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

Sanofi

Status and phase: Completed; Phase 4

Conditions: Meningitis; Meningococcal Disease

Treatments: Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01270503

MTA71

U1111-1116-4853 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 538 patients

Sex: All

Ages: 2 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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538 participants in 3 patient groups

Menactra® Group 1

Experimental group

Description:

Participants aged 2 to 11 on enrollment

Treatment:

Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Menactra® Group 2

Experimental group

Description:

Participants aged 12 to 17 on enrollment

Treatment:

Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Menactra® Group 3

Experimental group

Description:

Participants aged 18 to 55 on enrollment

Treatment:

Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate