Extended antigen sparing potential of AS03-adjuvanted pandemic H1N1 vaccines in children, and immunological equivalence of two formulations of AS03-adjuvanted H1N1 vaccines: results from two randomised trials

Table 3 Results of the inferential analysis comparing groups in the study in adults and in children (ATP immunogenicity cohorts)

Endpoint	Criteria to meet the primary objectives	Value (95% CI)	Criteria met?
Study in adults
Anti-H1N1 GMTs	95% CI for ratio is within [0.5; 2] at Day 21	1.20 (0.96;1.49)	Yes
Anti-H1N1 GMTs	95% CI for ratio is within [0.5; 2] at Day 42	0.9 (0.76; 1.06)	Yes
Seroconversion rate	95% CI for the difference in within [-10; +10] at Day 21	3.66 (-0.82; 8.74)	Yes
Study in children	(each group)
CHMP	Seroconversion rate >40%	≥98.7% for each group	Yes
	%(≥1:40) > 70%	≥98.3% for each group	Yes
	Seroconversion factor >2.5	≥25.7 for each group	Yes
CBER	LL of the 95% CI on the seroconversion rate >40%	≥90.8 for each group	Yes
CBER	LL of the 95% CI on the % ≥1:40 is >70%	≥ 90.8 for each group	Yes
Anti-H1N1 GMTs	95% CI for ratio (Q-Pan0.9/D-Pan0.9) is within [0.5; 2] at Day 21	0.96 (0.73; 1.26)	Yes

95% CI 95 percent confidence interval, LL lower limit of the 95% CI, GMT geometric mean antibody titre. See Table 1 for details of treatment groups in each study.

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