Trial record 1 of 1 for:
MTA71
Post-Marketing Safety Study of Menactra® in Healthy Children, Adolescents, and Adults in the Philippines
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01270503 |
|
Recruitment Status :
Completed
First Posted : January 5, 2011
Results First Posted : November 14, 2014
Last Update Posted : November 14, 2014
|
Sponsor:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Meningitis Meningococcal Disease | Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 538 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| 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 |
| Study Start Date : | December 2010 |
| Actual Primary Completion Date : | December 2013 |
| Actual Study Completion Date : | July 2014 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Menactra® Group 1
Participants aged 2 to 11 on enrollment
|
Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Name: Menactra® |
|
Experimental: Menactra® Group 2
Participants aged 12 to 17 on enrollment
|
Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Name: Menactra® |
|
Experimental: Menactra® Group 3
Participants aged 18 to 55 on enrollment
|
Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Name: Menactra® |
Primary Outcome Measures :
- Safety Overview Within 30 Days in Participants Vaccinated With Menactra® [ Time Frame: Day 0 up to Day 30 post-vaccination ]
Secondary Outcome Measures :
- Number of Subjects Reporting Non-serious Related Adverse Events Not Listed in Prescribing Information (PI) Following Vaccination With Menactra® [ Time Frame: Day 0 up to Day 30 post-vaccination ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 2 Years to 55 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01270503
Locations
Show 130 study locations
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
| Study Director: | Medical Director | Sanofi Pasteur Philippines, Inc. |
Additional Information:
| Responsible Party: | Sanofi Pasteur, a Sanofi Company |
| ClinicalTrials.gov Identifier: | NCT01270503 |
| Other Study ID Numbers: |
MTA71 U1111-1116-4853 ( Other Identifier: WHO ) |
| First Posted: | January 5, 2011 Key Record Dates |
| Results First Posted: | November 14, 2014 |
| Last Update Posted: | November 14, 2014 |
| Last Verified: | October 2014 |
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
|
Meningitis Meningococcal disease Menactra® |
Additional relevant MeSH terms:
|
Meningococcal Infections Meningitis Neuroinflammatory Diseases Nervous System Diseases Neisseriaceae Infections |
Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections |