Submitted by: Erah Jean Baria N/A Last Updated by: Erah Jean Baria 2020-07-02 14:26:05


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

PHRR121203-000026

Protocol No. MTA 71

Unspecified

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

The aim of this 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.

Start Date Duration in Months Target Completion Date Actual Completion Date
2010-12-01 36 2013-12-01 2012-11-15

Completed

Institution Classification Region LTO #
Sanofi Pasteur Private Business NCR
Institution Region
Sanofi Pasteur NCR
Name E-Mail Phone Number Postal Address
Erah Jean Baria erahjean.baria@sanofi pasteur.com +632 4799106 4F Feliza Bldg, 108 V.A Rufino St., Legaspi Village Makati City
Name E-Mail Phone Number Postal Address
Ruby Dizon ruby.dizon@sanofipasteur.com +632 4799124 4F Feliza Bldg, 108 V.A Rufino St., Legaspi Village Makati City
Name Expertise Affiliation
May Book-Montellano, MD Pediatric and Infectious Diseases Specialist Mary Chiles General Hospital
Project Location Institutional Ethics Review Board
Mary Chiles General Hospital Mary Chiles General Hospital Ethics Review Committee

Meningitis Meningococcal Disease

To describe the serious adverse events occurring within 30 days among participants who have received one dose of Menactra® vaccine

Unspecified

Recruiting

  • Philippines

Clinical Trial

Unspecified

0000-00-00

None

1. Aged 2 through 55 years of age on the day of inclusion 2. Children 2-11 years of age: Informed consent form signed by the parent(s) or legal representative Adolescents 12-17 years of age: Informed consent form signed by the parent(s) or legal representative and either the informed consent form or an assent form signed by the subject Adults 18-55 years of age: Informed consent form signed by the subject 3. Subject has received one dose of Menactra vaccination on the day of inclusion as per routine immunization practice

Observational

Unspecified

Unspecified

Unspecified

Unspecified

Unspecified

Not Applicable

Prevention

Phase IV

3000

Unspecified

NA

01 Dec 2010

Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
Posters
Others

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