Table 2: The summary of Experimental Designs of the Six Studies Study Population Intervention Control Outcome Measures
Dayan, et al( 2013)
Age: 9-16 Participants: 150 Mean Age: 12.7 Country: Brazil Baseline Seropositivity: 69 % in test group 71 % in control group
Three doses of CYD-TDV at 0, 6, and 12 months Enrollment and Dropout: 100 enrolled, 89 completed
Three doses of NaCl 0.9 % at 0, 6, and 12 months Enrollment and Dropout: 50 enrolled, 46 completed
Efficacy: Immunogenicity against DENV 1-4 measured at baseline and 28 days after each dose using PRNT50 and calculation of GMT Safety: Unsolicited systemic reaction, solicited injection site reactions, solicited systemic reactions, and Serious Adverse Effects( SAEs) were recorded
HSS, et al( 2013)
Age: 2-11 Participants: 250 Mean Age: 6.4 Country: Malaysia Baseline Seropositivity: 44.9 % in test group 48 % in control group
Three doses of CYD-TDV at 0, 6, and 12 months Enrollment and Dropout: 199 enrolled, 196 completed
Three doses of placebo at 0, 6, and 12 months Enrollment and Dropout: 51 enrolled, 50 completed
Efficacy: Immunogenicity against DENV 1-4 measured at baseline and 28 days after dose 2 and 3 using PRNT50 and calculation of GMT Safety: Unsolicited systemic reaction, solicited injection site reactions, solicited systemic reactions, and Serious Adverse Effects( SAEs) were recorded
Lanata, et al( 2012)
Age: 2-11 Participants: 300 Mean Age: 6.29 Country: Peru Baseline Seropositivity: 37.2 % in test group 48.5 % in control group
Three doses of CYD-TDV at 0, 6, and 12 months Enrollment and Dropout: 200 enrolled, 186 completed
Two doses of placebo at 0 and 6 months, pneumococc. vaccine at month 12 Enrollment and Dropout: 100 enrolled, 90 completed
Efficacy Immunogenicity against DENV 1-4 measured at baseline and 28 days after dose 2 and 3 using PRNT50 and calculation of GMT Safety: Unsolicited systemic reaction, solicited injection site reactions, solicited systemic reactions, and Serious Adverse Effects( SAEs) were recorded