Delving into the Latest Updates on Haemophilus b conjugate vaccine(Sanofi) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine, Toxoid vaccine, Conjugated vaccine

Synonyms

Haemophilus influenzae type b conjugate vaccine, Haemophilus influenzae type b conjugate vaccine (Sanofi), Haemophilus type b conjugate vaccine

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Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious Diseases

Active Indication

Haemophilus InfectionsMeningococcal Infections

Inactive Indication

DiphtheriaPoliomyelitisWhooping Cough

Originator Organization

Sanofi

Active Organization

Sanofi Pasteur SASanofi KK

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (04 Feb 2000),

Haemophilus Infections

Regulation-

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Primary Objective:
To describe the vaccine seroprotection (antibody titer greater than or equal to [>=] 1:8) to the antigens (meningococcal serogroups A, C, Y, and W) present in MenACYW Conjugate vaccine or Menveo® measured by serum bactericidal assay using human complement (hSBA), for Groups 1 and 2 when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in Mexico.
To describe the vaccine seroprotection (antibody titer >=1:8) to the antigens (meningococcal serogroups A, C, Y, and W) present in MenACYW Conjugate vaccine measured by hSBA, for Group 3, when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in the Russian Federation.
Secondary Objective:
To describe hSBA vaccine seroresponse to the antigens (meningococcal serogroups A, C, Y, and W) 30 days after the last vaccination of the infant series, when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in Mexico and Russian Federation (RF).
To describe immunogenicity profile of routine pediatric vaccines when administered concomitantly with MenACYW Conjugate vaccine or Menveo®; or when administered alone.
To describe hSBA antibody responses against meningococcal serogroups A, C, Y, and W when MenACYW Conjugate vaccine and Menveo® are administered concomitantly with routine pediatric vaccines in Mexico and RF.
To describe antibody titers to the antigens present in MenACYW Conjugate vaccine and Menveo®, before the first vaccination and 30 days after the last vaccination of the infant series and in the second year of life, when administered concomitantly with routine pediatric vaccines in a subset of participants in Mexico and RF.

Start Date17 Oct 2018

Sponsor / Collaborator

Sanofi Pasteur SA

NCT03691610

/ CompletedPhase 3

Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

The primary objective of this study is to demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with routine pediatric vaccines to infants and toddlers 6 to 7 months of age and 12 to 13 months of age.
The secondary objectives of the study are:
* To demonstrate the non-inferiority of the percentage of participants with antibody titers to meningococcal serogroups A, C, Y, and W ≥ 1:8 following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with pediatric routine vaccines to infants and toddlers at 6 to 7 months of age and 12 to 13 months of age.
* To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 12 to 13 months of age with MenACYW conjugate vaccine or MENVEO®.
* To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days and 6 months after the first vaccination at 6 to 7 months of age with MenACYW conjugate vaccine or MENVEO®.
* To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 20 to 23 months of age with MenACYW conjugate vaccine or Menactra®.

Start Date04 Oct 2018

Sponsor / Collaborator

Sanofi Pasteur SA

NCT01578070

/ CompletedPhase 1/2

A Single-centre Study Evaluating the Safety of ViscoGel® and Its Safety and Efficacy as an Adjuvant in Act-HIB® Vaccine Administered by Intramuscular Injection to Healthy Volunteers in a Single-blind Randomised, Parallel-group Design

The purpose of this study is to show that ViscoGel® is safe when administrated alone and as an adjuvant together with Act-HIB® vaccine in healthy volunteers and to evaluate the quantitative and qualitative effect on the immune response.

Start Date01 Mar 2012

Sponsor / Collaborator

Viscogel AB

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100 Clinical Results associated with Haemophilus b conjugate vaccine(Sanofi)

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100 Translational Medicine associated with Haemophilus b conjugate vaccine(Sanofi)

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100 Patents (Medical) associated with Haemophilus b conjugate vaccine(Sanofi)

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274

Literatures (Medical) associated with Haemophilus b conjugate vaccine(Sanofi)

10 Nov 2024·Cureus

Managing Epiglottitis in Adults: A Comprehensive Case Study

Article

Author: Anasi, Ayman ; Mayer, Brian ; Ahmed, Imtiaz ; Sadeghi, Nima ; McDermott, Jamie

Epiglottitis is an inflammatory condition involving the epiglottis and surrounding tissues. While it can develop at any age, it was traditionally more common in children, largely due to infections with Haemophilus influenzae type B (Hib). Since the introduction of the Hib vaccine, the incidence in children has significantly decreased, while cases in adults have become more prevalent. We present here the case of a 44-year-old male who presented to the emergency department with a one-day history of throat pain. He reported throat discomfort and pain exacerbated by swallowing and phonation that began one day prior after taking a dose of azithromycin. X-ray and CT imaging revealed inflammation and swelling of the epiglottis (thumbprint sign) with near-complete airway obstruction. Despite the absence of severe respiratory distress, the patient was intubated, differing from recommendations in previous studies. This case emphasizes the importance of developing standardized treatment protocols for acute epiglottitis in adults, particularly regarding airway management and minimizing unnecessary imaging.

01 Aug 2024·Infectious Disorders - Drug Targets

Efficacy and Prolonged Safety of Haemophilus influenzae Type b Conjugate Vaccines

Review

Author: Mukherjee, Sayali ; Tripathi, Nishita

Objective::The purpose of this study was to find data proving the influence of the Haemophilus influenzae type b (Hib) conjugate vaccination on the frequency of invasive Hib illness.Methodology::A systematic literature search was conducted on the PubMed database to identify peerreviewed publications pertaining to the epidemiology of Haemophilus influenzae meningitis, both before and after the introduction of Haemophilus influenzae type b (Hib) conjugate vaccines. The search query employed a combination of relevant keywords, including "invasive," "Haemophilus," "influenzae," "meningitis," and specific serotype b (Hib). Additionally, terms related to epidemiology, burden, risk factors, impact, Hib vaccine, Hib conjugate vaccine, combination vaccine, vaccine production, efficacy, immunisation coverage, surveillance, review, clinical aspects, outcomes, and various age groups (adults and children) were incorporated.Result::The search encompassed articles published till now. Subsequently, relevant research papers concerning Haemophilus influenzae meningitis were subjected to a comprehensive review and analysis.Conclusion::The Hib conjugate vaccination has shown to be extremely effective when administered to the entire population. However, changes to the immunisation protocol appear to be required in order to effectively manage invasive Hib illness.

01 Apr 2024·Vaccine

Immunogenicity and safety of adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain)-Haemophilus type b conjugate combined vaccine (DPT-IPV-Hib) in healthy Japanese Infants ≥ 2 and < 43 months of Age: A phase III, multicenter, active controlled, assessor-blinded, randomized, parallel-group study

Article

Author: Matsuda, Keiko ; Hasegawa, Masumi ; Tamai, Hoshio ; Nakano, Takashi ; Endo, Mai

OBJECTIVEThis study investigated the immunogenicity and safety of a pentavalent vaccine Gobik (DPT-IPV-Haemophilus influenzae type b [Hib]) in healthy Japanese infants aged ≥ 2 and < 43 months using a concomitant vaccination with ActHIB® (Hib) and Tetrabik (DPT-IPV) as a comparator.METHODSThis study was conducted as a phase 3, multicenter, active controlled, assessor-blinded, randomized, parallel-group study. Participants received a total of 4 subcutaneous doses (3 primary immunization doses and a booster dose) of either the experimental drug (DPT-IPV-Hib) or the active comparator (Hib + DPT-IPV). The primary endpoints were the anti-PRP antibody prevalence rate with ≥ 1 μg/mL, and the antibody prevalence rates against pertussis, diphtheria toxin, tetanus toxin, and attenuated poliovirus after the primary immunization.RESULTSIn 267 randomized participants (133 in the DPT-IPV-Hib group and 134 in the Hib + DPT-IPV group), the antibody prevalence rates after the primary immunization in both groups were 100.0 % and 88.7 % for anti-PRP antibody with ≥ 1 μg/mL, 99.2 % and 98.5 % against diphtheria toxin, and 100.0 % and 99.2 % against tetanus toxin, respectively. The antibody prevalence rates against pertussis and attenuated poliovirus were 100.0 % in both groups. The non-inferiority of the DPT-IPV-Hib group to the Hib + DPT-IPV group was verified for all measured antibodies. In both groups, all the GMTs of antibodies after the primary immunization were higher than those before the first dose, and those after the booster dose were higher than those after the primary immunization. No safety issues were identified.CONCLUSIONA single-agent Gobik, the first DPT-IPV-Hib pentavalent vaccine approved in Japan, was confirmed to simultaneously provide primary and booster immunizations against Hib infection, pertussis, diphtheria, tetanus, and poliomyelitis and to have a preventive effect and safety comparable to concomitant vaccination with Hib (ActHIB®) and DPT-IPV quadrivalent vaccine (Tetrabik).

100 Deals associated with Haemophilus b conjugate vaccine(Sanofi)

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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
Haemophilus Infections	United States	Sanofi Pasteur SA	04 Feb 2000

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Meningococcal Infections	Phase 3	United States	Sanofi Pasteur SA	04 Oct 2018
Meningococcal Infections	Phase 3	Puerto Rico	Sanofi Pasteur SA	04 Oct 2018
Diphtheria	Discovery	United States	Sanofi Pasteur SA	01 Nov 2005
Poliomyelitis	Discovery	United States	Sanofi Pasteur SA	01 Nov 2005
Whooping Cough	Discovery	United States	Sanofi Pasteur SA	01 Nov 2005

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03630705 (MET33, CTgov)	Phase 3	Meningococcal Infections	525	Rubella Virus Vaccine Live+W) Tetanus Toxoid Conjugate Vaccine+Pneumococcal 13-valent Conjugate Vaccine+Rotavirus Vaccine, Live, Pentavalent (Group 1: MenACYW Conjugate Vaccine (Mexico))	vinvrnpaxj(drfcyzybjt) = zrsynmgchv dhnsuhetsj (kwstjaooab, cztrlayciy - usbqlbfonu) View more	-	19 Oct 2023
				Rubella Virus Vaccine Live+W) Tetanus Toxoid Conjugate Vaccine+Hepatitis B Vaccine+Haemophilus influenza type b Conjugate Vaccine+Pneumococcal 13-valent Conjugate Vaccine (Group 3: MenACYW Conjugate Vaccine (Russian Federation))	tgdcokmeff(yeaanytsjc) = rwsnkyxilw ceghxzrkyx (spaehwysox, kndpbqfgio - smmrhatlpb) View more
NCT01411241 (CTgov)	Phase 3	Severe Dengue	720	Pneumococcal vaccine+4 virus+Hib vaccine+DTaP IPV/ (CYD Dengue Vaccine Group 1)	wspkdtazau(yxluaaukho) = kcdphlrdpj yhewayhdyc (gyzwnxrlim, wqsnkbxeyh - qjxnnqvjip) View more	-	29 Jul 2019
				Pneumococcal vaccine+4 virus+Hib vaccine+DTaP IPV/ (CYD Dengue Vaccine Group 2)	wspkdtazau(yxluaaukho) = mmahkqrdfw yhewayhdyc (gyzwnxrlim, gjmiazcfly - foxohyyrjw) View more
NCT00129129 (CTgov)	Phase 2	Meningitis \| Haemophilus Infections	756	GSK Biologicals' Haemophilus influenza type b+Prevnar+Pediarix (MenHibrix Group)	kmkneubuxq(xlbypqvprr) = rnqpetyiwc mbppymebnj (ydesmsuawi, rcqcmkhhlz - wanbmxuzjc) View more	-	30 Dec 2013
				ActHIB+Prevnar+Pediarix (ActHIB Group)	kmkneubuxq(xlbypqvprr) = wpilsyrejz mbppymebnj (ydesmsuawi, cfjldcabhe - elclemcoou) View more
NCT00359983 (CTgov)	Phase 3	Meningitis \| Haemophilus Infections	270	MenHibrix (Hib-MenCY-TT) (MenHibrix 4-dose Group)	mbhbnijwkt(lcebkmfvte) = pykwjkpbpg ysxtkgoemr (ulpcuvhbuu, bwfqvkuzwl - zqxgdvjdhc) View more	-	20 Jul 2012
				Hib conjugate vaccine (ActHIB) (ActHIB 4-dose Group)	mbhbnijwkt(lcebkmfvte) = bkavblbnuz ysxtkgoemr (ulpcuvhbuu, khjmxlknvz - qrqmzuklog) View more
NCT00197236 (CTgov)	Phase 3	Hepatitis A \| Diphtheria \| Whooping Cough \| Tetanus	468	Havrix™ (Havrix Group)	ddznwbgadt(rspwjxzrhh) = akquhiqgnm qayyiwhfvc (jawagfmykd, efoywpoarp - yxfwephirh) View more	-	24 Jul 2009
				ActHIB™+Infanrix™+Havrix™ (Havrix + Infanrix + ActHIB Group)	ddznwbgadt(rspwjxzrhh) = rltupobqmt qayyiwhfvc (jawagfmykd, ivbafjaiwa - wnziqcmbxs) View more