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
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: 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
Bacterial Infections
Gram-Negative Bacterial Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on October 23, 2014