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BCG Vaccination Scar Formation in Children Under Five Years :Factors Affecting Its Formation and Subsequent Adverse Effects . (bcgscars)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03548233
Recruitment Status : Not yet recruiting
First Posted : June 7, 2018
Last Update Posted : August 26, 2019
Information provided by (Responsible Party):
Shimaa Abd elhamid Mahran, Assiut University

Brief Summary:
Study of BCG Vaccination scars of under five years old children . Estimation of the frequency of children without BCG scar after BCG vaccine . Evaluation of factors which may affect scar formation . Tuberculin skin test response in children without BCG scar . Frequency of vaccine adverse effects as injection-site abscess, lymphadenitis, severe local reaction, and disseminated BCG infection.

Condition or disease Intervention/treatment Phase
BCG Vaccination Reaction Biological: bcg vaccine Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description: bcg vaccine
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: BCG Vaccination Scar Formation in Children Under Five Years :Factors Affecting Its Formation and Subsequent Adverse Effects .
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
bcg vaccinated
children under five year vaccinated by bcg vaccine
Biological: bcg vaccine
live attenuated vaccine

Primary Outcome Measures :
  1. number of children without bcg scar after bcg vaccination and factors that may lead to that nummber of children with adverse effects from bcg vaccine using clinical data about children included in the study [ Time Frame: one year ]
    bcg vaccination reaction and adverse effects and factors affecting scar formation

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

- Children between 6 and 60 months of age.

Exclusion Criteria:

  • • Infants with skin lesion on the left forearm.

    • Infant treated with steroids or intravenous immune globulins.
    • Infants with immunodeficiency and malnutrition.
    • Severe sepsis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03548233

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Contact: shimaa mahran, master 01140574639

Sponsors and Collaborators
Assiut University
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Principal Investigator: mohamed ghazaly, professor assiut universitypediatric hospital
Principal Investigator: mustafa embaby, assistprof assiut universitypediatric hospital

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Responsible Party: Shimaa Abd elhamid Mahran, principal investigator, Assiut University Identifier: NCT03548233     History of Changes
Other Study ID Numbers: bcgvaccinationscars
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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BCG Vaccine
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic