Advances in Preventive Medicine

Review Article

Conjugate Meningococcal Vaccines Development: GSK Biologicals Experience

Table 1

Published clinical vaccination trials of GSK’s conjugate meningococcal vaccines.


Vaccine	Study	Phase	Country	Target group	Schedule		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.