Risk of Injection-Site Abscess among Infants Receiving a Preservative-Free, Two-Dose Vial Formulation of Pneumococcal Conjugate Vaccine in Kenya.
There is a theoretical risk of adverse events following immunization with a preservative-free, 2-dose vial formulation of 10-valent-pneumococcal conjugate vaccine (PCV10). We set out to measure this risk. Four population-based surveillance sites in Kenya (total annual birth cohort of 11,500 infants)...
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Public Library of Science (PLoS)
2015-01-01
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| Series: | PLoS ONE |
| Online Access: | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0141896&type=printable |
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| author | Deron C Burton Godfrey M Bigogo Allan O Audi John Williamson Kenneth Munge Jackline Wafula Dominic Ouma Sammy Khagayi Isaac Mugoya James Mburu Shadrack Muema Evasius Bauni Tahreni Bwanaali Daniel R Feikin Peter M Ochieng Ondari D Mogeni George A Otieno Beatrice Olack Tatu Kamau Melissa K Van Dyke Robert Chen Paddy Farrington Joel M Montgomery Robert F Breiman J Anthony G Scott Kayla F Laserson |
| author_facet | Deron C Burton Godfrey M Bigogo Allan O Audi John Williamson Kenneth Munge Jackline Wafula Dominic Ouma Sammy Khagayi Isaac Mugoya James Mburu Shadrack Muema Evasius Bauni Tahreni Bwanaali Daniel R Feikin Peter M Ochieng Ondari D Mogeni George A Otieno Beatrice Olack Tatu Kamau Melissa K Van Dyke Robert Chen Paddy Farrington Joel M Montgomery Robert F Breiman J Anthony G Scott Kayla F Laserson |
| author_sort | Deron C Burton |
| collection | DOAJ |
| description | There is a theoretical risk of adverse events following immunization with a preservative-free, 2-dose vial formulation of 10-valent-pneumococcal conjugate vaccine (PCV10). We set out to measure this risk. Four population-based surveillance sites in Kenya (total annual birth cohort of 11,500 infants) were used to conduct a 2-year post-introduction vaccine safety study of PCV10. Injection-site abscesses occurring within 7 days following vaccine administration were clinically diagnosed in all study sites (passive facility-based surveillance) and, also, detected by caregiver-reported symptoms of swelling plus discharge in two sites (active household-based surveillance). Abscess risk was expressed as the number of abscesses per 100,000 injections and was compared for the second vs first vial dose of PCV10 and for PCV10 vs pentavalent vaccine (comparator). A total of 58,288 PCV10 injections were recorded, including 24,054 and 19,702 identified as first and second vial doses, respectively (14,532 unknown vial dose). The risk ratio for abscess following injection with the second (41 per 100,000) vs first (33 per 100,000) vial dose of PCV10 was 1.22 (95% confidence interval [CI] 0.37-4.06). The comparator vaccine was changed from a 2-dose to 10-dose presentation midway through the study. The matched odds ratios for abscess following PCV10 were 1.00 (95% CI 0.12-8.56) and 0.27 (95% CI 0.14-0.54) when compared to the 2-dose and 10-dose pentavalent vaccine presentations, respectively. In Kenya immunization with PCV10 was not associated with an increased risk of injection site abscess, providing confidence that the vaccine may be safely used in Africa. The relatively higher risk of abscess following the 10-dose presentation of pentavalent vaccine merits further study. |
| format | Article |
| id | doaj-art-5e78cd43f19b49e3a6a88f7b24e6ef6e |
| institution | Kabale University |
| issn | 1932-6203 |
| language | English |
| publishDate | 2015-01-01 |
| publisher | Public Library of Science (PLoS) |
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| series | PLoS ONE |
| spelling | doaj-art-5e78cd43f19b49e3a6a88f7b24e6ef6e2025-08-20T03:46:43ZengPublic Library of Science (PLoS)PLoS ONE1932-62032015-01-011010e014189610.1371/journal.pone.0141896Risk of Injection-Site Abscess among Infants Receiving a Preservative-Free, Two-Dose Vial Formulation of Pneumococcal Conjugate Vaccine in Kenya.Deron C BurtonGodfrey M BigogoAllan O AudiJohn WilliamsonKenneth MungeJackline WafulaDominic OumaSammy KhagayiIsaac MugoyaJames MburuShadrack MuemaEvasius BauniTahreni BwanaaliDaniel R FeikinPeter M OchiengOndari D MogeniGeorge A OtienoBeatrice OlackTatu KamauMelissa K Van DykeRobert ChenPaddy FarringtonJoel M MontgomeryRobert F BreimanJ Anthony G ScottKayla F LasersonThere is a theoretical risk of adverse events following immunization with a preservative-free, 2-dose vial formulation of 10-valent-pneumococcal conjugate vaccine (PCV10). We set out to measure this risk. Four population-based surveillance sites in Kenya (total annual birth cohort of 11,500 infants) were used to conduct a 2-year post-introduction vaccine safety study of PCV10. Injection-site abscesses occurring within 7 days following vaccine administration were clinically diagnosed in all study sites (passive facility-based surveillance) and, also, detected by caregiver-reported symptoms of swelling plus discharge in two sites (active household-based surveillance). Abscess risk was expressed as the number of abscesses per 100,000 injections and was compared for the second vs first vial dose of PCV10 and for PCV10 vs pentavalent vaccine (comparator). A total of 58,288 PCV10 injections were recorded, including 24,054 and 19,702 identified as first and second vial doses, respectively (14,532 unknown vial dose). The risk ratio for abscess following injection with the second (41 per 100,000) vs first (33 per 100,000) vial dose of PCV10 was 1.22 (95% confidence interval [CI] 0.37-4.06). The comparator vaccine was changed from a 2-dose to 10-dose presentation midway through the study. The matched odds ratios for abscess following PCV10 were 1.00 (95% CI 0.12-8.56) and 0.27 (95% CI 0.14-0.54) when compared to the 2-dose and 10-dose pentavalent vaccine presentations, respectively. In Kenya immunization with PCV10 was not associated with an increased risk of injection site abscess, providing confidence that the vaccine may be safely used in Africa. The relatively higher risk of abscess following the 10-dose presentation of pentavalent vaccine merits further study.https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0141896&type=printable |
| spellingShingle | Deron C Burton Godfrey M Bigogo Allan O Audi John Williamson Kenneth Munge Jackline Wafula Dominic Ouma Sammy Khagayi Isaac Mugoya James Mburu Shadrack Muema Evasius Bauni Tahreni Bwanaali Daniel R Feikin Peter M Ochieng Ondari D Mogeni George A Otieno Beatrice Olack Tatu Kamau Melissa K Van Dyke Robert Chen Paddy Farrington Joel M Montgomery Robert F Breiman J Anthony G Scott Kayla F Laserson Risk of Injection-Site Abscess among Infants Receiving a Preservative-Free, Two-Dose Vial Formulation of Pneumococcal Conjugate Vaccine in Kenya. PLoS ONE |
| title | Risk of Injection-Site Abscess among Infants Receiving a Preservative-Free, Two-Dose Vial Formulation of Pneumococcal Conjugate Vaccine in Kenya. |
| title_full | Risk of Injection-Site Abscess among Infants Receiving a Preservative-Free, Two-Dose Vial Formulation of Pneumococcal Conjugate Vaccine in Kenya. |
| title_fullStr | Risk of Injection-Site Abscess among Infants Receiving a Preservative-Free, Two-Dose Vial Formulation of Pneumococcal Conjugate Vaccine in Kenya. |
| title_full_unstemmed | Risk of Injection-Site Abscess among Infants Receiving a Preservative-Free, Two-Dose Vial Formulation of Pneumococcal Conjugate Vaccine in Kenya. |
| title_short | Risk of Injection-Site Abscess among Infants Receiving a Preservative-Free, Two-Dose Vial Formulation of Pneumococcal Conjugate Vaccine in Kenya. |
| title_sort | risk of injection site abscess among infants receiving a preservative free two dose vial formulation of pneumococcal conjugate vaccine in kenya |
| url | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0141896&type=printable |
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