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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 )

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.


Condition or disease Intervention/treatment Phase
Meningitis Meningococcal Disease Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 538 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : July 2014


Arm Intervention/treatment
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®




Primary Outcome Measures :
  1. Safety Overview Within 30 Days in Participants Vaccinated With Menactra® [ Time Frame: Day 0 up to Day 30 post-vaccination ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01270503


  Hide Study Locations
Locations
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Philippines
General Santos City, Antique, Philippines
Calamba, Bataan, Philippines
Marikina City, Batangas, Philippines
Montalban, Batangas, Philippines
Navotas City, Batangas, Philippines
Noveleta, Batangas, Philippines
Olongapo City, Batangas, Philippines
Paranaque, Batangas, Philippines
Pasay, Batangas, Philippines
Pasig, Batangas, Philippines
Plaridel, Batangas, Philippines
Quezon City, Batangas, Philippines
Angeles City, Benguet, Philippines
Bacolod City, Benguet, Philippines
Baguio City, Benguet, Philippines
Baliwag, Benguet, Philippines
Cagayan De Oro City, Bulacan, Philippines
Cardona, Bulacan, Philippines
Cavite City, Bulacan, Philippines
Cebu, Bulacan, Philippines
Cebu, Capiz, Philippines
Muntinlupa, Cavite, Philippines
Naguila, Cavite, Philippines
Olongapo City, Cavite, Philippines
Ormoc City, Cavite, Philippines
Ortigas, Cavite, Philippines
Paranaque, Cavite, Philippines
Pasay, Cavite, Philippines
Pasig City, Cavite, Philippines
Pasig, Cavite, Philippines
Pulilan, Cavite, Philippines
Quezon City, Cavite, Philippines
Quezon City, Cebu, Philippines
Roxas, Cebu, Philippines
San Fernando City, Cebu, Philippines
San Jose City, Cebu, Philippines
Sta. Rosa, Cebu, Philippines
Tagug, Davao Del Norte, Philippines
Sta. Rosa, Davao Del Sur, Philippines
Tacloban City, Davao Del Sur, Philippines
Taguig, Davao Del Sur, Philippines
Talisay City, Davao Del Sur, Philippines
Tarlac City, Davao Del Sur, Philippines
Taytay, Davao Del Sur, Philippines
Theresa, Davao Del Sur, Philippines
Valenzuela City, Davao Del Sur, Philippines
Bacolod City, Ilocos Norte, Philippines
Baguio City, Ilocos Norte, Philippines
Dasmarinas, Iloilo, Philippines
General Santos City, Iloilo, Philippines
Iloilo City, Iloilo, Philippines
Angeles City, Isabela, Philippines
Baguio City, Isabela, Philippines
Alaminos City, LA Union, Philippines
Bacolod City, La Union, Philippines
Muntinlupa, Laguna, Philippines
Ormoc City, Laguna, Philippines
Quezon City, Laguna, Philippines
Tacloban City, Lanao Del Norte, Philippines
Tanauan, Lanao Del Norte, Philippines
Quezon City, Leyte, Philippines
San Fernando City, Leyte, Philippines
San Miguel, Leyte, Philippines
Sta. Rosa, Misamis Oriental, Philippines
Taguig, Misamis Oriental, Philippines
Tarlac City, Misamis Oriental, Philippines
Batangas City, NCR, Philippines
Bocaue, NCR, Philippines
Cabanatuan City, NCR, Philippines
Calamba, NCR, Philippines
Caloocan City, NCR, Philippines
Cebu, NCR, Philippines
Concepcion, NCR, Philippines
Dagupan City, NCR, Philippines
Dasmarinas, NCR, Philippines
Davao City, NCR, Philippines
Fairview, NCR, Philippines
Guagua, NCR, Philippines
Iligan City, NCR, Philippines
Iloilo City, NCR, Philippines
Imus, NCR, Philippines
Kidapawan City, NCR, Philippines
La Trinidad, NCR, Philippines
Laoag City, NCR, Philippines
Las Pinas City, NCR, Philippines
Las Pinas, NCR, Philippines
Lipa City, NCR, Philippines
Lipa, NCR, Philippines
Los Banos, NCR, Philippines
Maasin City, NCR, Philippines
Makati City, NCR, Philippines
Makati, NCR, Philippines
Malabon City, NCR, Philippines
Malolos, NCR, Philippines
Mandaluyong, NCR, Philippines
Quezon City, Negros Occidental, Philippines
Roxas City, Negros Occidental, Philippines
San Fernando City, Negros Occidental, Philippines
San Jose Del Monte, Negros Occidental, Philippines
Urdaneta City, North Cotobato, Philippines
Manila, NRC, Philippines
Marikina City, NRC, Philippines
Marikina, NRC, Philippines
Baguio City, Nueva Ecija, Philippines
Batangas City, Pampanga, Philippines
Binan, Pampanga, Philippines
Cagayan De Oro City, Pampanga, Philippines
Caloocan City, Pampanga, Philippines
Cebu, Pampanga, Philippines
Angeles City, Pangasinan, Philippines
Bacoor, Pangasinan, Philippines
Baguio City, Pangasinan, Philippines
Balanga City, Pangasinan, Philippines
Imus, Pasig City, Philippines
Concepcion, Rizal, Philippines
Davao City, Rizal, Philippines
General Santos City, Rizal, Philippines
Imus, Rizal, Philippines
Tacloban City, South Cotabato, Philippines
Tagum City, South Cotabato, Philippines
Tanauan, South Cotabato, Philippines
Tarlac City, South Cotabato, Philippines
Taytay, South Cotabato, Philippines
San Pedro, Southern Leyte, Philippines
Angeles City, Tarlac, Philippines
Bacolod City, Tarlac, Philippines
Baguio City, Tarlac, Philippines
Batangas City, Zambales, Philippines
Calamba, Zambales, Philippines
Cauayan, Zambales, Philippines
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur Philippines, Inc.

Additional Information:
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01270503     History of Changes
Other Study ID Numbers: MTA71
U1111-1116-4853 ( Other Identifier: WHO )
First Posted: January 5, 2011    Key Record Dates
Results First Posted: November 14, 2014
Last Update Posted: November 14, 2014
Last Verified: October 2014
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Meningitis
Meningococcal disease
Menactra®
Additional relevant MeSH terms:
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Meningococcal Infections
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections