NCT03792022

Brief 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.

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
1,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

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

December 29, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 3, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

January 10, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2019

Completed
Last Updated

January 3, 2019

Status Verified

December 1, 2018

Enrollment Period

3 months

First QC Date

December 29, 2018

Last Update Submit

December 31, 2018

Conditions

Vaccination Failure

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Group 1

Adherence to timely vaccine uptake

Behavioral: Adherence to timely vaccine uptake

Interventions

Adherence to timely vaccine uptakeBEHAVIORAL

Adherence to timely vaccine uptake

Group 1

Eligibility Criteria

Age1 Month - 24 Months
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Vaccination records of children who have attended immunization clinics for the last 24 months.

You may qualify if:

  • Received all vaccines Available immunization records

You may not qualify if:

  • Did not receive all vaccines Non- available immunization records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 29, 2018

First Posted

January 3, 2019

Study Start

January 10, 2019

Primary Completion

March 31, 2019

Study Completion

April 2, 2019

Last Updated

January 3, 2019

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share