Safety of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate V… (NCT02640404) | Clinical Trial Compass
CompletedPhase 2
Safety of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine in Healthy Subjects in Vietnam
Vietnam224 participantsStarted 2016-06-06
Plain-language summary
The aim of the study is to assess the safety of Menactra vaccine in infants, toddlers, children, adolescents, and adults
Objective:
* To describe the safety profile after each and any dose (when applicable) of Menactra vaccine in participants aged 9 months to 55 years for registration.
Who can participate
Age range
9 Months – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 9 months to 55 years on the day of the first study visit
* For adults: Informed consent form had been signed and dated by the participant For minors: Informed consent form had been signed and dated by the parent or legally acceptable representative. In addition, in accordance with the Independent Ethics Committee /Institutional Review Board requirements and as appropriate for the age of the participant, the participant may be required to sign and date the informed consent form if aged 12 to 17 years or assent form if aged 8 to 11 years
* Participant and/or parent/legally acceptable representative (if applicable) were able to attend all scheduled visits and to comply with all study procedures
Exclusion Criteria:
* Participation at the time of study enrollment (or in the 4 weeks preceding study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
* Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine in the 4 weeks following study vaccination
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (\>=2 mg/kg/day prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
* Known systemic h…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Reporting Solicited Injection-Site Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months)
Timeframe: Within 7 days post-vaccination 1, Within 7 days post-vaccination 2
2
Number of Participants Reporting Solicited Injection-Site Reactions Following Vaccination: Menactra® Vaccine (2 to 55 Years)
Timeframe: Within 7 days post-vaccination
3
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months)
Timeframe: Within 7 days post-vaccination 1, Within 7 days post-vaccination 2
4
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (2 to 55 Years)