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

Meningitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01270503
• Other study ID #: MTA71
• Secondary ID: U1111-1116-4853
• Status: Completed
• Phase: Phase 4
• First received: January 4, 2011
• Last updated: October 31, 2014
• Start date: December 2010
• Est. completion date: July 2014

Study information

• Verified date: October 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Department of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 538
• Est. completion date: July 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningitis
• Meningococcal Disease
• Meningococcal Infections

Intervention

Biological:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Overview Within 30 Days in Participants Vaccinated With Menactra®		Day 0 up to Day 30 post-vaccination	No
Secondary	Number of Subjects Reporting Non-serious Related Adverse Events Not Listed in Prescribing Information (PI) Following Vaccination With Menactra®		Day 0 up to Day 30 post-vaccination	No

External Links

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