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

Sponsor

Lifespan Healthcare Resource Limited (Other)

Overall Status

Unknown status

CT.gov ID

NCT03792022

Collaborator

Bill and Melinda Gates Foundation (Other)

1,800

Enrollment

2.7

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vaccination Failure	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 Design

Study Type:

Observational

Anticipated Enrollment :

1800 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

Jan 10, 2019

Anticipated Primary Completion Date :

Mar 31, 2019

Anticipated Study Completion Date :

Apr 2, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

Group 1

Adherence to timely vaccine uptake

Behavioral: Adherence to timely vaccine uptake

Adherence to timely vaccine uptake

Outcome Measures

Primary Outcome Measures

Age specific timely vaccination rate for all vaccines in routine vaccination schedule [24 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 24 Months

Sexes Eligible for Study:

All

Inclusion Criteria:

Received all vaccines Available immunization records

Exclusion Criteria:

Did not receive all vaccines Non- available immunization records

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Lifespan Healthcare Resource Limited
Bill and Melinda Gates Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr.Ihedioha Emmanuel Chukwunwike, Principal Investigator, Lifespan Healthcare Resource Limited

ClinicalTrials.gov Identifier:

NCT03792022

Other Study ID Numbers:

First Posted:

Jan 3, 2019

Last Update Posted:

Jan 3, 2019

Last Verified:

Dec 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 3, 2019