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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

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ClinicalTrials.gov Identifier: NCT01894919
Recruitment Status : Completed
First Posted : July 10, 2013
Results First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Brief Summary:

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 (Bexsero®) 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 (Bexsero®) administered in children (2 to 10 years old) in group IV of the parent V72_28 study.


Condition or disease Intervention/treatment Phase
Meningoccocal Disease Meningococcal Meningitis Biological: Bexsero® vaccine (1 dose at study month zero) Biological: Bexsero® vaccine (2 doses 1 month apart) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 851 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : November 2015


Arm Intervention/treatment
Experimental: 2H3H511_V
In the parent study V72_28 (NCT01894919), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.
Biological: Bexsero® vaccine (1 dose at study month zero)
No Intervention: 2H3H511_NV
In the parent study V72_28 (NCT01894919), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. These subjects were evaluated only for persistence.
Experimental: 3H5_11_V
In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.
Biological: Bexsero® vaccine (1 dose at study month zero)
No Intervention: 3H5_11_NV
In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects were evaluated only for persistence.
Experimental: 68_11_V
In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.
Biological: Bexsero® vaccine (1 dose at study month zero)
No Intervention: 68_11_NV
In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects were evaluated only for persistence.
Experimental: 02_2_5_V
In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
Biological: Bexsero® vaccine (1 dose at study month zero)
No Intervention: 02_2_5_NV
In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects were evaluated only for persistence.
Experimental: 02_6_10_V
In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
Biological: Bexsero® vaccine (1 dose at study month zero)
No Intervention: 02_6_10_NV
In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects were evaluated only for persistence.
Experimental: NAIVE 123
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Biological: Bexsero® vaccine (2 doses 1 month apart)
Experimental: NAIVE_4A
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Biological: Bexsero® vaccine (2 doses 1 month apart)
Experimental: NAIVE_4B
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Biological: Bexsero® vaccine (2 doses 1 month apart)



Primary Outcome Measures :
  1. Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains [ Time Frame: 24 or 36 months after booster dose in the parent study; baseline for vaccine-naïve subjects ]

    The antibody persistence in subjects, 24 to 36 months after completion of Bexsero® vaccination course in the parent study according to different schedules, is presented in terms of the percentage of subjects in each vaccine group, with hSBA titers ≥ 4 for what concerns the H44/76, 5/99 and NZ98/254 strains, and hSBA titers ≥ 5 for M10713 strain, alongside with the corresponding antibody responses in age-matched vaccine naïve subjects at baseline.

    The functional bactericidal antibodies directed against serogroup B meningococcal were assessed by the Serum Bactericidal Assay (SBA) using human serum as the source of exogenous complement (hSBA).


  2. Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains [ Time Frame: At 24-36 months after booster dose in the parent study: baseline for vaccine-naïve subjects ]
    The antibody persistence in subjects, 24 to 36 months after completion of Bexsero® vaccination course in the parent study according to different schedules is presented in terms of the percentage of subjects in each vaccine group with hSBA titers ≥ 8, alongside with the corresponding antibody responses in age matched vaccine naïve subjects at baseline.

  3. The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains [ Time Frame: 24-36 months after booster dose in the parent study; baseline for vaccine-naïve subjects ]
    The hSBA antibody titers in subjects, 24 to 36 months after completion of Bexsero® vaccination course according to different schedules in the parent study, are presented in terms of vaccine-group-specific GMTs, alongside with the corresponding antibody responses in age-matched vaccine-naïve subjects at baseline.

  4. The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study. [ Time Frame: At Day 1 in this study over one month after the completion of the vaccination course in the parent study ]
    The within-subjects GMR of GMTs at 24 to 36 months versus 1 month after completion of Bexsero® vaccination course according to different schedules vaccination in parent study are reported.

  5. The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus Visit 1 in the Parent Study. [ Time Frame: At Day 1 in this study over visit 1 in the vaccination course in the parent study ]
    The within-subjects GMR of GMTs at 24 to 36 months versus visit 1 in the vaccination course according to different schedules vaccination in the parent study are reported.


Secondary Outcome Measures :
  1. Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. [ Time Frame: At 24-36 months (Visit 1) and one month after booster vaccination (Day 31) ]
    The percentage of subjects with hSBA titers ≥ 4 against H44/76, 5/99 and NZ98/254 strains, and with hSBA titers ≥ 5 against M10713 strain, after receiving Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study), alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects.

  2. Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. [ Time Frame: At 24-36 months (Visit 1) and one month after booster vaccination (Day 31) ]
    The percentage of subjects with hSBA titers ≥ 8, after receiving Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects.

  3. Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. [ Time Frame: One month after booster vaccination (day 31)/24-36 months (Visit 1) ]
    The percentage of subjects with a four-fold rise in hSBA titers after receiving Bexsero® booster vaccination in this study to pre vaccination (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects.

  4. The GMTs Against N.Meningitidis Serogroup B, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. [ Time Frame: At Visit 1 and one month post booster vaccination (Day 31) ]
    The hSBA antibody titers in subjects after receiving Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the corresponding response after the 1st dose of Bexsero® vaccine in age matched vaccine-naïve subjects in terms of GMTs.

  5. The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. [ Time Frame: Day 1 and Day 31 ]
    The within-subjects GMR of hSBA antibody titers (one month post booster vaccination versus pre vaccination) after Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the within-subject GMR for the 1st dose of rMenB+OMV NZ vaccination of age matched naïve subjects.

  6. Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination [ Time Frame: At Baseline and One month post second vaccination (Day 61) ]
    The percentage of vaccine-naïve subjects with hSBA titers ≥ 4 against H44/76, 5/99 and NZ98/254 strains, and ≥ 5 against M10713 strain, one month after receiving two catch up doses of Bexsero® booster vaccination in this study.

  7. Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. [ Time Frame: At Baseline and One month post second vaccination (Day 61) ]
    The percentage of vaccine-naïve subjects with hSBA titers ≥8, one month after receiving two catch up doses of Bexsero® booster vaccination in this study are reported.

  8. Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Two Catch up Doses of Bexsero® Vaccination. [ Time Frame: One month post second vaccination (Day 61) ]
    The percentage of vaccine-naïve subjects with a four-fold rise in hSBA titers from baseline, one month after receiving two catch up doses of Bexsero® booster vaccination in comparison to prevaccination in this study are reported.

  9. The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. [ Time Frame: At Baseline and One month post second vaccination (Day 61) ]
    The hSBA antibody titers in vaccine-naïve subjects , after receiving two catch up doses of Bexsero® vaccination in this study, are reported in terms of GMTs.

  10. The GMRs of hSBA Titers After Two Catch up Doses of Bexsero® Vaccination Versus hSBA Titers at Baseline. [ Time Frame: At Baseline (Day 1) ]
    The within-subject GMRs of hSBA titers at one month after receiving the second catch up dose to hSBA titers at baseline, for naïve subjects who received two catch up doses of Bexsero® vaccination in this study are reported.

  11. Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. [ Time Frame: From day 1 (6 hr) through day 7 after vaccination ]
    The number of subjects (35 months to 7 years of age) with solicited local and systemic adverse events after receivingBexsero® booster vaccine in the present study.

  12. Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. [ Time Frame: The number of newly recruited subjects (aged 35 months to 7 years) reporting solicited local and systemic adverse events after receiving two catch-up doses of Bexsero® vaccine in the present study ]
    The number of newly recruited subjects (aged 35 months to 7 years) reporting solicited local and systemic adverse events after receiving two catch-up doses of Bexsero® vaccine in the present study.

  13. Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. [ Time Frame: From day 1 (6 hr) through day 7 after vaccination ]
    Number of subjects (8 to 12 years of age) reporting solicited local and systemic adverse events after receiving Bexsero® booster vaccine.

  14. Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. [ Time Frame: From day 1(6 hr) through day 7 after vaccination ]
    The number newly recruited naïve subjects (aged 8 to12 years of age) reporting solicited local and systemic adverse events after receiving two catch-up doses of Bexsero® vaccine in the present study.

  15. Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination. [ Time Frame: From day 1 through day 7 after any vaccination and throughout entire study period for all other AEs. ]
    The number of subjects reporting unsolicited adverse events after receiving Bexsero® booster vaccination (24 to 36 months after completion of vaccination course according to different schedules in parent study) or two cach up schedule of Bexsero® vaccine is reported.

  16. Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs), Medically Attended AEs and AEs Leading to Withdrawal for Entire Study Period. [ Time Frame: Throughout the entire study period ]
    The number of subjects reporting unsolicited SAEs, medically attended AEs and AEs leading to withdrawal after receiving Bexsero® booster vaccination (24 to 36 months after completion of vaccination course according to different schedules in the parent study) or two catch-up schedule of Bexsero® vaccine is reported.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01894919


Locations
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Hungary
Site 34, General Pediatric Practice Somorjai
Debrecen, Bajcsi Ut 32, Hungary, 4025
Site 35, Praxis Dr Eva Kovacs
Szeged, Csongradi Sgt 63, Hungary, 6723
Site 36, General Practice Dr Edit Oszlacs
Szeged, Debreceni Utca 10-14, Hungary, 6723
Site 37, Praxis Dr Julianna Kovacs
Bordany, Honved Utca 2, Hungary, 6795
Site 31, General Practice Dr Olga Fekete
Miskolc, Kando Kalman Utca 1, Hungary, 3534
Site 40, General Pediatric Practice Hacsek
Budapest, Poth Iren U 80, Hungary, 1188
Site 30, General Practice Dr Simko
Miskolc, Selyemret U. 1., Hungary, 3527
Site 33, General Pediatric Practice Ujhelyi
Nyiregyhaza, Szent Istvan U 10, Hungary, 4400
Site 42, Praxis Dr Eszter Bari
Csongrad, Szentharomsag Ter 10, Hungary, 6640
Spain
Site 15
Almeria, Spain, 04007
Site 16
Almeria, Spain, 04120
Site 20
Barcelona, Spain, 08195
Site 17
Madrid, Spain, 28041
Site 18
Madrid, Spain, 28935
Site 13
Pontevedra, Spain, 36002
Site 10
Santiago de Compostela, Spain, 15706
Site 14
Sevilla, Spain, 41014
Sponsors and Collaborators
Novartis Vaccines
GlaxoSmithKline
Investigators
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Study Chair: Novartis Vaccines and Diagnostics Novartis Vaccines

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT01894919     History of Changes
Other Study ID Numbers: V72_28E1
2012-000657-30 ( EudraCT Number )
First Posted: July 10, 2013    Key Record Dates
Results First Posted: December 7, 2018
Last Update Posted: December 7, 2018
Last Verified: May 2018
Keywords provided by Novartis ( Novartis Vaccines ):
Meningococcal B disease,
Antibody persistence
Additional relevant MeSH terms:
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Meningitis, Meningococcal
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Central Nervous System Infections
Vaccines
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs