{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T18:37:13Z","timestamp":1792521433504,"version":"4.5.0"},"reference-count":44,"publisher":"BMJ","issue":"9","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2015,5,22]]},"published-print":{"date-parts":[[2015,9]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>This study (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT00969436\">NCT00969436<\/jats:ext-link>) compared the immunogenicity and safety of measles-mumps-rubella (MMR) followed by MMR+varicella (V) vaccines to (1) 2 doses of combined MMRV and (2) MMR followed by MMRV, in Indian children.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design<\/jats:title><jats:p>Phase III, open, randomised, non-inferiority study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Setting<\/jats:title><jats:p>6 tertiary care hospitals located in India.<\/jats:p><\/jats:sec><jats:sec><jats:title>Participants<\/jats:title><jats:p>Healthy participants aged 9\u201310\u2005months not previously vaccinated against\/exposed to measles, mumps, rubella and varicella or without a history of these diseases.<\/jats:p><\/jats:sec><jats:sec><jats:title>Interventions<\/jats:title><jats:p>Participants were randomised (2:2:1) to receive 2 doses of either MMRV (MMRV\/MMRV group) or MMR followed by MMRV (MMR\/MMRV group) or MMR followed by MMR+V (MMR\/MMR+V, control group) at 9 and 15\u2005months of age. Antibody titres against measles, mumps and rubella were measured using ELISA and against varicella using an immunofluorescence assay.<\/jats:p><\/jats:sec><jats:sec><jats:title>Main outcome measures<\/jats:title><jats:p>To demonstrate non-inferiority of the 2 vaccination regimens versus the control in terms of seroconversion rates, defined as a group difference with a lower bound of the 95% CI &gt;\u221210% for each antigen, 43\u2005days postdose 2. Parents\/guardians recorded solicited local and general symptoms for a 4-day and 43-day period after each vaccine dose, respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Seroconversion rates postdose 1 ranged from 87.5% to 93.2% for measles, 83.3% to 86.1% for mumps and 98.7% to 100% for rubella across the 3 vaccine groups. The seroconversion rates postdose 2 were 100% for measles, mumps and rubella and at least 95.8% for varicella across the 3 vaccine groups. Non-inferiority of MMRV\/MMRV and MMR\/MMRV to MMR\/MMR+V was achieved for all antigens, 43\u2005days postdose 2. The 3 vaccination regimens were generally well tolerated in terms of solicited local and general symptoms.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The immune responses elicited by the MMRV\/MMRV and MMR\/MMRV vaccination regimens were non-inferior to those elicited by the MMR\/MMR+V regimen for all antigens. The 3 vaccination schedules also exhibited an acceptable safety profile in Indian children.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration number<\/jats:title><jats:p>NCT00969436.<\/jats:p><\/jats:sec>","DOI":"10.1136\/bmjopen-2014-007202","type":"journal-article","created":{"date-parts":[[2015,9,12]],"date-time":"2015-09-12T01:23:41Z","timestamp":1442021021000},"page":"e007202","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":19,"title":["Immunogenicity and safety of early vaccination with two doses of a combined measles-mumps-rubella-varicella vaccine in healthy Indian children from 9\u2005months of age: a phase III, randomised, non-inferiority trial"],"prefix":"10.1136","volume":"5","clinical-trial-number":[{"clinical-trial-number":"nct00969436","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct00969436","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Sanjay","family":"Lalwani","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sukanta","family":"Chatterjee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sundaram","family":"Balasubramanian","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashish","family":"Bavdekar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shailesh","family":"Mehta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sanjoy","family":"Datta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Povey","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ouzama","family":"Henry","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2015,9,11]]},"reference":[{"key":"2024051513261710000_5.9.e007202.1","first-page":"349","article-title":"Measles vaccines: WHO position paper","volume":"84","author":"World Health Organization","year":"2009","journal-title":"Wkly Epidemiol Rec"},{"key":"2024051513261710000_5.9.e007202.2","first-page":"49","article-title":"Mumps virus vaccines","volume":"82","author":"World Health Organization","year":"2007","journal-title":"Wkly Epidemiol Rec"},{"key":"2024051513261710000_5.9.e007202.3","first-page":"301","article-title":"Rubella vaccines: WHO position paper","volume":"86","author":"World Health Organization","year":"2011","journal-title":"Wkly Epidemiol Rec"},{"issue":"(RR04)","key":"2024051513261710000_5.9.e007202.4","first-page":"1","article-title":"Prevention of varicella: recommendations of the Advisory Committee on Immunization Practices (ACIP)","volume":"56","author":"Marin","year":"2007","journal-title":"MMWR Recomm Rep"},{"key":"2024051513261710000_5.9.e007202.5","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(12)60522-4"},{"key":"2024051513261710000_5.9.e007202.6","unstructured":"World Health Organization Media Centre. 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