Immunogenicity, reactogenicity and safety of a human rotavirus vaccine (RIX4414) in Korean infants: A randomized, double-blind, placebo-controlled, phase IV study

Kim, Jung Soo; Bae, Chong‐Woo; Lee, Kyung-Yil; Park, Moon Sung; Choi, Young Youn; Kim, Kwang-Nam; Kim, Jong Duck; Park, Won-Soon; Sin, Jong-Beom; Kim, Ellen Ai‐Rhan; Lee, Sang-Geel; Kim, Chun Soo; Cha, Sung-Ho; Hong, Young Jin; Shin, Son Moon; Shim, Gyu-Hong; Choi, Kang‐Yell; Jun, Yang; Liu, Aixue; Suryakiran, P.V.; Han, Htay Htay

doi:10.4161/hv.19853

Cited by 20 publications

(13 citation statements)

References 18 publications

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“…The reactogenicity profile of the vaccine was comparable to that of placebo in all age groups studied. This is in keeping with the results of previous studies of the human RV vaccine conducted in other Asian countries, including Singapore, Hong Kong, Taiwan, Vietnam, Philippines and Korea 10 , 24 , 25 . The seroconversion rate of 86.7% observed in infants after two vaccine doses in this study is similar to that reported in Korean infants in a recent post-licensure study [88.1% (95% CI: 84.0–91.4).…”

supporting

confidence: 91%

“…The seroconversion rate of 86.7% observed in infants after two vaccine doses in this study is similar to that reported in Korean infants in a recent post-licensure study [88.1% (95% CI: 84.0–91.4). ] 25 Evaluation of the efficacy of the human RV vaccine in infants was not within the scope of these preliminary Phase I studies. A Phase III efficacy study of the liquid human RV vaccine in the infant population in China has now been completed (ROTA-075/NCT01171963).…”

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confidence: 99%

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Reactogenicity and safety of a liquid human rotavirus vaccine (RIX4414) in healthy adults, children and infants in China

et al. 2013

Human Vaccines & Immunotherapeutics

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We report the findings of three randomized, double-blind, placebo-controlled Phase I studies undertaken to support licensure of the liquid formulation of the human G1P[8] rotavirus (RV) vaccine (RIX4414; GlaxoSmithKline Biologicals SA) in China. Healthy adults aged 18–45 y (n = 48) and children aged 2–6 y (n = 50) received a single dose of the human RV vaccine or placebo. Healthy infants (n = 50) aged 6–16 weeks at the time of first vaccination received two oral doses of the human RV vaccine or placebo according to a 0, 1 mo schedule. In infants, blood samples were collected prior to vaccination and one month post-dose 2 to assess anti-RV IgA antibody concentrations using ELISA. Stool samples were collected from all infants on the day of each vaccination, at 7 and 15 d after each vaccination and one month post-dose 2. Stool samples were analyzed by ELISA for detection of RV antigen to assess RV antigen excretion. The reactogenicity profile of the human RV vaccine was found to be comparable to that of placebo in all age groups studied. The anti-RV IgA antibody seroconversion rate in infants after two vaccine doses was 86.7% (95% CI: 59.5–98.3). Vaccine take in infants who received the liquid human RV vaccine was 86.7% (95% CI: 59.5–98.3). A Phase III efficacy study of the human RV vaccine in the infant population in China has now been completed (ROTA-075/NCT01171963).

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confidence: 99%

Reactogenicity and safety of a liquid human rotavirus vaccine (RIX4414) in healthy adults, children and infants in China

et al. 2013

Human Vaccines & Immunotherapeutics

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“…In the previously published version of this review there were 41 included studies. The review now includes 55 independent trials (see Characteristics of included studies), 14 of which are new to this update (RV1 Colgate 2016‐BGD; RV1 Kim 2012‐KOR; RV1 Li 2013a‐CHN; RV1 Li 2013b‐CHN; RV1 Li 2014‐CHN; RV1 NCT00158756‐RUS; RV1 Zaman 2017‐BGD; RV5 Dhingra 2014‐IND; RV5 Levin 2017‐AF; RV5 Mo 2017‐CHN; VAC Bhandari 2006‐IND; VAC Bhandari 2009‐IND; VAC Bhandari 2014‐IND; VAC Chandola 2017‐IND) and we also added another 23 new companion papers to previously included trials with this update. The review also includes 15 ongoing studies (see Characteristics of ongoing studies).…”

Section: Resultsmentioning

confidence: 99%

Vaccines for preventing rotavirus diarrhoea: vaccines in use

Soares‐Weiser

Pitan

Cunliffe

2019

Cochrane Database of Systematic Reviews

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BackgroundRotavirus results in more diarrhoea‐related deaths in children under five years than any other single agent in countries with high childhood mortality. It is also a common cause of diarrhoea‐related hospital admissions in countries with low childhood mortality. Rotavirus vaccines that have been prequalified by the World Health Organization (WHO) include a monovalent vaccine (RV1; Rotarix, GlaxoSmithKline), a pentavalent vaccine (RV5; RotaTeq, Merck), and, more recently, another monovalent vaccine (Rotavac, Bharat Biotech).ObjectivesTo evaluate rotavirus vaccines prequalified by the WHO (RV1, RV5, and Rotavac) for their efficacy and safety in children.Search methodsOn 4 April 2018 we searched MEDLINE (via PubMed), the Cochrane Infectious Diseases Group Specialized Register, CENTRAL (published in the Cochrane Library), Embase, LILACS, and BIOSIS. We also searched the WHO ICTRP, ClinicalTrials.gov, clinical trial reports from manufacturers' websites, and reference lists of included studies and relevant systematic reviews.Selection criteriaWe selected randomized controlled trials (RCTs) in children comparing rotavirus vaccines prequalified for use by the WHO versus placebo or no intervention.Data collection and analysisTwo review authors independently assessed trial eligibility and assessed risks of bias. One review author extracted data and a second author cross‐checked them. We combined dichotomous data using the risk ratio (RR) and 95% confidence interval (CI). We stratified the analysis by country mortality rate and used GRADE to evaluate evidence certainty.Main resultsFifty‐five trials met the inclusion criteria and enrolled a total of 216,480 participants. Thirty‐six trials (119,114 participants) assessed RV1, 15 trials (88,934 participants) RV5, and four trials (8432 participants) Rotavac.RV1Children vaccinated and followed up the first year of lifeIn low‐mortality countries, RV1 prevents 84% of severe rotavirus diarrhoea cases (RR 0.16, 95% CI 0.09 to 0.26; 43,779 participants, 7 trials; high‐certainty evidence), and probably prevents 41% of cases of severe all‐cause diarrhoea (RR 0.59, 95% CI 0.47 to 0.74; 28,051 participants, 3 trials; moderate‐certainty evidence). In high‐mortality countries, RV1 prevents 63% of severe rotavirus diarrhoea cases (RR 0.37, 95% CI 0.23 to 0.60; 6114 participants, 3 trials; high‐certainty evidence), and 27% of severe all‐cause diarrhoea cases (RR 0.73, 95% CI 0.56 to 0.95; 5639 participants, 2 trials; high‐certainty evidence).Children vaccinated and followed up for two yearsIn low‐mortality countries, RV1 prevents 82% of severe rotavirus diarrhoea cases (RR 0.18, 95% CI 0.14 to 0.23; 36,002 participants, 9 trials; high‐certainty evidence), and probably prevents 37% of severe all‐cause diarrhoea episodes (rate ratio 0.63, 95% CI 0.56 to 0.71; 39,091 participants, 2 trials; moderate‐certainty evidence). In high‐mortality countries RV1 probably prevents 35% of severe rotavirus diarrhoea cases (RR 0.65, 95% CI 0.51 to 0.83; 13,768 participants, 2 trials; high‐certainty ev...

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“…The safety and tolerability of 2 doses of Rotarix™ has been previously documented from clinical trials conducted in various countries 10,14,15 and reported in an integrated safety summary of 8 double-blind, randomized, placebo-controlled, phase II and III studies. 16 This latter safety summary by Cheuvart et al, 16 indicated that the reactogenicity and safety profile of Rotarix™ was similar to that of placebo, with no reported safety concerns.…”

Section: Discussionmentioning

confidence: 99%

Reactogenicity and safety of the human rotavirus vaccine,Rotarix™ in The Philippines, Sri Lanka, and India: A post-marketing surveillance study

Bravo

Chitraka

Liu

et al. 2014

Human Vaccines & Immunotherapeutics

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Regulatory bodies in The Philippines, Sri Lanka, and India require post-marketing surveillance to provide additional safety data on Rotarix ™ in real-life settings. In such studies conducted in The Philippines (November 2006 to July 2012; NCT00353366), Sri Lanka (November 2008 to August 2009; NCT00779779), and India (August 2009 to April 2010; NCT00938327), 2 doses of Rotarix ™ were administered according to the local prescribing information (PI). The occurrence of at least Grade “2”/”3” solicited adverse event (AE) (fever, vomiting, or diarrhea), within 15 days in The Philippines or 8 days in Sri Lanka and India; unsolicited AEs within 31 days and serious adverse events (SAEs) throughout the study were recorded. Of the 1494, 522, and 332 infants enrolled in The Philippines, Sri Lanka, and India, 14.7% 14.9% and 12.7% infants, respectively recorded at least Grade “2”/”3” solicited AEs. The most commonly reported solicited AEs were irritability in The Philippines (32.2% post-Dose-1; 23.5% post-Dose-2) and India (23.0% post-Dose-1; 13.2% post-Dose-2), and fever (18.0% post-Dose-1; 20.2% post-Dose-2) in Sri Lanka. Unsolicited AEs were recorded in 24.5% (The Philippines), 4.8% (Sri Lanka), and 6.9% (India) of infants. Forty-one SAEs were recorded in the Philippines of which 6 (decreased oral intake with increased sleeping time and constipation; pneumonia, urinary tract infection, and intussusception) were considered by the investigators as causally related to vaccination. One vaccine-unrelated SAE occurred in a Sri Lankan infant. All SAEs resolved and the infants recovered. Two doses of Rotarix ™, administered to healthy infants according to local PI, were well tolerated in The Philippines, Sri Lanka, and India.

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Immunogenicity, reactogenicity and safety of a human rotavirus vaccine (RIX4414) in Korean infants: A randomized, double-blind, placebo-controlled, phase IV study

Cited by 20 publications

References 18 publications

Reactogenicity and safety of a liquid human rotavirus vaccine (RIX4414) in healthy adults, children and infants in China

Reactogenicity and safety of a liquid human rotavirus vaccine (RIX4414) in healthy adults, children and infants in China

Vaccines for preventing rotavirus diarrhoea: vaccines in use

Reactogenicity and safety of the human rotavirus vaccine,Rotarix™ in The Philippines, Sri Lanka, and India: A post-marketing surveillance study

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