Table 1.
Persistence of anti-HAV antibodies for Years 1 to 5 (MEIA) and Year 7 (ECLIA) after first vaccination.
| Year 1 (95% CI) | Year 2 (95% CI) | Year 3 (95% CI) | Year 4 (95% CI) | Year 5 (95% CI) | Year 7 (95% CI) | |
|---|---|---|---|---|---|---|
| Group 1: one dose of Avaxim™ 80U Pediatric prior to inclusion | ||||||
| M | 435a | 387 | 365 | 343 | 318 | 204 |
| ≥10 mIU/mL (n [%]) | 429 (98.6) | 387 (100) | 364 (99.7) | 342 (99.7) | 317 (99.7) | — |
| ≥3 mIU/mL (n [%]) | — | — | — | — | — | 204 (100) |
| GMC (95% CI) | 209.7 (190.6;230.6) | 216.0 (198.0;235.7) | 170.2 (155.7;186.0) | 150.3 (137.4;164.4) | 122.5 (111.2;135.0) | 125.6 (118.8;141.1) |
| GMCR (95% CI) | — | 0.95 (0.90;1.00) | 0.74 (0.70;0.79) | 0.66 (0.61;0.70) | 0.53 (0.49;0.57) | – |
| Group 2: two doses of Avaxim™ 80U Pediatric prior to inclusion | ||||||
| M | 108 | 103 | 94 | 90 | 85 | 53 |
| ≥10 mIU/mL (n [%]) | 107 (99.1) | 103 (100) | 94 (100) | 90 (100) | 85 (100) | — |
| ≥3 mIU/mL (n [%]) | — | — | — | — | — | 53 (100) |
| GMC (95% CI) | 1433.9 (1108.4;1855.1) | 1353.8 (1116.2;1641.9) | 872.9 (710.2;1073.0) | 814.6 (667.4;994.1) | 591.7 (479.9;729.4) | 712.5 (526.4;964.5) |
| GMCR (95% CI) | — | 0.88 (0.72;1.07) | 0.57 (0.47;0.70) | 0.54 (0.44;0.66) | 0.40 (0.33;0.50) | – |
| Group 3: one dose of Avaxim™ 80U Pediatric prior to inclusion and one booster doseb | ||||||
| M | 0 | 6 | 6 | 7 | 8 | 7 |
| ≥10 mIU/mL (n [%]) | — | 6 (100) | 6 (100) | 7 (100) | 8 (100) | — |
| ≥3 mIU/mL(n [%]) | — | — | — | — | — | 7 (100) |
| GMC (95% CI) | — | — | — | — | — | 257.2 (81.3;813.6) |
| Booster performed after visit | ||||||
| M | 6 | 0 | 1 | 1 | 1 | 0 |
| Pre-booster GMC (95% CI)c | 5 (3.7;6.7) | — | 7 (NC) | 9 (NC) | 9 (NC) | — |
| Post-booster GMC ([95% CI)d | 551.3 (130.3;2332.2) | — | 3000 (NC) | 153.0 (NC) | 2622.0 (NC) | — |
| Post-/pre- booster GMCR (95% CI) | 110.1 (27.5;440.6) | — | 428.57 (NC) | 17.0 (NC) | 291.33 (NC) | — |
Immunogenicity data missing for one participant.
No participant had a booster at Visit 1. Following Visit 1, 6 participants had low anti-HAV concentrations and received a booster dose – these participants were included in the 1 dose/booster set at Visit 2. Following Visit 3, 1 participant had low anti-HAV concentration and received a booster dose – this participant was included in the 1 dose/booster set at Visit 4. Following Visit 4, 1 participant had low anti-HAV concentration and received a booster dose – this participant was included in the 1 dose/booster set at Visit 5.
Sample taken at the indicated visit.
Sample taken after the booster regardless of the time window between booster and blood sampling.
n, number of subjects; M, number of participants with available data; CI, confidence interval; GMC, geometric mean concentration (mIU/mL); GMCR, geometric mean concentration ratio against Year 1 (not applicable for Year 7 due to different assays used for Years 1 to 5 [MEIA] and Year 7 [ECLIA]) or post-/pre-booster for Group 3; NC, not calculated (as only 1 participant).