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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

817 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Meningococcal Disease Meningococcal Meningitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

rMenB+OMV-NZ

Intervention Type BIOLOGICAL

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).

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.

Group Type OTHER

rMenB+OMV-NZ

Intervention Type BIOLOGICAL

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).

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.

Group Type OTHER

rMenB+OMV-NZ

Intervention Type BIOLOGICAL

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).

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.

Group Type OTHER

rMenB+OMV-NZ

Intervention Type BIOLOGICAL

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).

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.

Group Type OTHER

rMenB+OMV-NZ

Intervention Type BIOLOGICAL

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).

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.

Group Type OTHER

rMenB+OMV-NZ

Intervention Type BIOLOGICAL

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).

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.

Group Type OTHER

rMenB+OMV-NZ

Intervention Type BIOLOGICAL

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).

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.

Group Type OTHER

rMenB+OMV-NZ

Intervention Type BIOLOGICAL

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).

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.

Group Type OTHER

No Vaccine

Intervention Type BIOLOGICAL

Interventions

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No Vaccine

Intervention Type 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).

Intervention Type BIOLOGICAL

Other Intervention Names

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Serogroup B meningococcal recombinant vaccine

Eligibility Criteria

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Inclusion Criteria

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

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.

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

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.

Minimum Eligible Age

13 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes