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Post-Marketing Safety Study of Menactra® in Healthy Children, Adolescents, and Adults in the Philippines

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ClinicalTrials.gov Identifier: NCT01270503
Recruitment Status : Completed
First Posted : January 5, 2011
Results First Posted : November 14, 2014
Last Update Posted : November 14, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE January 4, 2011
First Posted Date  ICMJE January 5, 2011
Results First Submitted Date  ICMJE October 31, 2014
Results First Posted Date  ICMJE November 14, 2014
Last Update Posted Date November 14, 2014
Study Start Date  ICMJE December 2010
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2014)
Safety Overview Within 30 Days in Participants Vaccinated With Menactra® [ Time Frame: Day 0 up to Day 30 post-vaccination ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 4, 2011)
The occurrence, nature, relationship to vaccination, outcome and seriousness criteria of any serious adverse events occurring throughout the trial. [ Time Frame: 30 Days post-vacination ]
Change History Complete list of historical versions of study NCT01270503 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2014)
Number of Subjects Reporting Non-serious Related Adverse Events Not Listed in Prescribing Information (PI) Following Vaccination With Menactra® [ Time Frame: Day 0 up to Day 30 post-vaccination ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2011)
The occurrence, nature, maximum intensity of any related non serious adverse event not listed in the Summary of Product Characteristics occurring throughout the trial [ Time Frame: 30 Days post-vaccination ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Post-Marketing Safety Study of Menactra® in Healthy Children, Adolescents, and Adults in the Philippines
Official Title  ICMJE Meningococcal (Groups A, C, Y, W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) Post-Marketing Safety Study in Healthy Children (2-11 Years), Adolescents (12-17 Years) and Adults (18-55 Years) in the Philippines
Brief Summary

This aim of the study is to assess post-marketing safety of a single dose of Menactra® vaccine with the intent to support conversion from monitored release to initial registration of Menactra® vaccine in the Philippines.

Primary Objective:

To describe the serious adverse events occurring within 30 days among participants who have received one dose of Menactra® vaccine.

Detailed Description Each study participant will receive one dose of Menactra® vaccine and will be monitored for safety for 30 days post-vaccination.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Meningitis
  • Meningococcal Disease
Intervention  ICMJE Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Name: Menactra®
Study Arms  ICMJE
  • Experimental: Menactra® Group 1
    Participants aged 2 to 11 on enrollment
    Intervention: Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
  • Experimental: Menactra® Group 2
    Participants aged 12 to 17 on enrollment
    Intervention: Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
  • Experimental: Menactra® Group 3
    Participants aged 18 to 55 on enrollment
    Intervention: Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 31, 2014)
538
Original Estimated Enrollment  ICMJE
 (submitted: January 4, 2011)
3000
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged 2 to 11 years of age on the day of inclusion (Group 1)
  • Aged 12 to 17 years of age on the day of inclusion (Group 2)
  • Aged 18 to 55 years of age on the day of inclusion (Group 3)
  • Provision of informed consent form signed by the parent(s) or legal representative (Group 1)
  • Provision of assent form signed by the subject and informed consent form signed by the parent (s) or legal representative (Group 2)
  • Provision of informed consent form signed by the subject (Group 3)
  • If the subject (Group 3) or the subject's parents or legally accepted representative (Group 1 and 2) are illiterate, an independent witness is required to sign the consent form
  • Subject and parent/legally acceptable representative (if applicable) able to attend all scheduled visits and comply with all trial procedures
  • For a woman of child-bearing potential, sexually active, use of a medically acceptable and effective method of contraception for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination (not applicable for females not of child-bearing potential or not sexually active).

Exclusion Criteria:

  • For a woman of child-bearing potential sexually active, known or suspected pregnancy or positive serum/urine pregnancy test (not applicable for females not of child-bearing potential or not sexually active)
  • Breast-feeding woman
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroid therapy
  • Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
  • Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
  • Receipt of any vaccine in the 4 weeks preceding the trial vaccination
  • Planned receipt of any vaccine during the present trial period
  • Known personal or maternal Human Immunodeficiency virus (HIV), Hepatitis B antigen or Hepatitis C seropositivity as reported by the subject/parent/guardian and/or based on medical history
  • History of seizures
  • Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular injection
  • Personal of family history of Guillain-Barré Syndrome.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Philippines
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01270503
Other Study ID Numbers  ICMJE MTA71
U1111-1116-4853 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur Philippines, Inc.
PRS Account Sanofi
Verification Date October 2014

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