Phase 4
Completed N=538
Post-Marketing Safety Study of Menactra® in Healthy Children, Adolescents, and Adults in the Philippines
Source: ClinicalTrials.gov NCT01270503 ↗Enrolled (actual)
538
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcomePrimary: Safety Overview Within 30 Days in Participants Vaccinated With Menactra® — 0; 2 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Overview Within 30 Days in Participants Vaccinated With Menactra® |
0; 2 | — |
| SECONDARY Number of Subjects Reporting Non-serious Related Adverse Events Not Listed in Prescribing Information (PI) Following Vaccination With Menactra® |
2; 0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01270503). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.