Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years
NCT ID: NCT00329901
Last Updated: 2014-06-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1072 participants
INTERVENTIONAL
2006-04-30
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Tdap + MenACWY-CRM
Subjects received Tdap and MenACWY-CRM vaccines concomitantly, in separate arms
Meningococcal ACWY conjugate vaccine (MenACWY-CRM)
Combined tetanus, reduced diphtheria and acellular pertussis vaccine (Tdap)
Tdap + saline
Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
Combined tetanus, reduced diphtheria and acellular pertussis vaccine (Tdap)
saline placebo
4.5 mg sodium chloride per 0.5 ml dose
MenACWY-CRM + saline
Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
Meningococcal ACWY conjugate vaccine (MenACWY-CRM)
saline placebo
4.5 mg sodium chloride per 0.5 ml dose
Interventions
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Meningococcal ACWY conjugate vaccine (MenACWY-CRM)
Combined tetanus, reduced diphtheria and acellular pertussis vaccine (Tdap)
saline placebo
4.5 mg sodium chloride per 0.5 ml dose
Eligibility Criteria
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Inclusion Criteria
* who had received the primary immunization with a vaccine containing DT or Tdap antigens and a T, Td, or Tdap booster injection at least 5 years prior to study entry
Exclusion Criteria
* previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
* serious acute, chronic or progressive disease
* history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine component
* known or suspected impairment/alteration of immune function, either congenital or acquired
11 Years
25 Years
ALL
Yes
Sponsors
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Novartis Vaccines
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Vaccines - Information Services
Role: STUDY_CHAIR
Novartis Vaccines & Diagnostics
Locations
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Andria, , Italy
Catania, , Italy
Chieti, , Italy
Ferrara, , Italy
Genova, , Italy
Lanciano, , Italy
Massafra, , Italy
Modena, , Italy
Novara, , Italy
Palermo, , Italy
Pieve Di Soligo (TV), , Italy
Roma, , Italy
Sassari, , Italy
Taranto, , Italy
Countries
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References
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Gasparini R, Conversano M, Bona G, Gabutti G, Anemona A, Dull PM, Ceddia F. Randomized trial on the safety, tolerability, and immunogenicity of MenACWY-CRM, an investigational quadrivalent meningococcal glycoconjugate vaccine, administered concomitantly with a combined tetanus, reduced diphtheria, and acellular pertussis vaccine in adolescents and young adults. Clin Vaccine Immunol. 2010 Apr;17(4):537-44. doi: 10.1128/CVI.00436-09. Epub 2010 Feb 17.
Other Identifiers
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2005-005519-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
V59P11
Identifier Type: -
Identifier Source: org_study_id
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