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Assessment of Antibody Persistence at Eighteen Months After the Completion of the Vaccination Course in Study V72P10

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ClinicalTrials.gov Identifier: NCT01148524
Recruitment Status : Completed
First Posted : June 22, 2010
Results First Posted : March 11, 2014
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Brief Summary:

This was a Phase 2b/3, multi-center, extension study of V72P10 to assess antibody persistence at 18 months after the vaccination course in study V72P10 (NCT00661713).

Subjects who participated in study V72P10, and who meet all other enrollment criteria for this extension study, and a group of naïve subjects (defined as subjects who had never received rMenB+OMV NZ or other experimental MenB vaccines) of similar age to the subjects who were eligible to participate in this extension study, performed one study visit in which a single blood sample was drawn for MenB serological analyses.


Condition or disease Intervention/treatment Phase
Meningococcal Disease Meningococcal Meningitis Biological: No Vaccine Biological: rMenB+OMV-NZ Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 817 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 2b/3, Multi-Center, Extension Study of V72P10 to Assess Antibody Persistence at Eighteen Months After the Completion of the Vaccination Course in Study V72P10.
Study Start Date : August 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012


Arm Intervention/treatment
rMenB06
Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study had a blood draw.
Biological: rMenB+OMV-NZ
Subjects who had received either rMenB+OMV-NZ or placebo at study month 6 in V72P10 study had a blood sample drawn for serological analyses at 18 months later (-1/+3 months).
Other Name: Serogroup B meningococcal recombinant vaccine

rMenB0
Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study had a blood draw.
Biological: rMenB+OMV-NZ
Subjects who had received either rMenB+OMV-NZ or placebo at study month 6 in V72P10 study had a blood sample drawn for serological analyses at 18 months later (-1/+3 months).
Other Name: Serogroup B meningococcal recombinant vaccine

rMenB016
Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study had a blood draw.
Biological: rMenB+OMV-NZ
Subjects who had received either rMenB+OMV-NZ or placebo at study month 6 in V72P10 study had a blood sample drawn for serological analyses at 18 months later (-1/+3 months).
Other Name: Serogroup B meningococcal recombinant vaccine

rMenB01
Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 month) and placebo (at 2 and 6 months) in V72P10 study had a blood draw.
Biological: rMenB+OMV-NZ
Subjects who had received either rMenB+OMV-NZ or placebo at study month 6 in V72P10 study had a blood sample drawn for serological analyses at 18 months later (-1/+3 months).
Other Name: Serogroup B meningococcal recombinant vaccine

rMenB026
Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study had a blood draw.
Biological: rMenB+OMV-NZ
Subjects who had received either rMenB+OMV-NZ or placebo at study month 6 in V72P10 study had a blood sample drawn for serological analyses at 18 months later (-1/+3 months).
Other Name: Serogroup B meningococcal recombinant vaccine

rMenB02
Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study had a blood draw.
Biological: rMenB+OMV-NZ
Subjects who had received either rMenB+OMV-NZ or placebo at study month 6 in V72P10 study had a blood sample drawn for serological analyses at 18 months later (-1/+3 months).
Other Name: Serogroup B meningococcal recombinant vaccine

rMenB012
Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and 1 dose of placebo (at 6 months) in V72P10 study had a blood draw.
Biological: rMenB+OMV-NZ
Subjects who had received either rMenB+OMV-NZ or placebo at study month 6 in V72P10 study had a blood sample drawn for serological analyses at 18 months later (-1/+3 months).
Other Name: Serogroup B meningococcal recombinant vaccine

rMenB6
Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study had a blood draw.
Biological: rMenB+OMV-NZ
Subjects who had received either rMenB+OMV-NZ or placebo at study month 6 in V72P10 study had a blood sample drawn for serological analyses at 18 months later (-1/+3 months).
Other Name: Serogroup B meningococcal recombinant vaccine

Naive
An additional study group of naïve subjects that served as a baseline comparator for assessing antibody persistence in the vaccine groups and had blood draw for serological analyses at the time of enrollment.
Biological: No Vaccine



Primary Outcome Measures :
  1. Percentage of Subjects With hSBA Titers ≥1:4 Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. [ Time Frame: month 0 (bl=baseline), month 1 and 18 months after last vaccination in V72P10 study. ]
    The immune response was measured as the percentage of subjects with hSBA titers ≥1:4 against meningococcal strains 44/76-SL, 5/99 and NZ98/254, at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study, evaluated by serum bactericidal assay using human complement (hSBA).

  2. Geometric Mean hSBA Titers Directed Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. [ Time Frame: month 0 (bl=baseline), month 1 and 18 months after last vaccination in V72P10 study. ]
    The immune response was measured as the hSBA geometric mean titers (GMTs) directed against meningococcal strains 44/76-SL, 5/99 and NZ98/254, at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study.

  3. Geometric Mean Ratio at 18 Months After Month-6 Vaccination, Over Baselines at Month 0 and at One Month After the Last rMenB+OMV-NZ Vaccination in the V72P10 Study. [ Time Frame: month 0 (baseline), month 1 and 18 months after last vaccination in V72P10 study. ]
    The immune response was measured as the geometric mean ratio (GMRs) of hSBA GMTs against meningococcal strains 44/76-SL, 5/99 and NZ98/254 as follow: GMTs at 1 month after last vaccination to baseline GMTs; GMTs at 18 months after last vaccination to baselines GMTs; and GMTs at 18 months after last vaccination to GMTs at 1 month after last vaccination.

  4. Geometric Mean Concentration Against Meningococcal 287-953 Antigen, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. [ Time Frame: 18 months after last vaccination V72P10 study. ]
    The immune response was measured as the geometric mean concentrations (GMCs) directed against meningococcal 287-953 antigen, evaluated using enzyme-linked immunosorbent assay (ELISA), at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Informed consent was obtained from all the subjects before enrollment into the study after the nature of the study had been explained.

Inclusion criteria for naive subjects, newly enrolled:

  1. Healthy adolescents, 13-19 years of age (the age window is defined as the first day the subject turns 13 years of age up to the day before the subject turns 20 years of age).
  2. For Minor subjects:

    • subjects who had given their written assent and whose parent or legal guardians had given written informed consent at the time of enrollment, after the nature of the study had been explained.

    For Adult subjects:

    • subjects who had given their written informed consent at the time of enrollment, after the nature of the study had been explained.
  3. Were available for the visit scheduled in the study.
  4. Were in good health as determined by medical history, physical examination, clinical judgment of the investigator.

Inclusion criteria for subjects who participated in the V72P10 study (follow-on subjects):

  1. For Minor subjects: (≤18 years of age)

    • subjects who had given their written assent and whose parent or legal guardians had given written informed consent at the time of enrollment, after the nature of the study had been explained.

    For Adult subjects: (older than 18 years of age)

    • subjects who had given their written informed consent at the time of enrollment, after the nature of the study had been explained.
  2. Who had participated in the V72P10 study and had received their last vaccination 18 months (-30 + 90 days) before enrollment in V72P10E1.
  3. Who had completed the vaccination course in study V72P10, according to the protocol.
  4. Who had provided at least the blood sample one month after the last vaccination in V72P10 (blood sample at visit 6, month 7), according to the protocol.
  5. Were available for the study visit scheduled in the study.
  6. Were in good health as determined by medical history, physical examination, clinical judgment of the investigator.

Exclusion Criteria:

Exclusion criteria for naïve subjects newly enrolled:

  1. For Minor subjects:

    • subjects who were unwilling or unable to give written informed assent to participate in the study, and whose parent(s)/legal guardian(s) were unwilling or unable to give written informed consent to participate in the study

    For Adult subjects:

    • subjects who were 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. Antibiotic treatment within 6 days prior to enrollment.
  6. Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, 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).
  7. 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 enrollment (use of low or moderate doses of inhaled steroids is not an exclusion);
  8. Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within 90 days prior to enrollment.
  9. Participation in another clinical trial within 90 days prior to enrollment or planned for during study.
  10. Family members and household members of study staff.
  11. Any condition which, in the opinion of the investigator, could have interfered with the evaluation of the study objectives.

Exclusion criteria for subjects who participated in the V72P10 study (follow-on subjects):

Exclusion criteria were the same as for naïve subjects, with the exception of criterion 2.


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): NCT01148524


Locations
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Chile
Centro de Salud Lo Barnechea
Santiago, Chile
Centro para vacunas en desarrollo. Hospital de Niños Roberto del Río
Santiago, Chile
Escuela de Medicina de la Universidad de Valparaíso
Santiago, Chile
Hospital Luis Calvo Mackenna
Santiago, Chile
Liceo Jose Victorino Lastarria
Santiago, Chile
Universidad de Chile. Facultad de Medicina
Santiago, Chile
Sponsors and Collaborators
Novartis Vaccines
Investigators
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Study Chair: Novartis Vaccines Novartis Vaccines

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Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT01148524     History of Changes
Other Study ID Numbers: V72P10E1
First Posted: June 22, 2010    Key Record Dates
Results First Posted: March 11, 2014
Last Update Posted: June 15, 2018
Last Verified: May 2018
Keywords provided by Novartis ( Novartis Vaccines ):
Meningococcal disease
Vaccines
Adolescents
Additional relevant MeSH terms:
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Meningitis, Bacterial
Vaccines
Meningococcal Infections
Meningitis, Meningococcal
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Central Nervous System Bacterial Infections
Central Nervous System Infections
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs