Post-Marketing Safety Study of Menactra® in Healthy Children, Adolescents, and Adults in the Phil… (NCT01270503) | Clinical Trial Compass
CompletedPhase 4
Post-Marketing Safety Study of Menactra® in Healthy Children, Adolescents, and Adults in the Philippines
Philippines538 participantsStarted 2010-12
Plain-language 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.
Who can participate
Age range2 Years – 55 Years
SexALL
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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 …
What they're measuring
1
Safety Overview Within 30 Days in Participants Vaccinated With Menactra®