Lot quality assurance sampling for coverage evaluation of a new vaccine: A pilot study

Background: Worldwide, vaccine-preventable diseases have been a significant cause of mortality in the under-5 age group. To reduce the disease burden, new vaccines are being introduced in every country’s immunization programmes. For this to happen, high vaccination coverage is necessary. However, ra...

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Main Authors: Rhythm Hora, Arindam Ray, Imkongtemsu Longchar, G.R. Rio, Rashmi Mehra, Seema Singh Koshal, Amrita Kumari, Syed F. Quadri, Amanjot Kaur, Arup Deb Roy
Format: Article
Language:English
Published: Elsevier 2024-12-01
Series:Vaccine: X
Online Access:http://www.sciencedirect.com/science/article/pii/S2590136224001517
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author Rhythm Hora
Arindam Ray
Imkongtemsu Longchar
G.R. Rio
Rashmi Mehra
Seema Singh Koshal
Amrita Kumari
Syed F. Quadri
Amanjot Kaur
Arup Deb Roy
author_facet Rhythm Hora
Arindam Ray
Imkongtemsu Longchar
G.R. Rio
Rashmi Mehra
Seema Singh Koshal
Amrita Kumari
Syed F. Quadri
Amanjot Kaur
Arup Deb Roy
author_sort Rhythm Hora
collection DOAJ
description Background: Worldwide, vaccine-preventable diseases have been a significant cause of mortality in the under-5 age group. To reduce the disease burden, new vaccines are being introduced in every country’s immunization programmes. For this to happen, high vaccination coverage is necessary. However, rapidly identifying the areas that fail to reach the expected coverage becomes cumbersome. During recent years, lot quality assurance sampling (LQAS) has been widely used in evaluating immunization coverage across the globe. The present study aims to pilot this approach for field monitoring of a new vaccine against routine concurrent field monitoring in one of the North-Eastern states of India. Methodology: For LQAS, a community-based cross-sectional study was undertaken among 55 children aged 0–23 months in all 5 Primary health centres (lots) of Medziphema block, Dimapur, Nagaland. The total sample size for LQAS was calculated based on α = 5, β = 90 using Lemeshow and Taber-LQAS table with a target level of immunization defined as 90 % and the lower limit set to 55 %. For the concurrent field monitoring, a sample of 30 children in the same age group was selected through random sampling. Pre-designed, pre-tested questionnaire for the caregivers, scripted on a digital tool was employed with verification of immunization card and caregiver’s recall. Data was analyzed using SPSS software version 25.0. Results: The study found a slight difference in the percentage of children age-appropriately vaccinated for PCV (as per the schedule) in concurrent field monitoring (93.3 %) and LQAS (90.9 %). However, no statistically significant difference was found in comparing the immunization coverage using both methodologies (p > 0.05). Conclusion: The study findings encourage that LQAS can be considered for monitoring the immunization coverage of a newly introduced vaccine. It offers the added advantage of identifying poor/low-performing pockets that require focused attention.
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spelling doaj-art-d1fb4ed017224ef18b21d7ee80d2f1bc2025-08-20T03:14:00ZengElsevierVaccine: X2590-13622024-12-012110057810.1016/j.jvacx.2024.100578Lot quality assurance sampling for coverage evaluation of a new vaccine: A pilot studyRhythm Hora0Arindam Ray1Imkongtemsu Longchar2G.R. Rio3Rashmi Mehra4Seema Singh Koshal5Amrita Kumari6Syed F. Quadri7Amanjot Kaur8Arup Deb Roy9John Snow India, New Delhi, India; Corresponding author at: John Snow India, Plot Number 5 and 6, Local Shopping Complex, Nelson Mandela Marg (Near Post Office), Vasant Kunj, New Delhi 110070, India.Bill and Melinda Gates Foundation, New Delhi, IndiaDirectorate of Health and Family Welfare, Government of Nagaland, IndiaDirectorate of Health and Family Welfare, Government of Nagaland, IndiaJohn Snow India, New Delhi, IndiaJohn Snow India, New Delhi, IndiaJohn Snow India, New Delhi, IndiaJohn Snow India, New Delhi, IndiaJohn Snow India, New Delhi, IndiaJohn Snow India, New Delhi, IndiaBackground: Worldwide, vaccine-preventable diseases have been a significant cause of mortality in the under-5 age group. To reduce the disease burden, new vaccines are being introduced in every country’s immunization programmes. For this to happen, high vaccination coverage is necessary. However, rapidly identifying the areas that fail to reach the expected coverage becomes cumbersome. During recent years, lot quality assurance sampling (LQAS) has been widely used in evaluating immunization coverage across the globe. The present study aims to pilot this approach for field monitoring of a new vaccine against routine concurrent field monitoring in one of the North-Eastern states of India. Methodology: For LQAS, a community-based cross-sectional study was undertaken among 55 children aged 0–23 months in all 5 Primary health centres (lots) of Medziphema block, Dimapur, Nagaland. The total sample size for LQAS was calculated based on α = 5, β = 90 using Lemeshow and Taber-LQAS table with a target level of immunization defined as 90 % and the lower limit set to 55 %. For the concurrent field monitoring, a sample of 30 children in the same age group was selected through random sampling. Pre-designed, pre-tested questionnaire for the caregivers, scripted on a digital tool was employed with verification of immunization card and caregiver’s recall. Data was analyzed using SPSS software version 25.0. Results: The study found a slight difference in the percentage of children age-appropriately vaccinated for PCV (as per the schedule) in concurrent field monitoring (93.3 %) and LQAS (90.9 %). However, no statistically significant difference was found in comparing the immunization coverage using both methodologies (p > 0.05). Conclusion: The study findings encourage that LQAS can be considered for monitoring the immunization coverage of a newly introduced vaccine. It offers the added advantage of identifying poor/low-performing pockets that require focused attention.http://www.sciencedirect.com/science/article/pii/S2590136224001517
spellingShingle Rhythm Hora
Arindam Ray
Imkongtemsu Longchar
G.R. Rio
Rashmi Mehra
Seema Singh Koshal
Amrita Kumari
Syed F. Quadri
Amanjot Kaur
Arup Deb Roy
Lot quality assurance sampling for coverage evaluation of a new vaccine: A pilot study
Vaccine: X
title Lot quality assurance sampling for coverage evaluation of a new vaccine: A pilot study
title_full Lot quality assurance sampling for coverage evaluation of a new vaccine: A pilot study
title_fullStr Lot quality assurance sampling for coverage evaluation of a new vaccine: A pilot study
title_full_unstemmed Lot quality assurance sampling for coverage evaluation of a new vaccine: A pilot study
title_short Lot quality assurance sampling for coverage evaluation of a new vaccine: A pilot study
title_sort lot quality assurance sampling for coverage evaluation of a new vaccine a pilot study
url http://www.sciencedirect.com/science/article/pii/S2590136224001517
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