Vaccination FailureNCT03792022
Timeliness and Completeness of Routine Childhood Vaccinations by 2 Years of Age in Nigeria.
An observational study of Vaccination Failure, run by Lifespan Healthcare Resource Limited.
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. Read more about this study
- Who is it for?
- Ages 1 month to 24 months
- Conditions the study is for
- Vaccination Failure
- What is being tested?
- Adherence to timely vaccine uptake
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- How many people
- 1,800 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2019to 2 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 24 months
- All sexes
- Child
Study population: Vaccination records of children who have attended immunization clinics for the last 24 months.
Who may be able to join
- Received all vaccines Available immunization records
Who cannot join
- Did not receive all vaccines Non- available immunization records
About this study
Official title: 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.
Read the 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.
- Conditions
- Vaccination Failure
- Being tested
- Adherence to timely vaccine uptake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adherence to timely vaccine uptakeBehavioural
Adherence to timely vaccine uptake
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Adherence to timely vaccine uptake Receives: Behavioral: Adherence to timely vaccine uptake |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start10 Jan 2019 (estimated)
- Primary completion31 Mar 2019 (estimated)
- Study completion2 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccination FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lifespan Healthcare Resource Limited
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Dr.Ihedioha Emmanuel Chukwunwike, Lifespan Healthcare Resource Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792022
- Sponsor's protocol ID
- 002
- Status last verified
- Dec 2018
- First submitted
- 29 Dec 2018
- Last updated
- 3 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fully Vaccinated Yet Under-vaccinated: Timeliness and Completeness of Routine Childhood Vaccinations by 2 Years of Age in Nigeria
- ClinicalTrials.gov ID
- NCT03792022
- Acronym / sponsor ID
- 002
- Conditions
- Vaccination Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Lifespan Healthcare Resource LimitedUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 10 Jan 2019 (estimated)
- Primary completion
- 31 Mar 2019 (estimated)
- Study completion
- 2 Apr 2019 (estimated)
- First posted
- 3 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Behavioral: Adherence to timely vaccine uptakeAdherence to timely vaccine uptake |
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Age groups
- Child
- Study population
- Vaccination records of children who have attended immunization clinics for the last 24 months.
Key inclusion criteria (1 listed)
- Received all vaccines Available immunization records
Key exclusion criteria (1 listed)
- Did not receive all vaccines Non- available immunization records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adherence to timely vaccine uptakeAdherence to timely vaccine uptake | Behavioural | Group 1 |
Primary outcome
Age specific timely vaccination rate for all vaccines in routine vaccination schedule
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccination Failure, run by Lifespan Healthcare Resource Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age specific timely vaccination rate for all vaccines in routine vaccination schedule (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2019.