{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,3,24]],"date-time":"2025-03-24T08:46:54Z","timestamp":1742806014413,"version":"3.37.3"},"reference-count":36,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2022,1,15]],"date-time":"2022-01-15T00:00:00Z","timestamp":1642204800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,1,15]],"date-time":"2022-01-15T00:00:00Z","timestamp":1642204800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100000865","name":"bill and melinda gates foundation","doi-asserted-by":"publisher","award":["INV006724"],"award-info":[{"award-number":["INV006724"]}],"id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100011417","name":"united kingdom clinical research collaboration","doi-asserted-by":"publisher","award":["5356358"],"award-info":[{"award-number":["5356358"]}],"id":[{"id":"10.13039\/100011417","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Pneumococcal conjugate vaccines (PCVs) effectively prevent pneumococcal disease, but the global impact of pneumococcal vaccination is hampered by its cost. The evaluation of reduced dose schedules of PCV includes measurement of effects on immunogenicity and carriage acquisition compared to standard schedules. The relevance and feasibility of trials of reduced dose schedules is greatest in middle- and low-income countries, such as The Gambia, where the introduction of PCV resulted in good disease control but where transmission of vaccine-type pneumococci persists. We designed a large cluster-randomised field trial of an alternative reduced dose schedule of PCV compared to the standard schedule, the PVS trial. We will also conduct a sub-study to evaluate the individual-level effect of the two schedules on carriage acquisition, immunogenicity, and co-administration of PCV with yellow fever vaccine, the PVS-AcqImm trial.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>PVS-AcqImm is a prospective, cluster-randomised trial of one dose of PCV scheduled at age 6\u2009weeks with a booster dose at age 9\u2009months (i.e. alternative \u20181+1\u2019 schedule) compared to three primary doses scheduled at 6, 10, and 14\u2009weeks of age (i.e. standard \u20183+0\u2019 schedule). Sub-groups within the alternative schedule group will receive yellow fever vaccine separately or co-administered with PCV at 9\u2009months of age. The primary endpoints are (a) rate of nasopharyngeal vaccine-type pneumococcal acquisition from 9 to 14\u2009months of age, (b) geometric mean concentration of vaccine-type pneumococcal IgG at 18\u2009months of age, and (c) proportions with yellow fever neutralising antibody titre \u22658 four weeks after administration of yellow fever vaccine. Participants and field staff will not be masked to group allocation while the measurement of laboratory endpoints will be masked. Approximately equal numbers of participants will be resident in each of 28 geographic clusters (14 clusters in alternative and standard schedule groups); 784 enrolled for acquisition measurements and 336 for immunogenicity measurements.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>Analysis will account for potential non-independence of measurements by cluster and so interpretation of effects will be at the individual level (i.e. a population of individuals). PVS-AcqImm will evaluate whether acquisition of vaccine-type pneumococci is reduced by the alternative compared to the standard schedule, which is required if the alternative schedule is to be effective. Likewise, evidence of superior immune response at 18\u2009months of age and safety of PCV co-administration with yellow fever vaccine will support decision-making regarding the use of the alternative 1+1 schedule. Acquisition and immunogenicity outcomes will be essential for the interpretation of the results of the large field trial comparing the two schedules.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>International Standard Randomised Controlled Trial Number <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.isrctn.com\/ISRCTN72821613\">72821613<\/jats:ext-link>.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13063-021-05949-4","type":"journal-article","created":{"date-parts":[[2022,1,15]],"date-time":"2022-01-15T13:02:27Z","timestamp":1642251747000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Pneumococcal conjugate vaccination schedules in infants\u2014acquisition, immunogenicity, and pneumococcal conjugate and yellow fever vaccine co-administration study"],"prefix":"10.1186","volume":"23","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4994-2627","authenticated-orcid":false,"given":"Grant A.","family":"Mackenzie","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Isaac","family":"Osei","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rasheed","family":"Salaudeen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ousman","family":"Secka","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Umberto","family":"D\u2019Alessandro","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ed","family":"Clarke","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jonas","family":"Schmidt-Chanasit","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul V.","family":"Licciardi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cattram","family":"Nguyen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brian","family":"Greenwood","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kim","family":"Mulholland","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2022,1,15]]},"reference":[{"key":"5949_CR1","doi-asserted-by":"publisher","first-page":"e7586","DOI":"10.1136\/bmj.e7586","volume":"346","author":"AW Chan","year":"2013","unstructured":"Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. https:\/\/doi.org\/10.1136\/bmj.e7586.","journal-title":"BMJ."},{"key":"5949_CR2","unstructured":"Number of malaria deaths - Global Health Observatory data. World Health Organisation. http:\/\/www.who.int\/gho\/malaria\/epidemic\/deaths\/en\/. Accessed 29 Sept. 2016."},{"key":"5949_CR3","unstructured":"Estimated Hib and pneumococcal deaths for children under 5 years of age, 2008. World Health Organisation. http:\/\/www.who.int\/immunization\/monitoring_surveillance\/burden\/ estimates\/Pneumo_hib\/en\/. Accessed 15 Oct 2015."},{"key":"5949_CR4","unstructured":"Application Guidelines: GAVI\u2019s Support to Countries. Gavi the Vaccine Alliance. https:\/\/www.gavi.org\/our-support\/guidelines\/vaccines. Accessed 31 Dec 2019."},{"key":"5949_CR5","unstructured":"Advance Market Commitment for Pneumococcal Vaccines, Annual Report. GAVI Alliance Secretariat. GAVI Alliance. 21 Jan. 2015."},{"key":"5949_CR6","doi-asserted-by":"publisher","first-page":"493","DOI":"10.1016\/S0140-6736(15)60185-4","volume":"385","author":"AD Usher","year":"2015","unstructured":"Usher AD. GAVI exceeds US$7.5 billion fundraising target. Lancet. 2015;385:493.","journal-title":"Lancet."},{"key":"5949_CR7","doi-asserted-by":"publisher","first-page":"1975","DOI":"10.1016\/j.vaccine.2014.01.045","volume":"32","author":"E Usuf","year":"2014","unstructured":"Usuf E, Mackenzie G, Lowe-Jallow Y, Boye B, Atherly D, Suraratdecha C, et al. Costs of vaccine delivery in the Gambia before and after, pentavalent and pneumococcal conjugate vaccine introductions. Vaccine. 2014;32:1975\u201381. https:\/\/doi.org\/10.1016\/j.vaccine.2014.01.045.","journal-title":"Vaccine."},{"issue":"9465","key":"5949_CR8","doi-asserted-by":"publisher","first-page":"1139","DOI":"10.1016\/S0140-6736(05)71876-6","volume":"365","author":"FT Cutts","year":"2005","unstructured":"Cutts FT, Zaman SM, Enwere G, Jaffar S, Levine OS, Okoko JB, et al. Efficacy of nine-valent pneumococcal conjugate vaccine against pneumonia and invasive pneumococcal disease in The Gambia: randomised, double-blind, placebo-controlled trial. Lancet. 2005;365(9465):1139\u201346. https:\/\/doi.org\/10.1016\/S0140-6736(05)71876-6.","journal-title":"Lancet."},{"key":"5949_CR9","doi-asserted-by":"publisher","first-page":"703","DOI":"10.1016\/S1473-3099(16)00054-2","volume":"16","author":"GA Mackenzie","year":"2016","unstructured":"Mackenzie GA, Hill PC, Jeffries DJ, Hossain I, Uchendu U, Ameh D, et al. Effect of the introduction of pneumococcal conjugate vaccination on invasive pneumococcal disease in The Gambia: a population-based surveillance study. Lancet Infect Dis. 2016;16:703\u201311. https:\/\/doi.org\/10.1016\/S1473-3099(16)00054-2.","journal-title":"Lancet Infect Dis"},{"key":"5949_CR10","doi-asserted-by":"publisher","first-page":"965","DOI":"10.1016\/S1473-3099(17)30321-3","volume":"17","author":"GA Mackenzie","year":"2017","unstructured":"Mackenzie GA, Hill PC, Sahito SM, Jeffries DJ, Hossain I, Bottomley C, et al. Impact of the introduction of pneumococcal conjugate vaccination on pneumonia in The Gambia: population-based surveillance and case-control studies. Lancet Infect Dis. 2017;17:965\u201373. https:\/\/doi.org\/10.1016\/S1473-3099(17)30321-3.","journal-title":"Lancet Infect Dis"},{"key":"5949_CR11","doi-asserted-by":"publisher","first-page":"1293","DOI":"10.1016\/S1473-3099(20)30880-X","volume":"21","author":"GA Mackenzie","year":"2021","unstructured":"Mackenzie GA, Hill PC, Jeffries DJ, Ndiaye M, Sahito SM, Hossain I, et al. Impact of the introduction of pneumococcal conjugate vaccination on invasive pneumococcal disease and pneumonia in The Gambia: 10 years of population-based surveillance. Lancet Infect Dis. 2021;21:1293\u2013302. https:\/\/doi.org\/10.1016\/S1473-3099(20)30880-X.","journal-title":"Lancet Infect Dis"},{"key":"5949_CR12","doi-asserted-by":"publisher","first-page":"171","DOI":"10.1016\/S1473-3099(17)30654-0","volume":"18","author":"D Goldblatt","year":"2017","unstructured":"Goldblatt D, Southern J, Andrews NJ, Burbidge P, Partington J, Roalfe L, et al. Pneumococcal conjugate vaccine 13 delivered as one primary and one booster dose (1+1) compared with two primary doses and a booster (2+1) in UK infants: a multicentre, parallel group randomised controlled trial. Lancet Infect Dis. 2017;18:171\u20139, 2. https:\/\/doi.org\/10.1016\/S1473-3099(17)30654-0.","journal-title":"Lancet Infect Dis"},{"key":"5949_CR13","doi-asserted-by":"publisher","first-page":"1970","DOI":"10.1128\/CVI.00117-10","volume":"17","author":"FM Russell","year":"2010","unstructured":"Russell FM, Carapetis JR, Satzke C, Tikoduadua L, Waqatakirewa L, Chandra R, et al. Pneumococcal nasopharyngeal carriage following reduced doses of 7-valent pneumococcal conjugate vaccine and a 23-valent pneumococcal polysaccharide vaccine booster. Clin Vaccine Immunol. 2010;17:1970\u20136. https:\/\/doi.org\/10.1128\/CVI.00117-10.","journal-title":"Clin Vaccine Immunol"},{"key":"5949_CR14","doi-asserted-by":"publisher","first-page":"159","DOI":"10.1001\/jama.2009.975","volume":"302","author":"EJ van Gils","year":"2009","unstructured":"van Gils EJ, Veenhoven RH, Hak E, Rodenburg GD, Bogaert D, Ijzerman EP, et al. Effect of reduced-dose schedules with 7-valent pneumococcal conjugate vaccine on nasopharyngeal pneumococcal carriage in children: a randomized controlled trial. JAMA. 2009;302:159\u201367. https:\/\/doi.org\/10.1001\/jama.2009.975.","journal-title":"JAMA."},{"key":"5949_CR15","doi-asserted-by":"publisher","first-page":"2999","DOI":"10.1016\/j.vaccine.2011.01.098","volume":"29","author":"MO Ota","year":"2011","unstructured":"Ota MO, Akinsola A, Townend J, Antonio M, Enwere G, Nsekpong D, et al. The immunogenicity and impact on nasopharyngeal carriage of fewer doses of conjugate pneumococcal vaccine immunization schedule. Vaccine. 2011;29:2999\u20133007. https:\/\/doi.org\/10.1016\/j.vaccine.2011.01.098.","journal-title":"Vaccine."},{"key":"5949_CR16","unstructured":"Joint Committee on Vaccination and Immunisation. Meeting Minutes. Public Health England. 2017. https:\/\/app.box.com\/s\/iddfb4ppwkmtjusir2tc\/file\/247634612957. Accessed 15 Nov 2017."},{"key":"5949_CR17","doi-asserted-by":"publisher","first-page":"175","DOI":"10.1093\/cid\/ciw720","volume":"64","author":"S Jayasinghe","year":"2017","unstructured":"Jayasinghe S, Menzies R, Chiu C, Toms C, Blyth CC, Krause V, et al. Long-term impact of a \u201c3 + 0\u201d schedule for 7- and 13-valent pneumococcal conjugate vaccines on invasive pneumococcal disease in Australia, 2002\u20132014. Clin Infect Dis. 2017;64:175\u201383, 2. https:\/\/doi.org\/10.1093\/cid\/ciw720.","journal-title":"Clin Infect Dis"},{"key":"5949_CR18","doi-asserted-by":"publisher","first-page":"182","DOI":"10.1128\/CVI.00336-07","volume":"15","author":"EA Clutterbuck","year":"2008","unstructured":"Clutterbuck EA, Oh S, Hamaluba M, Westcar S, Beverley PC, Pollard AJ. Serotype-specific and age-dependent generation of pneumococcal polysaccharide-specific memory B-cell and antibody responses to immunization with a pneumococcal conjugate vaccine. Clin Vaccine Immunol. 2008;15:182\u201393. https:\/\/doi.org\/10.1128\/CVI.00336-07.","journal-title":"Clin Vaccine Immunol"},{"key":"5949_CR19","doi-asserted-by":"publisher","first-page":"2165","DOI":"10.4049\/jimmunol.180.4.2165","volume":"180","author":"RG Blanchard","year":"2008","unstructured":"Blanchard RG, Snape MD, Kelly DF, John T, Morant A, Yu LM, et al. The magnitude of the antibody and memory B cell responses during priming with a protein-polysaccharide conjugate vaccine in human infants is associated with the persistence of antibody and the intensity of booster response. J Immunol. 2008;180:2165\u201373. https:\/\/doi.org\/10.4049\/jimmunol.180.4.2165.","journal-title":"J Immunol"},{"key":"5949_CR20","doi-asserted-by":"publisher","first-page":"673","DOI":"10.1586\/erv.11.14","volume":"10","author":"G Blanchard-Rohner","year":"2011","unstructured":"Blanchard-Rohner G, Pollard AJ. Long-term protection after immunization with protein-polysaccharide conjugate vaccines in infancy. Expert Rev Vaccines. 2011;10:673\u201384. https:\/\/doi.org\/10.1586\/erv.11.14.","journal-title":"Expert Rev Vaccines"},{"key":"5949_CR21","doi-asserted-by":"publisher","first-page":"22","DOI":"10.1186\/1471-2334-10-22","volume":"10","author":"BD Gessner","year":"2010","unstructured":"Gessner BD, Mueller JE, Yaro S. African meningitis belt pneumococcal disease epidemiology indicates a need for an effective serotype 1 containing vaccine, including for older children and adults. BMC Infect Dis. 2010;10:22. https:\/\/doi.org\/10.1186\/1471-2334-10-22.","journal-title":"BMC Infect Dis"},{"key":"5949_CR22","doi-asserted-by":"publisher","first-page":"e1001839","DOI":"10.1371\/journal.pmed.1001839","volume":"12","author":"S Flasche","year":"2015","unstructured":"Flasche S, van Hoek AJ, Goldblatt D, Edmunds WJ, O'Brien KL, Scott JA, et al. The potential for reducing the number of pneumococcal conjugate vaccine doses while sustaining herd immunity in high-income countries. PLoS Med. 2015;12:e1001839. https:\/\/doi.org\/10.1371\/journal.pmed.1001839.","journal-title":"PLoS Med"},{"key":"5949_CR23","doi-asserted-by":"publisher","first-page":"1719","DOI":"10.1016\/j.vaccine.2015.02.005","volume":"33","author":"J Wysocki","year":"2015","unstructured":"Wysocki J, Brzostek J, Szymanski H, Tetiurka B, Toporowska-Kowalska E, Wasowska-Krolikowska K, et al. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine administered to older infants and children naive to pneumococcal vaccination. Vaccine. 2015;33:1719\u201325. https:\/\/doi.org\/10.1016\/j.vaccine.2015.02.005.","journal-title":"Vaccine."},{"key":"5949_CR24","doi-asserted-by":"publisher","first-page":"e493","DOI":"10.1542\/peds.2009-3027","volume":"126","author":"SH Yeh","year":"2010","unstructured":"Yeh SH, Gurtman A, Hurley DC, Block SL, Schwartz RH, Patterson S, et al. on behalf of the 004 Study Group Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in infants and toddlers. Pediatrics. 2010;126:e493\u2013505. https:\/\/doi.org\/10.1542\/peds.2009-3027.","journal-title":"Pediatrics."},{"key":"5949_CR25","doi-asserted-by":"publisher","first-page":"834","DOI":"10.1016\/S1473-3099(20)30735-0","volume":"21","author":"E Clarke","year":"2021","unstructured":"Clarke E, Bashorun A, Adigweme I, Badjie HM, Umesi A, Futa A, et al. Immunogenicity and safety of a novel ten-valent pneumococcal conjugate vaccine in healthy infants in The Gambia: a phase 3, randomised, double-blind, non-inferiority trial. Lancet Infect Dis. 2021;21:834\u201346. https:\/\/doi.org\/10.1016\/S1473-3099(20)30735-0.","journal-title":"Lancet Infect Dis"},{"key":"5949_CR26","doi-asserted-by":"publisher","first-page":"S586","DOI":"10.1093\/cid\/civ603","volume":"61","author":"RP Chowdhury","year":"2015","unstructured":"Chowdhury RP, Meier C, Laraway H, Tang Y, Hodgson A, Sow SO, et al. Immunogenicity of yellow fever vaccine coadministered with MenAfriVac in healthy infants in Ghana and Mali. Clin Infect Dis. 2015;61:S586\u201393. https:\/\/doi.org\/10.1093\/cid\/civ603.","journal-title":"Clin Infect Dis"},{"key":"5949_CR27","unstructured":"Recommendations to assure the quality, safety and efficacy of pneumococcal conjugate vaccines. In: 60th report: WHO technical report series n\u00b0977: 2009. Geneva. https:\/\/www.who.int\/publications\/i\/item\/9789241209779. Accessed 15 Dec 2021."},{"key":"5949_CR28","doi-asserted-by":"publisher","first-page":"497","DOI":"10.1016\/S1473-3099(18)30734-5","volume":"19","author":"B Temple","year":"2019","unstructured":"Temple B, Toan NT, Dai VTT, Bright K, Licciardi PV, Marimla RA, et al. Immunogenicity and reactogenicity of ten-valent versus 13-valent pneumococcal conjugate vaccines among infants in Ho Chi Minh City, Vietnam: a randomised controlled trial. Lancet Infect Dis. 2019;19:497\u2013509. https:\/\/doi.org\/10.1016\/S1473-3099(18)30734-5.","journal-title":"Lancet Infect Dis"},{"key":"5949_CR29","doi-asserted-by":"publisher","first-page":"e534","DOI":"10.1016\/S2214-109X(16)30075-4","volume":"4","author":"E Clarke","year":"2016","unstructured":"Clarke E, Saidu Y, Adetifa JU, Adigweme I, Hydara MB, Bashorun AO, et al. Safety and immunogenicity of inactivated poliovirus vaccine when given with measles-rubella combined vaccine and yellow fever vaccine and when given via different administration routes: a phase 4, randomised, non-inferiority trial in The Gambia. Lancet Glob. Health. 2016;4:e534\u201347. https:\/\/doi.org\/10.1016\/S2214-109X(16)30075-4.","journal-title":"Health."},{"key":"5949_CR30","doi-asserted-by":"publisher","unstructured":"Spijkerman J, Veenhoven RH, Wijmenga-Monsuur AJ, Elberse KE, van Gageldonk PG, Knol MJ, et al. Immunogenicity of 13-valent pneumococcal conjugate vaccine administered according to 4 different primary immunization schedules in infants: a randomized clinical trial. JAMA. 2013;310:930-937. https:\/\/doi.org\/10.1001\/jama.2013.228052.","DOI":"10.1001\/jama.2013.228052"},{"key":"5949_CR31","doi-asserted-by":"publisher","first-page":"5685","DOI":"10.1016\/j.vaccine.2009.06.098","volume":"27","author":"FM Russell","year":"2009","unstructured":"Russell FM, Balloch A, Tang ML, Carapetis JR, Licciardi P, Nelson J, et al. Immunogenicity following one, two, or three doses of the 7-valent pneumococcal conjugate vaccine. Vaccine. 2009;27:5685\u201391. https:\/\/doi.org\/10.1016\/j.vaccine.2009.06.098.","journal-title":"Vaccine."},{"key":"5949_CR32","doi-asserted-by":"publisher","unstructured":"Satzke C, Turner P, Virolainen-Julkunen A, Adrian PV, Antonio M, Hare KM, Henao-Restrepo AM, Leach AJ, Klugman KP, Porter BD, S\u00e1-Le\u00e3o R, Scott JA, Nohynek H, O'Brien KL, WHO Pneumococcal Carriage Working Group. Standard method for detecting upper respiratory carriage of Streptococcus pneumoniae: updated recommendations from the World Health Organization Pneumococcal Carriage Working Group. Vaccine. 2013;32:165-179, 1, DOI: https:\/\/doi.org\/10.1016\/j.vaccine.2013.08.062.","DOI":"10.1016\/j.vaccine.2013.08.062"},{"key":"5949_CR33","doi-asserted-by":"publisher","first-page":"1772","DOI":"10.1016\/j.jaci.2015.12.1303","volume":"137","author":"PV Licciardi","year":"2016","unstructured":"Licciardi PV, Toh ZQ, Clutterbuck EA, Balloch A, Marimla RA, Tikkanen L, et al. No long-term evidence of hyporesponsiveness after use of a pneumococcal conjugate vaccine in children previously immunized with pneumococcal polysaccharide vaccine. J Allergy Clin Immunol. 2016;137:1772\u20139. https:\/\/doi.org\/10.1016\/j.jaci.2015.12.1303.","journal-title":"J Allergy Clin Immunol"},{"key":"5949_CR34","unstructured":"Information security. UKRI Medical Research Council. 2018. https:\/\/mrc.ukri.org\/about\/ information-standards\/information-security\/. Accessed 6 June 2021."},{"key":"5949_CR35","doi-asserted-by":"publisher","first-page":"e1001903","DOI":"10.1371\/journal.pmed.1001903","volume":"12","author":"C Satzke","year":"2015","unstructured":"Satzke C, Dunne EM, Porter BD, Klugman KP, Mulholland EK. The PneuCarriage Project: a multi-centre comparative study to identify the best serotyping methods for examining pneumococcal carriage in vaccine evaluation studies. PLoS Med. 2015;12:e1001903; discussion e1001903. https:\/\/doi.org\/10.1371\/journal.pmed.1001903.","journal-title":"PLoS Med"},{"key":"5949_CR36","unstructured":"Data sharing. UKRI Medical Research Council. https:\/\/mrc.ukri.org\/research\/policies-and-guidance-for-researchers\/data-sharing-old\/policy\/. Accessed 6 June 2021."}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-021-05949-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-021-05949-4\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-021-05949-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,1,15]],"date-time":"2022-01-15T13:07:42Z","timestamp":1642252062000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-021-05949-4"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,1,15]]},"references-count":36,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2022,12]]}},"alternative-id":["5949"],"URL":"https:\/\/doi.org\/10.1186\/s13063-021-05949-4","relation":{},"ISSN":["1745-6215"],"issn-type":[{"type":"electronic","value":"1745-6215"}],"subject":[],"published":{"date-parts":[[2022,1,15]]},"assertion":[{"value":"19 August 2021","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"17 December 2021","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"15 January 2022","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The trial was approved by the GG\/MRCG JEC (trial ethics reference 17683) and the LSHTM EC (trial ethics reference 17683). Written, informed consent to participate is obtained from all participants.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate {24}"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication {32}"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests {28}"}}],"article-number":"39"}}