Delving into the Latest Updates on Hepatitis A vaccine, inactivated(GlaxoSmithKline Plc) with Synapse

Overview

Basic Info

Drug Type

Inactivated vaccine, Prophylactic vaccine

Synonyms

Havrix Junior, Havrix Monodose, Hepatitis A vaccine inactivated

+ [1]

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesDigestive System Disorders

Active Indication

Hepatitis A

Inactive Indication

ChickenpoxDiphtheriaHIV Infections+ [7]

Originator Organization

GSK Plc

Active Organization

GlaxoSmithKline LLC

Inactive Organization

GSK Plc

Drug Highest PhaseApproved

First Approval Date

United States (22 Feb 1995),

Hepatitis A

Regulation-

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A Phase 3a, Open-Label, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of Intramuscular Administration of an Investigational Varicella Vaccine and Priorix Compared With Subcutaneous Administration of Varivax and Priorix, When Given as a First Dose to Healthy Children 12 to 15 Months of Age

This study aims to assess the immune response and safety of GSKs candidate chickenpox and marketed MMR vaccines when given to children 12 to 15 months of age via a muscle injection. It compares the GSK vaccines to Mercks chickenpox vaccine, administered just under the skin, to determine which method is more effective. Additionally, the study will evaluate the immune response and safety of giving the GSK vaccines along with other childhood vaccines through a muscle injection.

Start Date21 Apr 2025

Sponsor / Collaborator

GSK Plc

NCT06824181

/ RecruitingPhase 3

A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, 4-arm Study to Investigate the Mixed Vaccination Schedules of a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers

This study is a Phase 3, randomized, modified double-blind study which aims to measure whether the investigational pneumococcal conjugate vaccine PCV21 is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) when it is given after 1 dose, 2 doses, or 3 doses of a licensed 20-valent pneumococcal vaccine compared to when 20-valent pneumococcal vaccine is given as a complete series in infants aged from approximately 2 months (42 to 89 days).
The study duration per participant will be up to approximately 19 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 to 15 months of age (MoA). Routine pediatric vaccines will be given as per local recommendations.
There will be 6 study visits:
Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age until 15 months of age, V06 separated from V05 by 30 days.

Start Date27 Feb 2025

Sponsor / Collaborator

Sanofi

NCT06824194

/ RecruitingPhase 3

A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, 2 Arm Study to Investigate the Safety of a 4-dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers

This study is a Phase 3, randomized, modified double-blind study which aims to document the safety profile of the PCV21 vaccine (investigational pneumococcal vaccine) compared to a licensed 20-valent pneumococcal conjugate vaccine in infants aged from approximately 2 months (42 to 89 days).
The study duration per participant will be up to approximately 19 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 to 15 months of age. Routine pediatric vaccines will be given as per local recommendations.
There will be 6 study visits:
Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age until 15 months of age, V06 separated from V05 by 30 days.

Start Date18 Feb 2025

Sponsor / Collaborator

Sanofi

100 Clinical Results associated with Hepatitis A vaccine, inactivated(GlaxoSmithKline Plc)

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100 Translational Medicine associated with Hepatitis A vaccine, inactivated(GlaxoSmithKline Plc)

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100 Patents (Medical) associated with Hepatitis A vaccine, inactivated(GlaxoSmithKline Plc)

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108

Literatures (Medical) associated with Hepatitis A vaccine, inactivated(GlaxoSmithKline Plc)

08 Dec 2023·Emerging Microbes & Infections

Durability of serologic responses to inactivated hepatitis A virus vaccination among people living with HIV following acute hepatitis A outbreak: a 5-year follow-up study

Article

Author: Sun, Hsin-Yun ; Liu, Wang-Da ; Hung, Chien-Ching ; Lin, Kuan-Yin ; Chen, Guan-Jhou ; Hsieh, Szu-Min ; Huang, Yu-Shan ; Huang, Sung-Hsi

Serologic responses to hepatitis A virus (HAV) vaccination may wane among immunocompromised populations. To evaluate the long-term seroresponses to 2-dose HAV vaccination, we retrospectively included people living with HIV (PLWH) who had achieved seroconversion within 12 months after vaccination at a university hospital during an outbreak of acute hepatitis A between 2015 and 2017. PLWH included in the study received either Havrix or Vaqta. The seroresponses were evaluated 60 months after the second dose of vaccination and estimated by the intention-to-treat (ITT) with last-observation-carried-forward (LOCF) and per-protocol (PP) analyses. Overall, 986 PLWH (median age, 34 years and CD4 count, 587 cells/µL) were included. The rates of PLWH with persistent seroprotection at month 60 of vaccination were 90.7% (894/986) and 97.4% (748/768) in the ITT with LOCF and PP analyses, respectively. PLWH with persistent seroprotection had achieved higher peak anti-HAV IgG titers after vaccination and had a slower decline in antibody levels compared with those with seroreversion. In the multivariable analysis, seroreversion at month 60 was associated with a higher body-mass index (per 1-kg/m² increase, AOR, 1.10; 95% CI, 1.04-1.17), lowest-ever CD4 count (per 10-cell/µL increase, AOR 0.98; 95% CI, 0.97-1.00), plasma HIV RNA <200 copies/ml at vaccination (AOR, 0.28; 95% CI, 0.14-0.59), and having received Vaqta as the first dose of HAV vaccination (AOR, 0.44; 95% CI, 0.27-0.70). The seroprotection against HAV remained high in the long-term follow-up among PLWH on antiretroviral therapy after 2-dose HAV vaccination. Regular monitoring of seroresponses and timely administration of HAV vaccines are warranted to maintain seroprotection.

06 Oct 2023·Vaccine

Immunogenicity and safety of Havisure^TM vaccine developed by Human Biologicals Institute in healthy subjects of 12 months to 49 years of age: A phase II/III, randomized, single blind, non-inferiority study.

Article

Author: Susarla, Sai Krishna ; Pradeep, N ; Sandhya, G ; Kanakasapapathy, Anand Kumar ; Uttam, Kheya Ghosh ; Rajashakar, B C ; Dhongade, Ashish Ramachandra ; Siva Ram Prasad, K ; Rajendra, L ; Palkar, Sonali ; Satish, M ; Gupta, Madhu ; Sahoo, Devi Prasad ; Ravi, M D ; Rajapantula, Vasudev

BACKGROUNDHepatitis A is an inflammation of the liver caused by the hepatitis A virus (HAV). It is transmitted mainly because of poor personal hygiene via the faecal/oral route through ingestion of contaminated food or water or through the direct contact with an infectious person. Though most of the infected individuals recover from the infection, a few may develop fatal fulminant hepatitis. In this randomized, multicenter study, immunogenicity and safety of Havisure™ vaccine of Human Biologicals Institute was compared with Havrix® vaccine.METHODSThe study was carried out in 528 eligible healthy subjects, in two age groups across eight centres in India. Group A included subjects of 19-49 years and Group B subjects of 12 months to below 19 years of age. All subjects received two doses of either Havisure™ vaccine or Havrix® vaccine as per randomization at six months interval. Blood samples for antibody titre estimation were collected before vaccination and 4-6 weeks after 2nd dose of vaccination. Immunogenicity was assessed by estimating seroconversion rate, seroprotection rate, and geometric mean titres of antibodies. Safety was evaluated by collection and analysis of data on solicited and unsolicited adverse events.RESULTSOf 528 enrolled subjects, 493 subjects completed the study. There was 100% seroconversion and seroprotection in both the vaccine arms. There was no statistical difference in the geometric mean titres between the two vaccine arms. Pain and swelling at the site of injection were the most common local adverse events whereas fever and headache were the most common systemic adverse events observed in both vaccine arms. No serious adverse event was reported in the study.CONCLUSIONThe study results indicate that the Havisure™ vaccine is immunogenic and safe when administered to healthy subjects of 12 months to 49 years of age, and is non-inferior to Havrix® Vaccine.

01 Aug 2023·Human Vaccines & Immunotherapeutics

Immunogenicity persistence of hepatitis A vaccines Healive® and Havrix® among children:15 years follow-up and long-term prediction

Article

Author: Wang, Yalong ; Yao, Hui ; Zhang, Ying ; Xu, Wenguo ; Xu, Li ; Hu, Yuansheng ; Wang, Xiaoli ; Ma, Minhua

Healive® was the only Chinese WHO-prequalified inactivated vaccine for the hepatitis A virus, which has been widely used in national immunization programs in China. Long-term follow-up studies are needed to estimate the persistence of vaccine-induced antibody levels and the necessity for booster vaccines. During the trial, geometric mean concentrations (GMCs) and seroconversion rates (SRs) of anti-HAV antibodies were compared based on two different inactivated hepatitis A vaccines, Healive® and Havrix®. Four hundred children were randomly assigned to receive two doses of Healive® or Havrix® at 0 and 6 months. The current study assessed antibody persistence for both vaccines 15 years post-immunization. A mixed linear model was used to predict long-term antibody persistence. The GMCs were significantly higher for Healive® compared to Havrix® at 1, 6, 7, 66, 138 months (P < .001) and 186 months (P = .004 < .05) post-vaccination. Healive® and Havrix® reached a GMC of 164.8 mIU/ml and 105.7 mIU/ml post-15 years of vaccination, respectively. The seroconversion rates of both vaccines showed no statistically significant differences (97.9% for Healive® and 94.7% for Havrix®, P = .20). The prediction showed that Healive® would provide protection for a minimum of 30 years following immunization, with a lower limit of the 95% confidence intervals for GMCs greater than 20mIU/mL. Compared to Havrix®, the vaccine Healive® showed a stronger protective effect and better persistence among children at 15 years post-full immunization. Prediction indicated at least 30 years of antibody persistence for Healive® and at least 25 years for Havrix®.

100 Deals associated with Hepatitis A vaccine, inactivated(GlaxoSmithKline Plc)

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hepatitis A	United States	GlaxoSmithKline LLC	22 Feb 1995

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pneumonia, Pneumococcal	Phase 2	Poland	GSK Plc	03 Mar 2008
Diphtheria	Phase 2	United States	GSK Plc	11 Nov 2003
Tetanus	Phase 2	United States	GSK Plc	11 Nov 2003
Whooping Cough	Phase 2	United States	GSK Plc	11 Nov 2003
Chickenpox	Phase 2	United States	GSK Plc	06 Oct 2003
Measles	Phase 2	United States	GSK Plc	06 Oct 2003
Rubella	Phase 2	United States	GSK Plc	06 Oct 2003
Hepatitis A	Phase 1	-	GSK Plc	01 Feb 2015
Mumps	Discovery	United States	GSK Plc	06 Oct 2003
HIV Infections	Discovery	France	GSK Plc	01 Jun 2003

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00624819 (CTgov)	Phase 3	Pneumonia, Pneumococcal	524	GSK1024805A+Varilrix+Infanrix hexa+Havrix (Synflorix + Infanrix + Havrix and/or Varilrix Group)	zqcqlqznhg(sxbeazdvoo) = zxhgdcgojx bgujydqdyx (nbbegrzspm, dwmhrtcrbx - fucuhpdzrk) View more	-	18 Mar 2020
				Varilrix+Infanrix hexa+Havrix+Prevenar (Prevenar + Infanrix + Havrix and/or Varilrix Group)	zqcqlqznhg(sxbeazdvoo) = oysmlidxzn bgujydqdyx (nbbegrzspm, vydsoyggxx - fpvsgmnvzt) View more
NCT01282216 (CTgov)	Phase 2	Neoplasms	120	PCV13+Havrix	mefdcjyxrj(lfnwyyqssh) = dqrqceyxhr nwjcnsykcm (hirqotczcx, nnrauqzlqv - wkbswixvxf) View more	-	30 May 2019
NCT01681992 (CTgov)	Phase 3	Rubella \| Mumps \| Measles	4,538	Priorix+Varivax+Havrix+Prevnar 13 (Inv_MMR_Min Group)	afhfrlguhf(leqdopptyu) = lmjqzkvkpm poyrmenxfl (ygzzmgaefo, wdtefrioei - zuyfvqyqnb) View more	-	17 Aug 2018
				Priorix+Varivax+Havrix+Prevnar 13 (Inv_MMR_Med Group)	afhfrlguhf(leqdopptyu) = vlngsjpvsa poyrmenxfl (ygzzmgaefo, jlwixnpqtr - azaslcpgta) View more
NCT02184572 (CTgov)	Phase 3	Rubella \| Mumps \| Measles	1,742	Priorix+Varivax+Havrix+Prevnar 13 (INV_MMR)	kqptuspzlc(yidldenmse) = aileiikmvi yktzxhtrij (oxxxqpxdsy, txhlsxbpcj - llmwvknxvb)	-	03 Jul 2018
				Varivax+Havrix+Prevnar 13+M-M-R II (COM_MMR)	kqptuspzlc(yidldenmse) = dhurgzxlxt yktzxhtrij (oxxxqpxdsy, ltnmbojqjj - eapfnmkaht)
NCT01978093 (CTgov)	Phase 3	Meningitis \| Haemophilus Infections	600	Hib-MenCY-TT (MenHibrix®)+Rotarix®+Havrix®+Prevnar 13®+Pediarix® (HibCY Group)	nquxdovobo(rowuxhgubz) = kfkzvokxhi smmwtncgdd (itefmxleww, hxvncgdrol - vubhviibts) View more	-	26 Jun 2018
				Rotarix®+PedvaxHIB®+Havrix®+Prevnar 13®+Pediarix® (PedHIB Group)	nquxdovobo(rowuxhgubz) = twymithrft smmwtncgdd (itefmxleww, qulqqbigpf - qjdqsdmbij) View more
NCT02212457 (CTgov)	Phase 2	Meningococcal Infections	1,063	Saline Placebo+MenABCWY+Havrix (ABCWY_ 0_2 Group)	rkgnfkvthj(nrjrpzaetb) = pptxwugjlp ckhwuqkvjg (ptfotazrzd, rziwxhsgsk - qzzisnwwxn) View more	-	21 Jul 2017
				Bexsero+Saline Placebo+Havrix (rMenB_0_2 Group)	rkgnfkvthj(nrjrpzaetb) = ruotzntqxs ckhwuqkvjg (ptfotazrzd, rjkyrbpugy - bqxruoqvyx) View more
NCT01379937 (115115, CTgov)	Phase 3	Influenza, Human	520	Influenza vaccine GSK1562902A Formulation 2+Havrix™ Junior (GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group)	spiopdsoke(qxlusehfek) = bpmnuittmh bghpxqbfuh (maeguzrqoa, ibfidmmrif - vauunnwqmg) View more	-	26 Mar 2014
				Influenza vaccine GSK1562902A Formulation 2+Havrix™ Junior (GSK1562902A Formulation 2 - Havrix / Havrix Jr Group)	spiopdsoke(qxlusehfek) = nigmfyeoow bghpxqbfuh (maeguzrqoa, tovvnlfvic - bxfaklrlkj) View more
NCT00466947 (CTgov)	Phase 3	Acute otitis media \| Streptococcal Infections \| Community Acquired Pneumonia	23,802	Pneumococcal conjugate vaccine GSK1024850A+Infanrix hexa+Havrix (Synflorix Group)	lweqzrmcfy(oulfvgeglb) = teqcbhsysx hxchyzougu (bihkvotsgg, reudtkpbdi - cxsjshzzah) View more	-	04 Sep 2013
				Engerix-B+GSK Biologicals' DTPa-IPV/Hib vaccine+Havrix (Control Group)	lweqzrmcfy(oulfvgeglb) = vfsnaouzgv hxchyzougu (bihkvotsgg, afzwswuzhn - xmtsllwmmn) View more
NCT00861744 (CTgov)	Phase 2	Hepatitis A \| Rubella \| Mumps \| Measles \| Chickenpox	1,259	GSK Biological's investigational vaccine 209762+Varivax®+Havrix®+Prevnar® (Priorix 1 Group)	khtksuklgc(exxnjnvmzh) = gocdcxfpdc fzzbwrfwef (kifbowyvmj, bydeygqeep - pyuvwfsolx) View more	-	04 Nov 2011
				GSK Biological's investigational vaccine 209762+Varivax®+Havrix®+Prevnar® (Priorix 2 Group)	khtksuklgc(exxnjnvmzh) = hygttocrcj fzzbwrfwef (kifbowyvmj, gypqsnbtkr - xknlwkfgnb) View more
NCT00057330 (CTgov)	Phase 3	Herpes Genitalis	8,323	HSV vaccine or SB208141, GSK Biologicals' glycoprotein D (gD)-Alum/3-deacylated form of Monophosphoryl Lipid A (MPL) candidate genital herpes vaccine (Herpes Simplex Virus Group)	pikskjaivu(cguuyazgwi) = vkshtmwyen lcibukktov (vbrvjxbodm, vpsophffyw - nofuelirks) View more	-	03 Nov 2011
				Havrix™, GlaxoSmithKline (GSK) Biologicals' licensed Hepatitis A vaccine (Havrix Group)	pikskjaivu(cguuyazgwi) = tvnafhdxln lcibukktov (vbrvjxbodm, hfjqcphkul - sfebosjfmm) View more