Post-Marketing Safety Study of Menactra® in Healthy Children, Adolescents, and Adults in the Philippines
NCT ID: NCT01270503
Last Updated: 2014-11-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
538 participants
INTERVENTIONAL
2010-12-31
2014-07-31
Brief Summary
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Primary Objective:
To describe the serious adverse events occurring within 30 days among participants who have received one dose of Menactra® vaccine.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Menactra® Group 1
Participants aged 2 to 11 on enrollment
Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Menactra® Group 2
Participants aged 12 to 17 on enrollment
Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Menactra® Group 3
Participants aged 18 to 55 on enrollment
Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Interventions
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Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
2 Years
55 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Philippines, Inc.
Locations
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General Santos, Antique, Philippines
Calamba, Bataan, Philippines
Marikina City, Batangas, Philippines
Montalban, Batangas, Philippines
Navotas, Batangas, Philippines
Noveleta, Batangas, Philippines
Olongapo City, Batangas, Philippines
Paranaque City, 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, Bulacan, Philippines
Cardona, Bulacan, Philippines
Cavite City, Bulacan, Philippines
Cebu, Bulacan, Philippines
Cebu, Capiz, Philippines
City of Muntinlupa, Cavite, Philippines
Naguila, Cavite, Philippines
Olongapo City, Cavite, Philippines
Ormoc City, Cavite, Philippines
Ortigas, Cavite, Philippines
Paranaque City, Cavite, Philippines
Pasay, 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, Cebu, Philippines
Santa Rosa, Cebu, Philippines
Tagug, Davao Del Norte, Philippines
City of Taguig, Davao Del Sur, Philippines
Santa Rosa, Davao Del Sur, Philippines
Tacloban City, 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, Davao Del Sur, Philippines
Bacolod City, Ilocos Norte, Philippines
Baguio City, Ilocos Norte, Philippines
Dasmariñas, Iloilo, Philippines
General Santos, Iloilo, Philippines
Iloilo City, Iloilo, Philippines
Angeles City, Isabela, Philippines
Baguio City, Isabela, Philippines
Alaminos, LA Union, Philippines
Bacolod City, La Union, Philippines
City of 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
City of Taguig, Misamis Oriental, Philippines
Santa Rosa, Misamis Oriental, Philippines
Tarlac City, Misamis Oriental, Philippines
Batangas, NCR, Philippines
Bocaue, NCR, Philippines
Cabanatuan City, NCR, Philippines
Calamba, NCR, Philippines
Caloocan City, NCR, Philippines
Cebu, NCR, Philippines
Concepcion, NCR, Philippines
Dagupan, NCR, Philippines
Dasmariñas, NCR, Philippines
Davao City, NCR, Philippines
Fairview, NCR, Philippines
Guagua, NCR, Philippines
Iligan City, NCR, Philippines
Iloilo City, NCR, Philippines
Imus, NCR, Philippines
Kidapawan, NCR, Philippines
La Trinidad, NCR, Philippines
Laoag, NCR, Philippines
Las Piñas, NCR, Philippines
Lipa, NCR, Philippines
Lipa City, NCR, Philippines
Los Baños, NCR, Philippines
Maasin, NCR, Philippines
Makati, NCR, Philippines
Makati City, NCR, Philippines
Malabon, 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, North Cotobato, Philippines
Manila, NRC, Philippines
Marikina City, NRC, Philippines
Baguio City, Nueva Ecija, Philippines
Batangas, Pampanga, Philippines
Biñan, Pampanga, Philippines
Cagayan de Oro, Pampanga, Philippines
Caloocan City, Pampanga, Philippines
Cebu, Pampanga, Philippines
Angeles City, Pangasinan, Philippines
Bacoor, Pangasinan, Philippines
Baguio City, Pangasinan, Philippines
Balanga, Pangasinan, Philippines
Imus, Pasig City, Philippines
Concepcion, Rizal, Philippines
Davao City, Rizal, Philippines
General Santos, Rizal, Philippines
Imus, Rizal, Philippines
Tacloban City, South Cotabato, Philippines
Tagum, 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, Zambales, Philippines
Calamba, Zambales, Philippines
Cauayan, Zambales, Philippines
Countries
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Related Links
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Related Info
Other Identifiers
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U1111-1116-4853
Identifier Type: OTHER
Identifier Source: secondary_id
MTA71
Identifier Type: -
Identifier Source: org_study_id