A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED TRIAL TO ASSESS THE LOT CONSISTENCY, SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MENINGOCOCCAL SEROGROUP B rLP2086 VACCINE IN HEALTHY SUBJECTS AGED =11 TO <19 YEARS

• Register: EUCTR
• Last refreshed on: 21 December 2021
• Main ID: EUCTR2010-023873-20-HU
• Date of registration: 26/08/2011
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc, 235 East 42nd Street, New York, NY 10017
• Public title: A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED TRIAL TO ASSESS THE LOT CONSISTENCY, SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MENINGOCOCCAL SEROGROUP B rLP2086 VACCINE IN HEALTHY SUBJECTS AGED =11 TO <19 YEARS
• Scientific title: A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED TRIAL TO ASSESS THE LOT CONSISTENCY, SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MENINGOCOCCAL SEROGROUP B rLP2086 VACCINE IN HEALTHY SUBJECTS AGED =11 TO <19 YEARS
• Date of first enrolment: 26/10/2011
• Target sample size: 3752
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-023873-20
• 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: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Canada, Czech Republic, Dominican Republic, Finland, Germany, Hungary, Italy, Poland, Spain, Sweden, United Kingdom, 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 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. 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.
7. Negative urine pregnancy test for female subjects.

Are the trial subjects under 18? yes
Number of subjects for this age range: 3658
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 94
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. A previous anaphylactic reaction to any vaccine or vaccine-related component.
3. Subjects who have received prior HAV vaccination.
4. Contraindication to vaccination with any HAV vaccine.
5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
6. 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. Please refer to the SRM for additional details.
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 (eg, child, grandchild or other family member) of study site personnel.
17. Subject is pregnant or breastfeeding.


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

Health Condition(s) or Problem(s) studied

BACTERIAL MENINGITIS.
MedDRA version: 14.0 Level: LLT Classification code 10004049 Term: Bacterial meningitis System Organ Class: 10021881 - Infections and infestations

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: 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: 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: 0.9%-

Primary Outcome(s)

Primary end point(s): Co-Primary Endpoints
? rLP2086 specific hSBA geometric mean titers (GMTs) for each of 2 primary strains measured 1 month after the third vaccination with rLP2086 vaccine for the subjects in group 1, group 2, and group 3.
? Proportion of subjects achieving an rLP2086-specific hSBA titer =1:4, for each of the 4 primary strains, measured 1 month after the third vaccination with rLP2086 vaccine in the subjects in group 1.

The 4 primary strains to be tested for the immunogenicity objective will be specified in the statistical analysis plan (SAP), which will include 2 subfamily A strains and 2 subfamily B strains. The 2 strains (1 strain each from subfamily A and subfamily B) to be tested for lot consistency are part of the 4 primary strains. The testing strategy of the 2 co-primary endpoints are specified in the Protocol.

Primary Safety Endpoints
? Proportion of subjects reporting local reactions (pain, redness and swelling) after each vaccination visit.
? Proportion of subjects reporting systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain other than muscle pain at any injection site, and joint pain) after each vaccination visit.
? Proportion of subjects reporting the use of antipyretic medication after each vaccination visit.
? Proportion of subjects reporting unsolicited AEs from signing of consent to visit 5 (post-vaccination 3 blood draw).
? Proportion of subjects reporting serious adverse events (SAEs) throughout the study (including both vaccination phase and follow-up phase [visit 6]).

Main Objective: Co-Primary
? To demonstrate that the immune response induced by 3 lots of rLP2086 vaccine are equivalent as measured by serum bactericidal assay using human complement (hSBA) performed with MnB strains expressing LP2086 subfamily A and B proteins, 1 month after study vaccination 3.
? To assess the immune response as measured by serum bactericidal assay using human complement (hSBA) performed with MnB strains expressing LP2086 subfamily A and B proteins, measured 1 month after study vaccination 3 in a subset of subjects in group 1.

Primary Safety
? To evaluate the safety profile of 3 lots of rLP2086 vaccine as measured by the proportion of subjects reporting local reactions, systemic events and adverse events (AEs).

Secondary Objective: ? To demonstrate that the immune response induced by 3 lots of rLP2086 vaccine are equivalent as measured by serum bactericidal assay using human complement (hSBA) performed with MnB strains expressing LP2086 subfamily A and B proteins, 1 month after study vaccination 2.
? To assess the immune response as measured by serum bactericidal assay using human complement (hSBA) performed with MnB strains expressing LP2086 subfamily A and B proteins, measured 1 month after study vaccination 2 in a subset of subjects in group 1.

Timepoint(s) of evaluation of this end point: The primary analysis will be the immunogenicity and safety analysis during the vaccination phase (visit 1 to visit 5), which will be conducted when all of the subjects have completed visit 5, and all of the data up to visit 5 are available for analysis.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: The primary analysis will be the immunogenicity and safety analysis during the vaccination phase (visit 1 to visit 5), which will be conducted when all of the subjects have completed visit 5, and all of the data up to visit 5 are available for analysis.

Secondary end point(s): The secondary endpoints for hypothesis testing are:
? rLP2086 specific hSBA titers (GMTs) for each of the 2 primary strains measured 1 month after the second vaccination with rLP2086 vaccine for the subjects in group 1, group 2, and group 3.
? Proportion of subjects achieving an rLP2086-specific hSBA titer =1:4, for each of the 4 primary strains, measured 1 month after the second vaccination with rLP2086 vaccine in the subjects in group 1.
Additional secondary endpoints for descriptive purposes are as follows:
1. hSBA measured as GMTs at prevaccination blood sampling time point;
2. Proportion of subjects with hSBA titers below the lower limit of quantitation (LLOQ) at each blood sampling time point;
3. Proportion of subjects achieving a 4-fold rise on rLP2086-specific hSBA titer from before vaccination 1 to each post-vaccination blood sampling time point;
4. Proportions of subjects achieving rLP2086-specific hSBA titers =1:4, =1:8, =1:16, =1:32, =1:64, and =1:128 at each blood sampling time point ;
5. Geometric mean fold rise (GMFR) from before vaccination 1 to 1 month after the second and third vaccination with rLP2086 vaccine.

Secondary ID(s)

B1971009 (6108A1-3001)

2010-023873-20-DE

Source(s) of Monetary Support

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

Ethics review

Status: Approved
Approval date: 05/10/2011
Contact:

Results

• Results available: Yes
• Date Posted: 19/11/2016
• Date Completed: 14/04/2015
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2010-023873-20/results