A trial to assess the safety, tolerability and immunogenicity of Repevax® and rLP2086 vaccine when given together in healthy subjects aged =11 to <19 years.

• Register: EUCTR
• Last refreshed on: 14 October 2013
• Main ID: EUCTR2010-022449-38-DE
• Date of registration: 08/12/2010
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc., 235 East 42nd Street, New York, NY 10017
• Public title: A trial to assess the safety, tolerability and immunogenicity of Repevax® and rLP2086 vaccine when given together in healthy subjects aged =11 to <19 years.
• Scientific title: A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, SINGLE-BLIND TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF REPEVAX AND BIVALENT rLP2086 VACCINE WHEN ADMINISTERED CONCOMITANTLY IN HEALTHY SUBJECTS AGED =11 TO <19 YEARS
• Date of first enrolment: 21/02/2011
• Target sample size: 664
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022449-38
• 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: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Finland, Germany

Contacts

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

• Name: Clinical Trials.gov Call Center
• 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.
1.Evidence of a personally signed and dated informed consent document (ICD) indicating that the parent/legally acceptable representative and/or subject has been informed of all pertinent aspects of the study.
2.Parent/legally acceptable representative and/or subjects who are willing and able to comply with scheduled visits, laboratory tests, and other study procedures.
3.Male or female subject aged =11 and <19 years at the 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.Has received full series of diphtheria, tetanus, and pertussis (DTP)/DTaP vaccines and oral poliomyelitis virus/inactivated polio virus (OPV)/IPV vaccines per countryspecific recommendations applicable at the time of receipt.
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 all 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: 664
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 83
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.Vaccination with any diphtheria, tetanus, pertussis, or poliomyelitis virus vaccine within 5 years of the first study vaccination.
3.A previous anaphylactic reaction to any vaccine or vaccine-related component.
4.Contraindication to vaccination with diphtheria, tetanus, pertussis, or poliomyelitis virus vaccine.
5.Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
6.A known or suspected disease of the immune system or those receiving immunosuppressive therapy.
7.History of culture-proven disease caused by Neisseria meningitidis or Neisseria gonorrhoeae.
8.Significant neurological disorder or history of seizure (excluding simple febrile seizure).
9.Receipt of any blood products, including immunoglobulin within 6 months before the first study vaccination.
10.Current chronic use of systemic antibiotics.
11.Participation in other studies during study participation. Participation in purely observational studies is acceptable.
12.Received any investigational drugs, vaccines or devices within 28 days before administration of the first study vaccination.
13.Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
14.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.
15.Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
16.Subject is a direct descendant (e.g. child, grandchild or other family member) of study site or Pfizer personnel.
17.Subject is pregnant or breastfeeding.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Healthy volunteers (prevention of bacterial meningitis).
MedDRA version: 15.1 Level: PT Classification code 10027202 Term: Meningitis bacterial System Organ Class: 10021881 - Infections and infestations

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

Intervention(s)

Product Name: rLP2086 Vaccine
Product Code: rLP2086 (PF-05212366)
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: 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: 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-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intramuscular use

Trade Name: Repevax
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: n/a
CAS Number: n/a
Current Sponsor code: n/a
Other descriptive name: DIPHTHERIA TOXOID
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 2-
INN or Proposed INN: n/a
CAS Number: n/a
Current Sponsor code: n/a
Other descriptive name: TETANUS TOXOID
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 20-
INN or Proposed INN: n/a
CAS Number: n/a
Current Sponsor code: n/a
Other descriptive name: PERTUSSIS TOXOID
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 2.5-
INN or Proposed INN: n/a
CAS Number: n/a
Current Sponsor code: n/a
Other descriptive name: PERTUSSIS FILAMENTOUS HAEMAGGLUTININ
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 5-
INN or Proposed INN: n/a
CAS Number: n/a
Current Sponsor code: n/a
Other descriptive name: PERTUSSIS PERTACTIN
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 3-
INN or Proposed INN: Fimbriae types 2 and 3
CAS Number: n/a
Current Sponsor code: n/a
Other descriptive name: n/a
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 5-
INN or Proposed INN: Polyomyelitis Virus

Primary Outcome(s)

Primary end point(s): The primary endpoints for this study are the proportions of subjects achieving the prespecified criteria for the concomitant antigens 1 month after vaccination 1.

Timepoint(s) of evaluation of this end point: One month after vaccination 1 in both groups.

Main Objective: To demonstrate that the immune response induced by Repevax given with bivalent rLP2086 vaccine (group 1) is non-inferior to the immune response induced by Repevax alone (group 2) when measured 1 month after vaccination 1. The immune responses to all components of Repevax will be assessed.

Secondary Objective: To describe the immune response as measured by hSBA performed with 4 primary MnB test strains, two expressing a LP2086 subfamily A protein and two expressing a LP2086 subfamily B protein, measured 1 month after the third vaccination with bivalent rLP2086 vaccine. Serum samples from approximately 50% of the subjects will have hSBA performed with test strains of LP2086 variants A22 and B24 and the other 50% will be tested with strains of variants A56 and B44.

Secondary Outcome(s)

Secondary end point(s): An additional descriptive endpoint for the primary objective is
? The concomitant antigens measured as geometric mean titer (GMT) or geometric mean concentrations (GMCs) at 1-month after vaccination 1 (visit 2).
Serum samples from approximately 50% of the subjects will have hSBA performed with test strains of LP2086 variants A22 and B24 and the other 50% will be tested with strains of variants A56 and B44. The hSBA endpoints for the secondary objectives will be considered as secondary endpoints:
? Proportion of subjects with hSBA titer = lower limit of quantitation (LLOQ) at visit 6 (1-month postvaccination 3) for each of the 4 primary MnB test strains.

Timepoint(s) of evaluation of this end point: One month after vaccination 1 in both groups.

Secondary ID(s)

B1971010(6108A1-2008)

Source(s) of Monetary Support

Pfizer Inc.