Table 2: The summary of Experimental Designs of the Six Studies Study Population Intervention Control Outcome Measures
Sabchareon et al( 2012)
Age: 4-11 Participants: 296 Mean Age: 8.21 Country: Thailand Baseline Seropositivity: 70 % in test group 68 % in control group
Three doses of CYD-TDV at 0, 6, and 12 months Enrollment and Dropout: 197 enrolled, 95 completed
Three doses of NaCl 0.9 % at 0, 6, and 12 months Enrollment and Dropout: 99 enrolled, 48 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
Villar, et al( 2013)
Age: 9-16 Participants: 600 Mean Age: 12.56 Region: Latin America Baseline Seropositivity: 75.1 % in test group 77.9 % in control group
Three doses of CYD-TDV at 0, 6, and 12 months Enrollment and Dropout: 401 enrolled, 364 completed
Two doses of NaCl 0.9 % at 0 and 6 months, and a dose of DPT at 12 months Enrollment and Dropout: 199 enrolled, 180 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
Leo, et al( 2013)
Age: 2-45( results were separated for all age groups, & data for ages 2-17 was extracted) Participants: 316( 2-11 y. o) 187( 12-17 y. o) Country: Singapore Baseline Seropositivity: 16.6 % in test group 20.8 % in control group
Three doses of CYD-TDV at 0, 6, and 12 months Enrollment: 236 enrolled( 2-11 y. o) 141 enrolled( 12-17 y. o) 93 % pts completed the trial
One dose of NaCl 0.9 % at 0 months, followed by two doses of either Hep-A or Influenza vaccines at months 6 and 12( based on age) Enrollment: 80 enrolled( 2-11 y. o) 46 enrolled( 12-17 y. o) 92 % pts completed the trial
Efficacy: Immunogenicity against DENV 1-4 measured at baseline and 28 days after third 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