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Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children
This study is ongoing, but not recruiting participants.
Study NCT00616421   Information provided by Novartis
First Received: January 31, 2008   Last Updated: October 22, 2009   History of Changes

January 31, 2008
October 22, 2009
February 2008
January 2009   (final data collection date for primary outcome measure)
To evaluate safety and immune response across groups at pre-defined time points [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00616421 on ClinicalTrials.gov Archive Site
To further evaluate safety and immunogencity across groups at pre-defined time points [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Same as current
 
Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children
A Phase 3, Randomized, Observer-blind, Multi-Center Study to Compare the Safety and Immunogenicity of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine With One Dose of Licensed Meningococcal ACWY Conjugate Vaccine Administered to Healthy Children 2-10 Years of Age

This study will evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given to healthy children compared to a licensed Meningococcal ACWY conjugate vaccine

 
Phase III
Interventional
Prevention, Randomized, Single Blind (Subject), Single Group Assignment
Meningococcal Infections
Biological: MenACWY
  • Experimental: Children 2-5 years of age, 1 dose of MenACWY
  • Active Comparator: Children 2-5 years of age, 1 dose of MenACWY
  • Experimental: Children 6-10 years of age, 1 dose of MenACWY
  • Active Comparator: Children 6-10 years of age, 1 dose of MenACWY
  • Experimental: Children 2-5 years of age, Men ACWY Day 1 and Men ACWY Day 61
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
2820
 
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy 2-10 years of age children, inclusive and for whom, after the nature of the study has been explained, the parent or legal guardian has provided written informed consent
  • who are available for all visits and telephone calls scheduled for the study
  • who are up-to-date with age-appropriate routine childhood vaccinations

Exclusion Criteria:

  • whose parent or legal guardian is unwilling or unable to give written informed consent
  • who had a previous or suspected disease caused by N. meningitidis;
  • who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
  • who have received any investigational agents or vaccines within 90 days prior to enrollment
  • who have any serious acute, chronic or progressive disease
  • who have epilepsy or any progressive neurological disease or history of Guillain Barré Syndrome
  • who have a history of anaphylaxis, serious vaccine reactions
  • who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from
  • 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
Both
2 Years to 10 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00616421
Novartis, Novartis Vaccines
V59P20, 11278
Novartis
Novartis Vaccines
Study Chair: Novartis Vaccines Novartis Vaccines
Novartis
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP