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Phua, K.B. et al. Safety and efficacy of human rotavirus vaccine during the first 2 years of life in Asian infants: randomised, double-blind, controlled study. Vaccine 27, 5936-5941

Department of Paediatrics, KK Women's and Children's Hospital, 100 Bukit, Timah Road, Singapore 229899, Singapore.
Vaccine (Impact Factor: 3.49). 09/2009; 27(43):5936-41. DOI: 10.1016/j.vaccine.2009.07.098
Source: PubMed

ABSTRACT This study evaluates the safety and efficacy against severe rotavirus gastroenteritis of the oral live attenuated human rotavirus vaccine RIX4414 (Rotarix) during the first 2 years of life in Asian infants from high-income countries. Healthy infants were enrolled to receive 2 doses of RIX4414 (N=5,359) or placebo (N=5,349). From 2 weeks post-dose 2 to 2 years of age, vaccine efficacy was 96.1% (95%CI:85.1%; 99.5%) against severe rotavirus gastroenteritis, 100% (95%CI:80.8%; 100%) against wild-type G1P[8] and 93.6% (95%CI:74.7%; 99.3%) against circulating non-G1 rotavirus types. No intussusception cases were reported within 31 days post-vaccination. RIX4414 shows a good safety profile and offers high protection during the first 2 years of life with potentially significant public health impact in this population.

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    • "$1 year follow up Europe (6 countries) High 2572 1302 96 (86–100) 100 (45–100) 100 (65–100) 95 (78–99) 75 (<0–100) Vesikari et al. (2007) Latin America (3 countries) Middle 1392 454 74 (41–88) 67 (<0–100) 67 (24–86) 100 (21–100) Salinas et al. (2005) Latin America (11 countries) Middle 9009 8858 91 (71–98) 86 (<0–100) 51 (<0–99) 91 (62–99) 45 (<0–86) Ruiz-Palacios et al. (2006) Latin America (6 countries) Middle 4211 2099 100 (<0–100) 81 (50–94) 75 (<0–100) Tregnaghi et al. (2011) South Africa, Malawi b Middle, low 2974 1443 G1: 64 (30–82) G3: 84 (10–98) G9: 57 (<0–86) G2: 79 (9–97) Steele et al. (2012) $2 years follow up Europe (6 countries) High 2554 1294 97 (86–100) 83 (<0–100) 87 (<0–100) 78 (53–90) 90 (9–100) Vesikari et al. (2007) Hong-Kong, Singapore, Taiwan High 5263 5256 100 (81–100) 95 (65–100) 92 (44–100) 100 (<0–100) Phua et al. (2009) Japan High 498 250 92 (31–100) 100 (24–100) 75 (<0–100) Kawamura et al. (2011) Latin America (10 countries) Middle 7205 7081 83 (64–93) 44 (<0–88) Linhares et al. (2008) China Middle 1575 1573 60 (5–85) 100 (<0–100) 100 (<0–100) 73 (46–87) Li et al. (2014) $3 years follow up Hong-Kong, Singapore, Taiwan High 5263 5256 100 (69–100) 96 (72–100) 93 (53–100) 89 (<0–99) Phua et al. (2009) "
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    ABSTRACT: While a monovalent Rotarix® [RV1] and a pentavalent RotaTeq® [RV5] have been extensively tested and found generally safe and equally efficacious in clinical trials, the question still lingers about the evolving diversity of circulating rotavirus strains over time and their relationship with protective immunity induced by rotavirus vaccines. We reviewed data from clinical trials and observational studies that assessed the efficacy or field effectiveness of rotavirus vaccines against different rotavirus strains worldwide. RV1 provided broad clinical efficacy and field effectiveness against severe diarrhea due to all major circulating strains, including the homotypic G1P[8] and the fully heterotypic G2P[4] strains. Similarly, RV5 provided broad efficacy and effectiveness against RV5 and non-RV5 strains throughout different locations. Rotavirus vaccination provides broad heterotypic protection; however continuing surveillance is needed to track the change of circulating strains and monitor the effectiveness and safety of vaccines.
    Infection Genetics and Evolution 10/2014; DOI:10.1016/j.meegid.2014.10.008 · 3.26 Impact Factor
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    • "This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/3.0/). high-income Asian and Latin American countries [14] [15] [16] [17] [18]. Further, vaccine efficacy declines significantly in developing countries in the second year of assessment [19]. "
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    ABSTRACT: Aim This study was undertaken to compare the immunogenicity of a three dose and five dose schedule of an oral live-attenuated human rotavirus vaccine, Rotarix® in south Indian infants. Method Healthy infants (N = 90), six to seven weeks of age were enrolled to receive three doses (n = 45) or five doses of Rotarix vaccine (n = 45) along with other scheduled vaccines, each dose separated by a four week interval. Blood samples were taken before vaccination and one month post-dose three in the Rotarix three dose group and one month post-dose five in the Rotarix five dose group; all were tested for anti-rotavirus IgA by an antibody sandwich enzyme immunoassay. Results At baseline, >50% of infants had >20 units of anti-rotavirus IgA. The seroconversion rates after three and five doses were low and not significantly different in the two groups. However, among vaccine responders, children seropositive at baseline showed a much greater absolute increase in IgA antibody levels than children seronegative at baseline. Conclusions Rotarix vaccine showed low immunogenicity in south Indian children and increasing the number of doses did not increase the proportion of infants seroconverting after vaccination.
    Vaccine 08/2014; 32:A129–A133. DOI:10.1016/j.vaccine.2014.03.002 · 3.49 Impact Factor
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    • "RV1 was 85% (95% CI: 71–83%) efficacious in preventing severe rotavirus gastroenteritis (Vesikari score ≥11) among Latin American infants [1]. In subsequent trials examining efficacy during the first two years of life, RV1 was 81% (95% CI: 71–87%) efficacious against severe rotavirus gastroenteritis in Latin American children, 90% (95% CI: 85–94%) efficacious in European children, and 96% (95% CI: 85–100%) efficacious in children in high income Asian countries [7] [8] [9]. Similarly, in clinical trials conducted mainly in the USA and Finland, RV5 was 96% (95% CI: 91–98%) efficacious against hospitalizations due to rotavirus gastroenteritis caused by G1–G4 strains, 94% (95% CI: 89–97%) against emergency department visits, and 86% (95% CI: 74–93%) against office visits [2]. "
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    ABSTRACT: Rotavirus vaccines are being introduced in several low- and middle-income countries across the world with and without support from the GAVI Alliance. India has the highest disease burden of rotavirus based on morbidity and mortality estimates and several indigenous vaccine manufacturers are developing rotavirus vaccines. One candidate has undergone phase III testing and others have completed evaluation in phase II. Global data on licensed vaccine performance in terms of impact on disease, strain diversity, safety and cost-effectiveness has been reviewed to provide a framework for decision making in India.
    Vaccine 08/2014; 32:A171–A178. DOI:10.1016/j.vaccine.2014.03.029 · 3.49 Impact Factor
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