Skip to main content
. 2014 Nov 21;10(10):2942–2957. doi: 10.4161/21645515.2014.972149

Table 1.

Overview of clinical trials performed in adults and included in the pooled analysis of safety

Clinical trial code(s) (NCT number) Age range in years Majority race Blinding Influenza Vaccine(s)* Dose (schedule), N vaccinated Control (schedule), N vaccinated
Controlled trials          
Q-H5N1–001 (NCT00510874)12 18–64 White/ Caucasian Observer-blind Q H5N1 3.75 AS03B 2Do (21d) = 151
D H5N1 3.75 AS03B 2Do (21d) = 148
Q H5N1 3.75 AS03A 2Do (21d) = 152
D H5N1 3.75 AS03A 2Do (21d) = 151
Q H5N1 1.9 AS03B 2Do (21d) = 50
Q H5N1 1.9 AS03A 2Do (21d) = 50		 Q H5N1 3.75 2Do (21d) = 78
Q-H5N1–002          
(NCT00616928)66 ≥18 White/ Caucasian Observer-blind Q H5N1 3.75 AS03A 2Do (21d) = 3422 Placebo = 1139
Q-H5N1–005          
(NCT00510874)69 ≥18 White/ Caucasian Observer-blind Q H5N1 3.75 AS03B 1Do = 239 Q H5N1 3.75 AS03A 1Do = 119
Q H5N1 7.5 AS03B 1Do = 241
Q H5N1 7.5 AS03A 1Do = 122		 Placebo = 120
Q-H5N1–010          
(NCT00771615)70 19–65 White/ Caucasian Observer-blind Q H5N1 3.75 AS03A 1D = 420
(booster extension of Q-Pan H5N1–001)		 Q H5N1 3.75 1D =
230
D-H5N1–002 (NCT00449670)71 18–60 Asian Observer-blind D H5N1 3.75 AS03A 2Do (21d) = 961 D H5N1 3.75 2Do (21d) = 245
D-H5N1–007 (NCT00309634)3 18–60 White/ Caucasian Observer-blind D H5N1 30 AS03A 2Do (21d) = 49
D H5N1 15 AS03A 2Do (21d) = 50
D H5N1 7.5 AS03A 2Do (21d) = 50
D H5N1 3.75 AS03A 2Do (21d) = 51		 D H5N1 30 2Do (21d) = 50 D H5N1 15 2Do (21d) = 50
D H5N1 7.5 2Do (21d)= 50
D H5N1 3.75 2Do (21d) = 50
D-H5N1–008/011 (NCT00319098)11 ≥18 White/ Caucasian Observer-blind D H5N1 15 AS03A 2Do (21d) = 3801
 Fluarix™/placebo = 1269
D-H5N1–010/021 (NCT00397215)72 >60 White/ Caucasian Open D H5N1 7.5 AS03A 2Do (21d) = 159
D H5N1 3.75 AS03A 2Do (21d) = 165		 D H5N1 7.5 2Do (21d)= 52
D H5N1 3.75 2Do (21d) = 61
Q-H1N1–001 (NCT00985088)9 >18 White/ Caucasian Observer-blind Q H1N1 3.75 AS03A 2Do (21d) = 222 Q H1N1 3.75 AS03A 1Do = 221
Q H1N1 1.9 AS03B 2Do (21d) = 114
Q H1N1 1.9 AS03B 1Do = 112		 Q H1N1 15 1Do = 223
Q H1N1 7.5 2Do (21d) = 115
Q H1N1 7.5 1Do = 111
Q H1N13.75 2Do (21d) = 222
Q-H1N1–002 (NCT00979602)7 >18 White/ Caucasian Observer-blind Q H1N1 3.75 AS03A 1Do = 2025 Q H1N1 15 1Do = 2023
Q-H1N1–019 (NCT00985673)73 19–40 White/ Caucasian Observer-blind FluLaval™ followed by 2Do of Q H1N1 3.75 AS03A (21d) = 104
FluLaval™ + Q H1N1 3.75 AS03A followed by 1Do of Q H1N1 3.75 AS03A (21d) = 100
2Do of Q H1N1 3.75 AS03A (21d) followed by FluLaval™ = 102		 2Do of Q H1N1 15 (21d) followed by FluLaval™ = 101 FluLaval™ + Q H1N1 15 followed by 1Do of Q H1N1 15 (21d) = 102
FluLaval™ followed by 2Do of Q H1N1 15 (21d) = 102
D-H1N1–007 (NCT00989287)6 18–60 White/ Caucasian Open D H1N1 3.75 AS03A 2Do (21d) = 64 D H1N1 15 2Do (21d) =66
D-H1N1–021 (NCT00951041)4 18–60 White/ Caucasian Observer-blind D H1N1 3.75 AS03A 2Do (21d) = 64 D H1N1 15 2Do (21d) =66
D-H1N1–033 (NCT00989287)6 18–60 White/ Caucasian Observer-blind D H1N1 3.75 AS03A 2Do (21d) = 65 D H1N1 3.75 2Do (21d) =66
Uncontrolled trials          
Q-H5N1–009 (NCT00695669)74 18–64 White/ Caucasian Open Q H5N1 3.75 AS03A 2Do (21d) = 78
Q H5N1 3.75 AS03A 2Do (14d) = 78
Q H5N1 3.75 AS03A 2Do (7d) = 78
Q H5N1 3.75 AS03A 2Do (0d) = 78		 None
Q-H5N1–011 (NCT00742885)75 20–64 Asian Open Q H5N1 3.75 AS03A 2Do (21d) = 100 None
D-H5N1–012 (NCT00430521)76 18–60 White/ Caucasian 0pen D H5N1 3.75 AS03A 2Do (21d) = 512 None
D-H5N1–015 (NCT00506350)77 19–61 White/ Caucasian Open D H5N1 3.75 AS03A 1D for subjects primed with AS =151 D H5N1 3.75 AS03A 2D for subjects primed without AS = 149** D H5N1 3.75 AS03A 2D for unprimed subjects = 50 None
D-H5N1–030 (NCT00449670)78 18–60 Asian Observer-blind D H5N1 3.75 AS03A 2Do (21d) = 501 (Booster extension of D-Pan H5N1–002 None
D-H5N1–038 (NCT00652743)78 18–60 Asian Open D H5N1 3.75 AS03A 1D = 623 None
D-H5N1–041 (NCT00812981)79 18–60 White/ Caucasian Observer-blind D H5N1 3.75 AS03A 2Do (21d) = 320 None
Q-H1N1–016 (NCT00989612)80 20–64 Asian Open Q H1N1 3.75 AS03A 2Do (21d) = 100 None
D-H1N1–008 (NCT00975884)81 >18 White/ Caucasian Open D H1N1 3.75 AS03A 2Do (21d) = 138 D H1N1 3.75 AS03A 1Do = 102 None
D-H1N1–017 (NCT00979407)82 18–60 White/ Caucasian Double blind Q H1N1 3.75 AS03A 2Do (21d) = 167 D H1N1 3.75 AS03A 2Do (21d) = 167 None
D-H1N1–018 (NCT00968890)83 >60 White/ Caucasian Open for H1N1 vaccine, observer-blind for Fluarix™/placebo D H1N1 3.75 AS03A 2Do (21d) + Fluarix™ at dose 1/placebo at dose 2 = 84 D H1N1 3.75 AS03A 2Do (21d) + placebo at dose 1/Fluarix™ at dose 2 = 84 None
D-H1N1–020 (NCT00971425)83 >60 White/ Caucasian Single blind D H1N1 3.75 AS03A 2Do (21d) then Fluarix™ = 72 Fluarix™ then D H1N1 3.75 AS03A 2Do (21d) = 73 None
D-H1N1–022 (NCT00975884) >18 White/ Caucasian Open D H1N1 1.9 AS03A 2Do (21d) = 184 D H1N1 1.9 AS03A 2Do (6m) = 122 None
D-H1N1–024 (NCT00992511)84 >18 White/ Caucasian Double blind (with respect to D H1N1 lots) D H1N1 3.75 AS03A 2Do (21d) = 148 D H1N1 3.75 AS03A 1Do = 152 None

Q, antigen produced in GSK facilities in St. Foy, Quebec; D antigen produced in GSK facilities in Dresden, Germany; Do, dose; d, day (interval between vaccine doses); N, number of participants enrolled and vaccinated.

* Vaccine formulations with quantity of HA (in micrograms) administered and presence of AS03.

**Data not included.