NCT03548233

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 7, 2018

Completed
2.9 years until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 16, 2021

Status Verified

March 1, 2021

Enrollment Period

7 months

First QC Date

May 11, 2018

Last Update Submit

March 13, 2021

Conditions

BCG Vaccination Reaction

Outcome Measures

Primary Outcomes (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

    bcg vaccination reaction and adverse effects and factors affecting scar formation

    one year

Study Arms (1)

bcg vaccinated

OTHER

children under five year vaccinated by bcg vaccine

Biological: bcg vaccine

Interventions

bcg vaccineBIOLOGICAL

live attenuated vaccine

bcg vaccinated

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \- Children between 6 and 60 months of age.

You may not qualify if:

  • Infants with skin lesion on the left forearm.
  • Infant treated with steroids or intravenous immune globulins.
  • Infants with immunodeficiency and malnutrition.
  • Severe sepsis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

BCG Vaccine

Intervention Hierarchy (Ancestors)

Tuberculosis VaccinesBacterial VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • mohamed ghazaly, professor

    assiut universitypediatric hospital

    PRINCIPAL INVESTIGATOR

  • mustafa embaby, assistprof

    assiut universitypediatric hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

shimaa mahran, master

CONTACT

01140574639shimaamahran88@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: bcg vaccine
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 11, 2018

First Posted

June 7, 2018

Study Start

May 1, 2021

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

March 16, 2021

Record last verified: 2021-03