Table 4.
The major clinical studies for licensure
| Study | Phase | Type | Population at enrollment | N° of arm(s) of the study* | N enrolled | Schedule (month) |
|---|---|---|---|---|---|---|
| V72P5 | 1 | Observer blind, randomized single center | Adult 18–40y | 1 | 28 | 0,1,2 |
| V72P4 | 2 | Open multicenter | Adult 18–50y | 1 | 54 | 0,2,6 |
| V72P6 | 2 | Open multicenter randomized controlled | Infants 2 mo | 2 | 50 24 |
2,4,6,12 12 |
| V72P6E1 | 2 | Open label single-center extension | Infants 2 mo, childfren 40 mo |
3 | 19 8 43 |
2,4,6,12,40 12,40,42 40,42 |
| V72P9 | 2 | Single-blind, randomized, single-center | Infants (6–8mo) | 1 | 30 | 6,8,12 |
| V72P9E1 | 2 | Open label single-center extension | Infants 6–8mo Childfen 40 mo Children 60 mo |
3 | 14 41 49 |
6,8,12,40 40,42 60,62 |
| V72P12 | 2 | Open multicenter randomized | Infants 2 mo | 3 | 627† 318† 628‡ |
2,4,6 2,3,4 2,4,6 |
| V72P12E1 | 2 | Open label multicenter extension | Toddlers 12, 18, 24 mo 4th booster dose at 12, 18 or 24 mo; 2 catch up doses at 12–14, 18–20 mo (naive) and in naive children (24–26 mo) |
3 | 1588 246 51 + 56 |
Booster at 12, 18 or 24 months of age in subjects who received 3 doses of at 2,4,6 + Routine at 2,3,4 or 2,4,6 months in V72P12 at 12 and 14 months (in subjects who received routine at 2,3,4) at 18, 20 and at 24, 26 months of age |
| VP72P16 | 2 | Partially observer-blind, randomized multicenter controlled | Infants (2mo) | 8 | Total 1507 | 2,3,4 8 vaccine groups injected with either different composition or formulation process of the meningococcal B antigens (groups I–VI), or with concomitant administration of paracetamol (Par+B+ OMV, group VIII), or receiving the control vaccine (MenC, group VII) |
| V72P10 | 3 | Observer-blind multicenter randomized controlled | Adolescents (11–17y) | 8 | Total 1631 | 1 dose, or 2 doses [0,1 or 0,2], or 3 doses [0,1,2 or 0,2,6 or 0,1,6] |
| V72P13 | 3 | Partially blinded randomized multicenter controlled | Infants (2mo) | 3 | Total 2481 | 2,4,6 Concomitant with routine Routine alone Routine+MenC |
| V72P13 E1 | 3 | open label randomized multicenter extension | Toddlers (12 mo) | 6 | Total 2249 | A booster 12 month for the groups of VP7213 (with MMRV) concomitantly or A mo aftewards |
| V72P13E2 | 3 | Open label randomized multicenter extension | Toddlers 23 mo (naives) | 3 | Total 508 305 86 116 |
12mo persistence 3rd dorse to 2-dose cach-up 2 doses in nive children 24mo and 26 mon |
*Only the arms that used the final formulation (rMenB+OMVNZ) are mentioned in the Table.
† concomitant with routine vaccines, ‡ intercalated with routine vaccines at 3,5,7mo.