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 seta

398 (100)

397 (100)

Full analysis setb

395 (99.2)

395 (99.5)

Per protocol setc

HI methodd

390 (98.0)

385 (97.0)

SRH methode

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 methodg

A/H1N1

391 (98.2)

389 (98.0)

A/H3N2

391 (98.2)

388 (97.7)

B

391 (98.2)

389 (98.0)

Safety seth

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.

Van Damme et al. BMC Infectious Diseases 2010 10:134   doi:10.1186/1471-2334-10-134

Open Data