CompletedNot Applicable

Safety Surveillance of MenACWY-CRM Vaccine in Children

United States393 participantsStarted 2011-09

Plain-language summary

The purpose of this study is to summarize the occurrence of incident serious medically attended events and events of interest up to 1 year following MenACWY-CRM vaccination administered as part of routine clinical care. This US FDA post-marketing commitment study is an open-label, descriptive, epidemiological safety surveillance study of MenACWY-CRM vaccine in subjects 2 to 10 years of age within a large US Healthcare Maintenance Organization. The 26 events of interest are events commonly evaluated in vaccine safety studies and include certain neurological, immunological, vascular, musculoskeletal and hematologic disorders. All events are collected retrospectively.

Who can participate

Age range

2 Years – 10 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: * Registered with the HMO for at least 6 months prior to vaccination. * Between the ages of 2 and 10 years (inclusive - i.e. has not reached their 11th birthday) at the time of the vaccination. * Received any MenACWY-CRM vaccination during the vaccination period at the participating centers. Exclusion Criteria: * None

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

Timing relative to vaccination date (mean days (SD)) for all serious medically attended events and events of interest

Timeframe: Observational period of 1 year following date of vaccination of that individual.

Frequency (n, %) for all serious medically attended events and events of interest

Timeframe: Observational period of 1 year following date of vaccination of that individual.

Incidence (n per person years, 95% CI) for all serious medically attended events and events of interest

Timeframe: Observational period of 1 year following date of vaccination of that individual.

Trial details

NCT IDNCT01452438

SponsorNovartis Vaccines

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-07

View on ClinicalTrials.gov More Meningococcal Disease trials

Plain-language summary

Who can participate

Age range

2 Years – 10 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.

What they're measuring

Timing relative to vaccination date (mean days (SD)) for all serious medically attended events and events of interest

Timeframe: Observational period of 1 year following date of vaccination of that individual.

Frequency (n, %) for all serious medically attended events and events of interest

Timeframe: Observational period of 1 year following date of vaccination of that individual.

Incidence (n per person years, 95% CI) for all serious medically attended events and events of interest

Timeframe: Observational period of 1 year following date of vaccination of that individual.