Clinical trial NCT01270503: Post-Marketing Safety Study of Menactra® in Healthy Children, Adolescents, and Adults in the Philippines
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meningitis
Meningococcal Disease
Keywords: Meningitis
Meningococcal disease
Menactra®
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-01-05
Enrollment: 538
Sex: ALL
Minimum age (years): 2
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Safety Overview Within 30 Days in Participants Vaccinated With Menactra®
timeFrame: Day 0 up to Day 30 post-vaccination
Secondary outcomes:
measure: Number of Subjects Reporting Non-serious Related Adverse Events Not Listed in Prescribing Information (PI) Following Vaccination With Menactra®
timeFrame: Day 0 up to Day 30 post-vaccination
Other outcomes:
Locations:
city: General Santos City
country: Philippines
state: Antique
city: Calamba
country: Philippines
state: Bataan
city: Marikina City
country: Philippines
state: Batangas
city: Montalban
country: Philippines
state: Batangas
city: Navotas City
country: Philippines
state: Batangas
city: Noveleta
country: Philippines
state: Batangas
city: Olongapo City
country: Philippines
state: Batangas
city: Paranaque
country: Philippines
state: Batangas
city: Pasay
country: Philippines
state: Batangas
city: Pasig
country: Philippines
state: Batangas
city: Plaridel
country: Philippines
state: Batangas
city: Quezon City
country: Philippines
state: Batangas
city: Angeles City
country: Philippines
state: Benguet
city: Bacolod City
country: Philippines
state: Benguet
city: Baguio City
country: Philippines
state: Benguet
city: Baliwag
country: Philippines
state: Benguet
city: Cagayan De Oro City
country: Philippines
state: Bulacan
city: Cardona
country: Philippines
state: Bulacan
city: Cavite City
country: Philippines
state: Bulacan
city: Cebu
country: Philippines
state: Bulacan
city: Cebu
country: Philippines
state: Capiz
city: Muntinlupa
country: Philippines
state: Cavite
city: Naguila
country: Philippines
state: Cavite
city: Olongapo City
country: Philippines
state: Cavite
city: Ormoc City
country: Philippines
state: Cavite
city: Ortigas
country: Philippines
state: Cavite
city: Paranaque
country: Philippines
state: Cavite
city: Pasay
country: Philippines
state: Cavite
city: Pasig City
country: Philippines
state: Cavite
city: Pasig
country: Philippines
state: Cavite
city: Pulilan
country: Philippines
state: Cavite
city: Quezon City
country: Philippines
state: Cavite
city: Quezon City
country: Philippines
state: Cebu
city: Roxas
country: Philippines
state: Cebu
city: San Fernando City
country: Philippines
state: Cebu
city: San Jose City
country: Philippines
state: Cebu
city: Sta. Rosa
country: Philippines
state: Cebu
city: Tagug
country: Philippines
state: Davao Del Norte
city: Sta. Rosa
country: Philippines
state: Davao Del Sur
city: Tacloban City
country: Philippines
state: Davao Del Sur
city: Taguig
country: Philippines
state: Davao Del Sur
city: Talisay City
country: Philippines
state: Davao Del Sur
city: Tarlac City
country: Philippines
state: Davao Del Sur
city: Taytay
country: Philippines
state: Davao Del Sur
city: Theresa
country: Philippines
state: Davao Del Sur
city: Valenzuela City
country: Philippines
state: Davao Del Sur
city: Bacolod City
country: Philippines
state: Ilocos Norte
city: Baguio City
country: Philippines
state: Ilocos Norte
city: Dasmarinas
country: Philippines
state: Iloilo
city: General Santos City
country: Philippines
state: Iloilo
city: Iloilo City
country: Philippines
state: Iloilo
city: Angeles City
country: Philippines
state: Isabela
city: Baguio City
country: Philippines
state: Isabela
city: Alaminos City
country: Philippines
state: LA Union
city: Bacolod City
country: Philippines
state: La Union
city: Muntinlupa
country: Philippines
state: Laguna
city: Ormoc City
country: Philippines
state: Laguna
city: Quezon City
country: Philippines
state: Laguna
city: Tacloban City
country: Philippines
state: Lanao Del Norte
city: Tanauan
country: Philippines
state: Lanao Del Norte
city: Quezon City
country: Philippines
state: Leyte
city: San Fernando City
country: Philippines
state: Leyte
city: San Miguel
country: Philippines
state: Leyte
city: Sta. Rosa
country: Philippines
state: Misamis Oriental
city: Taguig
country: Philippines
state: Misamis Oriental
city: Tarlac City
country: Philippines
state: Misamis Oriental
city: Batangas City
country: Philippines
state: NCR
city: Bocaue
country: Philippines
state: NCR
city: Cabanatuan City
country: Philippines
state: NCR
city: Calamba
country: Philippines
state: NCR
city: Caloocan City
country: Philippines
state: NCR
city: Cebu
country: Philippines
state: NCR
city: Concepcion
country: Philippines
state: NCR
city: Dagupan City
country: Philippines
state: NCR
city: Dasmarinas
country: Philippines
state: NCR
city: Davao City
country: Philippines
state: NCR
city: Fairview
country: Philippines
state: NCR
city: Guagua
country: Philippines
state: NCR
city: Iligan City
country: Philippines
state: NCR
city: Iloilo City
country: Philippines
state: NCR
city: Imus
country: Philippines
state: NCR
city: Kidapawan City
country: Philippines
state: NCR
city: La Trinidad
country: Philippines
state: NCR
city: Laoag City
country: Philippines
state: NCR
city: Las Pinas City
country: Philippines
state: NCR
city: Las Pinas
country: Philippines
state: NCR
city: Lipa City
country: Philippines
state: NCR
city: Lipa
country: Philippines
state: NCR
city: Los Banos
country: Philippines
state: NCR
city: Maasin City
country: Philippines
state: NCR
city: Makati City
country: Philippines
state: NCR
city: Makati
country: Philippines
state: NCR
city: Malabon City
country: Philippines
state: NCR
city: Malolos
country: Philippines
state: NCR
city: Mandaluyong
country: Philippines
state: NCR
city: Quezon City
country: Philippines
state: Negros Occidental
city: Roxas City
country: Philippines
state: Negros Occidental
city: San Fernando City
country: Philippines
state: Negros Occidental
city: San Jose Del Monte
country: Philippines
state: Negros Occidental
city: Urdaneta City
country: Philippines
state: North Cotobato
city: Manila
country: Philippines
state: NRC
city: Marikina City
country: Philippines
state: NRC
city: Marikina
country: Philippines
state: NRC
city: Baguio City
country: Philippines
state: Nueva Ecija
city: Batangas City
country: Philippines
state: Pampanga
city: Binan
country: Philippines
state: Pampanga
city: Cagayan De Oro City
country: Philippines
state: Pampanga
city: Caloocan City
country: Philippines
state: Pampanga
city: Cebu
country: Philippines
state: Pampanga
city: Angeles City
country: Philippines
state: Pangasinan
city: Bacoor
country: Philippines
state: Pangasinan
city: Baguio City
country: Philippines
state: Pangasinan
city: Balanga City
country: Philippines
state: Pangasinan
city: Imus
country: Philippines
state: Pasig City
city: Concepcion
country: Philippines
state: Rizal
city: Davao City
country: Philippines
state: Rizal
city: General Santos City
country: Philippines
state: Rizal
city: Imus
country: Philippines
state: Rizal
city: Tacloban City
country: Philippines
state: South Cotabato
city: Tagum City
country: Philippines
state: South Cotabato
city: Tanauan
country: Philippines
state: South Cotabato
city: Tarlac City
country: Philippines
state: South Cotabato
city: Taytay
country: Philippines
state: South Cotabato
city: San Pedro
country: Philippines
state: Southern Leyte
city: Angeles City
country: Philippines
state: Tarlac
city: Bacolod City
country: Philippines
state: Tarlac
city: Baguio City
country: Philippines
state: Tarlac
city: Batangas City
country: Philippines
state: Zambales
city: Calamba
country: Philippines
state: Zambales
city: Cauayan
country: Philippines
state: Zambales
Study officials:
affiliation: Sanofi Pasteur Philippines, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: