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

NCT01139021 | Completed Phase 3 Results DMC

• 2 other identifiers: V72P13E2EudraCT No 2009-018101-52
• Study Type: interventional
• Target: 508
• Locations: 2 countries
• Sites: 19

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

Keywords

Children; Meningococcal disease; Prevention; Vaccination

Outcome Measures

Primary Outcomes (3)

• Geometric Mean Titers (GMTs) to Assess Antibody Persistence at 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination.

  To assess the immunogenicity in terms of human Serum Bactericidal Assay (hSBA) GMTs through antibody persistence at 12 months after a booster (fourth) dose of Novartis Meningococcal B Recombinant Vaccine (rMenB+OMV NZ) in groups that received a three-dose primary series at 2, 4,6 months of age. Group B246\_12M12 received Measles, Mumps, Rubella, Varicella (MMRV) at 12 months of age (concomitantly) and group B246\_12M13 received MMRV at 13 months of age (separately). Analysis was done on Modified Intention-To-Treat (MITT) population- (Primary).

  12 months post booster (fourth) vaccination.

• 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.

  To assess the immunogenicity in terms of percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 through antibody persistence at 12 months after a booster (fourth) dose of rMenB+OMV NZ in groups that received a three-dose primary series at 2, 4, 6 months of age. Group B246\_12M12 received MMRV at 12 months of age (concomitantly) and group B246\_12M13 received MMRV at 13 months of age (separately). Analysis was done on MITT population (Primary).

  12 months post booster (fourth) vaccination.

• Geometric Mean Concentrations (GMCs) to Assess Antibody Persistence at One Year After a Booster Dose of rMenB+OMV NZ Vaccination.

  To assess the immunogenicity in terms of GMCs determined by Enzyme Linked Immunosorbent Assay (ELISA) through antibody persistence at one year after a booster (fourth) dose of rMenB+OMV NZ in groups that received a three-dose primary series at 2, 4, 6 months of age. Group B246\_12M12 received MMRV at 12 months of age (concomitantly) and group B246\_12M13 received MMRV at 13 months of age (separately) against vaccine antigen 287-953. Analysis was done on MITT population (Primary).

  12 months post booster (fourth) vaccination.

Secondary Outcomes (12)

• GMTs to Assess Antibody Persistence at 12 Months After Two Catch-up Doses and 6 Months After Booster Dose of rMenB+OMV NZ Vaccination.

  12 months post two catch-up dose vaccination and 6 months post booster dose.

• 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.

  6month post booster dose and 12 months post two catch-up dose vaccination.

• 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.

  1 month post booster dose versus prebooster.

• 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.

  12 months post two catch-up dose vaccination and 6 months post booster dose.

• 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.

  1 month and 6 months post two catch-up doses.

Study Arms (6)

B246_12_M12

EXPERIMENTAL

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.

Biological: rMenB+OMV NZ

B246_12M13

EXPERIMENTAL

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.

Biological: rMenB+OMV NZ

B13_15_27

EXPERIMENTAL

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.

Biological: rMenB+OMV NZ

B12_14_26

EXPERIMENTAL

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.

Biological: rMenB+OMV NZ

B_24_26

EXPERIMENTAL

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.

Biological: rMenB+OMV NZ

B12M13

EXPERIMENTAL

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

Biological: rMenB+OMV NZ

Interventions

rMenB+OMV NZ 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; B12_14_26; B13_15_27; B246_12M13; B246_12_M12; B_24_26

Eligibility Criteria

• Age: 23 Months - 27 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (19)

amostatná ordinace praktického lékaře pro děti a dorost Jindřichův Hradec

Hradec, Czechia

Location

Dětské oddělení nemocnice Náchod

Náchod, Czechia

Location

Dětské oddělení nemocnice Pardubice

Pardubice, Czechia

Location

University of Tampere Medical School, Vaccine Research Center Tampere

Biokatu 10, Pirkanmaa, 33520, Finland

Location

Espoo Vaccine Research Clinic,

Espoo, Finland

Location

Helsinki East, Vaccine Research Clinic,

Helsinki, Finland

Location

Helsinki South, Vaccine Research Clinic,

Helsinki, Finland

Location

Järvenpää, Vaccine Research Clinic

Jarvenpaa, Finland

Location

Kokkola Vaccine Research Clinic

Kokkola, Finland

Location

Kotka Vaccine Research Clinic

Kotka, Finland

Location

Kuopio Vaccine Research Clinic

Kuopio, Finland

Location

Lahti Vaccine Research Clinic

Lahti, Finland

Location

Oulu Vaccine Research Clinic

Oulu, Finland

Location

Pori Vaccine Research Clinic

Pori, Finland

Location

Seinäjoki Vaccine Research Clinic

Seinäjoki, Finland

Location

Tampere Vaccine Research Clinic

Tampere, Finland

Location

Turku Vaccine Research Clinic

Turku, Finland

Location

Vantaa East, Vaccine Research Clinic

Vantaa, Finland

Location

Vantaa West, Vaccine Research Clinic

Vantaa, Finland

Location

MeSH Terms

Conditions

Meningococcal Infections

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2010
• First Posted: June 8, 2010
• Study Start: June 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: September 1, 2011
• Last Updated: April 10, 2015
• Results First Posted: April 10, 2015

Record last verified: 2015-04

Locations

FI (16); CZ (3)