Clinical trial NCT01139021: One Year Antibody Persistence After a Fourth Dose Boost or Two Catch-Up Doses of Novartis Meningococcal B Recombinant Vaccine Administered Starting From 12 Months of Age and Response to a Third Dose Boost or Two Catch-Up Doses Starting at 24 Months of Age
Official title: A Phase 3, Open-Label, Multi-Center, Extension Study of V72P13E1 to Assess Antibody Persistence at One Year After a Fourth Dose Boost or Two Catch-Up Doses of Novartis Meningococcal B Recombinant Vaccine Administered Starting at 12 Months of Age and to Evaluate the Response to a Third Dose Boost or Two Catch-Up Doses Starting at 24 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningococcal Disease
Keywords: Children
Meningococcal disease
Prevention
Vaccination
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-06-08
Enrollment: 508
Sex: ALL
Minimum age (years): 23
Maximum age (years): 27
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: One year antibody persistence after the fourth dose boost or two catch-up doses administered starting from 12 months of age and to evaluate the response to a a third dose boost or two catch-up dose starting at 24 months of age.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female children, 23 to 27 months of age (naïve children)
* Available for all the visits scheduled in the study;
* For whom parent(s)/legal guardian(s) have given written informed consent according to local regulations after the nature of the study has been explained;
* Available for all the visits scheduled in the study;
* In good health as determined by medical history, physical examination, clinical judgment of the investigator.
* Healthy children who participated in the immunogenicity part of V72P13E1 and have received their last vaccination 12 months (-30/+60 days) before enrolment in V72P13E2;
* Who received all vaccinations with rMenB+OMV NZ in V72P13 and V72P13E1 according to the protocols;
* Who provided at least the blood sample one month after their fourth dose of rMenB+OMV NZ (groups B246_12M12/B246_12M13) or after their second dose of rMenB+OMV NZ (groups B13_15_27/B12_14_26) in V72P13E1 according to the protocol;
* For whom parent(s)/legal guardian(s) had given written informed consent after the nature of the study has been explained;
* In good health as determined by medical history, physical examination, clinical judgment of the investigator.

Exclusion Criteria:

* Subjects whose parent(s)/legal guardian(s) were unwilling or unable to give written informed consent to participate in the study;
* History of any meningococcal B vaccine administration;
* Previous ascertained or suspected disease caused by N. meningitidis;
* For whom parent(s)/legal guardian(s) have given written informed consent according to local regulations after the nature of the study has been explained;
* History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
* Antibiotics treatment within 6 days prior to enrolment;
* Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis;
* Any serious chronic or progressive disease
* Known or suspected impairment/ alteration of the immune system,
* Receipt of, or intent to immunize with another vaccine, within 30 days prior and after vaccination with the investigational vaccines (within 14 days for licensed flu vaccines)
* Significant acute or chronic infection within the previous 7 days or axillary temperature ≥38C within the previous day;
* Family members and household members of research staff;
* 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, Human Immunodeficiency Virus (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS), or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition);
* 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 enrolment (use of low or moderate doses of inhaled steroids is not an exclusion);
* Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within 90 days prior to enrolment;
* Participation in another clinical trial within 90 days prior to enrolment or planned for during study;
* Receipt of, or intent to immunize with any other vaccine(s) within 30 days prior to enrolment (exception: flu-vaccines should not be administered within 14 days prior to enrolment);
* Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

Primary outcomes:
measure: Geometric Mean Titers (GMTs) to Assess Antibody Persistence at 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination.
timeFrame: 12 months post booster (fourth) vaccination.
measure: Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at on 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination.
timeFrame: 12 months post booster (fourth) vaccination.
measure: Geometric Mean Concentrations (GMCs) to Assess Antibody Persistence at One Year After a Booster Dose of rMenB+OMV NZ Vaccination.
timeFrame: 12 months post booster (fourth) vaccination.
Secondary outcomes:
measure: GMTs to Assess Antibody Persistence at 12 Months After Two Catch-up Doses and 6 Months After Booster Dose of rMenB+OMV NZ Vaccination.
timeFrame: 12 months post two catch-up dose vaccination and 6 months post booster dose.
measure: Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at 12 Months After Two Catch up Doses and 6 Months After a Booster Doses of rMenB+OMV NZ Vaccination.
timeFrame: 6month post booster dose and 12 months post two catch-up dose vaccination.
measure: Percentage of Subjects With at Least Four Fold Increase in hSBA Titers to Evaluate Antibody Response 1 Month Post Booster Dose of rMenB+OMV NZ Vaccination.
timeFrame: 1 month post booster dose versus prebooster.
measure: GMCs to Assess Antibody Persistence at One Year After Two Catch-up Doses and 6 Months After Booster of rMenB+OMV NZ Vaccination Against 287-953 Strain.
timeFrame: 12 months post two catch-up dose vaccination and 6 months post booster dose.
measure: GMTs to Characterize Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.
timeFrame: 1 month and 6 months post two catch-up doses.
measure: Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.
timeFrame: 1 month and 6 months post two catch-up doses.
measure: Percentage of Subjects With Four Fold Increase in hSBA to Assess Antibody Response at 1 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.
timeFrame: 1 month post two catch-up doses versus prevaccination
measure: GMCs to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age Against 287-953 Strain.
timeFrame: 1 month and 6 months post two catch-up doses.
measure: Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Receiving a Booster (Third) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children.
timeFrame: Up to 7 days after any vaccination.
measure: Number of Subjects Reporting Unsolicited Adverse Events After Receiving a Booster (3rd) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children.
timeFrame: Up to 7 days after any vaccination.
measure: Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.
timeFrame: Up to 7 days after any vaccination.
measure: Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.
timeFrame: Up to 7 days after any vaccination
Other outcomes:
Locations:
city: Hradec
country: Czech Republic
facility: amostatná ordinace praktického lékaře pro děti a dorost Jindřichův Hradec
city: Náchod
country: Czech Republic
facility: Dětské oddělení nemocnice Náchod
city: Pardubice
country: Czech Republic
facility: Dětské oddělení nemocnice Pardubice
city: Biokatu 10
country: Finland
facility: University of Tampere Medical School, Vaccine Research Center Tampere
state: Tampere
city: Espoo
country: Finland
facility: Espoo Vaccine Research Clinic,
city: Helsinki
country: Finland
facility: Helsinki East, Vaccine Research Clinic,
city: Helsinki
country: Finland
facility: Helsinki South, Vaccine Research Clinic,
city: Järvenpää
country: Finland
facility: Järvenpää, Vaccine Research Clinic
city: Kokkola
country: Finland
facility: Kokkola Vaccine Research Clinic
city: Kotka
country: Finland
facility: Kotka Vaccine Research Clinic
city: Kuopio
country: Finland
facility: Kuopio Vaccine Research Clinic
city: Lahti
country: Finland
facility: Lahti Vaccine Research Clinic
city: Oulu
country: Finland
facility: Oulu Vaccine Research Clinic
city: Pori
country: Finland
facility: Pori Vaccine Research Clinic
city: Seinäjoki
country: Finland
facility: Seinäjoki Vaccine Research Clinic
city: Tampere
country: Finland
facility: Tampere Vaccine Research Clinic
city: Turku
country: Finland
facility: Turku Vaccine Research Clinic
city: Vantaa
country: Finland
facility: Vantaa East, Vaccine Research Clinic
city: Vantaa
country: Finland
facility: Vantaa West, Vaccine Research Clinic
Study officials:
References: