{"id":"https://openalex.org/W2790723906","doi":"https://doi.org/10.7860/jcdr/2018/29855.11125","title":"Immunogenicity and Safety of a Novel MMR Vaccine (Live) (Freeze-dried): Results of a Phase II Clinical Trial","display_name":"Immunogenicity and Safety of a Novel MMR Vaccine (Live) (Freeze-dried): Results of a Phase II Clinical Trial","publication_year":2018,"publication_date":"2018-01-01","ids":{"openalex":"https://openalex.org/W2790723906","doi":"https://doi.org/10.7860/jcdr/2018/29855.11125","mag":"2790723906"},"language":"en","primary_location":{"id":"doi:10.7860/jcdr/2018/29855.11125","doi":"https://doi.org/10.7860/jcdr/2018/29855.11125","is_oa":true,"landing_page_url":"https://doi.org/10.7860/jcdr/2018/29855.11125","pdf_url":null,"source":{"id":"https://openalex.org/S2737465529","display_name":"JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH","issn_l":"0973-709X","issn":["0973-709X","2249-782X"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","poland-40"],"host_organization":"https://openalex.org/P4310318655","host_organization_name":"JCDR Research and Publications Private Limited","host_organization_lineage":["https://openalex.org/P4310318655"],"host_organization_lineage_names":["JCDR Research and Publications Private Limited"],"type":"journal"},"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref","doaj"],"open_access":{"is_oa":true,"oa_status":"gold","oa_url":"https://doi.org/10.7860/jcdr/2018/29855.11125","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":null,"display_name":"Rajesh Joshi","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Rajesh Joshi","raw_affiliation_strings":["Professor and Head, Department of Paediatrics, Gujarat Medical Education and Research Society Medical College and Government Hospital, Sola, Ahmedabad, Gujarat, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Professor and Head, Department of Paediatrics, Gujarat Medical Education and Research Society Medical College and Government Hospital, Sola, Ahmedabad, Gujarat, India","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5024910650","display_name":"Neeta Hanumante","orcid":"https://orcid.org/0000-0002-0289-5544","observed_orcids":["https://orcid.org/0000-0002-0289-5544"]},"institutions":[{"id":"https://openalex.org/I887998513","display_name":"Bharati Vidyapeeth (Deemed to be University)","ror":"https://ror.org/0052mmx10","country_code":"IN","type":"education","lineage":["https://openalex.org/I887998513"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Neeta Hanumante","raw_affiliation_strings":["Assistant Professor, Department of Paediatrics, Bharati Hospital and Research Centre, Bharati Vidyapeeth, Pune, Maharashtra, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Assistant Professor, Department of Paediatrics, Bharati Hospital and Research Centre, Bharati Vidyapeeth, Pune, Maharashtra, India","institution_ids":["https://openalex.org/I887998513"]}]},{"author_position":"middle","author":{"id":null,"display_name":"Uma Nayak","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I2802014819","display_name":"Government of Gujarat","ror":"https://ror.org/035dsh769","country_code":"IN","type":"government","lineage":["https://openalex.org/I2802014819"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Uma Nayak","raw_affiliation_strings":["Professor and Head, Department of Paediatrics, Gujarat Medical Education and Research Society Medical College and Government Hospital, Gotri, Vadodara, Gujarat, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Professor and Head, Department of Paediatrics, Gujarat Medical Education and Research Society Medical College and Government Hospital, Gotri, Vadodara, Gujarat, India","institution_ids":["https://openalex.org/I2802014819"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5083348820","display_name":"Shalaka Agarkhedkar","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210089305","display_name":"Dr. D. Y. Patil Medical College, Hospital and Research Centre","ror":"https://ror.org/0088h4061","country_code":"IN","type":"healthcare","lineage":["https://openalex.org/I4210089305"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Shalaka Agarkhedkar","raw_affiliation_strings":["Research Consultant, Department of Paediatrics, Padmashree Dr. D.Y. Patil Medical College and Hospital, Pune, Maharashtra, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Research Consultant, Department of Paediatrics, Padmashree Dr. D.Y. Patil Medical College and Hospital, Pune, Maharashtra, India","institution_ids":["https://openalex.org/I4210089305"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5007397471","display_name":"Paresh Thakkar","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I259800356","display_name":"Sir Sayajirao General Hospital Medical College","ror":"https://ror.org/00j8xcs04","country_code":"IN","type":"education","lineage":["https://openalex.org/I259800356"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Paresh Thakkar","raw_affiliation_strings":["Associate Professor, Department of Paediatrics, Sir Sayajirao General Hospital, Vadodara, Gujarat, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Associate Professor, Department of Paediatrics, Sir Sayajirao General Hospital, Vadodara, Gujarat, India","institution_ids":["https://openalex.org/I259800356"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5086793559","display_name":"Jayesh Sanmukhani","orcid":"https://orcid.org/0000-0003-4663-4431","observed_orcids":["https://orcid.org/0000-0003-4663-4431"]},"institutions":[{"id":"https://openalex.org/I4210132663","display_name":"Zydus Lifesciences Limited (India)","ror":"https://ror.org/03ktyvw44","country_code":"IN","type":"company","lineage":["https://openalex.org/I4210132663"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Jayesh Sanmukhani","raw_affiliation_strings":["Senior Manager, Department of Clinical Research and Regulatory Affairs, Cadila Healthcare Limited, Ahmedabad, Gujarat, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Senior Manager, Department of Clinical Research and Regulatory Affairs, Cadila Healthcare Limited, Ahmedabad, Gujarat, India","institution_ids":["https://openalex.org/I4210132663"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5009659129","display_name":"Ravindra Mittal","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210132663","display_name":"Zydus Lifesciences Limited (India)","ror":"https://ror.org/03ktyvw44","country_code":"IN","type":"company","lineage":["https://openalex.org/I4210132663"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Ravindra Mittal","raw_affiliation_strings":["Senior Vice President, Department of Clinical Research and Regulatory Affairs, Cadila Healthcare Limited, Ahmedabad, Gujarat, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Senior Vice President, Department of Clinical Research and Regulatory Affairs, Cadila Healthcare Limited, Ahmedabad, Gujarat, India","institution_ids":["https://openalex.org/I4210132663"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":5,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":{"value":275,"currency":"USD","value_usd":275},"apc_paid":{"value":275,"currency":"USD","value_usd":275},"fwci":0.0,"has_fulltext":false,"cited_by_count":1,"citation_normalized_percentile":{"value":0.0,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":88,"max":93},"biblio":{"volume":null,"issue":null,"first_page":null,"last_page":null},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11135","display_name":"Virology and Viral Diseases","score":0.9961000084877014,"subfield":{"id":"https://openalex.org/subfields/2713","display_name":"Epidemiology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T11135","display_name":"Virology and Viral Diseases","score":0.9961000084877014,"subfield":{"id":"https://openalex.org/subfields/2713","display_name":"Epidemiology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10873","display_name":"Bacterial Infections and Vaccines","score":0.0010000000474974513,"subfield":{"id":"https://openalex.org/subfields/2404","display_name":"Microbiology"},"field":{"id":"https://openalex.org/fields/24","display_name":"Immunology and Microbiology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T13410","display_name":"Immune responses and vaccinations","score":0.00039999998989515007,"subfield":{"id":"https://openalex.org/subfields/2403","display_name":"Immunology"},"field":{"id":"https://openalex.org/fields/24","display_name":"Immunology and Microbiology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/mmr-vaccine","display_name":"MMR vaccine","score":0.8389999866485596},{"id":"https://openalex.org/keywords/measles","display_name":"measles","score":0.6600000262260437},{"id":"https://openalex.org/keywords/mumps","display_name":"mumps","score":0.9990000128746033},{"id":"https://openalex.org/keywords/rubella","display_name":"rubella","score":0.9990000128746033},{"id":"https://openalex.org/keywords/immunogenicity","display_name":"immunogenicity","score":0.7599999904632568},{"id":"https://openalex.org/keywords/vaccine-safety","display_name":"vaccine safety","score":0.9929999709129333},{"id":"https://openalex.org/keywords/seroconversion","display_name":"seroconversion","score":0.9330000281333923},{"id":"https://openalex.org/keywords/igg","display_name":"IgG","score":0.6589999794960022},{"id":"https://openalex.org/keywords/paediatric-vaccination","display_name":"paediatric vaccination","score":0.7210000157356262},{"id":"https://openalex.org/keywords/adverse-events","display_name":"adverse events","score":0.7770000100135803},{"id":"https://openalex.org/keywords/india","display_name":"India","score":0.37299999594688416}],"concepts":[{"id":"https://openalex.org/C2780868878","wikidata":"https://www.wikidata.org/wiki/Q1660197","display_name":"Immunogenicity","level":3,"score":0.8936381340026855},{"id":"https://openalex.org/C159047783","wikidata":"https://www.wikidata.org/wiki/Q7215","display_name":"Virology","level":1,"score":0.5348492860794067},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.51483553647995},{"id":"https://openalex.org/C2776646718","wikidata":"https://www.wikidata.org/wiki/Q908104","display_name":"MMR vaccine","level":5,"score":0.4566246271133423},{"id":"https://openalex.org/C203014093","wikidata":"https://www.wikidata.org/wiki/Q101929","display_name":"Immunology","level":1,"score":0.203264057636261},{"id":"https://openalex.org/C22070199","wikidata":"https://www.wikidata.org/wiki/Q192995","display_name":"Vaccination","level":2,"score":0.16906356811523438},{"id":"https://openalex.org/C159654299","wikidata":"https://www.wikidata.org/wiki/Q79460","display_name":"Antibody","level":2,"score":0.11435398459434509},{"id":"https://openalex.org/C2778814567","wikidata":"https://www.wikidata.org/wiki/Q155857","display_name":"Rubella","level":4,"score":0.06264349818229675},{"id":"https://openalex.org/C2776438120","wikidata":"https://www.wikidata.org/wiki/Q79793","display_name":"Measles","level":3,"score":0.05242377519607544}],"mesh":[],"locations_count":2,"locations":[{"id":"doi:10.7860/jcdr/2018/29855.11125","doi":"https://doi.org/10.7860/jcdr/2018/29855.11125","is_oa":true,"landing_page_url":"https://doi.org/10.7860/jcdr/2018/29855.11125","pdf_url":null,"source":{"id":"https://openalex.org/S2737465529","display_name":"JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH","issn_l":"0973-709X","issn":["0973-709X","2249-782X"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","poland-40"],"host_organization":"https://openalex.org/P4310318655","host_organization_name":"JCDR Research and Publications Private Limited","host_organization_lineage":["https://openalex.org/P4310318655"],"host_organization_lineage_names":["JCDR Research and Publications Private Limited"],"type":"journal"},"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH","raw_type":"journal-article"},{"id":"pmh:oai:doaj.org/article:8ea10934717b44a8878d720300e2792f","doi":null,"is_oa":true,"landing_page_url":"https://doaj.org/article/8ea10934717b44a8878d720300e2792f","pdf_url":null,"source":{"id":"https://openalex.org/S4306401280","display_name":"DOAJ (DOAJ: Directory of Open Access Journals)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by-sa","license_id":"https://openalex.org/licenses/cc-by-sa","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Journal of Clinical and Diagnostic Research, Vol 12, Iss 1, Pp SC09-SC13 (2018)","raw_type":"article"}],"best_oa_location":{"id":"doi:10.7860/jcdr/2018/29855.11125","doi":"https://doi.org/10.7860/jcdr/2018/29855.11125","is_oa":true,"landing_page_url":"https://doi.org/10.7860/jcdr/2018/29855.11125","pdf_url":null,"source":{"id":"https://openalex.org/S2737465529","display_name":"JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH","issn_l":"0973-709X","issn":["0973-709X","2249-782X"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","poland-40"],"host_organization":"https://openalex.org/P4310318655","host_organization_name":"JCDR Research and Publications Private Limited","host_organization_lineage":["https://openalex.org/P4310318655"],"host_organization_lineage_names":["JCDR Research and Publications Private Limited"],"type":"journal"},"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH","raw_type":"journal-article"},"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","score":1.0,"display_name":"Good health and well-being"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W2599983054","https://openalex.org/W2328460585","https://openalex.org/W2350954529","https://openalex.org/W2380539230","https://openalex.org/W2373832635","https://openalex.org/W4390973713","https://openalex.org/W2807997192","https://openalex.org/W4246132346","https://openalex.org/W1990576932","https://openalex.org/W4386333926"],"abstract_inverted_index":{"Introduction:":[0],"This":[1,32],"is":[2],"the":[3,12,28,46,51,62,71,76,82,105,111,114,119,128,139,143,152,176,184,188,191,196,199,237,251,281,284,288],"first":[4],"study":[5,35,155,238,252],"in":[6,54,183,187,255,264],"Indian":[7],"paediatric":[8,299],"subjects":[9,189,228,257,266,300],"to":[10,44],"evaluate":[11,45,70],"novel":[13,52,83,106,289],"Measles,":[14],"Mumps":[15],"and":[16,48,73,78,86,90,131,135,163,210,218,262,283,294],"Rubella":[17],"(MMR)":[18],"vaccine":[19,53,108,120,144,193,223,291],"developed":[20],"by":[21,123,147,260,297],"M/s":[22],"Cadila":[23],"Healthcare":[24],"Limited,":[25],"India,":[26],"containing":[27],"Hoshino":[29],"mumps":[30,130],"strain.":[31],"phase":[33,65,274],"II":[34,275],"was":[36,121,145,166,173,180,213,224,253],"done":[37],"as":[38],"part":[39],"of":[40,50,57,75,81,97,104,118,142,207,230,242,272,287],"clinical":[41,276],"development":[42],"programme":[43],"safety":[47,74],"immunogenicity":[49,72],"small":[55],"cohort":[56],"target":[58],"population":[59],"before":[60,134],"conducting":[61],"larger":[63],"comparative":[64],"III":[66],"study.":[67],"Aim:":[68],"To":[69],"singledose":[77],"multi-dose":[79,115,200,285],"formulations":[80],"vaccine.":[84],"Materials":[85],"Methods:":[87],"One":[88],"hundred":[89],"twenty":[91],"three":[92],"healthy":[93,298],"children":[94],"15-18":[95,302],"months":[96],"age":[98],"were":[99],"administered":[100],"a":[101],"single":[102],"dose":[103],"MMR":[107,177,192,290],"from":[109,195],"either":[110,194],"single-dose":[112,197,282],"or":[113,198],"formulation.":[116,201],"Immunogenicity":[117],"assessed":[122,146],"measuring":[124],"IgG":[125],"antibodies":[126,165,172,212],"against":[127],"measles,":[129],"rubella":[132],"viruses":[133],"six":[136,153],"weeks":[137],"after":[138,175],"vaccination.":[140,178],"Safety":[141],"recording":[148],"adverse":[149,234,247],"events":[150,235],"during":[151,236,250],"week":[154],"period.":[156],"Results:":[157],"The":[158,202,222,244,270],"seroconversion":[159,185],"rate":[160,241],"for":[161,170],"anti-measles":[162],"antimumps":[164],"100%":[167],"while":[168],"that":[169,279],"anti-rubella":[171,211],"98.9%":[174],"There":[179],"no":[181],"difference":[182],"rates":[186],"receiving":[190],"Geometric":[203],"Mean":[204],"Titre":[205],"(GMT)":[206],"anti-measles,":[208],"anti-mumps":[209],"3154.0":[214],"mIU/mL,":[215],"90.6":[216],"EU/mL":[217],"141.7":[219],"IU/mL,":[220],"respectively.":[221],"well":[225,295],"tolerated,":[226],"28":[227],"(out":[229],"123)":[231],"reported":[232,249],"43":[233],"(adverse":[239],"event":[240,248],"21.8%).":[243],"most":[245],"common":[246],"fever":[254],"19":[256],"(15.4%)":[258],"followed":[259],"rash":[261],"rhinorrhoea":[263],"five":[265],"(4.1%)":[267],"each.":[268],"Conclusion:":[269],"results":[271],"this":[273],"trial":[277],"show":[278],"both":[280],"formulation":[286],"are":[292],"immunogenic":[293],"tolerated":[296],"aged":[301],"months.":[303]},"counts_by_year":[{"year":2024,"cited_by_count":1}],"updated_date":"2026-09-29T14:09:16.559479","created_date":"2018-03-29T00:00:00"}
