A prospective, multicentre, comparative, open label, randomised phase III study to assess immunogenicity and safety of LBVF0101 {DTwP-HB-Hib (combined vaccine which is reconstituted from LBVW0101 (Diphtheria-Tetanus-whole cell Pertussis-Hepatitis B) and LBVH0101 (Haemophilus influenzae type b tetanus toxoid conjugate vaccine) just before intramuscular injection} compared with combined vaccine which is reconstituted from Tritanrix HBÂ®(Diphtheria-Tetanus-whole cell Pertussis-Hepatitis B) and HiberixÂ® (Haemophilus influenzae type b tetanus toxoid conjugate vaccine) just before intramuscular injection in healthy infants at six, ten and fourteen weeks of age.

开始日期2009-10-23

申办/合作机构

LG Life Sciences Ltd.

100 项与 Hib-DTP-hepatitis-B vaccine(LG Life Sciences Ltd.) 相关的临床结果

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100 项与 Hib-DTP-hepatitis-B vaccine(LG Life Sciences Ltd.) 相关的转化医学

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100 项与 Hib-DTP-hepatitis-B vaccine(LG Life Sciences Ltd.) 相关的专利（医药）

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项与 Hib-DTP-hepatitis-B vaccine(LG Life Sciences Ltd.) 相关的文献（医药）

2024-12-31·Human Vaccines & Immunotherapeutics

Antibody persistence to diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens, and Haemophilus influenzae type b following primary and first booster with pentavalent versus hexavalent vaccines

Article

作者: Sarawanangkoor, Nasiri ; Poovorawan, Yong ; Thongmee, Thanunrat ; Thatsanathorn, Thaksaporn ; Wanlapakorn, Nasamon ; Srimuan, Donchida

Thailand has incorporated the whole-cell (wP) pertussis vaccine into the expanded program on immunization since 1977 and has offered the acellular pertussis (aP) vaccine as an optional vaccine for infants since 2001. We followed healthy children from a clinical trial (ClinicalTrials.gov NCT02408926) in which children were randomly assigned to receive either pentavalent (DTwP-HB-Hib) or hexavalent (DTaP-IPV-HB-Hib) vaccines for their primary series (administered at 2, 4, and 6 months) and first booster vaccination (18 months). Both groups received Tdap-IPV as a second booster at the age of 4 y. Blood samples were collected for evaluation of antibody persistence to diphtheria toxoid (DT), tetanus toxoid (TT), and Bordetella pertussis (B. pertussis) between 2 and 6 y of age annually, and for the immunogenicity study of Tdap-IPV at 1 month after the second booster. Antibody persistence to Haemophilus influenzae type b (Hib) was followed until 3 y of age. A total of 105 hexavalent-vaccinated children and 91 pentavalent-vaccinated children completed this study. Both pentavalent and hexavalent groups demonstrated increased antibody levels against DT, TT, and B. pertussis antigens following the second booster with Tdap-IPV. All children achieved a seroprotective concentration for anti-DT and anti-TT IgG at 1 month post booster. The hexavalent group possessed significantly higher anti-pertactin IgG (adjusted p = .023), whereas the pentavalent group possessed significantly higher anti-pertussis toxin IgG (adjusted p < .001) after the second booster. Despite declining levels post-second booster, a greater number of children sustained protective levels of anti-DT and anti-TT IgG compared to those after the first booster.

2024-10-01·Vaccine: X

Persistence of hepatitis B surface antibody until 7 years of age following administration of hexavalent and pentavalent vaccines in children at 2, 4, 6, and 18 months

Article

作者: Klinfueng, Sirapa ; Sarawanangkoor, Nasiri ; Poovorawan, Yong ; Thatsanathorn, Thaksaporn ; Wanlapakorn, Nasamon ; Srimuan, Donchida

Thailand incorporated the hepatitis B (HepB) vaccine into the infant combination vaccine known as pentavalent wP-containing vaccines (DTwP-HB-Hib) and hexavalent aP-containing vaccines (DTaP-IPV-HB-Hib). We followed healthy children from the clinical trial (ClinicalTrials.gov NCT02408926) in which children were randomly assigned to receive either pentavalent or hexavalent vaccines for their primary series (administered at 2, 4, and 6 months) and first booster vaccination (at 18 months), following the monovalent HepB vaccine at birth. Blood samples were collected to evaluate the persistence of hepatitis B surface antibody (anti-HBs) at 3, 4, 5, 6 and 7 years of age. The results showed that at 7 years of age, a higher percentage of children in the hexavalent group maintained anti-HBs levels ≥ 10 mIU/mL compared to those in the pentavalent group (86.9 % vs. 59.7 %). This study showed good persistence of anti-HBs among hexavalent-vaccinated children 5.5 years after the last dose of the HepB vaccine.

2023-06-01·Vaccine

Immunogenicity of the pentavalent DTwP-HB-Hib vaccine (Shan-5) used in the Thai Expanded Program on Immunization compared to the hexavalent DTaP-HB-Hib-IPV and DTwP-HB-Hib (Quinvaxem) vaccines administered to infants at 2, 4, 6 months of age

Article

作者: Sarawanangkoor, Nasiri ; Thongmee, Thanunrat ; Posuwan, Nawarat ; Srimuan, Donchida ; Wanlapakorn, Nasamon ; Phanphanit, Kanchana ; Pruetarat, Napa ; Poovorawan, Yong ; Thatsanathorn, Thaksaporn

BACKGROUNDThe pentavalent DTwP-HB-Hib (Shan-5) vaccine was first introduced into the Thailand Expanded Program on Immunization (EPI) in 2019. The Shan-5 vaccine is administered to infants at 2, 4, and 6 months of age, after initial vaccination with monovalent hepatitis B (HepB) and Bacillus Calmette-Guérin (BCG) vaccines at birth. This study compared the immunogenicity of the HepB, diphtheria, tetanus, and Bordetella pertussis antigens incorporated in the EPI Shan-5 vaccine versus the optional pentavalent (DTwP-HB-Hib) Quinvaxem and hexavalent (DTaP-HB-Hib-IPV) Infanrix-hexa vaccine.METHODSThree-dose Shan-5-vaccinated children were prospectively enrolled at the Regional Health Promotion Centre 5, Ratchaburi province, Thailand, between May 2020 and May 2021. Blood sampling was performed at months 7 and 18. The levels of HepB surface antibody (anti-HBs), anti-diphtheria toxoid (DT) IgG, anti-tetanus toxoid (TT) IgG, and anti-pertussis toxin (PT) IgG were evaluated using commercially available enzyme-linked immunoassays.RESULTSAnti-HBs levels of ≥10 mIU/mL were achieved in 100 %, 99.2 %, and 99.2 % of infants in the Shan-5 EPI group, hexavalent group and Quinvaxem group one month after four dose immunization (at 0, 2, 4, 6 months of age), respectively. The geometric mean concentrations of the EPI Shan-5 and hexavalent groups were comparable but were higher than those of the Quinvaxem group. At one month after primary vaccination (month 7), infants in the Shan-5 EPI group had significantly higher levels of anti-DT IgG, anti-TT IgG, and anti-PT IgG than infants in the hexavalent and Quinvaxem groups.CONCLUSIONSThe immunogenicity of the HepB surface antigen in the EPI Shan-5 vaccine was similar to that achieved by the hexavalent vaccine, but was higher than that achieved by the Quinvaxem vaccine. The Shan-5 vaccine is highly immunogenic and generates robust antibody responses after primary immunization.

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