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CompletedNCT05592756Updated Jun 13, 2023

Secondary Attack Rate Measles Vaccine In Second Situation Contacts Cases Confirmed

An observational study in Measles, sponsored by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz). Completed at 1 site in Brazil. Per ClinicalTrials.gov, last updated 2023-06-13.

Sponsored by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
2,964
Sex
All
01

Study 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. 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.

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.

02

Conditions studied

  • Measles

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Keywords

  • soroprotegido
03

In context

Measles

134 studies on the registry are indexed under Measles; 17 are open to participants now.

This study's enrollment of 2,964 is above the median of 282 across 26 observational studies indexed under Measles.

Browse Measles studies →

Lead sponsor

The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) is the lead sponsor of 28 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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).
  • 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 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.

Exclusion criteria

Exclusion Criteria:

  • Contact with the index case outside the contagion period, that is, after 18 days.
  • Inform that you do not know the vaccination status.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
2,964 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Measles case after index case

    Measles case after index case, confirmed by laboratory or epidemiological link

    Time frame: 18 days after the index case

07

Study locations

1 site
  • Eliane Matos dos Santos
    Rio de Janeiro, ematos@bio.fiocruz.br, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05592756
Lead sponsor
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Responsible party
Sponsor
First posted
Oct 25, 2022
Start date
Apr 6, 2020
Primary completion
Aug 31, 2021
Completion
Mar 31, 2022
Last update
Jun 13, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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