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.

Start Date23 Oct 2009

Sponsor / Collaborator

LG Life Sciences Ltd.

100 Clinical Results associated with Hib-DTP-hepatitis-B vaccine(LG Life Sciences Ltd.)

100 Translational Medicine associated with Hib-DTP-hepatitis-B vaccine(LG Life Sciences Ltd.)

100 Patents (Medical) associated with Hib-DTP-hepatitis-B vaccine(LG Life Sciences Ltd.)

Literatures (Medical) associated with Hib-DTP-hepatitis-B vaccine(LG Life Sciences Ltd.)

31 Dec 2024·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

Author: 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.

01 Oct 2024·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

Author: 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.

01 Jun 2023·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

Author: 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.

100 Deals associated with Hib-DTP-hepatitis-B vaccine(LG Life Sciences Ltd.)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	J07CA11	-

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Diphtheria	-	LG Life Sciences Ltd.	-
Haemophilus Infections	-	LG Life Sciences Ltd.	-
Hepatitis B	-	LG Life Sciences Ltd.	-
Tetanus	-	LG Life Sciences Ltd.	-
Whooping Cough	-	LG Life Sciences Ltd.	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis


No Data

Hib-DTP-hepatitis-B vaccine(LG Life Sciences Ltd.)

Overview

Basic Info

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation