Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian infants: a randomised, double-blind, placebo-controlled trial
Summary Background Rotavirus is the most common cause of severe dehydrating gastroenteritis in developing countries. Safe, effective, and affordable rotavirus vaccines are needed in these countries. We aimed to assess the efficacy and tolerability of a monovalent human-bovine rotavirus vaccine for s...
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| Veröffentlicht in: | The Lancet (British edition) 2014-06, Vol.383 (9935), p.2136-2143 |
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| creator | Bhandari, Nita, PhD Rongsen-Chandola, Temsunaro, MSc Bavdekar, Ashish, DNB John, Jacob, MD Antony, Kalpana, MBA Taneja, Sunita, PhD Goyal, Nidhi, DPH Kawade, Anand, MD Kang, Gagandeep, Prof Rathore, Sudeep Singh, MBBS Juvekar, Sanjay, PhD Muliyil, Jayaprakash, Prof Arya, Alok, MPharm Shaikh, Hanif, MPharm Abraham, Vinod, MPH Vrati, Sudhanshu, Prof Proschan, Michael, PhD Kohberger, Robert, PhD Thiry, Georges, PhD Glass, Roger, PhD Greenberg, Harry B, Prof Curlin, George, MD Mohan, Krishna, PhD Harshavardhan, G V J A, BVSc Prasad, Sai, MBA Rao, T S, PhD Boslego, John, MD Bhan, Maharaj Kishan, Dr Prof |
| description | Summary Background Rotavirus is the most common cause of severe dehydrating gastroenteritis in developing countries. Safe, effective, and affordable rotavirus vaccines are needed in these countries. We aimed to assess the efficacy and tolerability of a monovalent human-bovine rotavirus vaccine for severe rotavirus gastroenteritis in low-resource urban and rural settings in India. Methods We did a randomised double-blind, placebo-controlled, multicentre trial at three sites in Delhi (urban), Pune (rural), and Vellore (urban and rural) between March 11, 2011, and Nov 5, 2012. Infants aged 6–7 weeks were randomly assigned (2:1), via a central interactive voice or web response system with a block size of 12, to receive either three doses of oral human-bovine natural reassortant vaccine (116E) or placebo at ages 6–7 weeks, 10 weeks, and 14 weeks. Infants' families, study investigators, paediatricians in referral hospitals, laboratory staff, and committee members were all masked to treatment allocation. The primary outcome was incidence of severe rotavirus gastroenteritis (≥11 on the Vesikari scale). Efficacy outcomes and adverse events were ascertained through active surveillance. Analysis was by intention to treat and per protocol. The trial is registered with Clinical Trial Registry–India (CTRI/2010/091/000102) and ClinicalTrials.gov ( NCT01305109 ). Findings 4532 infants were assigned to receive the 116E vaccine and 2267 to receive placebo, of whom 4354 (96%) and 2187 (96%) infants, respectively, were included in the primary per-protocol efficacy analysis. 71 events of severe rotavirus gastroenteritis were reported in 4752 person-years in infants in the vaccine group compared with 76 events in 2360 person-years in those in the placebo group; vaccine efficacy against severe rotavirus gastroenteritis was 53·6% (95% CI 35·0–66·9; p=0·0013) and 56·4% (36·6–70·1; p |
| doi_str_mv | 10.1016/S0140-6736(13)62630-6 |
| format | Article |
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Safe, effective, and affordable rotavirus vaccines are needed in these countries. We aimed to assess the efficacy and tolerability of a monovalent human-bovine rotavirus vaccine for severe rotavirus gastroenteritis in low-resource urban and rural settings in India. Methods We did a randomised double-blind, placebo-controlled, multicentre trial at three sites in Delhi (urban), Pune (rural), and Vellore (urban and rural) between March 11, 2011, and Nov 5, 2012. Infants aged 6–7 weeks were randomly assigned (2:1), via a central interactive voice or web response system with a block size of 12, to receive either three doses of oral human-bovine natural reassortant vaccine (116E) or placebo at ages 6–7 weeks, 10 weeks, and 14 weeks. Infants' families, study investigators, paediatricians in referral hospitals, laboratory staff, and committee members were all masked to treatment allocation. The primary outcome was incidence of severe rotavirus gastroenteritis (≥11 on the Vesikari scale). Efficacy outcomes and adverse events were ascertained through active surveillance. Analysis was by intention to treat and per protocol. The trial is registered with Clinical Trial Registry–India (CTRI/2010/091/000102) and ClinicalTrials.gov ( NCT01305109 ). Findings 4532 infants were assigned to receive the 116E vaccine and 2267 to receive placebo, of whom 4354 (96%) and 2187 (96%) infants, respectively, were included in the primary per-protocol efficacy analysis. 71 events of severe rotavirus gastroenteritis were reported in 4752 person-years in infants in the vaccine group compared with 76 events in 2360 person-years in those in the placebo group; vaccine efficacy against severe rotavirus gastroenteritis was 53·6% (95% CI 35·0–66·9; p=0·0013) and 56·4% (36·6–70·1; p<0·0001) in the first year of life. The number of infants needed to be immunised to prevent one severe rotavirus gastroenteritis episode was 55 (95% CI 37–97). The incidence of severe rotavirus gastroenteritis per 100 person-years was 1·5 in the vaccine group and 3·2 in the placebo group, with an incidence rate ratio of 0·46 (95% CI 0·33–0·65). Prevalence of immediate, solicited, and serious adverse events was similar in both groups. One case of urticaria in the vaccine group and one each of acute gastroenteritis and suspected sepsis in the placebo group were regarded as related to the study product. We recorded six cases of intussusception in the vaccine group and two in the placebo group, all of which happened after the third dose. 25 (<1%) infants in the vaccine group and 17 (<1%) in the placebo group died; no death was regarded as related to the study product. Interpretation Monovalent human-bovine (116E) rotavirus vaccine is effective and well tolerated in Indian infants. Funding Department of Biotechnology and the Biotechnology Industry Research Assistance Council, Government of India; Bill & Melinda Gates Foundation to PATH, USA; Research Council of Norway; UK Department for International Development; National Institutes of Health, Bethesda, USA; and Bharat Biotech International, Hyderabad, India.</description><identifier>ISSN: 0140-6736</identifier><identifier>EISSN: 1474-547X</identifier><identifier>DOI: 10.1016/S0140-6736(13)62630-6</identifier><identifier>PMID: 24629994</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>Kidlington: Elsevier Ltd</publisher><subject>Biological and medical sciences ; Biotechnology ; Children & youth ; Developing countries ; Diarrhea ; Double-Blind Method ; Female ; Gastroenteritis ; Gastroenteritis - prevention & control ; General aspects ; Humans ; Immunization ; India ; Infant ; Infants ; Internal Medicine ; LDCs ; Male ; Medical sciences ; Mortality ; Rotavirus ; Rotavirus Infections - prevention & control ; Rotavirus Vaccines - therapeutic use ; Vaccines ; Viruses</subject><ispartof>The Lancet (British edition), 2014-06, Vol.383 (9935), p.2136-2143</ispartof><rights>Elsevier Ltd</rights><rights>2014 Elsevier Ltd</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2014 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Limited Jun 21, 2014</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c735t-a046c14f384d55a3ff855de93baceb536675fe56d34a256745a7affcd516cfab3</citedby><cites>FETCH-LOGICAL-c735t-a046c14f384d55a3ff855de93baceb536675fe56d34a256745a7affcd516cfab3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0140673613626306$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,314,776,780,881,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=28558698$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24629994$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bhandari, Nita, PhD</creatorcontrib><creatorcontrib>Rongsen-Chandola, Temsunaro, MSc</creatorcontrib><creatorcontrib>Bavdekar, Ashish, DNB</creatorcontrib><creatorcontrib>John, Jacob, MD</creatorcontrib><creatorcontrib>Antony, Kalpana, MBA</creatorcontrib><creatorcontrib>Taneja, Sunita, PhD</creatorcontrib><creatorcontrib>Goyal, Nidhi, DPH</creatorcontrib><creatorcontrib>Kawade, Anand, MD</creatorcontrib><creatorcontrib>Kang, Gagandeep, Prof</creatorcontrib><creatorcontrib>Rathore, Sudeep Singh, MBBS</creatorcontrib><creatorcontrib>Juvekar, Sanjay, PhD</creatorcontrib><creatorcontrib>Muliyil, Jayaprakash, Prof</creatorcontrib><creatorcontrib>Arya, Alok, MPharm</creatorcontrib><creatorcontrib>Shaikh, Hanif, MPharm</creatorcontrib><creatorcontrib>Abraham, Vinod, MPH</creatorcontrib><creatorcontrib>Vrati, Sudhanshu, Prof</creatorcontrib><creatorcontrib>Proschan, Michael, PhD</creatorcontrib><creatorcontrib>Kohberger, Robert, PhD</creatorcontrib><creatorcontrib>Thiry, Georges, PhD</creatorcontrib><creatorcontrib>Glass, Roger, PhD</creatorcontrib><creatorcontrib>Greenberg, Harry B, Prof</creatorcontrib><creatorcontrib>Curlin, George, MD</creatorcontrib><creatorcontrib>Mohan, Krishna, PhD</creatorcontrib><creatorcontrib>Harshavardhan, G V J A, BVSc</creatorcontrib><creatorcontrib>Prasad, Sai, MBA</creatorcontrib><creatorcontrib>Rao, T S, PhD</creatorcontrib><creatorcontrib>Boslego, John, MD</creatorcontrib><creatorcontrib>Bhan, Maharaj Kishan, Dr Prof</creatorcontrib><creatorcontrib>for the India Rotavirus Vaccine Group</creatorcontrib><creatorcontrib>India Rotavirus Vaccine Group</creatorcontrib><title>Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian infants: a randomised, double-blind, placebo-controlled trial</title><title>The Lancet (British edition)</title><addtitle>Lancet</addtitle><description>Summary Background Rotavirus is the most common cause of severe dehydrating gastroenteritis in developing countries. Safe, effective, and affordable rotavirus vaccines are needed in these countries. We aimed to assess the efficacy and tolerability of a monovalent human-bovine rotavirus vaccine for severe rotavirus gastroenteritis in low-resource urban and rural settings in India. Methods We did a randomised double-blind, placebo-controlled, multicentre trial at three sites in Delhi (urban), Pune (rural), and Vellore (urban and rural) between March 11, 2011, and Nov 5, 2012. Infants aged 6–7 weeks were randomly assigned (2:1), via a central interactive voice or web response system with a block size of 12, to receive either three doses of oral human-bovine natural reassortant vaccine (116E) or placebo at ages 6–7 weeks, 10 weeks, and 14 weeks. Infants' families, study investigators, paediatricians in referral hospitals, laboratory staff, and committee members were all masked to treatment allocation. The primary outcome was incidence of severe rotavirus gastroenteritis (≥11 on the Vesikari scale). Efficacy outcomes and adverse events were ascertained through active surveillance. Analysis was by intention to treat and per protocol. The trial is registered with Clinical Trial Registry–India (CTRI/2010/091/000102) and ClinicalTrials.gov ( NCT01305109 ). Findings 4532 infants were assigned to receive the 116E vaccine and 2267 to receive placebo, of whom 4354 (96%) and 2187 (96%) infants, respectively, were included in the primary per-protocol efficacy analysis. 71 events of severe rotavirus gastroenteritis were reported in 4752 person-years in infants in the vaccine group compared with 76 events in 2360 person-years in those in the placebo group; vaccine efficacy against severe rotavirus gastroenteritis was 53·6% (95% CI 35·0–66·9; p=0·0013) and 56·4% (36·6–70·1; p<0·0001) in the first year of life. The number of infants needed to be immunised to prevent one severe rotavirus gastroenteritis episode was 55 (95% CI 37–97). The incidence of severe rotavirus gastroenteritis per 100 person-years was 1·5 in the vaccine group and 3·2 in the placebo group, with an incidence rate ratio of 0·46 (95% CI 0·33–0·65). Prevalence of immediate, solicited, and serious adverse events was similar in both groups. One case of urticaria in the vaccine group and one each of acute gastroenteritis and suspected sepsis in the placebo group were regarded as related to the study product. We recorded six cases of intussusception in the vaccine group and two in the placebo group, all of which happened after the third dose. 25 (<1%) infants in the vaccine group and 17 (<1%) in the placebo group died; no death was regarded as related to the study product. Interpretation Monovalent human-bovine (116E) rotavirus vaccine is effective and well tolerated in Indian infants. Funding Department of Biotechnology and the Biotechnology Industry Research Assistance Council, Government of India; Bill & Melinda Gates Foundation to PATH, USA; Research Council of Norway; UK Department for International Development; National Institutes of Health, Bethesda, USA; and Bharat Biotech International, Hyderabad, India.</description><subject>Biological and medical sciences</subject><subject>Biotechnology</subject><subject>Children & youth</subject><subject>Developing countries</subject><subject>Diarrhea</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Gastroenteritis</subject><subject>Gastroenteritis - prevention & control</subject><subject>General aspects</subject><subject>Humans</subject><subject>Immunization</subject><subject>India</subject><subject>Infant</subject><subject>Infants</subject><subject>Internal Medicine</subject><subject>LDCs</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Mortality</subject><subject>Rotavirus</subject><subject>Rotavirus Infections - prevention & control</subject><subject>Rotavirus Vaccines - therapeutic 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of a monovalent human-bovine (116E) rotavirus vaccine in Indian infants: a randomised, double-blind, placebo-controlled trial</title><author>Bhandari, Nita, PhD ; Rongsen-Chandola, Temsunaro, MSc ; Bavdekar, Ashish, DNB ; John, Jacob, MD ; Antony, Kalpana, MBA ; Taneja, Sunita, PhD ; Goyal, Nidhi, DPH ; Kawade, Anand, MD ; Kang, Gagandeep, Prof ; Rathore, Sudeep Singh, MBBS ; Juvekar, Sanjay, PhD ; Muliyil, Jayaprakash, Prof ; Arya, Alok, MPharm ; Shaikh, Hanif, MPharm ; Abraham, Vinod, MPH ; Vrati, Sudhanshu, Prof ; Proschan, Michael, PhD ; Kohberger, Robert, PhD ; Thiry, Georges, PhD ; Glass, Roger, PhD ; Greenberg, Harry B, Prof ; Curlin, George, MD ; Mohan, Krishna, PhD ; Harshavardhan, G V J A, BVSc ; Prasad, Sai, MBA ; Rao, T S, PhD ; Boslego, John, MD ; Bhan, Maharaj Kishan, Dr Prof</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c735t-a046c14f384d55a3ff855de93baceb536675fe56d34a256745a7affcd516cfab3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Biological and medical sciences</topic><topic>Biotechnology</topic><topic>Children & youth</topic><topic>Developing countries</topic><topic>Diarrhea</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Gastroenteritis</topic><topic>Gastroenteritis - prevention & control</topic><topic>General aspects</topic><topic>Humans</topic><topic>Immunization</topic><topic>India</topic><topic>Infant</topic><topic>Infants</topic><topic>Internal Medicine</topic><topic>LDCs</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Mortality</topic><topic>Rotavirus</topic><topic>Rotavirus Infections - prevention & control</topic><topic>Rotavirus Vaccines - therapeutic use</topic><topic>Vaccines</topic><topic>Viruses</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bhandari, Nita, PhD</creatorcontrib><creatorcontrib>Rongsen-Chandola, Temsunaro, MSc</creatorcontrib><creatorcontrib>Bavdekar, Ashish, DNB</creatorcontrib><creatorcontrib>John, Jacob, MD</creatorcontrib><creatorcontrib>Antony, Kalpana, MBA</creatorcontrib><creatorcontrib>Taneja, Sunita, PhD</creatorcontrib><creatorcontrib>Goyal, Nidhi, DPH</creatorcontrib><creatorcontrib>Kawade, Anand, MD</creatorcontrib><creatorcontrib>Kang, Gagandeep, Prof</creatorcontrib><creatorcontrib>Rathore, Sudeep Singh, MBBS</creatorcontrib><creatorcontrib>Juvekar, Sanjay, PhD</creatorcontrib><creatorcontrib>Muliyil, Jayaprakash, Prof</creatorcontrib><creatorcontrib>Arya, Alok, MPharm</creatorcontrib><creatorcontrib>Shaikh, Hanif, MPharm</creatorcontrib><creatorcontrib>Abraham, Vinod, MPH</creatorcontrib><creatorcontrib>Vrati, Sudhanshu, Prof</creatorcontrib><creatorcontrib>Proschan, Michael, PhD</creatorcontrib><creatorcontrib>Kohberger, Robert, PhD</creatorcontrib><creatorcontrib>Thiry, Georges, PhD</creatorcontrib><creatorcontrib>Glass, Roger, PhD</creatorcontrib><creatorcontrib>Greenberg, Harry B, Prof</creatorcontrib><creatorcontrib>Curlin, George, MD</creatorcontrib><creatorcontrib>Mohan, Krishna, PhD</creatorcontrib><creatorcontrib>Harshavardhan, G V J A, BVSc</creatorcontrib><creatorcontrib>Prasad, Sai, MBA</creatorcontrib><creatorcontrib>Rao, T S, PhD</creatorcontrib><creatorcontrib>Boslego, John, MD</creatorcontrib><creatorcontrib>Bhan, Maharaj Kishan, Dr Prof</creatorcontrib><creatorcontrib>for the India Rotavirus Vaccine Group</creatorcontrib><creatorcontrib>India Rotavirus Vaccine Group</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>News PRO</collection><collection>Pharma and Biotech Premium PRO</collection><collection>Global News & ABI/Inform Professional</collection><collection>ProQuest Central (Corporate)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Biology Database (Alumni Edition)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni 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Database (Alumni Edition)</collection><collection>ProQuest Newsstand Professional</collection><collection>ProQuest Biological Science Collection</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>ProQuest Psychology</collection><collection>Research Library</collection><collection>Science Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest Central (New)</collection><collection>ProQuest One Academic (New)</collection><collection>ProQuest Health & Medical Research Collection</collection><collection>ProQuest One Academic Middle East (New)</collection><collection>ProQuest One Health & Nursing</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Applied & Life Sciences</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>SIRS Editorial</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>The Lancet (British edition)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bhandari, Nita, PhD</au><au>Rongsen-Chandola, Temsunaro, MSc</au><au>Bavdekar, Ashish, DNB</au><au>John, Jacob, MD</au><au>Antony, Kalpana, MBA</au><au>Taneja, Sunita, PhD</au><au>Goyal, Nidhi, DPH</au><au>Kawade, Anand, MD</au><au>Kang, Gagandeep, Prof</au><au>Rathore, Sudeep Singh, MBBS</au><au>Juvekar, Sanjay, PhD</au><au>Muliyil, Jayaprakash, Prof</au><au>Arya, Alok, MPharm</au><au>Shaikh, Hanif, MPharm</au><au>Abraham, Vinod, MPH</au><au>Vrati, Sudhanshu, Prof</au><au>Proschan, Michael, PhD</au><au>Kohberger, Robert, PhD</au><au>Thiry, Georges, PhD</au><au>Glass, Roger, PhD</au><au>Greenberg, Harry B, Prof</au><au>Curlin, George, MD</au><au>Mohan, Krishna, PhD</au><au>Harshavardhan, G V J A, BVSc</au><au>Prasad, Sai, MBA</au><au>Rao, T S, PhD</au><au>Boslego, John, MD</au><au>Bhan, Maharaj Kishan, Dr Prof</au><aucorp>for the India Rotavirus Vaccine Group</aucorp><aucorp>India Rotavirus Vaccine Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian infants: a randomised, double-blind, placebo-controlled trial</atitle><jtitle>The Lancet (British edition)</jtitle><addtitle>Lancet</addtitle><date>2014-06-21</date><risdate>2014</risdate><volume>383</volume><issue>9935</issue><spage>2136</spage><epage>2143</epage><pages>2136-2143</pages><issn>0140-6736</issn><eissn>1474-547X</eissn><coden>LANCAO</coden><abstract>Summary Background Rotavirus is the most common cause of severe dehydrating gastroenteritis in developing countries. Safe, effective, and affordable rotavirus vaccines are needed in these countries. We aimed to assess the efficacy and tolerability of a monovalent human-bovine rotavirus vaccine for severe rotavirus gastroenteritis in low-resource urban and rural settings in India. Methods We did a randomised double-blind, placebo-controlled, multicentre trial at three sites in Delhi (urban), Pune (rural), and Vellore (urban and rural) between March 11, 2011, and Nov 5, 2012. Infants aged 6–7 weeks were randomly assigned (2:1), via a central interactive voice or web response system with a block size of 12, to receive either three doses of oral human-bovine natural reassortant vaccine (116E) or placebo at ages 6–7 weeks, 10 weeks, and 14 weeks. Infants' families, study investigators, paediatricians in referral hospitals, laboratory staff, and committee members were all masked to treatment allocation. The primary outcome was incidence of severe rotavirus gastroenteritis (≥11 on the Vesikari scale). Efficacy outcomes and adverse events were ascertained through active surveillance. Analysis was by intention to treat and per protocol. The trial is registered with Clinical Trial Registry–India (CTRI/2010/091/000102) and ClinicalTrials.gov ( NCT01305109 ). Findings 4532 infants were assigned to receive the 116E vaccine and 2267 to receive placebo, of whom 4354 (96%) and 2187 (96%) infants, respectively, were included in the primary per-protocol efficacy analysis. 71 events of severe rotavirus gastroenteritis were reported in 4752 person-years in infants in the vaccine group compared with 76 events in 2360 person-years in those in the placebo group; vaccine efficacy against severe rotavirus gastroenteritis was 53·6% (95% CI 35·0–66·9; p=0·0013) and 56·4% (36·6–70·1; p<0·0001) in the first year of life. The number of infants needed to be immunised to prevent one severe rotavirus gastroenteritis episode was 55 (95% CI 37–97). The incidence of severe rotavirus gastroenteritis per 100 person-years was 1·5 in the vaccine group and 3·2 in the placebo group, with an incidence rate ratio of 0·46 (95% CI 0·33–0·65). Prevalence of immediate, solicited, and serious adverse events was similar in both groups. One case of urticaria in the vaccine group and one each of acute gastroenteritis and suspected sepsis in the placebo group were regarded as related to the study product. We recorded six cases of intussusception in the vaccine group and two in the placebo group, all of which happened after the third dose. 25 (<1%) infants in the vaccine group and 17 (<1%) in the placebo group died; no death was regarded as related to the study product. Interpretation Monovalent human-bovine (116E) rotavirus vaccine is effective and well tolerated in Indian infants. Funding Department of Biotechnology and the Biotechnology Industry Research Assistance Council, Government of India; Bill & Melinda Gates Foundation to PATH, USA; Research Council of Norway; UK Department for International Development; National Institutes of Health, Bethesda, USA; and Bharat Biotech International, Hyderabad, India.</abstract><cop>Kidlington</cop><pub>Elsevier Ltd</pub><pmid>24629994</pmid><doi>10.1016/S0140-6736(13)62630-6</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0140-6736 |
| ispartof | The Lancet (British edition), 2014-06, Vol.383 (9935), p.2136-2143 |
| issn | 0140-6736 1474-547X |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4532697 |
| source | MEDLINE; Elsevier ScienceDirect Journals Complete |
| subjects | Biological and medical sciences Biotechnology Children & youth Developing countries Diarrhea Double-Blind Method Female Gastroenteritis Gastroenteritis - prevention & control General aspects Humans Immunization India Infant Infants Internal Medicine LDCs Male Medical sciences Mortality Rotavirus Rotavirus Infections - prevention & control Rotavirus Vaccines - therapeutic use Vaccines Viruses |
| title | Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian infants: a randomised, double-blind, placebo-controlled trial |
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