Table 1.
Trial | Trial group | N | Vaccination schedule | Immune response sampling schedule |
---|---|---|---|---|
Homologous prime-boost studies in adults | ||||
Trial 1: A/H1N125 | A/H1N1 AS03 | 29 |
A/California/07/2009 3.75 µg + AS03A on D0 and D21 Seasonal IIV3 on D42 |
D0, D21, D42, D182 |
A/H1N1 non-adjuvanted | 29 |
A/California/07/2009 15 µg on D0 and D21 Seasonal IIV3 on D42 |
||
Trial 2: A/H5N126 | A/H5N1 AS03 | 29 | A/Indonesia/5/2005 3.75 µg + AS03A on D0 and D21 | D0, D21, D42, D182, D385 |
A/H5N1 non-adjuvanted | 27 | A/Indonesia/5/2005 15 µg on D0 and D21 | ||
Trial 3: A/H9N227 | A/H9N2 AS03 | 30 | A/chicken/Hong Kong/G9/1997 3.75 µg + AS03A on D0 and D21 | D0, D21, D42, D182 |
A/H9N2 non-adjuvanted | 30 | A/chicken/Hong Kong/G9/1997 15 µg on D0 and D21 | ||
Seasonal IIV4 study in adults | ||||
Trial 4: IIV428 | IIV4 non-adjuvanted | 30 |
Seasonal IIV4 15 µg per strain at D0 A/Christchurch/16/2010 (H1N1 pdm09) A/Texas/50/2012 (H3N2) B/Massachusetts/02/2012 (B Yamagata) B/Brisbane/60/2008 (B Victoria) |
D0, D21 |
Heterologous prime-boost studies in adults | ||||
Trial 5: A/H5N1 booster29 |
A/H5N1 AS03 Indonesia > Turkey |
26 |
A/Indonesia/5/05 3.75 µg + AS03A on D0 Placebo on D182 A/turkey/Turkey/1/2005 3.75 µg + AS03A on D549 |
D0, D42, D182, D224, D549, D591, D729 |
A/H5N1 AS03 Turkey > Turkey |
29 |
Placebo on D0 A/turkey/Turkey/1/2005 3.75 µg + AS03A on D182 and D549 |
||
Trial 6: A/H5N1 booster30,31 |
A/H5N1 AS03 Vietnam > Vietnam |
53 | A/Vietnam/1194/2004 3.75 µg + AS03A on D0 and D365 | D0, D21, D182, D365, D385, D549 |
A/H5N1 AS03 Vietnam > Indonesia |
49 |
A/Vietnam/1194/2004 + AS03A on D0 A/Indonesia/5/05 3.75 µg + AS03A on D365 |
||
Homologous prime-boost study in children | ||||
Trial 7: A/H5N132 | A/H5N1 AS03 | 33 | A/Indonesia/5/2005 1.90 µg + AS03B at D0 and D21 | D0, D21, D42, D385 |
Placebo | 20 | Placebo at D0 and D21 |
aTrials 1, 2 and 3: serum samples from participants who received adjuvanted vaccine were randomly selected, and samples matched by age and study center were then selected from the non-adjuvanted group
bTrial 4: serum samples from participants 18−39 years of age were randomly selected
cTrials 5 and 6: all evaluable samples from eligible participants were used (i.e. no random selection)
dTrial 7: only samples from children (6−35 months) who were seronegative for A/H1N1pdm09 (A/California/07/2009-like) antibodies were selected to ensure that the children had not been primed through prior exposure to A/H1N1 virus. Not all study groups in the original trials were included; only the vaccines that were administered to participants whose samples were used in the present study are shown. IIV3: trivalent inactivated influenza vaccine; IIV4: quadrivalent inactivated influenza vaccine