus
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: Inactivated hepatitis A virus
CAS Number: N/a
Current Sponsor code: N/a
Other descriptive name: Inactivated hepatitis A virus
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

Primary Outcome(s)

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.

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

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

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.

Secondary Outcome(s)

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)]
- 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).

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

Secondary ID(s)

2009-015198-11-SE

B1971014(6108A1-3003)

Source(s) of Monetary Support

Pfizer Inc