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

NCT01270503 | Completed Phase 4 Results

• 2 other identifiers: MTA71U1111-1116-4853
• Study Type: interventional
• Target: 538
• Locations: 1 country
• Sites: 127

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.

Conditions

Meningitis; Meningococcal Disease

Keywords

Meningitis; Meningococcal disease; Menactra®

Outcome Measures

Primary Outcomes (1)

• Safety Overview Within 30 Days in Participants Vaccinated With Menactra®

  Day 0 up to Day 30 post-vaccination

Secondary Outcomes (1)

• 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

Study Arms (3)

Menactra® Group 1

EXPERIMENTAL

Participants aged 2 to 11 on enrollment

Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Menactra® Group 2

EXPERIMENTAL

Participants aged 12 to 17 on enrollment

Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Menactra® Group 3

EXPERIMENTAL

Participants aged 18 to 55 on enrollment

Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Interventions

Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Menactra®

Menactra® Group 1

Eligibility Criteria

• Age: 2 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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
• Personal of family history of Guillain-Barré Syndrome.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (127)

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General Santos, Antique, Philippines

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Calamba, Bataan, Philippines

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Marikina City, Batangas, Philippines

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Montalban, Batangas, Philippines

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Navotas, Batangas, Philippines

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Noveleta, Batangas, Philippines

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Olongapo City, Batangas, Philippines

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Paranaque City, Batangas, Philippines

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Pasay, Batangas, Philippines

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Pasig, Batangas, Philippines

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Plaridel, Batangas, Philippines

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Quezon City, Batangas, Philippines

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Angeles City, Benguet, Philippines

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Bacolod City, Benguet, Philippines

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Baguio City, Benguet, Philippines

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Baliwag, Benguet, Philippines

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Cagayan de Oro, Bulacan, Philippines

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Cardona, Bulacan, Philippines

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Cavite City, Bulacan, Philippines

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Cebu, Bulacan, Philippines

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Cebu, Capiz, Philippines

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City of Muntinlupa, Cavite, Philippines

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Naguila, Cavite, Philippines

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Olongapo City, Cavite, Philippines

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Ormoc City, Cavite, Philippines

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Ortigas, Cavite, Philippines

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Paranaque City, Cavite, Philippines

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Pasay, Cavite, Philippines

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Pasig, Cavite, Philippines

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Pulilan, Cavite, Philippines

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Quezon City, Cavite, Philippines

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Quezon City, Cebu, Philippines

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Roxas, Cebu, Philippines

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San Fernando City, Cebu, Philippines

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San Jose, Cebu, Philippines

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Santa Rosa, Cebu, Philippines

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Tagug, Davao Del Norte, Philippines

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City of Taguig, Davao Del Sur, Philippines

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Santa Rosa, Davao Del Sur, Philippines

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Tacloban City, Davao Del Sur, Philippines

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Talisay City, Davao Del Sur, Philippines

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Tarlac City, Davao Del Sur, Philippines

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Taytay, Davao Del Sur, Philippines

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Theresa, Davao Del Sur, Philippines

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Valenzuela, Davao Del Sur, Philippines

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Bacolod City, Ilocos Norte, Philippines

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Baguio City, Ilocos Norte, Philippines

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Dasmariñas, Iloilo, Philippines

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General Santos, Iloilo, Philippines

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Iloilo City, Iloilo, Philippines

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Angeles City, Isabela, Philippines

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Baguio City, Isabela, Philippines

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Alaminos, LA Union, Philippines

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Bacolod City, La Union, Philippines

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City of Muntinlupa, Laguna, Philippines

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Ormoc City, Laguna, Philippines

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Quezon City, Laguna, Philippines

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Tacloban City, Lanao Del Norte, Philippines

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Tanauan, Lanao Del Norte, Philippines

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Quezon City, Leyte, Philippines

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San Fernando City, Leyte, Philippines

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San Miguel, Leyte, Philippines

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City of Taguig, Misamis Oriental, Philippines

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Santa Rosa, Misamis Oriental, Philippines

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Tarlac City, Misamis Oriental, Philippines

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Batangas, NCR, Philippines

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Bocaue, NCR, Philippines

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Cabanatuan City, NCR, Philippines

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Calamba, NCR, Philippines

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Caloocan, NCR, Philippines

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Cebu, NCR, Philippines

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Concepcion, NCR, Philippines

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Dagupan, NCR, Philippines

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Dasmariñas, NCR, Philippines

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Davao City, NCR, Philippines

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Fairview, NCR, Philippines

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Guagua, NCR, Philippines

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Iligan City, NCR, Philippines

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Iloilo City, NCR, Philippines

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Imus, NCR, Philippines

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Kidapawan, NCR, Philippines

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La Trinidad, NCR, Philippines

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Laoag, NCR, Philippines

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Las Piñas, NCR, Philippines

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Lipa, NCR, Philippines

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Lipa City, NCR, Philippines

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Los Baños, NCR, Philippines

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Maasin, NCR, Philippines

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Makati, NCR, Philippines

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Makati City, NCR, Philippines

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Malabon, NCR, Philippines

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Malolos, NCR, Philippines

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Mandaluyong, NCR, Philippines

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Quezon City, Negros Occidental, Philippines

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Roxas City, Negros Occidental, Philippines

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San Fernando City, Negros Occidental, Philippines

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San Jose del Monte, Negros Occidental, Philippines

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Urdaneta, North Cotobato, Philippines

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Manila, NRC, Philippines

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Marikina City, NRC, Philippines

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Baguio City, Nueva Ecija, Philippines

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Batangas, Pampanga, Philippines

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Biñan, Pampanga, Philippines

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Cagayan de Oro, Pampanga, Philippines

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Caloocan, Pampanga, Philippines

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Cebu, Pampanga, Philippines

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Angeles City, Pangasinan, Philippines

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Bacoor, Pangasinan, Philippines

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Baguio City, Pangasinan, Philippines

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Balanga, Pangasinan, Philippines

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Imus, Pasig City, Philippines

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Concepcion, Rizal, Philippines

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Davao City, Rizal, Philippines

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General Santos, Rizal, Philippines

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Imus, Rizal, Philippines

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Tacloban City, South Cotabato, Philippines

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Tagum, South Cotabato, Philippines

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Tanauan, South Cotabato, Philippines

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Tarlac City, South Cotabato, Philippines

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Taytay, South Cotabato, Philippines

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San Pedro, Southern Leyte, Philippines

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Angeles City, Tarlac, Philippines

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Bacolod City, Tarlac, Philippines

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Baguio City, Tarlac, Philippines

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Batangas, Zambales, Philippines

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Calamba, Zambales, Philippines

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Cauayan, Zambales, Philippines

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Related Links

• Related Info

MeSH Terms

Conditions

Meningitis; Meningococcal Infections

Interventions

Meningococcal Vaccines

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur Philippines, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2011
• First Posted: January 5, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: July 1, 2014
• Last Updated: November 14, 2014
• Results First Posted: November 14, 2014

Record last verified: 2014-10

Locations

PH (127)