1 Table, Supplemental Digital Content 1 Anti-HBsAb geometric mean concentrations (IU/L) for PP population of neonates in Stratum 1 and 2, and in Substratum 1a and 1b at Months 2, 7 and 12

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(1)Table, Supplemental Digital Content 1 Anti-HBsAb geometric mean concentrations (IU/L) for PP population of neonates in Stratum 1 and 2, and in Substratum 1a and 1b at Months 2, 7 and 12 Hepavax-Gene TF Timepoint. Stratum. N. GMC. Adj. Mean. N. (95% CI) Month 2. 1. 338. 64.19. 1. 293. 259.42. 1.807. 166. 1. 276. 97.01. 2.414. 144. 1a. 122. 51.01. 1.987. 143. 1a. 113. 203.79. 1.708. 62. 1a. 109. 86.31. 2.309. 56. 1b. 216. 73.08. 1.936. 56. 1b. 293. 259.42. 1.864. 104. 1b. 276. 97.01. 2.414. 144. 2. 390. 397.77 (326.77, 484.21). 48.29. 182.38. 99.84. 70.37. 340.40. 1.987. 143. 135.42. 1.684. 411. 525.65 (428.61, 644.67). -0.118. 0.202. -0.145. 0.108. 0.024. 0.848. (-0.221, 0.269) 2.261. 0.048. 0.784. (-0.299, 0.395) 1.999. -0.063. 0.703. (-0.390, 0.264) 1.847. 0.016. 0.567. (-0.04, 0.073) 2.532. -0.118. 0.202. (-0.300, 0.064) 2.132. (98.92, 185.39) 2.600. 0.669. (-0.322, 0.032). (231.93, 499.60). (75.98, 123.85) Month 7. 2.132. (63.83, 77.58). (207.03, 325.07) Month 12. 135.42. 0.021. (-0.300, 0.064). (55.02, 181.17). (67.66, 78.94) Month 7. 2.532. (83.47, 398.52). (55.09, 135.23) Month 2. 340.40. p-value. (-0.076, 0.118). (31.18, 74.79). (134.65, 308.43) Month 12. 1.786. (98.92, 185.39). (36.39, 71.51) Month 7. 61.14. Difference (95%CI). (231.93, 499.60). (75.98, 123.85) Month 2. Adj. Mean. (51.38, 72.75). (207.03, 325.07) Month 12. GMC (95% CI). (56.27, 73.22) Month 7. Hepavax-Gene – Engerix-B. Engerix-B. -0.145. 0.108. (-0.322, 0.032) 2.721. -0.121. 0.054. (-0.244, 0.002). 1. (2) Month 12. 2. 368. 152.60 (129.97, 179.17). 2.184. 396. 173.98 (144.80, 209.04). 2.240. -0.057. 0.294. (-0.163, 0.049). CI = confidence interval; GMC = geometric mean concentration calculated by taking anti-log10 of the adjusted mean antibody concentration; Adj. mean=arithmetic mean of log10- transformed antibody concentrations, N = number of participants in PP population; HBsAb = hepatitis B surface antibody; * statistically significant; Stratum 1: neonates whose mothers were HBsAg (hepatitis B surface antigen) positive; Substratum 1a: HBsAg and HBeAg (hepatitis B e antigen) positive; Substratum 1b: HBsAg positive and HBeAg negative; Stratum 2: neonates whose mothers were HBsAg, HBeAg and HBeAb (hepatitis B e antibodies) negative; Month 2, one month after injection of second vaccine dose at one month of age; Month 7, one month after injection of the third vaccine dose at six months of age; Month 12, six months after injection of the third vaccine dose at six months of age.. 2. (3) Table, Supplemental Digital Content 2 Summary of the unsolicited AEFIs by system organ class reported by at least 0.5% of neonates in the safety population in Stratum 1 and 2 combined Hepavax-Gene TF. Engerix-B. Total. N = 959. N = 779. N = 1738. SOC Preferred term. n. %. n. %. n. %. All AEs. 289. 30.1. 223. 28.6. 512. 29.5. General disorders and. 144. 15.0. 97. 12.5. 241. 13.9. Fever*. 141. 14.7. 95. 12.2. 236. 13.6. Crying. 7. 0.7. 6. 0.8. 13. 0.7. 98. 10.2. 76. 9.8. 174. 10.0. Nasopharyngitis. 36. 3.8. 26. 3.3. 62. 3.6. Upper respiratory tract. 17. 1.8. 19. 2.4. 36. 2.1. Bronchopneumonia. 15. 1.6. 10. 1.3. 25. 1.4. Pneumonia. 11. 1.1. 6. 0.8. 17. 1.0. Bronchitis. 7. 0.7. 6. 0.8. 13. 0.7. 62. 6.5. 50. 6.4. 112. 6.4. Diarrhoea. 43. 4.5. 39. 5.0. 82. 4.7. Abdominal distension. 8. 0.8. 7. 0.9. 15. 0.9. Vomiting. 8. 0.8. 4. 0.5. 12. 0.7. 48. 5.0. 32. 4.1. 80. 4.6. Cough. 38. 4.0. 29. 3.7. 67. 3.9. Rhinorrhoea. 7. 0.7. 3. 0.4. 10. 0.6. 22. 2.3. 15. 1.9. 37. 2.1. 22. 2.3. 15. 1.9. 37. 2.1. 11. 1.1. 14. 1.8. 25. 1.4. 6. 0.6. 6. 0.8. 12. 0.7. administration site conditions. Infections and infestations. Infection. Gastrointestinal disorders. Respiratory, thoracic and mediastinal disorders. Pregnancy, puerperium and perinatal conditions Jaundice neonatal Skin and subcutaneous tissue disorders Eczema. Percentages are based on N = number of participants in the safety population; AEFI - Adverse event following immunization; SOC = System Organ Class, * fever = axillary temperature ≥37.1C.. 3. (4) Table, Supplemental Digital Content 3 Summary of solicited local adverse events within first seven days after each vaccine dose in safety population in Stratum 1 and 2 combined Hepavax-Gene TF Engerix-B Total Dose and time period N = 959 N = 779 N = 1738 Preferred term n % n % n % After any dose: Day 0 to Day 7 43 4.5 39 5.0 82 4.7 Erythema 27 2.8 24 3.1 51 2.9 Induration 18 1.9 9 1.2 27 1.6 Pain 13 1.4 13 1.7 26 1.5 Rash (injection site) 3 0.3 2 0.3 5 0.3 Skin mucous membranea 9 0.9 18 2.3 27 1.6 Swelling 14 1.5 10 1.3 24 1.4 After first dose: Day 0 to Day 7 19 2.0 19 2.4 38 2.2 Erythema 10 1.0 10 1.3 20 1.2 Induration 2 0.2 4 0.5 6 0.3 Pain 9 0.9 9 1.2 18 1.0 Skin mucous membranea 7 0.7 10 1.3 17 1.0 Swelling 3 0.3 3 0.4 6 0.3 After the second dose: Day 0 to Day 7 8 0.8 13 1.7 21 1.2 Erythema 4 0.4 8 1.0 12 0.7 Induration 3 0.3 1 0.1 4 0.2 Pain 2 0.2 2 0.3 4 0.2 Skin mucous membranea 5 0.5 7 0.9 12 0.7 Swelling 2 0.2 2 0.3 4 0.2 After the third dose: Day 0 to Day 7 21 2.2 9 1.2 30 1.8 Erythema 16 1.7 7 0.9 23 1.4 Induration 13 1.4 4 0.5 17 1.0 Pain 3 0.3 2 0.3 5 0.3 Rash (injection site) 3 0.3 2 0.3 5 0.3 Skin mucous membranea 0 0 1 0.1 1 0.1 Swelling 9 1.0 5 0.7 14 0.8 a skin and mucosa reactions, Percentages are based on N = number of participants in the corresponding safety population. 4. (5) Table, Supplemental Digital Content 4 Summary of solicited systemic adverse events within first seven days after each vaccine dose in safety population in Stratum 1 and 2 combined Hepavax-Gene TF. Engerix-B. Total. N = 959. N = 779. N = 1738. Dose and time period Preferred term. n. %. n. %. n. %. 411. 42.9. 336. 43.1. 747. 43.0. Activity level. 4. 0.4. 3. 0.4. 7. 0.4. Allergic reaction. 2. 0.2. 4. 0.5. 6. 0.3. Breastfeeding or eating disorder. 5. 0.5. 6. 0.8. 11. 0.6. Convulsions. 1. 0.1. 2. 0.3. 3. 0.2. 403. 42.0. 329. 42.2. 732. 42.1. Mental state. 9. 0.9. 5. 0.6. 14. 0.8. Nausea. 1. 0.1. 2. 0.3. 3. 0.2. Screaming. 27. 2.8. 19. 2.4. 46. 2.6. Vomiting. 9. 0.9. 15. 1.9. 24. 1.4. 272. 28.4. 216. 27.7. 488. 28.1. Activity level. 1. 0.1. 2. 0.3. 3. 0.2. Allergic reaction. 2. 0.2. 3. 0.4. 5. 0.3. Breastfeeding or eating disorder. 3. 0.3. 4. 0.5. 7. 0.4. Convulsions. 1. 0.1. 1. 0.1. 2. 0.1. 265. 27.6. 207. 26.6. 472. 27.2. Mental state. 5. 0.5. 4. 0.5. 9. 0.5. Nausea. 0. 0. 1. 0.1. 1. 0.1. Screaming. 14. 1.5. 9. 1.2. 23. 1.3. Vomiting. 6. 0.6. 8. 1.0. 14. 0.8. 202. 21.2. 164. 21.2. 366. 21.2. Activity level. 2. 0.2. 1. 0.1. 3. 0.2. Allergic reaction. 0. 0. 1. 0.1. 1. 0.1. Breastfeeding or eating disorder. 1. 0.1. 3. 0.4. 4. 0.2. Convulsions. 0. 0. 1. 0.1. 1. 0.1. 197. 20.6. 157. 20.3. 354. 20.5. Mental state. 3. 0.3. 2. 0.3. 5. 0.3. Nausea. 1. 0.1. 1. 0.1. 2. 0.1. Screaming. 8. 0.8. 10. 1.3. 18. 1.0. Vomiting. 3. 0.3. 5. 0.6. 8. 0.5. After any dose: Day 0 to Day 7. Fever axillary temperature. After first dose: Day 0 to Day 7. Fever axillary temperature. After the second dose: Day 0 to Day 7. Fever axillary temperature. 5. (6) Hepavax-Gene TF. Engerix-B. Total. N = 959. N = 779. N = 1738. Dose and time period Preferred term. n. %. n. %. n. %. 118. 12.6. 115. 15.2. 233. 13.8. Activity level. 1. 0.1. 0. 0. 1. 0.1. Breastfeeding or eating disorder. 1. 0.1. 0. 0. 1. 0.1. 115. 12.3. 114. 15.1. 229. 13.6. Mental state. 1. 0.1. 0. 0. 1. 0.1. Screaming. 5. 0.5. 1. 0.1. 6. 0.4. Vomiting. 0. 0. 2. 0.3. 2. 0.1. After the third dose: Day 0 to Day 7. Fever axillary temperature. Percentages are based on N = number of participants in the corresponding safety population; Fever is defined as body temperature ≥37.1 °C, Screaming is defined as crying or abnormal crying.. 6. (7)