Estimates of Inactivated Influenza Vaccine Effectiveness Among Children in Senegal: Results From 2 Consecutive Cluster-Randomized Controlled Trials in 2010 and 2011
Abstract Background We report results of years 2 and 3 of consecutive cluster-randomized controlled trials of trivalent inactivated influenza vaccine (IIV3) in Senegal. Methods We cluster-randomized (1:1) 20 villages to annual vaccination with IIV3 or inactivated poliovirus vaccine (IPV) of age-elig...
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| Veröffentlicht in: | Clinical infectious diseases 2021-06, Vol.72 (12), p.e959-e969 |
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| creator | Niang, Mbayame Nd Sugimoto, Jonathan D Diallo, Aldiouma Diarra, Bou Ortiz, Justin R Lewis, Kristen D C Lafond, Kathryn E Halloran, M Elizabeth Widdowson, Marc-Alain Neuzil, Kathleen M Victor, John C |
| description | Abstract
Background
We report results of years 2 and 3 of consecutive cluster-randomized controlled trials of trivalent inactivated influenza vaccine (IIV3) in Senegal.
Methods
We cluster-randomized (1:1) 20 villages to annual vaccination with IIV3 or inactivated poliovirus vaccine (IPV) of age-eligible residents (6 months–10 years). The primary outcome was total vaccine effectiveness against laboratory-confirmed influenza illness (LCI) among age-eligible children (modified intention-to-treat population [mITT]). Secondary outcomes were indirect (herd protection) and population (overall community) vaccine effectiveness.
Results
We vaccinated 74% of 12 408 age-eligible children in year 2 (June 2010–April 11) and 74% of 11 988 age-eligible children in year 3 (April 2011–December 2011) with study vaccines. Annual cumulative incidence of LCI was 4.7 (year 2) and 4.2 (year 3) per 100 mITT child vaccinees of IPV villages. In year 2, IIV3 matched circulating influenza strains. The total effectiveness was 52.8% (95% confidence interval [CI], 32.3–67.0), and the population effectiveness was 36.0% (95% CI, 10.2–54.4) against LCI caused by any influenza strain. The indirect effectiveness against LCI by A/H3N2 was 56.4% (95% CI, 39.0–68.9). In year 3, 74% of influenza detections were vaccine-mismatched to circulating B/Yamagata and 24% were vaccine-matched to circulating A/H3N2. The year 3 total effectiveness against LCI was −14.5% (95% CI, −81.2–27.6). Vaccine effectiveness varied by type/subtype of influenza in both years.
Conclusions
IIV3 was variably effective against influenza illness in Senegalese children, with total and indirect vaccine effectiveness present during the year when all circulating strains matched the IIV3 formulation.
Clinical Trials Registration
NCT00893906.
Inactivated influenza vaccine given to children in Senegal as part of a multiyear village-randomized trial provided moderate total and indirect protection against laboratory-confirmed influenza illness in year 2 but was not protective during year 3. |
| doi_str_mv | 10.1093/cid/ciaa1689 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_8204774</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><oup_id>10.1093/cid/ciaa1689</oup_id><sourcerecordid>2458958885</sourcerecordid><originalsourceid>FETCH-LOGICAL-c450t-e7cdd5ed382ea4621c912790d3b4b7f691da96035172573477697aa95014d49d3</originalsourceid><addsrcrecordid>eNp9kl1rFDEUhgdRbK3eeS25U8HRfE4SL4Rl2drCglCrtyGbZHYjmWSbzCzY3-MPNcO2Rb3wIuRNznPek4_TNC8RfI-gJB-Mt3VojTohHzWniBHedkyix1VDJloqiDhpnpXyA0KEBGRPmxNCUMdY1502v1Zl9IMeXQGpB5dRm9Ef6tJW3YfJxVsNvmtjfHRg1fduDrvoSgGLIcUtWO58sNlF4CP4WgNbHT6CK1emMBZwntMAMFimWJyZ5kywDFMZXW6vdLRp8Le1UA2POYVQ5XX2OpTZC0MEQWVmgZ43T_q6717czWfNt_PV9fKiXX_5fLlcrFtDGRxbx421zFkisNO0w8hIhLmElmzohvedRFbLDhKGOGacUM47ybWWDCJqqbTkrPl09N1Pm8FZ4-rBdFD7XF8o_1RJe_V3JPqd2qaDEhhWN1oN3h4Ndv-kXSzWat6DhGJEMD-gyr65K5bTzeTKqAZfjAtBR5emojBlQjIhBKvouyNqciolu_7BG0E1N4GqTaDum6Dir_68xgN8_-sVeH0E0rT_v9VvRLG8Eg</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2458958885</pqid></control><display><type>article</type><title>Estimates of Inactivated Influenza Vaccine Effectiveness Among Children in Senegal: Results From 2 Consecutive Cluster-Randomized Controlled Trials in 2010 and 2011</title><source>MEDLINE</source><source>Oxford University Press Journals All Titles (1996-Current)</source><source>EZB-FREE-00999 freely available EZB journals</source><source>Alma/SFX Local Collection</source><creator>Niang, Mbayame Nd ; Sugimoto, Jonathan D ; Diallo, Aldiouma ; Diarra, Bou ; Ortiz, Justin R ; Lewis, Kristen D C ; Lafond, Kathryn E ; Halloran, M Elizabeth ; Widdowson, Marc-Alain ; Neuzil, Kathleen M ; Victor, John C</creator><creatorcontrib>Niang, Mbayame Nd ; Sugimoto, Jonathan D ; Diallo, Aldiouma ; Diarra, Bou ; Ortiz, Justin R ; Lewis, Kristen D C ; Lafond, Kathryn E ; Halloran, M Elizabeth ; Widdowson, Marc-Alain ; Neuzil, Kathleen M ; Victor, John C</creatorcontrib><description>Abstract
Background
We report results of years 2 and 3 of consecutive cluster-randomized controlled trials of trivalent inactivated influenza vaccine (IIV3) in Senegal.
Methods
We cluster-randomized (1:1) 20 villages to annual vaccination with IIV3 or inactivated poliovirus vaccine (IPV) of age-eligible residents (6 months–10 years). The primary outcome was total vaccine effectiveness against laboratory-confirmed influenza illness (LCI) among age-eligible children (modified intention-to-treat population [mITT]). Secondary outcomes were indirect (herd protection) and population (overall community) vaccine effectiveness.
Results
We vaccinated 74% of 12 408 age-eligible children in year 2 (June 2010–April 11) and 74% of 11 988 age-eligible children in year 3 (April 2011–December 2011) with study vaccines. Annual cumulative incidence of LCI was 4.7 (year 2) and 4.2 (year 3) per 100 mITT child vaccinees of IPV villages. In year 2, IIV3 matched circulating influenza strains. The total effectiveness was 52.8% (95% confidence interval [CI], 32.3–67.0), and the population effectiveness was 36.0% (95% CI, 10.2–54.4) against LCI caused by any influenza strain. The indirect effectiveness against LCI by A/H3N2 was 56.4% (95% CI, 39.0–68.9). In year 3, 74% of influenza detections were vaccine-mismatched to circulating B/Yamagata and 24% were vaccine-matched to circulating A/H3N2. The year 3 total effectiveness against LCI was −14.5% (95% CI, −81.2–27.6). Vaccine effectiveness varied by type/subtype of influenza in both years.
Conclusions
IIV3 was variably effective against influenza illness in Senegalese children, with total and indirect vaccine effectiveness present during the year when all circulating strains matched the IIV3 formulation.
Clinical Trials Registration
NCT00893906.
Inactivated influenza vaccine given to children in Senegal as part of a multiyear village-randomized trial provided moderate total and indirect protection against laboratory-confirmed influenza illness in year 2 but was not protective during year 3.</description><identifier>ISSN: 1058-4838</identifier><identifier>EISSN: 1537-6591</identifier><identifier>DOI: 10.1093/cid/ciaa1689</identifier><identifier>PMID: 33165566</identifier><language>eng</language><publisher>US: Oxford University Press</publisher><subject>Bacteriology ; Cardiology and cardiovascular system ; Child ; Emerging diseases ; Human health and pathology ; Humans ; Infectious diseases ; Influenza A Virus, H3N2 Subtype ; Influenza Vaccines ; Influenza, Human - epidemiology ; Influenza, Human - prevention & control ; Life Sciences ; Microbiology and Parasitology ; Online Only ; Parasitology ; Senegal - epidemiology ; Vaccines, Inactivated ; Virology</subject><ispartof>Clinical infectious diseases, 2021-06, Vol.72 (12), p.e959-e969</ispartof><rights>Published by Oxford University Press for the Infectious Diseases Society of America 2020. 2020</rights><rights>Published by Oxford University Press for the Infectious Diseases Society of America 2020.</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c450t-e7cdd5ed382ea4621c912790d3b4b7f691da96035172573477697aa95014d49d3</citedby><cites>FETCH-LOGICAL-c450t-e7cdd5ed382ea4621c912790d3b4b7f691da96035172573477697aa95014d49d3</cites><orcidid>0000-0002-3138-5965 ; 0000-0002-7970-6588 ; 0000-0003-0792-6722</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,1584,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33165566$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://amu.hal.science/hal-03421327$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Niang, Mbayame Nd</creatorcontrib><creatorcontrib>Sugimoto, Jonathan D</creatorcontrib><creatorcontrib>Diallo, Aldiouma</creatorcontrib><creatorcontrib>Diarra, Bou</creatorcontrib><creatorcontrib>Ortiz, Justin R</creatorcontrib><creatorcontrib>Lewis, Kristen D C</creatorcontrib><creatorcontrib>Lafond, Kathryn E</creatorcontrib><creatorcontrib>Halloran, M Elizabeth</creatorcontrib><creatorcontrib>Widdowson, Marc-Alain</creatorcontrib><creatorcontrib>Neuzil, Kathleen M</creatorcontrib><creatorcontrib>Victor, John C</creatorcontrib><title>Estimates of Inactivated Influenza Vaccine Effectiveness Among Children in Senegal: Results From 2 Consecutive Cluster-Randomized Controlled Trials in 2010 and 2011</title><title>Clinical infectious diseases</title><addtitle>Clin Infect Dis</addtitle><description>Abstract
Background
We report results of years 2 and 3 of consecutive cluster-randomized controlled trials of trivalent inactivated influenza vaccine (IIV3) in Senegal.
Methods
We cluster-randomized (1:1) 20 villages to annual vaccination with IIV3 or inactivated poliovirus vaccine (IPV) of age-eligible residents (6 months–10 years). The primary outcome was total vaccine effectiveness against laboratory-confirmed influenza illness (LCI) among age-eligible children (modified intention-to-treat population [mITT]). Secondary outcomes were indirect (herd protection) and population (overall community) vaccine effectiveness.
Results
We vaccinated 74% of 12 408 age-eligible children in year 2 (June 2010–April 11) and 74% of 11 988 age-eligible children in year 3 (April 2011–December 2011) with study vaccines. Annual cumulative incidence of LCI was 4.7 (year 2) and 4.2 (year 3) per 100 mITT child vaccinees of IPV villages. In year 2, IIV3 matched circulating influenza strains. The total effectiveness was 52.8% (95% confidence interval [CI], 32.3–67.0), and the population effectiveness was 36.0% (95% CI, 10.2–54.4) against LCI caused by any influenza strain. The indirect effectiveness against LCI by A/H3N2 was 56.4% (95% CI, 39.0–68.9). In year 3, 74% of influenza detections were vaccine-mismatched to circulating B/Yamagata and 24% were vaccine-matched to circulating A/H3N2. The year 3 total effectiveness against LCI was −14.5% (95% CI, −81.2–27.6). Vaccine effectiveness varied by type/subtype of influenza in both years.
Conclusions
IIV3 was variably effective against influenza illness in Senegalese children, with total and indirect vaccine effectiveness present during the year when all circulating strains matched the IIV3 formulation.
Clinical Trials Registration
NCT00893906.
Inactivated influenza vaccine given to children in Senegal as part of a multiyear village-randomized trial provided moderate total and indirect protection against laboratory-confirmed influenza illness in year 2 but was not protective during year 3.</description><subject>Bacteriology</subject><subject>Cardiology and cardiovascular system</subject><subject>Child</subject><subject>Emerging diseases</subject><subject>Human health and pathology</subject><subject>Humans</subject><subject>Infectious diseases</subject><subject>Influenza A Virus, H3N2 Subtype</subject><subject>Influenza Vaccines</subject><subject>Influenza, Human - epidemiology</subject><subject>Influenza, Human - prevention & control</subject><subject>Life Sciences</subject><subject>Microbiology and Parasitology</subject><subject>Online Only</subject><subject>Parasitology</subject><subject>Senegal - epidemiology</subject><subject>Vaccines, Inactivated</subject><subject>Virology</subject><issn>1058-4838</issn><issn>1537-6591</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kl1rFDEUhgdRbK3eeS25U8HRfE4SL4Rl2drCglCrtyGbZHYjmWSbzCzY3-MPNcO2Rb3wIuRNznPek4_TNC8RfI-gJB-Mt3VojTohHzWniBHedkyix1VDJloqiDhpnpXyA0KEBGRPmxNCUMdY1502v1Zl9IMeXQGpB5dRm9Ef6tJW3YfJxVsNvmtjfHRg1fduDrvoSgGLIcUtWO58sNlF4CP4WgNbHT6CK1emMBZwntMAMFimWJyZ5kywDFMZXW6vdLRp8Le1UA2POYVQ5XX2OpTZC0MEQWVmgZ43T_q6717czWfNt_PV9fKiXX_5fLlcrFtDGRxbx421zFkisNO0w8hIhLmElmzohvedRFbLDhKGOGacUM47ybWWDCJqqbTkrPl09N1Pm8FZ4-rBdFD7XF8o_1RJe_V3JPqd2qaDEhhWN1oN3h4Ndv-kXSzWat6DhGJEMD-gyr65K5bTzeTKqAZfjAtBR5emojBlQjIhBKvouyNqciolu_7BG0E1N4GqTaDum6Dir_68xgN8_-sVeH0E0rT_v9VvRLG8Eg</recordid><startdate>20210615</startdate><enddate>20210615</enddate><creator>Niang, Mbayame Nd</creator><creator>Sugimoto, Jonathan D</creator><creator>Diallo, Aldiouma</creator><creator>Diarra, Bou</creator><creator>Ortiz, Justin R</creator><creator>Lewis, Kristen D C</creator><creator>Lafond, Kathryn E</creator><creator>Halloran, M Elizabeth</creator><creator>Widdowson, Marc-Alain</creator><creator>Neuzil, Kathleen M</creator><creator>Victor, John C</creator><general>Oxford University Press</general><general>Oxford University Press (OUP)</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>1XC</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-3138-5965</orcidid><orcidid>https://orcid.org/0000-0002-7970-6588</orcidid><orcidid>https://orcid.org/0000-0003-0792-6722</orcidid></search><sort><creationdate>20210615</creationdate><title>Estimates of Inactivated Influenza Vaccine Effectiveness Among Children in Senegal: Results From 2 Consecutive Cluster-Randomized Controlled Trials in 2010 and 2011</title><author>Niang, Mbayame Nd ; Sugimoto, Jonathan D ; Diallo, Aldiouma ; Diarra, Bou ; Ortiz, Justin R ; Lewis, Kristen D C ; Lafond, Kathryn E ; Halloran, M Elizabeth ; Widdowson, Marc-Alain ; Neuzil, Kathleen M ; Victor, John C</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c450t-e7cdd5ed382ea4621c912790d3b4b7f691da96035172573477697aa95014d49d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Bacteriology</topic><topic>Cardiology and cardiovascular system</topic><topic>Child</topic><topic>Emerging diseases</topic><topic>Human health and pathology</topic><topic>Humans</topic><topic>Infectious diseases</topic><topic>Influenza A Virus, H3N2 Subtype</topic><topic>Influenza Vaccines</topic><topic>Influenza, Human - epidemiology</topic><topic>Influenza, Human - prevention & control</topic><topic>Life Sciences</topic><topic>Microbiology and Parasitology</topic><topic>Online Only</topic><topic>Parasitology</topic><topic>Senegal - epidemiology</topic><topic>Vaccines, Inactivated</topic><topic>Virology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Niang, Mbayame Nd</creatorcontrib><creatorcontrib>Sugimoto, Jonathan D</creatorcontrib><creatorcontrib>Diallo, Aldiouma</creatorcontrib><creatorcontrib>Diarra, Bou</creatorcontrib><creatorcontrib>Ortiz, Justin R</creatorcontrib><creatorcontrib>Lewis, Kristen D C</creatorcontrib><creatorcontrib>Lafond, Kathryn E</creatorcontrib><creatorcontrib>Halloran, M Elizabeth</creatorcontrib><creatorcontrib>Widdowson, Marc-Alain</creatorcontrib><creatorcontrib>Neuzil, Kathleen M</creatorcontrib><creatorcontrib>Victor, John C</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Clinical infectious diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Niang, Mbayame Nd</au><au>Sugimoto, Jonathan D</au><au>Diallo, Aldiouma</au><au>Diarra, Bou</au><au>Ortiz, Justin R</au><au>Lewis, Kristen D C</au><au>Lafond, Kathryn E</au><au>Halloran, M Elizabeth</au><au>Widdowson, Marc-Alain</au><au>Neuzil, Kathleen M</au><au>Victor, John C</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Estimates of Inactivated Influenza Vaccine Effectiveness Among Children in Senegal: Results From 2 Consecutive Cluster-Randomized Controlled Trials in 2010 and 2011</atitle><jtitle>Clinical infectious diseases</jtitle><addtitle>Clin Infect Dis</addtitle><date>2021-06-15</date><risdate>2021</risdate><volume>72</volume><issue>12</issue><spage>e959</spage><epage>e969</epage><pages>e959-e969</pages><issn>1058-4838</issn><eissn>1537-6591</eissn><abstract>Abstract
Background
We report results of years 2 and 3 of consecutive cluster-randomized controlled trials of trivalent inactivated influenza vaccine (IIV3) in Senegal.
Methods
We cluster-randomized (1:1) 20 villages to annual vaccination with IIV3 or inactivated poliovirus vaccine (IPV) of age-eligible residents (6 months–10 years). The primary outcome was total vaccine effectiveness against laboratory-confirmed influenza illness (LCI) among age-eligible children (modified intention-to-treat population [mITT]). Secondary outcomes were indirect (herd protection) and population (overall community) vaccine effectiveness.
Results
We vaccinated 74% of 12 408 age-eligible children in year 2 (June 2010–April 11) and 74% of 11 988 age-eligible children in year 3 (April 2011–December 2011) with study vaccines. Annual cumulative incidence of LCI was 4.7 (year 2) and 4.2 (year 3) per 100 mITT child vaccinees of IPV villages. In year 2, IIV3 matched circulating influenza strains. The total effectiveness was 52.8% (95% confidence interval [CI], 32.3–67.0), and the population effectiveness was 36.0% (95% CI, 10.2–54.4) against LCI caused by any influenza strain. The indirect effectiveness against LCI by A/H3N2 was 56.4% (95% CI, 39.0–68.9). In year 3, 74% of influenza detections were vaccine-mismatched to circulating B/Yamagata and 24% were vaccine-matched to circulating A/H3N2. The year 3 total effectiveness against LCI was −14.5% (95% CI, −81.2–27.6). Vaccine effectiveness varied by type/subtype of influenza in both years.
Conclusions
IIV3 was variably effective against influenza illness in Senegalese children, with total and indirect vaccine effectiveness present during the year when all circulating strains matched the IIV3 formulation.
Clinical Trials Registration
NCT00893906.
Inactivated influenza vaccine given to children in Senegal as part of a multiyear village-randomized trial provided moderate total and indirect protection against laboratory-confirmed influenza illness in year 2 but was not protective during year 3.</abstract><cop>US</cop><pub>Oxford University Press</pub><pmid>33165566</pmid><doi>10.1093/cid/ciaa1689</doi><orcidid>https://orcid.org/0000-0002-3138-5965</orcidid><orcidid>https://orcid.org/0000-0002-7970-6588</orcidid><orcidid>https://orcid.org/0000-0003-0792-6722</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | Clinical infectious diseases, 2021-06, Vol.72 (12), p.e959-e969 |
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| source | MEDLINE; Oxford University Press Journals All Titles (1996-Current); EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection |
| subjects | Bacteriology Cardiology and cardiovascular system Child Emerging diseases Human health and pathology Humans Infectious diseases Influenza A Virus, H3N2 Subtype Influenza Vaccines Influenza, Human - epidemiology Influenza, Human - prevention & control Life Sciences Microbiology and Parasitology Online Only Parasitology Senegal - epidemiology Vaccines, Inactivated Virology |
| title | Estimates of Inactivated Influenza Vaccine Effectiveness Among Children in Senegal: Results From 2 Consecutive Cluster-Randomized Controlled Trials in 2010 and 2011 |
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