Comparison of Immunogenicity and Safety of Diphtheria–Tetanus–Pertussis–Hepatitis B–Haemophilus influenza B (Bio Farma) with Pentabio® Vaccine Primed with Recombinant Hepatitis B at Birth (Using Different Source of Hepatitis B) in Indonesian Infants
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design and Population
2.2. Vaccine
2.3. Study Vaccine
2.4. Immunogenicity Assessment
2.5. Safety Assessment
2.6. Statistical Analysis
3. Results
3.1. Study Population
3.2. Diphtheria
3.3. Tetanus
3.4. Pertussis
3.5. Hepatitis B
3.6. Hemophilus Influenzae Type b
3.7. Safety Assessment
3.8. Local and Systemic Reactions
3.9. Serious Adverse Events
4. Discussion
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Age | Group | 0–3 (Days) | 6–11 Weeks | 10–15 Weeks | 14–19 Weeks |
---|---|---|---|---|---|
0–3 days | A | Recombinant hepatitis B vaccine using different source | DTP–HB–Hib using different source of hepatitis B bulk | DTP–HB–Hib using different source of hepatitis B bulk | DTP–HB–Hib using different source of hepatitis B bulk |
B | Recombinant Hepatitis B® vaccine (Bio Farma) | Pentabio® | Pentabio® | Pentabio® |
Description | Control Product (A) | Investigational Product (B) | Total |
---|---|---|---|
N included | 109 | 111 | 220 |
Gender Male n (%) Female n (%) | 53 (48.6%) 56 (51.4%) | 57 (51.4%) 54 (48.6%) | 110 110 |
Age (days) | |||
Mean ± SD * | 0.51 ± 0.55 | 0.54 ± 0.57 | 0.53 ± 0.56 |
Min; Max | 0; 3 | 0; 2 | 0; 3 |
Antibody Response | Pre-Vaccination/V2 (n = 103) | Post-Vaccination/V5 (n = 103) |
---|---|---|
Anti-D ≥ 0.01 IU/mL n (%) | 63 (61.2) | 103 (100) |
Anti-T ≥ 0.01 IU/mL n (%) | 101 (98.1) | 103 (100) |
Anti-PRP-T ≥ 0.15 μg/mL n (%) | 83 (80.6) | 99 (96.1) |
Anti-pertussis ≥ 40 1/dil n (%) | 1 (1.0) | 85 (82.5) |
Pre-vaccination/V0 (n = 104) | Post-vaccination/V5 (n= 103) | |
Anti-HBsAg ≥ 10 mIU/mL n (%) | 18 (17.3) | 103 (100) |
Antibody | Assessment | Criterion | Group A | Group B | p-Value | ||||
---|---|---|---|---|---|---|---|---|---|
N | %NSP | 95% CI | N | %NSP | 95% CI | ||||
Diphtheria | Pre-vaccination/V2 | ≥0.01 IU/mL | 55 | 53.9 | 44.3–63.3 | 63 | 61.2 | 51.5–70.0 | 0.294 |
≥0.1 IU/mL | 31 | 30.4 | 22.3–39.9 | 37 | 35.9 | 27.3–45.5 | 0.400 | ||
Post-vaccination/V5 | ≥0.01 IU/mL | 99 | 97.1 | 91.7–99.0 | 103 | 100 | 96.4–100 | 0.080 | |
≥0.1 IU/mL | 90 | 97.4 | 79.6–92.5 | 90 | 87.4 | 79.6–92.5 | 0.529 | ||
Tetanus | Pre-vaccination/V2 | ≥0.01 IU/mL | 100 | 98 | 93.1–99.5 | 101 | 98.1 | 93.2–99.5 | 1.000 |
≥0.01 IU/mL | 93 | 91.2 | 84.1–95.3 | 99 | 96.1 | 90.4–98.4 | 0.147 | ||
Post-vaccination/V5 | ≥0.1 IU/mL | 102 | 100 | 96.4–100 | 103 | 100 | 96.4–100 | 1.000 | |
≥0.01 IU/mL | 102 | 100 | 96.4–100 | 103 | 100 | 96.4–100 | 1.000 | ||
Pertussis | Pre-vaccination/V2 | >40 1/dil | 4 | 3.9 | 1.5–9.6 | 1 | 1.0 | 0.17–5.3 | 0.212 |
>80 1/dil | 1 | 1.0 | 0.17–5.35 | 1 | 1.0 | 0.17–5.3 | 1.000 | ||
>160 1/dil | 0 | 0 | 0–3.63 | 1 | 1.0 | 0.17–5.3 | 1.000 | ||
>320 1/dil | 0 | 0 | – | 0 | 0 | – | - | ||
Post-vaccination/V5 | >40 1/dil | 94 | 92.2 | 85.3–96.0 | 85 | 82.5 | 74.1–88.6 | 0.038 * | |
>80 1/dil | 86 | 84.3 | 76.0–90.1 | 79 | 76.7 | 67.7–83.3 | 0.169 | ||
>160 1/dil | 68 | 66.7 | 57.1–75.1 | 60 | 58.3 | 48.6–67.3 | 0.214 | ||
>320 1/dil | 31 | 30.4 | 22.5–33.9 | 36 | 35.0 | 26.4–44.6 | 0.487 | ||
Hepatitis B | Pre-vaccination/V0 | ≥10 mIU/mL | 19 | 18.1 | 11.9–26.5 | 11 | 10.5 | 5.9–17.8 | 0.115 |
Pre-vaccination/V2 | ≥10 mIU/mL | 27 | 26.0 | 18.5–35.1 | 18 | 17.3 | 11.2–25.7 | 0.130 | |
Post-vaccination/V5 | ≥10 mIU/mL | 101 | 99.0 | 94.6–99.8 | 103 | 100 | 96.4–100 | 0.498 | |
PRP (Hib) | Pre-vaccination/V2 | ≥0.15 µg/mL | 77 | 75.7 | 66.3–82.8 | 83 | 80.6 | 71.9–87.1 | 0.378 |
≥1.0 µg/mL | 5 | 4.9 | 2.1–11.0 | 4 | 3.9 | 1.5–9.6 | 0.748 | ||
Post-vaccination/V5 | ≥0.15 µg/mL | 101 | 99.0 | 94.6–99.8 | 99 | 96.1 | 90.4–98.5 | 0.369 | |
≥1.0 µg/mL | 81 | 79.4 | 70.6–86.1 | 84 | 81.6 | 73.0–87.9 | 0.699 |
Antibody | Assessment | Group A | Group B | p-Value | ||
---|---|---|---|---|---|---|
GMT, IU/mL | 95% CI | GMT, IU/mL | 95% CI | |||
Diphtheria | Pre-vaccination/V2 | 0.1465 | 0.0088–0.2431 | 0.0201 | 0.0122–0.03323 | 0.440 |
Post-vaccination/V5 | 0.3260 | 0.2419–0.4393 | 0.4215 | 0.3380–0.5256 | 0.270 | |
Tetanus | Pre-vaccination/V2 | 0.5950 | 0.4557–0.7770 | 0.6414 | 0.4944–0.8320 | 0.678 |
Post-vaccination/V5 | 1.0268 | 0.8929–1.1808 | 1.2653 | 1.0691–1.4976 | 0.065 | |
Pertussis | Pre-vaccination/V2 | 5.8462 | 5.2944–6.4570 | 5.606 | 5.128–6.117 | 0.596 |
Post-vaccination/V5 | 133.179 | 106.346–166.783 | 105.419 | 80.868–137.423 | 0.407 | |
Hepatitis B | Pre-vaccination/V0 | 0.3347 | 0.1551–0.72 | 0.1986 | 0.100–0.394 | 0.491 |
Pre-vaccination/V2 | 1.4824 | 0.823–2.669 | 0.5458 | 0.280–1.063 | 0.076 | |
Post-vaccination/V5 | 533.303 | 415.090–85.184 | 2372.378 | 1905.03–2956.87 | 0.001 * | |
PRP-Hib | Pre-vaccination/V2 | 0.1643 | 0.1156–0.2336 | 0.2075 | 0.1529–0.2816 | 0.252 |
Post-vaccination/V5 | 3.4965 | 2.6706–4.7936 | 2.9457 | 2.0478–4.2372 | 0.974 |
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Fadlyana, E.; Rusmil, K.; Dhamayanti, M.; Tarigan, R.; Kartasasmita, C.B.; Sari, R.M.; Putra, M.G.D.; Sukandar, H. Comparison of Immunogenicity and Safety of Diphtheria–Tetanus–Pertussis–Hepatitis B–Haemophilus influenza B (Bio Farma) with Pentabio® Vaccine Primed with Recombinant Hepatitis B at Birth (Using Different Source of Hepatitis B) in Indonesian Infants. Vaccines 2023, 11, 498. https://doi.org/10.3390/vaccines11030498
Fadlyana E, Rusmil K, Dhamayanti M, Tarigan R, Kartasasmita CB, Sari RM, Putra MGD, Sukandar H. Comparison of Immunogenicity and Safety of Diphtheria–Tetanus–Pertussis–Hepatitis B–Haemophilus influenza B (Bio Farma) with Pentabio® Vaccine Primed with Recombinant Hepatitis B at Birth (Using Different Source of Hepatitis B) in Indonesian Infants. Vaccines. 2023; 11(3):498. https://doi.org/10.3390/vaccines11030498
Chicago/Turabian StyleFadlyana, Eddy, Kusnandi Rusmil, Meita Dhamayanti, Rodman Tarigan, Cissy B. Kartasasmita, Rini Mulia Sari, Muhammad Gilang Dwi Putra, and Hadyana Sukandar. 2023. "Comparison of Immunogenicity and Safety of Diphtheria–Tetanus–Pertussis–Hepatitis B–Haemophilus influenza B (Bio Farma) with Pentabio® Vaccine Primed with Recombinant Hepatitis B at Birth (Using Different Source of Hepatitis B) in Indonesian Infants" Vaccines 11, no. 3: 498. https://doi.org/10.3390/vaccines11030498
APA StyleFadlyana, E., Rusmil, K., Dhamayanti, M., Tarigan, R., Kartasasmita, C. B., Sari, R. M., Putra, M. G. D., & Sukandar, H. (2023). Comparison of Immunogenicity and Safety of Diphtheria–Tetanus–Pertussis–Hepatitis B–Haemophilus influenza B (Bio Farma) with Pentabio® Vaccine Primed with Recombinant Hepatitis B at Birth (Using Different Source of Hepatitis B) in Indonesian Infants. Vaccines, 11(3), 498. https://doi.org/10.3390/vaccines11030498