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

NCT ID: NCT01139021

Last Updated: 2015-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 508 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-09-30

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.

Conditions

Meningococcal Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

B246_12_M12

Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.

Group Type: EXPERIMENTAL

rMenB+OMV NZ

Intervention Type: BIOLOGICAL

Subjects will be assigned to a study group based on the group assignment in the parent study (follow-on subjects). In addition, one group of naïve age-matched subjects will be recruited at the same study sites. Subjects who had received 4 doses of rMenB+OMV NZ will have one visit including one blood draw. Subjects who had received two catch-up doses in V72P13E1 will receive a third dose boost and will have 3 blood samples drawn. Naïve subjects will receive two catch-up doses and have 3 blood samples drawn.

B246_12M13

Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.

Group Type: EXPERIMENTAL

rMenB+OMV NZ

Intervention Type: BIOLOGICAL

Subjects will be assigned to a study group based on the group assignment in the parent study (follow-on subjects). In addition, one group of naïve age-matched subjects will be recruited at the same study sites. Subjects who had received 4 doses of rMenB+OMV NZ will have one visit including one blood draw. Subjects who had received two catch-up doses in V72P13E1 will receive a third dose boost and will have 3 blood samples drawn. Naïve subjects will receive two catch-up doses and have 3 blood samples drawn.

B13_15_27

Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.

Group Type: EXPERIMENTAL

rMenB+OMV NZ

Intervention Type: BIOLOGICAL

Subjects will be assigned to a study group based on the group assignment in the parent study (follow-on subjects). In addition, one group of naïve age-matched subjects will be recruited at the same study sites. Subjects who had received 4 doses of rMenB+OMV NZ will have one visit including one blood draw. Subjects who had received two catch-up doses in V72P13E1 will receive a third dose boost and will have 3 blood samples drawn. Naïve subjects will receive two catch-up doses and have 3 blood samples drawn.

B12_14_26

Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.

Group Type: EXPERIMENTAL

rMenB+OMV NZ

Intervention Type: BIOLOGICAL

Subjects will be assigned to a study group based on the group assignment in the parent study (follow-on subjects). In addition, one group of naïve age-matched subjects will be recruited at the same study sites. Subjects who had received 4 doses of rMenB+OMV NZ will have one visit including one blood draw. Subjects who had received two catch-up doses in V72P13E1 will receive a third dose boost and will have 3 blood samples drawn. Naïve subjects will receive two catch-up doses and have 3 blood samples drawn.

B_24_26

Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.

Group Type: EXPERIMENTAL

rMenB+OMV NZ

Intervention Type: BIOLOGICAL

Subjects will be assigned to a study group based on the group assignment in the parent study (follow-on subjects). In addition, one group of naïve age-matched subjects will be recruited at the same study sites. Subjects who had received 4 doses of rMenB+OMV NZ will have one visit including one blood draw. Subjects who had received two catch-up doses in V72P13E1 will receive a third dose boost and will have 3 blood samples drawn. Naïve subjects will receive two catch-up doses and have 3 blood samples drawn.

B12M13

Subject was randomized in group B13\_15\_27 but treated as group B12\_M13.

Group Type: EXPERIMENTAL

rMenB+OMV NZ

Intervention Type: BIOLOGICAL

Subjects will be assigned to a study group based on the group assignment in the parent study (follow-on subjects). In addition, one group of naïve age-matched subjects will be recruited at the same study sites. Subjects who had received 4 doses of rMenB+OMV NZ will have one visit including one blood draw. Subjects who had received two catch-up doses in V72P13E1 will receive a third dose boost and will have 3 blood samples drawn. Naïve subjects will receive two catch-up doses and have 3 blood samples drawn.

Interventions

rMenB+OMV NZ

Subjects will be assigned to a study group based on the group assignment in the parent study (follow-on subjects). In addition, one group of naïve age-matched subjects will be recruited at the same study sites. Subjects who had received 4 doses of rMenB+OMV NZ will have one visit including one blood draw. Subjects who had received two catch-up doses in V72P13E1 will receive a third dose boost and will have 3 blood samples drawn. Naïve subjects will receive two catch-up doses and have 3 blood samples drawn.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 23 Months
• Maximum Eligible Age: 27 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Vaccines

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

amostatná ordinace praktického lékaře pro děti a dorost Jindřichův Hradec

Hradec, , Czechia

Dětské oddělení nemocnice Náchod

Náchod, , Czechia

Dětské oddělení nemocnice Pardubice

Pardubice, , Czechia

University of Tampere Medical School, Vaccine Research Center Tampere

Biokatu 10, Pirkanmaa, Finland

Espoo Vaccine Research Clinic,

Espoo, , Finland

Helsinki East, Vaccine Research Clinic,

Helsinki, , Finland

Helsinki South, Vaccine Research Clinic,

Helsinki, , Finland

Järvenpää, Vaccine Research Clinic

Järvenpää, , Finland

Kokkola Vaccine Research Clinic

Kokkola, , Finland

Kotka Vaccine Research Clinic

Kotka, , Finland

Kuopio Vaccine Research Clinic

Kuopio, , Finland

Lahti Vaccine Research Clinic

Lahti, , Finland

Oulu Vaccine Research Clinic

Oulu, , Finland

Pori Vaccine Research Clinic

Pori, , Finland

Seinäjoki Vaccine Research Clinic

Seinäjoki, , Finland

Tampere Vaccine Research Clinic

Tampere, , Finland

Turku Vaccine Research Clinic

Turku, , Finland

Vantaa East, Vaccine Research Clinic

Vantaa, , Finland

Vantaa West, Vaccine Research Clinic

Vantaa, , Finland

Countries

Czechia; Finland

Other Identifiers

EudraCT No 2009-018101-52

Identifier Type: -

Identifier Source: secondary_id

V72P13E2

Identifier Type: -

Identifier Source: org_study_id