MeaslesNCT05592756
Secondary Attack Rate Measles Vaccine In Second Situation Contacts Cases Confirmed
An observational study of Measles, run by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) at 1 site in Brazil.
Trial summary
This study will be an epidemiological inquiry, in communicating confirmed measles cases. The contacts of the index cases will be asked about the measles diagnosis and previous measles vaccination, and will have their vaccination cards checked. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Measles
- How many people
- 2,964 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Apr 2020to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Communicants referring to index cases will be interviewed. Approximately 846 contacts, with 5% of losses this amount will be 890 contacts (445 vaccinated and 445 not vaccinated). Assuming an average of 20 contacts per index case, we will need approximately 45 index cases.
Who may be able to join
- Characterize contact with confirmed case of measles at home, waiting room, work, etc.
- Both sexes.
- Willingness to answer the study questionnaire.
- Have had contact with the index case, 6 days before the appearance of the rash, up to 18 days after.
- Have proof of vaccination (or authorize access to health unit vaccination records) or if you no longer have a vaccination card, state whether you have had a vaccine in the past or not.
- Willingness to provide name, address, telephone and other information so that the principal investigator and his team can contact you, if necessary (example: in case of missed visit).
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- Willingness to strictly follow the study protocol.
- At least one of the legal guardians for the research participants must be able to understand and sign the Free and Informed Consent Form. If those responsible are unable to sign (illiterate), the IC can be signed by an impartial witness who has accompanied the entire procedure
- For those over 6 years old, and under 18 years old, ability to understand and sign the Informed Consent Form.
- For those over 18, ability to understand and sign the Informed Consent Form.
Who cannot join
- Contact with the index case outside the contagion period, that is, after 18 days.
- Inform that you do not know the vaccination status.
Trial locations and contacts
1 site in 1 country.
About this study
This study will be an epidemiological inquiry, in communicating confirmed measles cases. The contacts of the index cases will be asked about the measles diagnosis and previous measles vaccination, and will have their vaccination cards checked. They will also be asked about blocking vaccination (opportune or not opportune) and about the development or not of symptoms. Thus, the investigators will have a group of people exposed to infection with a history of vaccination for measles prior to the outbreak versus a group of people exposed without previous vaccination. The frequency of measles cases will be compared in those two groups, allowing to analyze the effectiveness of the vaccine for individual protection. The effectiveness of the vaccine in preventing the spread of the disease will be analyzed, comparing the relative risk of the vaccine history of contact, in the subgroups of index cases with and without previous measles vaccination.
The proposed study will involve the collection and analysis of contact data from measles cases oriented to compare vaccinated and unvaccinated, differing from health surveillance actions. This is based on an exhaustive search for contacts of measles cases, preferably aimed at detecting susceptible individuals, with the purpose of implementing blocking vaccination and interrupting the transmission chain.
Read more
The proposed study seeks a representation of contacts, without the intention of being exhaustive in the search and detection, but prioritizing selection without bias for one of the exposure groups (vaccination).
The results may provide technical and scientific support for future decisions by the Ministry of Health regarding the primary immunization schedule, the priority of the age group in vaccination campaigns, the identification of susceptible individuals, and the assessment of the need for a 3rd dose of the vaccine, for measles.
Read the detailed description
This is a retrospective cohort study in which measles case contacts will be categorized according to their vaccination history and the secondary attack rate will be compared in vaccinated and non-vaccinated nodes.
- Conditions
- Measles
- Keywords
- soroprotegido
- Medical subject headings
- Measles
What is being measured
The primary outcome is the main question the study is designed to answer.
Measles case after index case
Measles case after index case, confirmed by laboratory or epidemiological link
Measured: 18 days after the index case
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start6 Apr 2020
- Primary completion31 Aug 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeaslesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,964 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592756
- Sponsor's protocol ID
- ASCLIN 003/2019
- Status last verified
- Jun 2023
- First submitted
- 20 Oct 2022
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Attack Rate Measles Vaccine In Second Situation Contacts Cases Confirmed
- ClinicalTrials.gov ID
- NCT05592756
- Acronym / sponsor ID
- ASCLIN 003/2019
- Conditions
- Measles
- Keywords
- soroprotegido
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,964 participants (actual)
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)University, hospital or other
- Study start
- 6 Apr 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 25 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be an epidemiological inquiry, in communicating confirmed measles cases. The contacts of the index cases will be asked about the measles diagnosis and previous measles vaccination, and will have their vaccination cards checked. They will also be asked about blocking vaccination (opportune or not opportune) and about the development or not of symptoms. Thus, the investigators will have a group of people exposed to infection with a history of vaccination for measles prior to the outbreak versus a group of people exposed without previous vaccination. The frequency of measles cases will be compared in those two groups, allowing to analyze the effectiveness of the vaccine for individual protection. The effectiveness of the vaccine in preventing the spread of the disease will be analyzed, comparing the relative risk of the vaccine history of contact, in the subgroups of index cases with and without previous measles vaccination.
The proposed study will involve the collection and analysis of contact data from measles cases oriented to compare vaccinated and unvaccinated, differing from health surveillance actions. This is based on an exhaustive search for contacts of measles cases, preferably aimed at detecting susceptible individuals, with the purpose of implementing blocking vaccination and interrupting the transmission chain.
The proposed study seeks a representation of contacts, without the intention of being exhaustive in the search and detection, but prioritizing selection without bias for one of the exposure groups (vaccination).
The results may provide technical and scientific support for future decisions by the Ministry of Health regarding the primary immunization schedule, the priority of the age group in vaccination campaigns, the identification of susceptible individuals, and the assessment of the need for a 3rd dose of the vaccine, for measles.
Detailed description
This is a retrospective cohort study in which measles case contacts will be categorized according to their vaccination history and the secondary attack rate will be compared in vaccinated and non-vaccinated nodes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Communicants referring to index cases will be interviewed. Approximately 846 contacts, with 5% of losses this amount will be 890 contacts (445 vaccinated and 445 not vaccinated). Assuming an average of 20 contacts per index case, we will need approximately 45 index cases.
Key inclusion criteria (10 listed)
- Characterize contact with confirmed case of measles at home, waiting room, work, etc.
- Both sexes.
- Willingness to answer the study questionnaire.
- Have had contact with the index case, 6 days before the appearance of the rash, up to 18 days after.
- Have proof of vaccination (or authorize access to health unit vaccination records) or if you no longer have a vaccination card, state whether you have had a vaccine in the past or not.
Key exclusion criteria (2 listed)
- Contact with the index case outside the contagion period, that is, after 18 days.
- Inform that you do not know the vaccination status.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measles case after index case
Time frame: 18 days after the index case
Measles case after index case, confirmed by laboratory or epidemiological link
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Measles, run by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measles case after index case (time frame: 18 days after the index case). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.