Delving into the Latest Updates on Adsorbed Hib-DTP-hepatitis B vaccine (Serum Institute of India) with Synapse

Overview

Basic Info

Drug Type

Combination vaccine, Prophylactic vaccine, Conjugated vaccine

Synonyms

DTPwHBHib vaccine, Diphtheria Tetanus Pertussis Hepatitis B and Haemophilus influenzae type b Conjugate Vaccine Adsorbed Serum Institute of India, Pentavac PFS

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesDigestive System DisordersRespiratory Diseases+ [1]

Active Indication

Hepatitis BHaemophilus InfectionsWhooping Cough+ [2]

Inactive Indication-

Originator Organization

Serum Institute of India Pvt Ltd.

Active Organization

Serum Institute of India Pvt Ltd.

Inactive Organization

The Company for Vaccine & Biological Production No. 1

Drug Highest PhaseApproved

First Approval Date

IN (25 Nov 2008),

Tetanus

Regulation-

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An Open Label, Multicentric, Bridging Study to Assess the Safety of Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus Influenzae Type b Conjugate Vaccine (Adsorbed) Manufactured by Serum Institute of India Pvt. Ltd in Vietnamese Infants Aged 6-12 Weeks, Given as a 3-dose Regime, With 4 Week Intervals Between the Doses

The objective of this study is to evaluate safety and tolerability of Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenzae type b Conjugate Vaccine Adsorbed in Vietnamese infants aged 6-12 weeks. This is an open label, single group, bridging study.

Start Date01 Mar 2018

Sponsor / Collaborator

The Company for Vaccine & Biological Production No. 1

[+1]

NCT02409095 / TerminatedPhase 4

A Phase IV, Non-Inferiority, Observer Blind, Randomized Clinical Study Comparing Safety And Immunogenicity Of DTP-HB-Hib Vaccination by Disposable-Syringe Jet Injector To Vaccination By Needle And Syringe In Healthy Infants In India

This is a study planned to determine and compare immunogenicity and reactogenicity of DTP-HB-Hib vaccine of SIIL delivered either with disposable-Syringe Jet Injector (DSJI) or disposable-syringe needle in total 340 Indian infants aged 6 to 8 weeks at the time of enrollment.
It will provide information to aid managers, device regulatory control officials, immunization programs, and clinicians who make decisions on safe clinical practice standards.

Start Date01 Jan 2015

Sponsor / Collaborator

Serum Institute of India Pvt Ltd.

[+1]

NCT02097472 / CompletedPhase 1/2IIT

A Dose-Finding Study to Assess the Safety, Tolerability, and Immunogenicity of Inactivated Streptococcus Pneumoniae Whole Cell Vaccine Formulated With Alum (PATH-wSP) in Healthy Kenyan Young Adults and PCV-Primed Toddlers

The purpose of this study is to assess the safety and tolerability of PATH-wSP, administered intramuscularly to healthy Kenyan adults and toddlers who have been primed with a pneumococcal conjugate vaccine (PCV).
Additionally, the study will explore whether a measurable immune response is elicited when PATH-wSP is administered to healthy Kenyan adults and toddlers who have been primed with PCV.

Start Date01 Apr 2014

Sponsor / Collaborator

Program for Appropriate Technology in Health

100 Clinical Results associated with Adsorbed Hib-DTP-hepatitis B vaccine (Serum Institute of India)

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100 Translational Medicine associated with Adsorbed Hib-DTP-hepatitis B vaccine (Serum Institute of India)

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100 Patents (Medical) associated with Adsorbed Hib-DTP-hepatitis B vaccine (Serum Institute of India)

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28

Literatures (Medical) associated with Adsorbed Hib-DTP-hepatitis B vaccine (Serum Institute of India)

01 Dec 2024·Vaccine

A randomized, active-controlled, multi-centric, phase-II clinical study to assess safety and immunogenicity of a fully liquid DTwP-HepB-IPV-Hib hexavalent vaccine (HEXASIIL®) in Indian toddlers

Article

Author: Ravi, M.D. ; Ramanan, Padmasani Venkat ; Pujari, Pramod ; Gautam, Manish ; Shewale, Sunil ; Gairola, Sunil ; Agarwal, Anurag ; Jaganathan, K S ; Jaganathan, K.S. ; Desai, Shivani ; Kumar, Rakesh ; Dogar, Vikas ; Sharma, Hitt ; Parekh, Sameer ; Sharma, Inderjit ; Kamath, Veena ; Lalwani, Sanjay ; Ravi, M D ; Kawade, Anand

BACKGROUNDCombination vaccines are effective in simplifying complex vaccination schedules involving multiple vaccines. A fully liquid hexavalent diphtheria (D)-tetanus (T)-whole-cell pertussis (wP)- hepatitis B (HepB)-inactivated poliovirus (IPV)-Haemophilus influenzae b (Hib) vaccine (HEXASIIL®), manufactured by Serum Institute of India Pvt. Ltd. was tested for safety and immunogenicity following booster vaccination.METHODSThis was a phase-II/III, open label, multicentric, controlled trial in toddlers (phase II) and infants (phase III) in India. This manuscript presents results of phase II. Healthy toddlers aged 12-24 months were randomized (1:1) to receive a 0.5 ml booster dose of HEXASIIL® or comparator Pentavac SD + Poliovac, intramuscularly and followed for 28 days for safety assessment. Blood samples were collected pre-vaccination and 28 days post-vaccination to assess immunogenicity. Descriptive summary statistics were provided for safety and immunogenecity analyses.RESULTSA total of 223 subjects were randomized. One subject droped out prior to dosing, due to consent withdrawal. Thus, 222 subjects received study vaccine (110 HEXASIIL® and 112 comparator). Frequency of solicited adverse events was comparable between HEXASIIL® and comparator (85.5 % vs 90.2 %). Most local and systemic solicited AEs were mild to moderate in severity. All events resolved completely without any sequelae and none led to subject discontinuation. No vaccine related serious AE was reported. Post vaccination, seroprotection rates against tetanus, Hib and polio type 1 and 3 were 100 % in both the groups. Seroprotection rates for diphtheria (99.1 % vs 100 %) and polio type 2 (98.2 % vs 100 %) were observed in HEXASIIL® and comparator group, respectively. For Hepatitis B, seroprotection was >99 % in both groups. Seroconversion observed for Bordetella Pertussis (94.5 % vs 95.4 %) and Pertussis Toxin (77.1 % vs 87.2 %) in HEXASIIL® and comparator group, respectively.CONCLUSIONHEXASIIL® vaccine was found to be safe and immunogenic in toddlers and supported its further clinical development in infants. Clinical Trial Registration - CTRI/2019/11/022052.

01 Jan 2023·Science in One Health

Human health implications of emerging diseases and the current situation in India's vaccine industry

Review

Author: Jena, Anway Kumar ; Behera, Bhaskar ; Bhattacharya, Manojit ; Behera, Jiban Kumar ; Mishra, Pabitra

Emerging diseases are infectious diseases that pose significant threat to human health, causing millions of deaths and disabilities in the upcoming days. Periodic epidemics of new infections and old reinfections increase the global burden of disease prevalence. They can be caused by new pathogens or evolving ones, which change human behavior and environmental factors. Researchers have studied the dynamic connections between microbes, hosts, and the environment, but new infectious diseases like coronavirus disease 2019 (COVID-19), re-emerging diseases, and deliberately disseminated diseases persist despite earlier hopes of elimination. With heavy privatesector investments, Indian pharmacology now provides core Expanded Programme on Immunization vaccines to United Nations International Children's Emergency Fund, producing previously unattainable vaccines for diseases like meningitis, hepatitis B, pneumococcal conjugate, rotavirus, influenza A (H1N1), and COVID-19. India's vaccine sector has emerged, among the oriented leaders of the Bharat Biotech, Serum Institute of India, Panacea Biotech and Biological E. Specifically, the technology transferred from Western countries has benefited the sector, which produces 1.3 billion doses annually. The Serum Institute is the world's largest manufacturer of vaccines, providing measles and diphtheria-tetanus-pertussis vaccines to United Nations. The Serum Institute has developed several vaccines, including Nasovac, MenAfriVac, Pentavac, and an inactivated polio vaccine. India's success in vaccinations can be attributed to attractive investment conditions, government assistance, international alliances, and rising domestic technical talent. Despite its booming economy and technical advances, India's disproportionate share of the world's child mortality rate remains unchanged. However, the growing production and distribution of vaccinations in developing nations has initiated a new era, leading to a worldwide decline in childhood death and disease.

15 Sep 2022·Molecular Biology of the Cell

Cardiac inducing colonies halt fibroblast activation and induce cardiac/endothelial cells to move and expand via paracrine signaling

Article

Author: Mahapatra, Samiksha ; Gallicano, Vaughn E. ; Gallicano, G. Ian ; Sharma, Michael V. R. ; Brownson, Breanna

Cardiac inducing colonies generated from germline stem cells secrete at least 18 paracrine factors that promote a full spectrum of events involved in cardiac regeneration. Events include preventing fibroblast activation (scarring), myocyte movement, and myocyte cell cycle up-regulation.

100 Deals associated with Adsorbed Hib-DTP-hepatitis B vaccine (Serum Institute of India)

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hepatitis B	IN	Serum Institute of India Pvt Ltd.	09 Jan 2009
Haemophilus Infections	IN	Serum Institute of India Pvt Ltd.	18 Dec 2008
Whooping Cough	IN	Serum Institute of India Pvt Ltd.	15 Dec 2008
Diphtheria	IN	Serum Institute of India Pvt Ltd.	14 Dec 2008
Tetanus	IN	Serum Institute of India Pvt Ltd.	25 Nov 2008

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diphtheria	Discovery	VN	The Company for Vaccine & Biological Production No. 1	-
Haemophilus Infections	Discovery	VN	The Company for Vaccine & Biological Production No. 1	-
Hepatitis B	Discovery	VN	The Company for Vaccine & Biological Production No. 1	-
Tetanus	Discovery	VN	The Company for Vaccine & Biological Production No. 1	-
Whooping Cough	Discovery	VN	The Company for Vaccine & Biological Production No. 1	-