Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00657709
First received: April 2, 2008
Last updated: October 21, 2011
Last verified: October 2011
  Purpose

The proposed study is aimed to assess the immunogenicity, safety and lot to lot consistency of 3 lots of Novartis Meningococcal B vaccine when given concomitantly with routine infant vaccines.


Condition Intervention Phase
Meningococcal Disease
Biological: Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1)
Biological: Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2)
Biological: Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)
Biological: Routine vaccination
Biological: Meningococcal group C
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 3, Partially Blinded, Randomized, Multi-Center, Controlled Study to Evaluate Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Immunogenicity as measured by serum bactericidal activity (SBA) of 3 doses of Meningococcal B vaccine when given to infants concomitantly with routine infant vaccines [ Time Frame: 10 months of study participation, including 6 months safety follow up ] [ Designated as safety issue: No ]
  • Consistency of immune response from 3 lots of Meningococcal B Vaccine (SBA geometric mean titer) [ Time Frame: 10 months of study participation, including 6 months safety follow up ] [ Designated as safety issue: No ]
  • Safety and tolerability of 3 doses of Meningococcal B vaccine when given concomitantly with routine infant vaccines [ Time Frame: 10 months of study participation, including 6 months safety follow up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Consistency of immune response from 3 lots of Meningococcal B vaccine, as measured by percentage of subjects with SBA titer ≥1:4 [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Non-inferiority of immunogenicity of routine infant vaccines when given concomitantly with Meningococcal B vaccine to that of routine infant vaccines given alone. [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Prevalence of meningococcal B antibodies in the subjects that received routine infant vaccines only. [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Enrollment: 3630
Study Start Date: March 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1)
One dose of rMenB Lot concomitantly with the routinely administered infant vaccines
Experimental: 2 Biological: Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2)
One dose of rMenB concomitantly with the routinely administered infant vaccines
Experimental: 3 Biological: Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)
One dose of rMenB concomitantly with the routinely administered infant vaccines
Active Comparator: 4 Biological: Routine vaccination
Routine vaccination
Active Comparator: 5 Biological: Meningococcal group C
One dose of the routinely administered infant vaccines + MenC vaccine

  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)

Exclusion Criteria:

  • 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;
  • Any serious chronic or progressive disease
  • Known or suspected impairment or alteration of the immune system
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00657709

  Show 71 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: NCT00657709     History of Changes
Other Study ID Numbers: V72P13, EUDRACT 2007-007781-38
Study First Received: April 2, 2008
Last Updated: October 21, 2011
Health Authority: United States: Food and Drug Administration
Finland: Finnish Medicines Agency
Germany: Paul-Ehrlich-Institut
Switzerland: Swissmedic
Czech Republic: SUKL
Austria: Federal Office for Safety in Health Care

Keywords provided by Novartis:
infant
Meningococcal disease
prevention
vaccination

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

ClinicalTrials.gov processed this record on April 21, 2014