Evaluation of non-inferiority of intradermal versus adjuvanted seasonal influenza vaccine using two serological techniques: a randomised comparative study

Table 1 Description of analysis sets and numbers (percentage) of subjects by vaccine group; subjects were analysed according to the vaccine they received except for the randomised set

	Intradermal vaccine, n (%)	Adjuvanted vaccine, n (%)
Randomised set^a	398 (100)	397 (100)
Full analysis set^b	395 (99.2)	395 (99.5)
Per protocol set^c
HI method^d	390 (98.0)	385 (97.0)
SRH method^e	389 (97.7)	382 (96.2)
Other immunogenicity analysis set for EMA immunogenicity criteria ^f
HI method (full analysis set)
A/H1N1	395 (99.2)	395 (99.5)
A/H3N2	395 (99.2)	395 (99.5)
B	395 (99.2)	395 (99.5)
SRH method^g
A/H1N1	391 (98.2)	389 (98.0)
A/H3N2	391 (98.2)	388 (97.7)
B	391 (98.2)	389 (98.0)
Safety set^h	398 (100)	397 (100)

^a All individuals randomised who received a study vaccine.
^b All randomised individuals who received a study vaccine and who had post-vaccination immunogenicity results. Intradermal vaccine group: one participant withdrew due to a serious adverse event, and insufficient blood samples for testing were noted for two participants; adjuvanted vaccine group: one participant withdrew consent and an insufficient blood sample for testing was noted for one participant.
^c All randomised individuals except those with protocol violations that could interfere with the immunogenicity evaluation.
^d Additional participants with at least one protocol deviation excluded: intradermal vaccine group n = 5, adjuvanted vaccine group n = 10.
^e Additional excluded participants with insufficient blood samples: intradermal vaccine group n = 1, adjuvanted vaccine group n = 3.
^f Participants who received a study vaccine and for whom pre-and post-vaccination titres on days 0 and 21 were available for each strain.
^g Additional participants excluded because of missing pre-and/or post-vaccination SRH method results: intrademal vaccine group n = 4 for all three strains; adjuvanted vaccine group n = 6 for A/H1N1 and B and n = 7 for A/H3N2.
^h Participants who received a study vaccine and who had post-vaccination safety data.

ISSN: 1471-2334