Table 1.
Published clinical vaccination trials of GSK's conjugate meningococcal vaccines.
| Vaccine | Study | Phase | Country | Target group | Schedule | N | Publication |
|---|---|---|---|---|---|---|---|
| NCT00317174 | Phase II | Philippines | Infants | 6, 10, 14 weeks PS challenge at 10 months |
524 217 |
Gatchalian et al., 2008 [59]* | |
| DTPw-HBV/Hib-MenAC | ISRCTN35754083 | Phase II | Ghana | Infants | 6, 10, 14 weeks PS challenge at 12 months |
280 260 |
Hodgson et al., 2008 [60] |
| NCT00317161 and NCT00317187 | Phase III | Philippines, Thailand | Infants | 2, 4, 6 months | 1780 | Kerdpanich et al., 2008 [61] | |
|
| |||||||
| NCT00135486 and NCT00135564 | Phase II | Germany | Infants | 2, 3, 4 months PS challenge at 12–15 months |
520 | Schmitt et al., 2007 [70] | |
| NCT00323050 and NCT00322335 | Phase III | Spain | Infants | 2, 4, 6 months 13-14 months |
237 358 |
Tejedor et al., 2007 [62] Tejedor et al., 2008 [74] |
|
| Hib-MenC-TT | NCT00263653 | Phase III | Spain | Toddlers | 13-14 months | 297 | Carmona et al., 2010 [75] |
| NCT00258700 | Phase III | UK, Poland | Infants | 2, 3, 4 months 12 months |
500 476 |
Pace et al., 2007 [69] Pace et al., 2008 [73] Khatami et al., 2011 [76] |
|
|
NCT00334334 NCT00463437 |
Phase III | Germany, Poland, Spain | Infants | 2, 4, 6 months 11–18 months |
1548 1437 |
Wysocki et al., 2009 [80] Knuf et al., 2009 [71] |
|
| NCT00326118 | Phase III | Australia | Toddlers | 12–18 months | 433 | Booy et al., 2011 [72] | |
| ISRCTN72858898 | Phase IV | UK | Children | 6–12 years | 249 | Perrett et al., 2010 [77] | |
|
| |||||||
| NCT00127855 | Phase II | Australia | Infants | 2, 4, 6 months PS challenge at 11–14 months |
407 394 |
Nolan et al., 2007 [81] | |
| NCT00129116 | Phase II | Belgium, Germany | Infants | 2, 3, 4 months 12–18 months |
388 221 |
Habermehl et al., 2010 [68] | |
| Hib-MenCY-TT | NCT00129129 | Phase II | US | Infants | 2, 4, 6 months 12–15 months |
756 498 |
Marchant et al., 2010 [82] Marshall et al., 2010 [83] |
| NCT00134719 | Phase II | Australia | Infants | 2, 4, 6 months 12–15 months |
1103 1037 |
Nolan et al., 2011 [84] | |
| NCT00289783 | Phase III | US, Mexico, Australia | Infants | 2, 4, 6 months 12–15 months |
4180 | Bryant et al., 2011 [85] | |
|
| |||||||
|
NCT00196950 NCT00126945 |
Phase II | Belgium, Denmark | Adolescents Adults |
15–25 years | 175 | Østergaard et al., 2009 [86] | |
| NCT00126984 | Phase II | Germany, Austria | Toddlers Children |
12–14 months or 3–5 years |
508 | Knuf et al., 2010 [87] | |
| MenACWY-TT |
NCT00464815 NCT00453986 |
Phase III | Philippines, India, Taiwan + Philippines, Lebanon | Adolescents Adults |
11–17 years and 18–55 years |
2272† | Bermal et al., 2011 [88] |
| NCT00454909 | Phase II | US | Adolescents Adults |
11–25 years | 872 | Baxter et al., 2011 [89] | |
| NCT00474266 | Phase III | Finland | Toddlers | 12–23 months | 1000 | Vesikari et al., 2011 [90] | |
| NCT00508261 | Phase III | Austria, Germany, Greece | Toddlers | 12–23 months | 793 | Knuf et al., 2011 [91] | |
N: Total vaccinated cohort including subjects who received the study vaccine and control vaccines, NCT: Clinical Trial Registry Numbers, ISRCTN: International Standard Randomized Controlled Trial Number, *Number of the publication in the reference list, †1025 subjects from study NCT00464815 (Philippines, India, Taiwan) and 1247 from study NCT00453986 (Philippines, Lebanon), For study NCT00453986 only safety data are summarised here.