Timeliness and Completeness of Routine Childhood Vaccinations by 2 Years of Age in Nigeria.

Fully Vaccinated Yet Under-vaccinated: Timeliness and Completeness of Routine Childhood Vaccinations by 2 Years of Age in Nigeria

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.

Study Overview

• Status: Unknown
• Conditions: Vaccination Failure
• Intervention / Treatment: Behavioral: Adherence to timely vaccine uptake

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 1800

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 years (CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Received all vaccines Available immunization records

Exclusion Criteria:

• Did not receive all vaccines Non- available immunization records

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Adherence to timely vaccine uptake	Behavioral: Adherence to timely vaccine uptake; Adherence to timely vaccine uptake

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Lifespan Healthcare Resource Limited
• Collaborators: Bill and Melinda Gates Foundation

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 10, 2019
• Primary Completion (ANTICIPATED): March 31, 2019
• Study Completion (ANTICIPATED): April 2, 2019

Study Registration Dates

• First Submitted: December 29, 2018
• First Submitted That Met QC Criteria: December 31, 2018
• First Posted (ACTUAL): January 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 3, 2019
• Last Update Submitted That Met QC Criteria: December 31, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 002 (University of CT Health Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No