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

April 2, 2008
October 21, 2011
March 2008
January 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00657709 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Meningococcal Disease
  • Biological: Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1)
    One dose of rMenB Lot concomitantly with the routinely administered infant vaccines
  • Biological: Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2)
    One dose of rMenB concomitantly with the routinely administered infant vaccines
  • Biological: Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)
    One dose of rMenB concomitantly with the routinely administered infant vaccines
  • Biological: Routine vaccination
    Routine vaccination
  • Biological: Meningococcal group C
    One dose of the routinely administered infant vaccines + MenC vaccine
  • Experimental: 1
    Intervention: Biological: Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1)
  • Experimental: 2
    Intervention: Biological: Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2)
  • Experimental: 3
    Intervention: Biological: Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)
  • Active Comparator: 4
    Intervention: Biological: Routine vaccination
  • Active Comparator: 5
    Intervention: Biological: Meningococcal group C
Vesikari T, Esposito S, Prymula R, Ypma E, Kohl I, Toneatto D, Dull P, Kimura A; EU Meningococcal B Infant Vaccine Study group. Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials. Lancet. 2013 Mar 9;381(9869):825-35.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3630
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
55 Days to 89 Days
Yes
Contact information is only displayed when the study is recruiting subjects
Austria,   Czech Republic,   Finland,   Germany,   Italy
 
NCT00657709
V72P13, EUDRACT 2007-007781-38
Not Provided
Novartis ( Novartis Vaccines )
Novartis Vaccines
Not Provided
Study Chair: Novartis Vaccines Novartis Vaccines
Novartis
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP