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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01270503
First received: January 4, 2011
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Meningitis
Meningococcal Disease
Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 3000
Study Start Date: December 2010
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Menactra® Group 1
Participants aged 2 to 11 on enrollment
Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Name: Menactra®
Experimental: Menactra® Group 2
Participants aged 12 to 17 on enrollment
Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Name: Menactra®
Experimental: Menactra® Group 3
Participants aged 18 to 55 on enrollment
Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Name: Menactra®

Detailed Description:

Each study participant will receive one dose of Menactra® vaccine and will be monitored for safety for 30 days post-vaccination.

  Eligibility

Ages Eligible for Study:   2 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01270503

Contacts
Contact: Public Registry Sanofi Pasteur RegistryContactUs@sanofipasteur.com

  Show 130 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Director Sanofi Pasteur Philippines, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01270503     History of Changes
Other Study ID Numbers: MTA71, U1111-1116-4853
Study First Received: January 4, 2011
Last Updated: March 12, 2014
Health Authority: Philippines: Department of Health

Keywords provided by Sanofi:
Meningitis
Meningococcal disease
Menactra®

Additional relevant MeSH terms:
Meningitis
Meningococcal Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 15, 2014