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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03792022
Other study ID # 002
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 10, 2019
Est. completion date April 2, 2019

Study information

Verified date December 2018
Source Lifespan Healthcare Resource Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The timeliness of routine childhood immunization should be an important component in measuring vaccination coverage rates especially in LMIC countries like Nigeria, yet this is overlooked. This study will determine the age- specific immunization timely uptake rates for the various vaccines covered in the routine childhood immunization and seek out factors that affect timely vaccine uptake among Nigerian children.


Description:

This study will determine the extent of timely and complete routine childhood vaccination uptake in Nigeria. The investigators will also seek to understand the factors that influence timely/complete uptake and make recommendations. this study will also determine if the present immunization records system in Nigeria is capable of measuring timely immunization uptake.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1800
Est. completion date April 2, 2019
Est. primary completion date March 31, 2019
Accepts healthy volunteers
Gender All
Age group 1 Month to 24 Months
Eligibility Inclusion Criteria:

- Received all vaccines Available immunization records

Exclusion Criteria:

- Did not receive all vaccines Non- available immunization records

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Adherence to timely vaccine uptake
Adherence to timely vaccine uptake

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Lifespan Healthcare Resource Limited Bill and Melinda Gates Foundation

Outcome

Type Measure Description Time frame Safety issue
Primary Age specific timely vaccination rate for all vaccines in routine vaccination schedule The primary outcome measure, age- appropriate immunization is defined as receipt of a scheduled vaccine dose within 30 days of the recommended age. Timeliness will be calculated using child health card data as at 31st December 2018. Descriptive statistics will be produced to describe the characteristics of the sample using frequencies and proportions. Descriptive outcome measures for each dose will be coded as either 'no delay'- age appropriately immunized, delay of 1-6 months' , 'delay greater than 6 months', vaccine received 'acceptably early' (within 30 days prior to when it was due), vaccines received 'too early' (within 30 days prior to when it was due) or vaccine dose not recorded. 24 months
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