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

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00657709

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+OMV NZ Lot 1) Biological: Serogroup B meningococcal Vaccine lot 2 (rMenB+OMV NZ Lot 2) Biological: Serogroup B meningococcal Vaccine lot 3 (rMenB+OMV NZ Lot 3) Biological: Combined DTaP-IPV-HBV-Hib vaccine or Pneumococcal 7-valent Conjugate Vaccine Biological: Meningococcal group C oligosaccharide conjugate vaccine	Phase III

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines Meningococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment:	3600
Study Start Date:	March 2008
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: Serogroup B meningococcal Vaccine lot 1 (rMenB+OMV NZ Lot 1) One dose of rMenB+OMV NZ Lot 1 at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines (i.e. combined DTaP-IPV-HBV-Hib1 vaccine and Pneumococcal 7-valent Conjugate Vaccine).
2: Experimental	Biological: Serogroup B meningococcal Vaccine lot 2 (rMenB+OMV NZ Lot 2) One dose of rMenB+OMV NZ Lot 2 at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines (i.e., combined DTaP-IPV-HBV-Hib vaccine and Pneumococcal 7-valent Conjugate Vaccine).
3: Experimental	Biological: Serogroup B meningococcal Vaccine lot 3 (rMenB+OMV NZ Lot 3) One dose of rMenB+OMV NZ Lot 3 at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines (i.e., combined DTaP-IPV-HBV-Hib vaccine and Pneumococcal 7-valent Conjugate Vaccine).
4: Active Comparator	Biological: Combined DTaP-IPV-HBV-Hib vaccine or Pneumococcal 7-valent Conjugate Vaccine One dose of the routinely administered infant vaccines (i.e., combined DTaP-IPV-HBV-Hib1 vaccine and Pneumococcal 7-valent Conjugate Vaccine)at 2, 4, 6 months of age
5: Active Comparator	Biological: Meningococcal group C oligosaccharide conjugate vaccine One dose of the routinely administered infant vaccines (i.e., combined DTaP-IPV-HBV-Hib1 vaccine and Pneumococcal 7-valent Conjugate Vaccine)+ Meningococcal group C oligosaccharide conjugate vaccine at 2, 4 and 6 months of age

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

Contacts

Contact: Novartis Vaccines

+1 800 244 7668

Show 77 Study Locations

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Study Chair:

Novartis Vaccines

More Information

Responsible Party:	Novartis Vaccines ( Novartis Vaccines & Diagnostics S.r.l.; Via Fiorentina 1, I-53100 Siena, Italy. )
Study ID Numbers:	V72P13, EUDRACT 2007-007781-38
Study First Received:	April 2, 2008
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00657709
Health Authority:	United States: Food and Drug Administration; Finland: National Agency for Medicines; 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

Study placed in the following topic categories:

Bacterial Infections
Meningococcal Infections
Healthy

Meningococcal infection
Gram-Negative Bacterial Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on January 16, 2009