Source: European Medicines Agency (EU) Revision Year: 2015 Publisher: Novartis Vaccines and Diagnostics S.r.l. - Via Fiorentina, 1 – Siena, Italy
Pharmacotherapeutic group: Vaccines. Influenza vaccine.
ATC Code: J07BB02
Clinical studies with Focetria H1N1v currently provide:
Clinical studies in which a version of Focetria containing HA derived from A/Vietnam/1194/2004 (H5N1) was administered at day 1 and at day 22 provide:
Immunogencity results with two doses of 7.5 µg Focetria H1N1v vaccine from the ongoing clinical trial in adults and elderly are shown below.
The seroprotection rate*, seroconversion rate* and the seroconversion factor ** for anti-HA antibody to A/H1N1v in adult and elderly subjects by HI assay after administration of 7.5 µg of Focetria were as follows:
| Adults (18-60 years) | ||||
|---|---|---|---|---|
| Anti-HA antibody | 21 days after 1st dose (day 22) | 21 days after 2nd dose (day 43) | ||
| <>_.Total N=120 | Seronegative at baseline N=46 | Total N=120 | Seronegative at baseline N=46 | |
| Seroprotection rate (95% CI) | 96% (91-99) | 98% (88-100) | 100% (97-100) | 100% (92-100) |
| GMR (95% CI) | 17 (13-23) | 44 (24-80) | 23 (17-30) | 75 (45-124) |
| Seroconversion or Significant Increase (95% CI) | 88% (81-93) | 98% (88-100) | 95% (89-98) | 100% (92-100) |
* measured by HI assay
** geometric mean ratios of HI
| Elderly (>60 years) | ||||
|---|---|---|---|---|
| Anti-HA antibody | 21 days after 1st dose(day 22) | 21 days after 2nd dose (day 43) | ||
| Total N=117 | Seronegative at baseline N=25 | Total N=117 | Seronegative at baseline N=25 | |
| Seroprotection rate (95% CI) | 73% (64-80) | 60% (39-79) | 88% (81-93) | 84% (64-95) |
| GMR (95% CI) | 4.02 (3.1-5.2) | 5.48 (2.82-11) | 6.85 (5.36-8.75) | 18 (8.9-35) |
| Seroconversion or Significant Increase (95% CI) | 43% (34-52) | 60% (39-79) | 62% (53-71) | 84% (64-95) |
The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H1N1v in children and adolescents aged 9-17 years by HI assay after administration of 7.5 µg of Focetria were as follows:
| Children and Adolescents (9-17 years) | ||||
|---|---|---|---|---|
| Anti-HA antibody | 21 days after 1st dose (day 22) | 21 days after 2nd dose (day 43) | ||
| Total N=88 | Seronegative at baseline N=51 | Total N=88 | Seronegative at baseline N=51 | |
| Seroprotection rate (95% CI) | 97% (90-99) | 94% (84-99) | 99% (94-100) | 98% (90-100) |
| GMR (95% CI) | 62 (38-100) | 102 (60-170) | 83 (54-127) | 169 (122-235) |
| Seroconversion or Significant Increase (95% CI) | 94% (87-98) | 94% (84-99) | 94% (87-98) | 98% (90-100) |
* measured by HI assay
** geometric mean ratios of HI
Data on responses to a second dose administered after an interval of three weeks showed an increase in overall GMT from 793 to 1065 (N=88) and an increase in GMT from 522 to 870 in children who were seronegative at baseline (N=51).
The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H1N1v in children aged 3-8 years by HI assay after administration of 7.5 µg of Focetria were as follows:
| Children (3-8 years) | ||||
|---|---|---|---|---|
| Anti-HA antibody | 21 days after 1st dose (day 22) | 21 days after 2nd dose (day 43) | ||
| Total N=70 | Seronegative at baseline N=48 | Total N=70 | Seronegative at baseline N=48 | |
| Seroprotection rate (95% CI) | 100% (95-100) | 100% (93-100) | 100% (95-100) | 100% (93-100) |
| GMR (95% CI) | 37 (25-55) | 50 (32-76) | 81 (52-125) | 146 (100-212) |
| Seroconversion or Significant Increase (95% CI) | 99% (92-100) | 100% (93-100) | 99% (92-100) | 100% (93-100) |
* measured by HI assay
** geometric mean ratios of HI
Data on responses to a second dose administered after an interval of three weeks showed an increase in overall GMT from 319 to 702 (N=70) and an increase in GMT from 247 to 726 in children who were seronegative at baseline (N=48).
The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H1N1v in children aged 12-35 months by HI assay after administration of 7.5 µg of Focetria were as follows:
| Children 12-35 months | ||||
|---|---|---|---|---|
| Anti-HA antibody | 21 days after 1st dose(day 22) | 21 days after 2nd dose (day 43) | ||
| Total N=66 | Seronegative at baseline N=45 | Total N=66 | Seronegative at baseline N=45 | |
| Seroprotection rate (95% CI) | 100% (95-100) | 100% (92-100) | 100% (95-100) | 100% (92-100) |
| GMR (95% CI) | 33 (21-51) | 48 (29-79) | 93 (54-159) | 145 (88-238) |
| Seroconversion or Significant Increase (95% CI) | 100% (95-100) | 100% (92-100) | 100% (95-100) | 100% (92-100) |
* measured by HI assay
** geometric mean ratios of HI
Data on responses to a second dose administered after an interval of three weeks showed an increase in overall GMT from 307 to 873 (N=66) and an increase in GMT from 243 to 733 in children who were seronegative at baseline (N=45).
The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H1N1v in infants aged 6-11 months by HI assay after administration of 7.5 µg of Focetria were as follows:
| Infants 6-11 months | ||||
|---|---|---|---|---|
| Anti-HA antibody | 21 days after 1st dose(day 22) | 21 days after 2nd dose (day 43) | ||
| Total N=57 | Seronegative at baseline N=37 | Total N=57 | Seronegative at baseline N=37 | |
| Seroprotection rate (95% CI) | 100% (94-100) | 100% (91-100) | 100% (94-100) | 100% (91-100) |
| GMR (95% CI) | 21 (14-30) | 32 (18-55) | 128 (74-221) | 274 (196-383) |
| Seroconversion or Significant Increase (95% CI) | 96% (88-100) | 100% (91-100) | 98% (91-100) | 100% (91-100) |
* measured by HI assay
** geometric mean ratios of HI
Data on responses to a second dose administered after an interval of three weeks showed an increase in overall GMT from 274 to 1700 (N=57) and an increase in GMT from 162 to 1399 in children who were seronegative at baseline (N=37).
Additional information is available from the studies conducted with a vaccine similar in composition to Focetria but containing antigen derived from H5N1 viruses. Please consult the Product Information of: Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted).
Not applicable.
Non-clinical data obtained with the mock-up vaccine (MF59C.1-adjuvanted H5N1 vaccine) and with seasonal vaccine containing MF59C.1 adjuvant reveal no special hazard for humans based on conventional studies of efficacy, repeated dose toxicity, and reproductive and developmental toxicity.
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