Safety and Immunogenicity of Meningococcal ACWY Conjugate Versus Polysaccharide Vaccine in Children 2 to 10 Years of Age
This study has been completed.
Sponsor:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00329849
First received: May 23, 2006
Last updated: March 2, 2012
Last verified: March 2012
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Purpose
Safety and immunogenicity of Meningococcal ACWY conjugate versus polysaccharide vaccine in children 2 to 10 years of age
| Condition | Intervention | Phase |
|---|---|---|
|
Meningococcal Disease |
Biological: Meningococcal ACWY conjugate vaccine Biological: Meningococcal ACWY polysaccharide vaccine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | A Phase III, Randomized, Observer Blind Multi-Center Study to Compare the Safety of One Dose of Chiron Meningococcal ACWY Conjugate Vaccine With That of a Licensed Meningococcal ACWY Polysaccharide Vaccine Administered to Healthy Children 2-10 Years of Age |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Comparison of percentage of subjects presenting at least one severe systemic reaction to the study vaccines [ Time Frame: during the first 7 days following immunization ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Comparison of the immunogenicity as percentage of subjects with human Serum Bactericidal Assay (hSBA) ³ 1:8 against N. meningitidis [ Time Frame: at 1 month after vaccination ] [ Designated as safety issue: No ]
- Comparison of the immunogenicity as: (1) percentage of subjects with hSBA ³1:4 and (2) hSBA geometric mean titers (GMTs) against N. meningitidis [ Time Frame: at 1 month after vaccination ] [ Designated as safety issue: No ]
- Comparison of the immunogenicity as: (1) percentage of subjects with hSBA ³1:8, (2) percentage of subjects with hSBA ³1:4 and (3) hSBA GMTs against N. meningitidis [ Time Frame: at day 181 after vaccination ] [ Designated as safety issue: No ]
| Enrollment: | 1500 |
| Study Start Date: | May 2006 |
| Study Completion Date: | May 2007 |
| Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Biological: Meningococcal ACWY conjugate vaccine
MenACWY vaccine, single dose, IM injection, deltoid are of arm without BCG scar
|
| Active Comparator: Arm: 2 |
Biological: Meningococcal ACWY polysaccharide vaccine
Polysaccharide vaccine, single dose, IM injection, deltoid are of arm without BCG scar.
|
Eligibility| Ages Eligible for Study: | 2 Years to 10 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy children 2 to 10 years of age inclusive
Exclusion Criteria:
- Previous or suspected disease caused by N. meningitidis Previous vaccination with a meningitis vaccine
- Any household contact with an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment
- Any auto-immune disease or other serious acute, chronic or progressive disease.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00329849
Locations
| Argentina | |
| FUNCEI, French 3085 | |
| Buenos Aires, Argentina | |
| Centro di Desarrollo de Projectos Avanzados (CEDEPAP) Roma 1465 | |
| Cordoba, Argentina | |
| Hospital de Pediatria "Sor Maria Ludovica", Calle 14, N°1632 | |
| La Plata, Argentina | |
Sponsors and Collaborators
Novartis Vaccines
Investigators
| Study Chair: | Novartis Vaccines - Drug Information Services | Novartis Vaccines & Diagnostics |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Vaccines ) |
| ClinicalTrials.gov Identifier: | NCT00329849 History of Changes |
| Other Study ID Numbers: | V59P10 |
| Study First Received: | May 23, 2006 |
| Last Updated: | March 2, 2012 |
| Health Authority: | United States: Food and Drug Administration Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
Keywords provided by Novartis:
|
Meningitis children vaccine safety efficacy |
Additional relevant MeSH terms:
|
Meningococcal Infections Neisseriaceae Infections Gram-Negative Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on May 23, 2013