Safety, Tolerability and Immunogenicity of Three Doses of Novartis Meningococcal B Vaccine When Administered to Healthy At-risk Adults
This study has been completed.
Sponsor:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00560313
First received: November 16, 2007
Last updated: December 8, 2011
Last verified: December 2011
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Purpose
This study is aimed to evaluate safety, tolerability and immunogenicity of three doses of Novartis 4CMenB and of one dose of Novartis Meningococcal ACWY vaccine when administered to healthy at-risk adults.
| Condition | Intervention | Phase |
|---|---|---|
|
Meningococcal Disease |
Biological: Men ACWY CRM Biological: 4CMenB |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Phase 2, Multi-Center, Open-label Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2, 6-Month Schedule and of a Single Dose of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy At-risk Adults 18-50 Years of Age |
Resource links provided by NLM:
MedlinePlus related topics:
Meningococcal Infections
Drug Information available for:
Lactitol
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination [ Time Frame: one month after vaccination ] [ Designated as safety issue: No ]Geometric mean titers(GMT) and the respective confidence intervals measured after each vaccination against the three different meningococcal strains.
- Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination [ Time Frame: one month after vaccination ] [ Designated as safety issue: No ]
Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; %≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains:
- prior to the first vaccination
- 30 days following the first, second, prior to the third and 30 days after the third vaccination
- Geometric Mean Titer (GMT) of the Meningococcal ACWY Vaccine at One Month After Vaccination [ Time Frame: one month after vaccination ] [ Designated as safety issue: No ]Geometric mean titer (GMT) of the Meningococcal ACWY Vaccine at One Month After the Immunization against the A, C, W-135 and Y strains.
- Percentage of Participants With Serum Bactericidal Activity of the Meningococcal ACWY Vaccine at One Month After Vaccination [ Time Frame: one month after vaccination ] [ Designated as safety issue: No ]
Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; %≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains:
- prior to the first vaccination
- 30 days following the first, second, prior to the third and 30 days after the third vaccination
- Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination [ Time Frame: one month after vaccination ] [ Designated as safety issue: Yes ]the number of subjects who reported solicited reactions after the administration of the Meningococcal B vaccine at a 0, 2, 6-month schedule and the administration of the Meningococcal A, C, W, and Y vaccine at month 7.
| Enrollment: | 54 |
| Study Start Date: | July 2007 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 4CMenB |
Biological: 4CMenB
All subjects will receive the study vaccine following a 0,2,6 vaccination schedule. Pre-filled syringe, administered by intramuscular injection into the deltoid area of the non dominant arm.
|
| Experimental: MenACWY CRM |
Biological: Men ACWY CRM
a single dose of a 0.5 mL injectable solution
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- healthy adults,18 through 50 years of age, who are or may be routinely exposed to N. meningitidis cultures
Exclusion Criteria:
- previous ascertained or suspected disease caused by N. meningitidis;
- pregnancy or breastfeeding;
- history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
- any present or suspected serious acute or chronic disease
- known or suspected autoimmune disease or impairment /alteration of immune function
Contacts and Locations More Information
Publications:
| Responsible Party: | Novartis ( Novartis Vaccines ) |
| ClinicalTrials.gov Identifier: | NCT00560313 History of Changes |
| Other Study ID Numbers: | V72P4, 2007-001563-29 |
| Study First Received: | November 16, 2007 |
| Results First Received: | June 6, 2011 |
| Last Updated: | December 8, 2011 |
| Health Authority: | Germany: Paul-Ehrlich-Institut |
Keywords provided by Novartis:
|
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 16, 2013