A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents
A Phase 3, Single-Center, Open-label, Controlled, Randomized Study to Evaluate the Safety and Immunogenicity of Novartis Men ACWY Vaccine Administered Either Alone or Concomitantly With a Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine and Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine in Healthy Adolescents
This date has not been verified as actual or estimated.
Primary Completion
April 2008
Actual (reported)
Study Completion
October 2008
Actual (reported)
Brief Summary
This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with Tdap and HPV vaccinations to healthy adolescents
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
completed
Actual enrollment (reported)
1,620 participants
Study completion date
October 2008
Actual (reported)
Listed locations
1 countries · 1 sites
Trial Relationships
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Related Scientific Literature
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
Study Start
July 2007
Date type not reported
This date has not been verified as actual or estimated.
Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse
Immune responses to MenACWY, as measured by the percentage of hSBA seroresponders, when given: (a) alone; (b) concomitantly with a Tetanus diphtheria acellular pertussis (Tdap) vaccine and a Human Papillomavirus Recombinant (HPV) vaccine; and (c) when given one month after a Tdap vaccine.
Seroresponse to MenACWY: For a subject with baseline hSBA titer \<1:4, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with baseline hSBA titer ≥ 1:4, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
1 month post MenACWY vaccination
Percentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL
To compare the immune response to Tdap given concomitantly with MenACWY and HPV vaccine with the immune response to Tdap when administered alone
1 month post Tdap vaccination
Study Arms (3)
MenACWY + Tdap + HPV
EXPERIMENTAL
Subjects received MenACWY concomitantly with Tdap and HPV at study month 0 followed by two injections of HPV at month 2 and 6
Arguedas A, Soley C, Loaiza C, Rincon G, Guevara S, Perez A, Porras W, Alvarado O, Aguilar L, Abdelnour A, Grunwald U, Bedell L, Anemona A, Dull PM. Safety and immunogenicity of one dose of MenACWY-CRM, an investigational quadrivalent meningococcal glycoconjugate vaccine, when administered to adolescents concomitantly or sequentially with Tdap and HPV vaccines. Vaccine. 2010 Apr 19;28(18):3171-9. doi: 10.1016/j.vaccine.2010.02.045. Epub 2010 Feb 26.
Meningitis, BacterialCentral Nervous System Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsMeningococcal InfectionsNeisseriaceae InfectionsGram-Negative Bacterial InfectionsCentral Nervous System InfectionsCentral Nervous System Diseases
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who have been properly vaccinated against diphtheria, tetanus, pertussis
You may not qualify if:
who had a previous confirmed or suspected disease caused by N. meningitidis;
who have previously been immunized with a meningococcal vaccine
who have received prior human papillomavirus (HPV) vaccine;
who have any serious acute, chronic or progressive disease
who have epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome;
who have a known or suspected impairment/alteration of immune function, either congenital or acquired
who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
who have Down's syndrome or other known cytogenic disorders;
Contact the study team to confirm eligibility.
Nervous System Diseases
Neuroinflammatory Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Communicable Diseases
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Genital Diseases
Urogenital Diseases
Disease Attributes
Pathologic Processes
Pathological Conditions, Signs and Symptoms
Bordetella Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Primary Completion
April 2008
Actual (reported)
Study Completion
October 2008
Actual (reported)
Last Updated
May 18, 2016
Results First Posted
October 4, 2010
Record last verified: 2016-04
Source record
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Source: ClinicalTrials.gov.
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