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

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:

MedlinePlus related topics: Meningococcal Infections

Drug Information available for: Meningococcal Vaccines

U.S. FDA Resources

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

More Information

No publications provided

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 May 19, 2013