One Year Antibody Persistence After a Fourth Dose Boost or Two Catch-Up Doses of Novartis Meningococcal B Recombinant Vaccine and Response to a Third Dose Boost or Two Catch-Up Doses Starting at 24 Months of Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01139021
First received: June 4, 2010
Last updated: December 30, 2013
Last verified: December 2013
  Purpose

One year antibody persistence after the fourth dose boost or two catch-up doses administered starting from 12 months of age.


Condition Intervention Phase
Meningococcal Disease
Biological: Serogroup B meningococcal Vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 1-yr antibody persistence after the fourth dose of rMenB+OMV NZ administered at 12 months of age assessed by SBA [ Time Frame: Individual subject participation is either one study visit, approx. 6 months or approx. 8 months, depending on the study group. ] [ Designated as safety issue: Yes ]
  • Number of subjects with solicited local and systemic reactions and SAEs as a measure of safety and tolerability of a booster (third) dose or two catch-up doses of rMenB+OMV NZ administered starting at 24 months of age. [ Time Frame: Individual subject participation is either one study visit, approx. 6 months or approx. 8 months, depending on the study group. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ab persistence at 1 yr after 2 catch-up doses starting 12 mo of age [ Time Frame: Individual subject participation is either one study visit, approx. 6 months or approx. 8 months, depending on the study group. ] [ Designated as safety issue: Yes ]
  • Ab response and 6 m Ab persistence of third dose at 1 yr after 2 catch-up doses [ Time Frame: Individual subject participation is either one study visit, approx. 6 months or approx. 8 months, depending on the study group. ] [ Designated as safety issue: Yes ]
  • Ab response and 6 m Ab persistence of 2 catch-up doses administered to naïve children at 24 and 26 m of age. [ Time Frame: Individual subject participation is either one study visit, approx. 6 months or approx. 8 months, depending on the study group. ] [ Designated as safety issue: Yes ]

Enrollment: 508
Study Start Date: June 2010
Study Completion Date: September 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 Biological: Serogroup B meningococcal Vaccine
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.
Experimental: Group 2 Biological: Serogroup B meningococcal Vaccine
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.
Active Comparator: Group 3 Biological: Serogroup B meningococcal Vaccine
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.

  Eligibility

Ages Eligible for Study:   23 Months to 27 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female children, 23 to 27 months of age (naïve children)
  • Healthy male and female children who have participated in the immunogenicity part of V72P13E1 and have received their last vaccination 12 months before enrollment in V72P13E2, who have received all vaccinations with rMenB+OMV NZ in V72P13 and V72P13E1 according to the protocols and have provided at least the blood sample one month after their fourth dose of rMenB+OMV NZ (Groups 1a/1b) or after their second dose of rMenB+OMV NZ (Groups 2a/2b)

Exclusion Criteria:

  • Previous ascertained or suspected disease caused by N. meningitidis;
  • History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01139021

Locations
Czech Republic
Dětské oddělení nemocnice Náchod
Náchod, Czech Republic
Dětské oddělení nemocnice Pardubice
Pardubice, Czech Republic
Finland
University of Tampere Medical School, Vaccine Research Center Tampere
Biokatu 10, Tampere, Finland, 33520
Espoo Vaccine Research Clinic,
Espoo, Finland
Helsinki South, Vaccine Research Clinic,
Helsinki, Finland
Helsinki East, 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
Sponsors and Collaborators
Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01139021     History of Changes
Other Study ID Numbers: V72P13E2, EudraCT No 2009-018101-52
Study First Received: June 4, 2010
Last Updated: December 30, 2013
Health Authority: Finland: Finnish Medicines Agency
United States: Food and Drug Administration
European Union: European Medicines Agency

Keywords provided by Novartis:
Children
Meningococcal disease
Prevention
Vaccination

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 18, 2014