Children who received PCV-10 vaccine from a two-dose vial without preservative are not more likely to develop injection site abscess compared with those who received pentavalent (DPT-HepB-Hib) vaccine : a longitudinal multi-site study

Yemane Berhane; Alemayehu Worku; Meaza Demissie; Neghist Tesfaye; Nega Asefa; Worku Aniemaw; Berhe Weldearegawi; Yigzaw Kebede; Tigist Shiferaw; Amare Worku; Lemessa Olijira; Behailu Merdekios; Yemane Ashebir; Takele Tadesse; Yadeta Dessie; Solomon Meseret; Gestane Ayele

doi:10.1371/journal.pone.0097376

Children who received PCV-10 vaccine from a two-dose vial without preservative are not more likely to develop injection site abscess compared with those who received pentavalent (DPT-HepB-Hib) vaccine : a longitudinal multi-site study

Yemane Berhane, Alemayehu Worku, Meaza Demissie, Neghist Tesfaye, Nega Asefa, Worku Aniemaw, Berhe Weldearegawi, Yigzaw Kebede, Tigist Shiferaw, Amare Worku, Lemessa Olijira, Behailu Merdekios, Yemane Ashebir, Takele Tadesse, Yadeta Dessie, Solomon Meseret, Gestane Ayele

Western Sydney University

Research output: Contribution to journal › Article › peer-review

Abstract

Background: The single dose pneumonia ten-valent vaccine has been widely used and is highly efficacious against selected strains Streptococcus pneumonia. A two-dose vial without preservative is being introduced in developing countries to reduce the cost of the vaccine. In routine settings improper immunization practice could result in microbial contamination leading to adverse events following immunization. Objective: To monitor adverse events following immunization recommended for routine administration during infancy by comparing the rate of injection-site abscess between children who received PCV-10 vaccine and children who received the Pentavalent (DPT-HepB-Hib) vaccine. Methods: A longitudinal population-based multi-site observational study was conducted between September 2011 and October 2012. The study was conducted in four existing Health and Demographic Surveillance sites run by public universities of Abraminch, Haramaya, Gondar and Mekelle. Adverse events following Immunization were monitored by trained data collectors. Children were identified at the time of vaccination and followed at home at 48 hour and 7 day following immunization. Incidence of abscess and relative risk with the corresponding 95% Confidence Intervals were calculated to examine the risk difference in the comparison groups. Results: A total of 55, 268 PCV and 37, 480 Pentavalent (DPT-HepB-Hib) vaccinations were observed. A total of 19 adverse events following immunization, 10 abscesses and 9 deaths, were observed during the one year study period. The risk of developing abscess was not statistically different between children who received PCV-10 vaccine and those received Pentavalent (RR = 2.7, 95% CI 0.576-12.770), and between children who received the first aliquot of PCV and those received the second aliquot of PCV (RR = 1.72, 95% CI 0.485-6.091). Conclusion: No significant increase in the risk of injection site abscess was observed between the injection sites of PCV-10 vaccine from a two-dose vial without preservative and pentavalent (DPT-HepB-Hib) vaccine in the first 7 days following vaccination.

Original language	English
Article number	e97376
Number of pages	7
Journal	PLoS One
Volume	9
Issue number	6
DOIs	https://doi.org/10.1371/journal.pone.0097376
Publication status	Published - 2014

Open Access - Access Right Statement

© 2014 Berhane et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Keywords

DPT vaccine
abscess
injections
vaccines

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Berhane, Y., Worku, A., Demissie, M., Tesfaye, N., Asefa, N., Aniemaw, W., Weldearegawi, B., Kebede, Y., Shiferaw, T., Worku, A., Olijira, L., Merdekios, B., Ashebir, Y., Tadesse, T., Dessie, Y., Meseret, S., & Ayele, G. (2014). Children who received PCV-10 vaccine from a two-dose vial without preservative are not more likely to develop injection site abscess compared with those who received pentavalent (DPT-HepB-Hib) vaccine : a longitudinal multi-site study. PLoS One, 9(6), Article e97376. https://doi.org/10.1371/journal.pone.0097376

@article{ce6de26412ea481a80b92da555af6c31,

title = "Children who received PCV-10 vaccine from a two-dose vial without preservative are not more likely to develop injection site abscess compared with those who received pentavalent (DPT-HepB-Hib) vaccine : a longitudinal multi-site study",

abstract = "Background: The single dose pneumonia ten-valent vaccine has been widely used and is highly efficacious against selected strains Streptococcus pneumonia. A two-dose vial without preservative is being introduced in developing countries to reduce the cost of the vaccine. In routine settings improper immunization practice could result in microbial contamination leading to adverse events following immunization. Objective: To monitor adverse events following immunization recommended for routine administration during infancy by comparing the rate of injection-site abscess between children who received PCV-10 vaccine and children who received the Pentavalent (DPT-HepB-Hib) vaccine. Methods: A longitudinal population-based multi-site observational study was conducted between September 2011 and October 2012. The study was conducted in four existing Health and Demographic Surveillance sites run by public universities of Abraminch, Haramaya, Gondar and Mekelle. Adverse events following Immunization were monitored by trained data collectors. Children were identified at the time of vaccination and followed at home at 48 hour and 7 day following immunization. Incidence of abscess and relative risk with the corresponding 95% Confidence Intervals were calculated to examine the risk difference in the comparison groups. Results: A total of 55, 268 PCV and 37, 480 Pentavalent (DPT-HepB-Hib) vaccinations were observed. A total of 19 adverse events following immunization, 10 abscesses and 9 deaths, were observed during the one year study period. The risk of developing abscess was not statistically different between children who received PCV-10 vaccine and those received Pentavalent (RR = 2.7, 95% CI 0.576-12.770), and between children who received the first aliquot of PCV and those received the second aliquot of PCV (RR = 1.72, 95% CI 0.485-6.091). Conclusion: No significant increase in the risk of injection site abscess was observed between the injection sites of PCV-10 vaccine from a two-dose vial without preservative and pentavalent (DPT-HepB-Hib) vaccine in the first 7 days following vaccination.",

keywords = "DPT vaccine, abscess, injections, vaccines",

author = "Yemane Berhane and Alemayehu Worku and Meaza Demissie and Neghist Tesfaye and Nega Asefa and Worku Aniemaw and Berhe Weldearegawi and Yigzaw Kebede and Tigist Shiferaw and Amare Worku and Lemessa Olijira and Behailu Merdekios and Yemane Ashebir and Takele Tadesse and Yadeta Dessie and Solomon Meseret and Gestane Ayele",

year = "2014",

doi = "10.1371/journal.pone.0097376",

language = "English",

volume = "9",

journal = "PLoS One",

issn = "1932-6203",

publisher = "Public Library of Science",

number = "6",

}

Berhane, Y, Worku, A, Demissie, M, Tesfaye, N, Asefa, N, Aniemaw, W, Weldearegawi, B, Kebede, Y, Shiferaw, T, Worku, A, Olijira, L, Merdekios, B, Ashebir, Y, Tadesse, T, Dessie, Y, Meseret, S & Ayele, G 2014, 'Children who received PCV-10 vaccine from a two-dose vial without preservative are not more likely to develop injection site abscess compared with those who received pentavalent (DPT-HepB-Hib) vaccine : a longitudinal multi-site study', PLoS One, vol. 9, no. 6, e97376. https://doi.org/10.1371/journal.pone.0097376

Children who received PCV-10 vaccine from a two-dose vial without preservative are not more likely to develop injection site abscess compared with those who received pentavalent (DPT-HepB-Hib) vaccine : a longitudinal multi-site study. / Berhane, Yemane; Worku, Alemayehu; Demissie, Meaza et al.
In: PLoS One, Vol. 9, No. 6, e97376, 2014.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Children who received PCV-10 vaccine from a two-dose vial without preservative are not more likely to develop injection site abscess compared with those who received pentavalent (DPT-HepB-Hib) vaccine : a longitudinal multi-site study

AU - Berhane, Yemane

AU - Worku, Alemayehu

AU - Demissie, Meaza

AU - Tesfaye, Neghist

AU - Asefa, Nega

AU - Aniemaw, Worku

AU - Weldearegawi, Berhe

AU - Kebede, Yigzaw

AU - Shiferaw, Tigist

AU - Worku, Amare

AU - Olijira, Lemessa

AU - Merdekios, Behailu

AU - Ashebir, Yemane

AU - Tadesse, Takele

AU - Dessie, Yadeta

AU - Meseret, Solomon

AU - Ayele, Gestane

PY - 2014

Y1 - 2014

N2 - Background: The single dose pneumonia ten-valent vaccine has been widely used and is highly efficacious against selected strains Streptococcus pneumonia. A two-dose vial without preservative is being introduced in developing countries to reduce the cost of the vaccine. In routine settings improper immunization practice could result in microbial contamination leading to adverse events following immunization. Objective: To monitor adverse events following immunization recommended for routine administration during infancy by comparing the rate of injection-site abscess between children who received PCV-10 vaccine and children who received the Pentavalent (DPT-HepB-Hib) vaccine. Methods: A longitudinal population-based multi-site observational study was conducted between September 2011 and October 2012. The study was conducted in four existing Health and Demographic Surveillance sites run by public universities of Abraminch, Haramaya, Gondar and Mekelle. Adverse events following Immunization were monitored by trained data collectors. Children were identified at the time of vaccination and followed at home at 48 hour and 7 day following immunization. Incidence of abscess and relative risk with the corresponding 95% Confidence Intervals were calculated to examine the risk difference in the comparison groups. Results: A total of 55, 268 PCV and 37, 480 Pentavalent (DPT-HepB-Hib) vaccinations were observed. A total of 19 adverse events following immunization, 10 abscesses and 9 deaths, were observed during the one year study period. The risk of developing abscess was not statistically different between children who received PCV-10 vaccine and those received Pentavalent (RR = 2.7, 95% CI 0.576-12.770), and between children who received the first aliquot of PCV and those received the second aliquot of PCV (RR = 1.72, 95% CI 0.485-6.091). Conclusion: No significant increase in the risk of injection site abscess was observed between the injection sites of PCV-10 vaccine from a two-dose vial without preservative and pentavalent (DPT-HepB-Hib) vaccine in the first 7 days following vaccination.

AB - Background: The single dose pneumonia ten-valent vaccine has been widely used and is highly efficacious against selected strains Streptococcus pneumonia. A two-dose vial without preservative is being introduced in developing countries to reduce the cost of the vaccine. In routine settings improper immunization practice could result in microbial contamination leading to adverse events following immunization. Objective: To monitor adverse events following immunization recommended for routine administration during infancy by comparing the rate of injection-site abscess between children who received PCV-10 vaccine and children who received the Pentavalent (DPT-HepB-Hib) vaccine. Methods: A longitudinal population-based multi-site observational study was conducted between September 2011 and October 2012. The study was conducted in four existing Health and Demographic Surveillance sites run by public universities of Abraminch, Haramaya, Gondar and Mekelle. Adverse events following Immunization were monitored by trained data collectors. Children were identified at the time of vaccination and followed at home at 48 hour and 7 day following immunization. Incidence of abscess and relative risk with the corresponding 95% Confidence Intervals were calculated to examine the risk difference in the comparison groups. Results: A total of 55, 268 PCV and 37, 480 Pentavalent (DPT-HepB-Hib) vaccinations were observed. A total of 19 adverse events following immunization, 10 abscesses and 9 deaths, were observed during the one year study period. The risk of developing abscess was not statistically different between children who received PCV-10 vaccine and those received Pentavalent (RR = 2.7, 95% CI 0.576-12.770), and between children who received the first aliquot of PCV and those received the second aliquot of PCV (RR = 1.72, 95% CI 0.485-6.091). Conclusion: No significant increase in the risk of injection site abscess was observed between the injection sites of PCV-10 vaccine from a two-dose vial without preservative and pentavalent (DPT-HepB-Hib) vaccine in the first 7 days following vaccination.

KW - DPT vaccine

KW - abscess

KW - injections

KW - vaccines

UR - http://handle.westernsydney.edu.au:8081/1959.7/uws:48124

U2 - 10.1371/journal.pone.0097376

DO - 10.1371/journal.pone.0097376

M3 - Article

SN - 1932-6203

VL - 9

JO - PLoS One

JF - PLoS One

IS - 6

M1 - e97376

ER -

Children who received PCV-10 vaccine from a two-dose vial without preservative are not more likely to develop injection site abscess compared with those who received pentavalent (DPT-HepB-Hib) vaccine : a longitudinal multi-site study

Abstract

Open Access - Access Right Statement

Keywords

UN SDGs

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