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. 2019 Oct 28;2019(10):CD008521. doi: 10.1002/14651858.CD008521.pub5
Vaccine Trial No. of deaths Cause of death
Vaccine Placebo Unclear Total
RV1 RV1 Anh 2011‐PHL 1 0 0 1 Salmonella gastroenteritis
RV1 Anh 2011‐VNM 0 0 0 0
RV1 Bernstein 1998‐USA 0 0 0 0
RV1 Bernstein 1999‐USA 0 0 1 (1) 1 Pneumococcal sepsis
RV1 Colgate 2016‐BGD 1 1 0 2 Reasons not reported
RV1 GSK[021] 2007‐PAN 0 0 0 0
RV1 Tregnaghi 2011‐LA 10 2 0 12 Meningitis bacterial (1 vaccine, 1 placebo), pneumonia (3 vaccine), aortic valve stenosis (1 vaccine), bronchiolitis (1 vaccine), dengue fever (1 vaccine), endocarditis bacterial (1 vaccine), intussusception (1 vaccine), multi‐organ failure (1 placebo), respiratory failure (1 vaccine), sepsis (2 vaccine)
RV1 GSK[033] 2007‐LA 3 0 0 3 Gastroenteritis (1 vaccine), bronchopneumonia (1 vaccine), aspiration (1 vaccine)
RV1 GSK[041] 2007‐KOR 0 0 0 2 Not reported
RV1 GSK[101555] 2008‐PHL 0 0 0 0
RV1 Kawamura 2011‐JPN 0 0 0 0
RV1 Kerdpanich 2010‐THA 0 0 0 0
RV1 Kim 2012‐KOR 0 0 0 0
RV1 Li 2013a‐CHN 0 0 0 0
RV1 Li 2013b‐CHN 0 0 0 0
RV1 Li 2014‐CHN 6 7 0 13 Vaccine (6): Asphyxia, Drowning, Central nervous system infection, Bronchopneumonia, Cortical dysplasia, Intracranial Haemorrhage, Asphyxia, Meningitis, Multi‐organ failure, Hemotophagic histiocytosis, Acute lymphocytic leukemia, Multi‐organ failure
 
 Placebo (7): Diarrhea, Multi‐organ failure, Congenital heart disease, Respiratory failure, brain contusion, subarachnoid hemorrhage, skull fracture, cerebral hematoma, and brain herniation
RV1 Madhi 2010‐AF 83 43 0 126 Reasons not stated
RV1 Narang 2009‐IND 0 0 0 0
RV1 NCT00158756‐RUS 0 0 0 0
RV1 Phua 2005‐SGP 3 0 0 3 Leukaemia (1 vaccine); accident‐induced subarachnoid haemorrhage (1 vaccine); cardiorespiratory failure after acute viral pneumonitis (1 vaccine)
RV1 Phua 2009‐AS 1 3 0 4 Aspiration and metabolic disorder, adenoviral pneumonia, interstitial pneumonia, and sudden infant death syndrome (not stated which group)
RV1 Rivera 2011‐DOM 0 0 0 0
RV1 Ruiz‐Palac 06‐LA/EU 56 43 0 99 Diarrhoea (4 vaccine, 2 placebo); pneumonia (16 vaccine, 6 placebo); other causes not mentioned
RV1 Salinas 2005‐LA 2 1 0 3 Generalized visceral congestion (1 placebo); sepsis (1 vaccine); automobile accident (1 vaccine)
RV1 Steele 2008‐ZAF 3 5 0 8 Bronchopneumonia (1 placebo), pneumonia (2 vaccine, 2 placebo), hepatic steatosis (1 placebo), brain oedema (1 vaccine, 1 placebo)
RV1 Steele 2010a‐ZAF 6 9 0 15 Bronchopneumonia, sepsis, and gastroenteritis were the most common causes
RV1 Steele 2010b‐ZAF 3 0 0 3 Bronchopneumonia and gastroenteritis (3 vaccines)
RV1 Vesikari 2004b‐FIN 0 0 0 0
RV1 Vesikari 2007a‐EU 0 0 0 0
RV1 Vesikari 2011‐FIN 0 0 0 0
RV1 Zaman 2009‐BGD 1 0 0 1
RV5
 
RV5 Armah 2010‐AF 76 82 0 158 Gastroenteritis (20 vaccine, 16 placebo); 11 deaths occurred in identified HIV‐infected participants in Kenya; sudden infant death syndrome (1 placebo); other causes not mentioned
RV5 Block 2007‐EU/USA 1 0 0 1 Sudden infant death syndrome (1 vaccine)
RV5 Ciarlet 2009‐EU 0 0 0 0
RV5 Iwata 2013‐JPN 0 0 0 0
RV5 Lawrence 2012‐CHN 0 0 0 0
RV5 Levin 2017‐AF 1 2 0 3 Pneumonia
RV5 Merck[009] 2005‐USA 0 0 0 0
RV5 Mo 2017‐CHN 0 1 0 1 Reasons not reported
RV5 Vesikari 2006a‐FIN 0 0 0 0
RV5 Vesikari 2006b‐INT 24 20 0 44 Sudden infant death syndrome (7 vaccine and 7 placebo), other causes not mentioned
RV5 Zaman 2010‐AS 3 4 0 7 Not all causes reported, most common causes were drowning and sepsis
Rotavac VAC Bhandari 2014‐IND 30 18 0 48 The most common causes of death were infection and infestations followed by general disorders and administration site conditions. Days after vaccination not reported. None were considered to be vaccine‐related
VAC Chandola 2017‐IND 5 0 0 5 Cause of death: sepsis and aspiration (79 ‐ 141 days after Rotavac vaccination), unexplained sudden death (3 days after Rotavac vaccination). None were considered to be vaccine‐related