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Antibody Persistence, and Safety and Tolerability of a Booster Dose of the Meningococcal B Vaccine After the Completion of the Vaccination Course in Study V72_28

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01894919
First received: June 26, 2013
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

The aim of this extension study is to explore the antibody persistence 24 to 36 months after the last dose of vaccine, in infants that received a two or three dose primary series plus a booster dose at 11 months of age, of the Novartis meningococcal B vaccine (rMenB + OMV NZ) in groups I to III of the parent V72_28 study.

This study will also explore the antibody persistence 24 to 36 months after two catch-up doses of the Novartis meningococcal B vaccine (rMenB + OMV NZ) administered in children (2 to 10 years old) in group IV of the parent V72_28 study.


Condition Intervention Phase
Meningoccocal Disease,
Meningococcal Meningitis
Biological: rMenB + OMV vaccine (1 dose at study month zero)
Biological: rMenB + OMV vaccine (2 doses 1 month apart)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase IIIb, Open Label, Multi Center Extension Study of V72_28 to Assess Antibody Persistence, and the Safety and Tolerability of a Booster Dose After the Completion of the Vaccination Course in Study V72_28

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentage of subjects with hSBA titers ≥ 5 directed against strains of N. meningitidis serogroup B. [ Time Frame: At day 1 ] [ Designated as safety issue: No ]
    To evaluate the antibody persistence 24 to 36 months after the completion of the vaccination course, in subjects who participated in the V72_28 study in Groups I to IV.

  • Percentage of subjects with hSBA titers ≥ 8 against strains of N. meningitidis serogroup B. [ Time Frame: At day 1 ] [ Designated as safety issue: No ]
    To evaluate the antibody persistence 24 to 36 months after the completion of the vaccination course, in subjects who participated in the V72_28 study in Groups I to IV.

  • hSBA GMTs directed against N. meningitidis serogroup B. [ Time Frame: At day 1 ] [ Designated as safety issue: No ]
    To evaluate the antibody persistence 24 to 36 months after the completion of the vaccination course, in subjects who participated in the V72_28 study in Groups I to IV.

  • GMCs (ELISA) for vaccine antigen 287-953. [ Time Frame: At day 1 ] [ Designated as safety issue: No ]
    To evaluate the antibody persistence 24 to 36 months after the completion of the vaccination course, in subjects who participated in the V72_28 study in Groups I to IV.

  • hSBA GMRs directed against N. meningitidis serogroup B [ Time Frame: At day 1 ] [ Designated as safety issue: No ]

    Groups A to F: from 1 month to 24 - 36 months after the completion of the vaccination course in the parent study (Group A and B: Visit 6, Groups C, D, E and F: Visit 5).

    Group G to J: from 1 month to 24 - 36 months after the completion of the vaccination course in the parent study (Visit 3).



Secondary Outcome Measures:
  • Percentage of subjects with hSBA titers ≥5 and ≥8 directed against strains of N. meningitidis serogroup B at Visit 1 (prevaccination) and Visit 2 (one month after the booster administration). [ Time Frame: 30 (-4+10) days after study entry ] [ Designated as safety issue: No ]
    To evaluate the immune response at one month after a booster dose administered 24 to 36 months after completion of the vaccination course in the parent study (Groups A, C, E, G and I).

  • Percentage of subjects with four-fold rise in titers from Visit 1 to Visit 2 directed against strains of N. meningitidis serogroup B. [ Time Frame: 30 (-4+10) days after study entry ] [ Designated as safety issue: No ]
    To evaluate the immune response at one month after a booster dose administered 24 to 36 months after completion of the vaccination course in the parent study (Groups A, C, E, G and I).

  • GMCs (ELISA) for vaccine antigen 287-953 at Visit 1 and Visit 2. [ Time Frame: 30 (-4+10) days after study entry ] [ Designated as safety issue: No ]
    To evaluate the immune response at one month after a booster dose administered 24 to 36 months after completion of the vaccination course in the parent study (Groups A, C, E, G and I).

  • Percentage of subjects with four-fold rise in concentrations of antigen 287-953 at Visit 1 and Visit 2 [ Time Frame: 30 (-4+10) days after study entry ] [ Designated as safety issue: No ]
    To evaluate the immune response at one month after a booster dose administered 24 to 36 months after completion of the vaccination course in the parent study (Groups A, C, E, G and I).

  • hSBA GMTs directed against N. meningitidis serogroup B at Visit 1 and Visit 2. [ Time Frame: 30 (-4+10) days after study entry ] [ Designated as safety issue: No ]
    To evaluate the immune response at one month after a booster dose administered 24 to 36 months after completion of the vaccination course in the parent study (Groups A, C, E, G and I).

  • hSBA GMRs directed against N. meningitidis serogroup B: Visit 1 to Visit 2 [ Time Frame: 30 (-4+10) days after study entry ] [ Designated as safety issue: No ]
    To evaluate the immune response at one month after a booster dose administered 24 to 36 months after completion of the vaccination course in the parent study (Groups A, C, E, G and I)

  • Percentage of subjects with hSBA titers ≥ 1:5 and ≥ 1:8 directed against strains of N. meningitidis serogroup B at Visits 1, 2 and 3. [ Time Frame: 60 (-4+10) days after study entry ] [ Designated as safety issue: No ]
    To evaluate the immune response of two catch-up doses of rMenB+OMV NZ administered 1 month apart to naïve children (Group K, L and M).

  • Percentage of subjects with four-fold rise in titers from Visit 1 to Visit 3 directed against strains of N. meningitidis serogroup B. [ Time Frame: 60 (-4+10) days after study entry ] [ Designated as safety issue: No ]
    To evaluate the immune response of two catch-up doses of rMenB+OMV NZ administered 1 month apart to naïve children (Group K, L and M).

  • hSBA GMTs directed against N. meningitidis serogroup B at Visits 1, 2 and 3. [ Time Frame: 60 (-4+10) days after study entry ] [ Designated as safety issue: No ]
    To evaluate the immune response of two catch-up doses of rMenB+OMV NZ administered 1 month apart to naïve children (Group K, L and M).

  • hSBA GMRs directed against N. meningitidis serogroup B: Visit 1 to Visit 3. [ Time Frame: 60 (-4+10) days after study entry ] [ Designated as safety issue: No ]
    To evaluate the immune response of two catch-up doses of rMenB+OMV NZ administered 1 month apart to naïve children (Group K, L and M).

  • GMCs (ELISA) for vaccine antigen 287-953 at Visits 1, 2 and 3. [ Time Frame: 60 (-4+10) days after study entry ] [ Designated as safety issue: No ]
    To evaluate the immune response of two catch-up doses of rMenB+OMV NZ administered 1 month apart to naïve children (Group K, L and M).

  • Percentage of subjects with four-fold rise in concentrations of antigen 287-953 at Visit 2 (one month after the first vaccination) as compared to pre-vaccination (Visit 1) and Visit 3 (one month after the second vaccination) [ Time Frame: 60 (-4+10) days after study entry ] [ Designated as safety issue: No ]
    To evaluate the immune response of two catch-up doses of rMenB+OMV NZ administered 1 month apart to naïve children (Group K, L and M).

  • Safety will be assessed in terms of the number/percentage of subjects reporting adverse events, and number/percentage of reported adverse events for all subjects [ Time Frame: along all the trial ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1350
Study Start Date: June 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
5th dose of vaccine
Biological: rMenB + OMV vaccine (1 dose at study month zero)
No Intervention: B
Blood draw only
Experimental: C
4th dose of vaccine (3 ½, 5 + booster at 11 months of age)
Biological: rMenB + OMV vaccine (1 dose at study month zero)
No Intervention: D
Blood draw only
Experimental: E
4th dose of vaccine (6, 8 + booster at 11 months of age)
Biological: rMenB + OMV vaccine (1 dose at study month zero)
No Intervention: F
Blood draw only
Experimental: G
3rd dose of vaccine (0,2-month schedule, Subjects 2 to 5 years of age)
Biological: rMenB + OMV vaccine (1 dose at study month zero)
No Intervention: H
Blood draw only
Experimental: I
3rd dose of vaccine (0,2-month schedule, Subjects 6 to 10 years of age)
Biological: rMenB + OMV vaccine (1 dose at study month zero)
No Intervention: J
Blood draw only
Experimental: K
Naïve subjects (35-47 months of age)
Biological: rMenB + OMV vaccine (2 doses 1 month apart)
Experimental: L
Naïve subjects (4 to 7 years old)
Biological: rMenB + OMV vaccine (2 doses 1 month apart)
Experimental: M
Naïve subjects (8 to 12 years old)
Biological: rMenB + OMV vaccine (2 doses 1 month apart)

  Eligibility

Ages Eligible for Study:   35 Months to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For naïve subjects newly enrolled:

  1. Healthy infants and children according to the following age groups:

    1. Healthy subjects from 35 to 47 months of age, (only applicable to group K) (The age window is defined as the first day the subject turns 35 months of age up to the day before the subject turns 48 months of age),
    2. Healthy subjects 4 to 7 years of age (only applicable to group L) (The age window is defined as the first day the subject turns 4 years of age up to the day before the subject turns 8 years of age).
    3. Healthy subjects 8 to 12 years of age (only applicable to group M) (The age window is defined as the first day the subject turns 8 years of age up to the day before the subject turns 13 years of age).
  2. for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained;
  3. for whom a parent/legal guardian confirmed availability for the visit scheduled in the study;
  4. in good health as determined by medical history, physical examination, clinical judgment of the investigator.

For Subjects who participated in the V72_28 study (Follow-on Subjects):

  1. for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained;
  2. for whom a parent/legal guardian confirmed availability for the visit scheduled in the study;
  3. in good health as determined by medical history, physical examination, clinical judgment of the investigator
  4. who have completed the vaccination course in the V72_28 study and have received their last vaccination 24 to 36 months before enrollment in V72_28E1

Exclusion Criteria:

For naïve subjects newly enrolled:

  1. History of any serogroup B meningococcal vaccine administration;
  2. Previous known or suspected disease caused by N. meningitidis;
  3. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection or colonization;
  4. History of severe allergic reaction after previous vaccinations or hypersensitivity to any component of the vaccine;
  5. Pregnancy or nursing (breastfeeding) mothers;
  6. Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine device, surgical sterilization, transdermal delivery, congenital sterility or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods at least two months prior to study entry;
  7. Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from (for example):

    • Receipt of any chronic immunosuppressive therapy
    • Receipt of any chronic immunostimulants
    • Immune deficiency disorder, or known HIV infection
  8. History of seizure, any progressive neurological disease or Guillain Barré Syndrome (exception: one self-limited febrile seizure is acceptable).
  9. Known bleeding diathesis or any condition that may be associated with a prolonged bleeding time.
  10. Subject's parent(s) or legal guardian(s) are not able to comprehend and to follow all required study procedures for the whole period of the study.
  11. Intent to participate in another clinical study during this study.
  12. Family members and household members of study staff;
  13. History or any illness/condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or pose additional risk to the subjects due to participation in the study.
  14. Any significant chronic infection.
  15. Any serious chronic or progressive disease according to judgment of the investigator (e.g. neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).

For Subjects who participated in the V72_28 study (Follow-on Subjects):

Exclusion criteria are the same as for naïve subjects, with the exception of criterion 1.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01894919

Contacts
Contact: Novartis Drug Information Services 18002447668

Locations
Hungary
Site 34, General Pediatric Practice Somorjai Recruiting
Debrecen, Bajcsi ut 32, Hungary, 4025
Site 35, Praxis Dr Eva Kovacs Recruiting
Szeged, Csongradi sgt 63, Hungary, 6723
Site 36, General Practice Dr Edit Oszlacs Completed
Szeged, Debreceni utca 10-14, Hungary, 6723
Site 37, Praxis Dr Julianna Kovacs Recruiting
Bordany, Honved utca 2, Hungary, 6795
Site 31, General Practice Dr Olga Fekete Completed
Miskolc, Kando Kalman utca 1, Hungary, 3534
Site 40, General Pediatric Practice Hacsek Recruiting
Budapest, Poth Iren u 80, Hungary, 1188
Site 30, General Practice Dr Simko Recruiting
Miskolc, Selyemret u. 1., Hungary, 3527
Site 33, General Pediatric Practice Ujhelyi Recruiting
Nyiregyhaza, Szent Istvan u 10, Hungary, 4400
Site 42, Praxis Dr Eszter Bari Recruiting
Csongrad, Szentharomsag ter 10, Hungary, 6640
Spain
Site 15 Not yet recruiting
Almeria, Spain, 04007
Site 16 Recruiting
Almeria, Spain, 04120
Site 20 Not yet recruiting
Barcelona, Spain, 08195
Site 17 Not yet recruiting
Madrid, Spain, 28041
Site 18 Not yet recruiting
Madrid, Spain, 28935
Site 13 Not yet recruiting
Pontevedra, Spain, 36002
Site 10 Recruiting
Santiago de Compostela, Spain, 15706
Site 14 Recruiting
Sevilla, Spain, 41014
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines and Diagnostics Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01894919     History of Changes
Other Study ID Numbers: V72_28E1, 2012-000657-30
Study First Received: June 26, 2013
Last Updated: April 2, 2014
Health Authority: European Union: European Medicines Agency

Keywords provided by Novartis:
Meningococcal B disease,
Antibody persistence

Additional relevant MeSH terms:
Meningitis
Meningitis, Meningococcal
Meningitis, Bacterial
Bacterial Infections
Central Nervous System Bacterial Infections
Central Nervous System Diseases
Central Nervous System Infections
Gram-Negative Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Nervous System Diseases
Antibodies
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014