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Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered With or Without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00721396
First received: July 22, 2008
Last updated: October 21, 2011
Last verified: October 2011
History of Changes
  Purpose

The proposed study is aimed to assess the safety and immunogenicity of rMenB when administered with or without routine infant vaccinations to healthy infants in their first year of life according to different immunization schedules. This study will also demonstrate that the immunogenicity of routine infant vaccines when given concomitantly with rMenB at 2, 3 and 4 months of age, is non-inferior to that of routine infant vaccines given without rMenB.


Condition Intervention Phase
Meningococcal Infections
 Biological: rMenB and concomitantly routine infant vaccinations
Biological: rMenB and routine infant vaccinations
Biological: rMenB and concomitantly routine infant vaccinations
Biological: Routine infant vaccines
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase 2b, Open Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered With or Without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Immunogenicity (percentage of subjects with serum bactericidal activity (SBA) titer ≥1:5) of rMenB, given with or without routine infant vaccines to healthy infants at 2, 4 and 6 and 2, 3 and 4 months of age, at 1 month after the third vaccination [ Time Frame: 5 months (groups 1 and 2); 3 months (groups 3 and 4) ] [ Designated as safety issue: No ]
  • Safety and tolerability of 3 doses of rMenB given: - concomitantly with routine infant vaccines at 2, 4 and 6 months of age - concomitantly with routine vaccines at 2, 3 and 4 months of age - alone at 2, 4 and 6 months of age [ Time Frame: 10 months (groups 1 and 2); 8 months (groups 3 and 4) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Non-inferiority of rMenB immunogenicity given concomitantly with routine infant vaccines at 2, 4 and 6 months versus that of rMenB without routine infant vaccines at the same time points [ Time Frame: 5 months (groups 1 and 2); 3 months (groups 3 and 4) ] [ Designated as safety issue: No ]
  • Non-inferiority of routine infant vaccines immunogenicity when given concomitantly with rMenB to healthy infants at 2, 3 and 4 months of age versus that of routine infant vaccines given without rMenB at the same time points [ Time Frame: 5 months (groups 1 and 2); 3 months (groups 3 and 4) ] [ Designated as safety issue: No ]
  • Prevalence of meningococcal B antibodies over the study period by evaluation of the serum bactericidal activity (SBA), at baseline and at 1 month after the third vaccination, in the subjects receiving routine infant vaccines alone [ Time Frame: 5 months (groups 1 and 2); 3 months (groups 3 and 4) ] [ Designated as safety issue: No ]

Enrollment: 1467
Study Start Date: August 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: rMenB and concomitantly routine infant vaccinations
rMenB and concomitantly routine infant vaccinations
Experimental: 2 Biological: rMenB and routine infant vaccinations
rMenB and routine infant vaccinations
Experimental: 3 Biological: rMenB and concomitantly routine infant vaccinations
rMenB and concomitantly routine infant vaccinations
Active Comparator: 4 Biological: Routine infant vaccines
Routine infant vaccines only

  Eligibility

Ages Eligible for Study:   55 Days to 89 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy 2-month old infants (55-89 days, inclusive), who were born after full term pregnancy with an estimated gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg;
  • for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained.

Exclusion Criteria:

  • History of any meningococcal B or C vaccine administration;
  • prior vaccination with routine infant vaccines (Diphtheria, Tetanus, Pertussis, Polio, Haemophilus influenzae type b (Hib), and Pneumococcal antigens);
  • previous ascertained or suspected disease caused by N. meningitidis
  • History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
  • significant acute or chronic infection within the previous 7 days or axillary temperature major or equal to38 degrees within the previous day;
  • antibiotics within 6 days prior to enrollment;
  • any serious chronic or progressive disease
  • known or suspected impairment or alteration of the immune system;
  • receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00721396

  Show 66 Study Locations
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00721396     History of Changes
Other Study ID Numbers: V72P12
Study First Received: July 22, 2008
Last Updated: October 21, 2011
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices
Belgium: Federal Agency for Medicinal Products and Health Products
Spain: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)
Netherlands: Ministry of Health, Welfare and Sport

Keywords provided by Novartis:
Meningococcal disease,
Neisseria meningitidis serogroup B,
Prevention,
Vaccination,
Infants

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

ClinicalTrials.gov processed this record on May 16, 2013