Table 3.
Proportions of participants meeting specified antigen responses at Day 30.
| Antigen | Endpoint | Group 1 (VVV) |
Group 2 (HHV) |
||
|---|---|---|---|---|---|
| Observed % (m/n) | 95% CI | Observed % (m/n) | 95% CI | ||
| Hib-PRP | % ≥1.0 µg/mL | 89.0 (65/73) | (79.5, 95.1) | 90.8 (69/76) | (81.9, 96.2) |
| HBsAg | % ≥10 mIU/mL | 100.0 (56/56) | (93.6, 100.0) | 94.2 (65/69) | (85.8, 98.4) |
| Diphtheria toxoid | % ≥0.1 IU/mL | 100.0 (69/69) | (94.8, 100.0) | 98.6 (73/74) | (92.7, 100.0) |
| Tetanus toxoid | % ≥0.1 IU/mL | 98.6 (68/69) | (92.2, 100.0) | 98.6 (73/74) | (92.7, 100.0) |
| Pertussis – PT | % vaccine responsea | 98.4 (63/64) | (91.6, 100.0) | 94.4 (67/71) | (86.2, 98.4) |
| Pertussis – FHA | % vaccine responsea | 98.4 (63/64) | (91.6, 100.0) | 90.1 (64/71) | (80.7, 95.9) |
| Pertussis – PRNb | % vaccine responsea | 92.2 (59/64) | (82.7, 97.4) | 22.5 (16/71) | (13.5, 34.0) |
| Pertussis – FIM 2/3b | % vaccine responsea | 95.3 (61/64) | (86.9, 99.0) | 69.0 (49/71) | (56.9, 79.5) |
| Poliovirus 1 | % Nab ≥ 1:8 dilution | 100.0 (66/66) | (94.6, 100.0) | 95.7 (66/69) | (87.8, 99.1) |
| Poliovirus 2 | % Nab ≥ 1:8 dilution | 100.0 (66/66) | (94.6, 100.0) | 100.0 (69/69) | (94.8, 100.0) |
| Poliovirus 3 | % Nab ≥ 1:8 dilution | 97.0 (64/66) | (89.5, 99.6) | 100.0 (69/69) | (94.8, 100.0) |
aThe pertussis vaccine response is defined as follows.
1) If prevaccination <LLOQ, then postvaccination should be ≥4 times the LLOQ.
2) If prevaccination ≥LLOQ but <2 times the LLOQ, then postvaccination should achieve a 4-fold rise (postvaccination/prevaccination ≥4).
3) If prevaccination ≥ 2 times the LLOQ, then postvaccination should achieve a 2-fold response (postvaccination/prevaccination ≥2)
bAntigen contained only in Vaxelis®.
H = Hexyon®; V = Vaxelis®.
N = number of participants randomized and vaccinated; n = number of participants contributing to the analysis; m = number of participants with the indicated response
CI = confidence interval; IU = international unit; PT = pertussis toxin; FHA = filamentous hemagglutinin; Hib = Haemophilus influenzae type b; PRP = polyribosylribitol phosphate; HBsAg = hepatitis B surface antigen; Nab = neutralizing antibodies; FIM 2/3 = fimbriae types 2 and 3; PRN = pertactin.