Clinical trial NCT01148524: Assessment of Antibody Persistence at Eighteen Months After the Completion of the Vaccination Course in Study V72P10
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Meningococcal Disease
Meningococcal Meningitis
Keywords: Meningococcal disease
Vaccines
Adolescents
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-06-22
Enrollment: 817
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: month 0 (bl=baseline), month 1 and 18 months after last vaccination in V72P10 study.
measure: Geometric Mean hSBA Titers Directed Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects.
timeFrame: month 0 (bl=baseline), month 1 and 18 months after last vaccination in V72P10 study.
measure: 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.
timeFrame: month 0 (baseline), month 1 and 18 months after last vaccination in V72P10 study.
measure: Geometric Mean Concentration Against Meningococcal 287-953 Antigen, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects.
timeFrame: 18 months after last vaccination V72P10 study.
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Centro de Salud Lo Barnechea
city: Santiago
country: Chile
facility: Centro para vacunas en desarrollo. Hospital de Niños Roberto del Río
city: Santiago
country: Chile
facility: Escuela de Medicina de la Universidad de Valparaíso
city: Santiago
country: Chile
facility: Hospital Luis Calvo Mackenna
city: Santiago
country: Chile
facility: Liceo Jose Victorino Lastarria
city: Santiago
country: Chile
facility: Universidad de Chile. Facultad de Medicina
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References: