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

July 22, 2008
October 21, 2011
August 2008
July 2010   (final data collection date for primary outcome measure)
  • 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 ]
  • Immunogenicity (percentage of subjects with serum bactericidal activity (SBA) titer ≥1:4) 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 ]
Complete list of historical versions of study NCT00721396 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered With or Without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules
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

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Meningococcal Infections
  • Biological: rMenB and concomitantly routine infant vaccinations
    rMenB and concomitantly routine infant vaccinations
  • Biological: rMenB and routine infant vaccinations
    rMenB and routine infant vaccinations
  • Biological: rMenB and concomitantly routine infant vaccinations
    rMenB and concomitantly routine infant vaccinations
  • Biological: Routine infant vaccines
    Routine infant vaccines only
  • Experimental: 1
    Intervention: Biological: rMenB and concomitantly routine infant vaccinations
  • Experimental: 2
    Intervention: Biological: rMenB and routine infant vaccinations
  • Experimental: 3
    Intervention: Biological: rMenB and concomitantly routine infant vaccinations
  • Active Comparator: 4
    Intervention: Biological: Routine infant vaccines
Gossger N, Snape MD, Yu LM, Finn A, Bona G, Esposito S, Principi N, Diez-Domingo J, Sokal E, Becker B, Kieninger D, Prymula R, Dull P, Ypma E, Toneatto D, Kimura A, Pollard AJ; European MenB Vaccine Study Group. Immunogenicity and tolerability of recombinant serogroup B meningococcal vaccine administered with or without routine infant vaccinations according to different immunization schedules: a randomized controlled trial. JAMA. 2012 Feb 8;307(6):573-82. doi: 10.1001/jama.2012.85.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1467
July 2010
July 2010   (final data collection date for primary outcome measure)

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.
Both
55 Days to 89 Days
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czech Republic,   Germany,   Italy,   Spain,   United Kingdom
 
NCT00721396
V72P12
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