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

This study is currently recruiting participants.
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
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 April 15, 2014