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