Immunity Duration Study Eight Years After Vaccination of Children 12 to 23 Months With the Triple… (NCT05154097) | Clinical Trial Compass
UnknownNot Applicable
Immunity Duration Study Eight Years After Vaccination of Children 12 to 23 Months With the Triple Viral Vaccine (Measles, Mumps and Rubella)
190 participantsStarted 2022-01-04
Plain-language summary
Several studies on the duration of immunity after the vaccine try to explain the cause of susceptibility to the measles virus even after the administration of 2 doses of the viral triple vaccine, based not only on the finding of low vaccine coverage.
In the recent measles epidemic that occurred in Brazil, beginning in 2018, we verified the predominance of the D8 genotype, with different strains. The detection of these strains is an important molecular marker to define different introductions of the same genotype, in the same geographic area, enabling better knowledge and discussion of the control strategies used.
Some news circulated in the press about a possible failure of the vaccine to protect the vaccinated population against this D8 genotype.
Regarding the mumps and rubella components, analyzes of the duration of immunity will be carried out for these 2 components, in addition to measles, since the children received in 2012 the triple viral vaccine, and there are data in the literature on the drop in antibodies to mumps, over the years. For rubella, Brazil received the rubella virus elimination certificate, and the results of duration of immunity from this study, may collaborate to know the profile of duration of immunity to rubella, in this cohort vaccinated in 2012, and who is living in a period without circulation of the wild virus.
Who can participate
Age range
6 Years – 9 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:
* Children of both sexes, aged between 8 and 9 years and who have provenly participated in the previous 2012 study.
* Agreement by the father and / or mother, or the legal guardian, with the child's participation in the study, and signing of the Informed Consent Form (ICF) and the Informed Consent Form (TALE) by the minor.
* Willingness of the father or mother, or legal guardian, to provide name, address, telephone and other information so that they can be contacted if necessary.
* Responsible (s) able (S) to understand the risks of the experiment that, although minimal, exist.
* Child able to understand TALE and accept to participate in the study.
* Responsible to understand and sign the IC. If the guardian is not able to sign (eg illiterate), the IC can be signed by an impartial witness who has accompanied the entire procedure.
* Participation availability by performing blood collection for immunity assessment.
Exclusion Criteria:
* Refusal to collect blood.
* Skin lesions at venipuncture sites that prevent collection - in this case, postpone collection.
* Child subject to abnormal bleeding after injections.
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
Duration of immunity from the triple viral vaccine
Timeframe: 8 years after the 1st dose of measles vaccine applied in the 2012 clinical study
Trial details
NCT IDNCT05154097
SponsorThe Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)