Meningitis, Meningococcal Disease
Conditions
Keywords
Meningitis, Meningococcal disease, Menactra®
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.
Detailed description
Each study participant will receive one dose of Menactra® vaccine and will be monitored for safety for 30 days post-vaccination.
Interventions
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Overview Within 30 Days in Participants Vaccinated With Menactra® | Day 0 up to Day 30 post-vaccination |
Secondary
| Measure | Time frame |
|---|---|
| Number of Subjects Reporting Non-serious Related Adverse Events Not Listed in Prescribing Information (PI) Following Vaccination With Menactra® | Day 0 up to Day 30 post-vaccination |
Countries
Philippines
Participant flow
Recruitment details
The study participants were enrolled from 16 December 2010 through 15 November 2012 at 130 clinic centers in thePhillipines
Pre-assignment details
A total of 538 participants who met all of the inclusion and none of the exclusion criteria were vaccinated in this study.
Participants by arm
| Arm | Count |
|---|---|
| Menactra® Vaccine Group Participants who received a single dose of Menactra vaccine | 538 |
| Total | 538 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Menactra® Vaccine Group |
|---|---|
| Age, Categorical <=18 years | 468 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 70 Participants |
| Age, Continuous Age Continuous | 9.3 Years STANDARD_DEVIATION 10.3 |
| Gender Female | 272 participants |
| Gender Male | 263 participants |
| Region of Enrollment Philippines | 538 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 537 |
| serious Total, serious adverse events | 0 / 538 |
Outcome results
Primary
Safety Overview Within 30 Days in Participants Vaccinated With Menactra®
Time frame: Day 0 up to Day 30 post-vaccination
Population: Post-vaccination safety were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra® Vaccine Group | Safety Overview Within 30 Days in Participants Vaccinated With Menactra® | Serious adverse event | 0 Participants |
| Menactra® Vaccine Group | Safety Overview Within 30 Days in Participants Vaccinated With Menactra® | Non-serious related adverse event not listed in PI | 2 Participants |
Secondary
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
Population: Post-vaccination safety were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra® Vaccine Group | Number of Subjects Reporting Non-serious Related Adverse Events Not Listed in Prescribing Information (PI) Following Vaccination With Menactra® | Pyrexia | 2 Participants |
| Menactra® Vaccine Group | Number of Subjects Reporting Non-serious Related Adverse Events Not Listed in Prescribing Information (PI) Following Vaccination With Menactra® | Other non-serious related adverse events | 0 Participants |