A Phase 4 interventional study of Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate and Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate in Meningitis and Meningococcal Disease, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 130 sites in Philippines. Open to participants aged 2 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-11-14.
Sponsored by Sanofi Pasteur, a Sanofi Company · Phase 4, Interventional, and Prevention
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.
Each study participant will receive one dose of Menactra® vaccine and will be monitored for safety for 30 days post-vaccination.
219 studies on the registry are indexed under Meningococcal Infections; 6 are open to participants now.
This study's enrollment of 538 is above the median of 450 across 190 interventional studies indexed under Meningococcal Infections.
Browse Meningococcal Infections studies →Sanofi Pasteur, a Sanofi Company is the lead sponsor of 366 studies on the registry; 4 are open to participants now.
Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants aged 2 to 11 on enrollment
Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Participants aged 12 to 17 on enrollment
Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Participants aged 18 to 55 on enrollment
Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Also known as: Menactra®
0.5 mL, Intramuscular
Also known as: Menactra®
0.5 mL, Intramuscular
Also known as: Menactra®
Safety Overview Within 30 Days in Participants Vaccinated With Menactra®
Time frame: Day 0 up to Day 30 post-vaccination
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
The study participants were enrolled from 16 December 2010 through 15 November 2012 at 130 clinic centers in thePhillipines
| Milestone | Menactra® Vaccine Group |
|---|---|
| Started | 538 |
| Completed | 537 |
| Not completed | 1 |
| Withdrew: Lost to follow-up | 1 |
| Participants | Menactra® Vaccine Group |
|---|---|
| Serious adverse event | 0 |
| Non-serious related adverse event not listed in PI | 2 |
| Participants | Menactra® Vaccine Group |
|---|---|
| Pyrexia | 2 |
| Other non-serious related adverse events | 0 |
Collected over Adverse event data were collected from Day 0 (post vaccination) up to Day 30 post vaccination.. Non-serious events are listed at a 5.00% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Menactra® Vaccine Group | — | 0/538 (0%) | 0/537 (0%) |
Safety analysis set
| Age, Categorical(Participants) | Menactra® Vaccine Group |
|---|---|
| <=18 years | 468 |
| Between 18 and 65 years | 70 |
| >=65 years | 0 |
| Age, Continuous(Years) | Menactra® Vaccine Group |
|---|---|
| Age Continuous | 9.3 ± 10.3 |
| Gender(participants) | Menactra® Vaccine Group |
|---|---|
| Female | 272 |
| Male | 263 |
| Region of Enrollment(Participants) | Menactra® Vaccine Group |
|---|---|
| Philippines | 538 |
Showing the first 100 of 130 sites.
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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Sanofi Pasteur, a Sanofi Company