A Phase 2b, Open Label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of a Booster Dose of Novartis Meningococcal B Recombinant Vaccine Administered at 12, 18 or 24 Months of Age in Subjects Who Previously Received a Three-Dose Primary Series of the Novartis Meningococcal B Recombinant Vaccine as Infants in Study V72P12 - ND

• Register: EUCTR
• Last refreshed on: 24 April 2012
• Main ID: EUCTR2009-011676-30-IT
• Date of registration: 07/09/2009
• Prospective Registration: No
• Primary sponsor: NOVARTIS VACCINES AND DIAGNOSTICS S.R.L.
• Public title: A Phase 2b, Open Label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of a Booster Dose of Novartis Meningococcal B Recombinant Vaccine Administered at 12, 18 or 24 Months of Age in Subjects Who Previously Received a Three-Dose Primary Series of the Novartis Meningococcal B Recombinant Vaccine as Infants in Study V72P12 - ND
• Scientific title: A Phase 2b, Open Label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of a Booster Dose of Novartis Meningococcal B Recombinant Vaccine Administered at 12, 18 or 24 Months of Age in Subjects Who Previously Received a Three-Dose Primary Series of the Novartis Meningococcal B Recombinant Vaccine as Infants in Study V72P12 - ND
• Date of first enrolment: 23/07/2009
• Target sample size: 1900
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-011676-30
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Belgium, Czech Republic, Germany, Italy, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Informed consent must be obtained for all the subjects before enrollment into the study after the nature of the study has been explained. The inclusion criteria will be checked at Visit 1. Inclusion Criteria for naive subjects, newly enrolled (Groups 5 and 6): Healthy male and female subjects will be recruited from the same sites as in study V72P12. Subjects eligible to be enrolled in the study: 1. Group 5: healthy 18-month-old toddlers (0/ +29 days window); Group 6: healthy 24-month-old toddlers (0/ +29 days window); 2. for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained; 3. available for all the visits scheduled in the study; 4. in good health as determined by medical history, physical examination, clinical judgment of the investigator Inclusion Criteria for follow-on participants (Groups 1, 2, 3 and 4): Inclusion criteria are the same as for Groups 5 and 6, with the addition that are subjects: 1. who participated and completed V72P12 study 2. who are aged: o 12 months or older - Groups 1a, 2a, 3a, 4 o 18 months (0/ +29 days window) - Groups 1b, 2b, 3b o 24 months (0/ +29 days window) - Groups 1c, 2c, 3c
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Exclusion Criteria for na?ve subjects, newly enrolled (Groups 5 and 6): 1. subjects whose parents/legal guardians are unwilling or unable to give written informed consent to participate in the study; 2. history of any meningococcal B vaccine administration; 3. previous ascertained or suspected disease caused by N. meningitidis; 4. household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis; 5. history of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component; 6. significant acute or chronic infection within the previous 7 days or axillary temperature ≥ 38C within the day before Visit 1; 7. antibiotics within 7 days prior to Visit 1; 8. any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, progressive neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition); 9. known or suspected impairment/alteration of the immune system, immunosuppressive therapy, use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within 30 days prior to Visit 1; 10. receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within 90 days prior to Visit 1; 11. receipt of, or intent to immunize with any other vaccine(s), within 30 days prior to Visit 1; 12. participation in another clinical trial within 90 days prior to enrolment or planned for during study; 13. family members and household members of research staff; 14. any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. Exclusion Criteria for follow-on participants (Groups 1, 2, 3 and 4): Exclusion criteria are the same as for Groups 5 and 6, with the exception of criterion 2.


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

Health Condition(s) or Problem(s) studied

Prophylaxis against Meningitis and/or Septicemia due to Meningococcus B.
MedDRA version: 12.0 Level: LLT Classification code 10027249 Term: Meningitis meningococcal

Intervention(s)

Product Name: Novartis Meningococcal B Recombinant + OMV NZ Vaccine
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Meningococcus B, outer membrane vesicle vaccine
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Primary end point(s): Primary endpoint is > 99%, assuming 180 evaluable subjects and at least 90% of the subjects showing SBA titers ≥ 1:5 after four doses of rMenB OMV NZ for each of the three strains. If there are only 100 evaluable subjects per group the overall power will be 85%, assuming at least 90% of the subjects showing SBA titer ≥ 1:5 after four doses of rMenB OMV NZ for each of the three reference strains.

Secondary Objective: a) To demonstrate a sufficient immune response following a fourth (booster) dose of rMenB+OMV NZ in at least one of the time points, when given at 12, 18 or 24 months of age to toddlers previously primed with three doses of rMenB+OMV NZ as infants at 2, 4 and 6 months of age without concomitant routine vaccines. The primary criterion for determining sufficient response is the same as for primary objective; b) To characterize the immune response following a fourth (booster) dose of rMenB+OMV NZ, when given at 12, 18 or 24 months of age to toddlers previously primed with three doses of rMenB+OMV NZ as infants at 2, 3 and 4 months of age, as measured by the percentage of subjects with SBA titers ≥ 1:5 at one month after the fourth vaccination, directed against N. meningitidis serogroup B reference strains H44/76, NZ98/254 and 5/99.

Main Objective: To demonstrate a sufficient immune response following a fourth (booster) dose of rMenB+OMV NZ in at least one of the time points, when given at 12, 18 or 24 months of age to toddlers previously primed with three doses of rMenB+OMV NZ as infants at 2, 4 and 6 months of age with concomitant routine vaccines. The immune response will be measured by the percentage of subjects with serum bactericidal assay (SBA) titers ≥ 1:5 at one month after the fourth dose, directed against N. meningitidis serogroup B reference strains H44/76, NZ98/254 and 5/99. A sufficient immune response will be defined as ≥ 75% for the lower limit of the two-sided 98.3% CI for the percentage of subjects achieving SBA titers ≥ 1:5 for all 3 reference strains.

Secondary ID(s)

2009-011676-30-GB

V72P12E1