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 PasteurSanofi KK

Inactive 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

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

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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157

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

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

OBJECTIVE:

This 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.

METHODS:

This 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.

RESULTS:

In 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.

CONCLUSION:

A 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).

01 Dec 2021·BMC medicineQ1 · MEDICINE

National and provincial impact and cost-effectiveness of Haemophilus influenzae type b conjugate vaccine in China: a modeling analysis

Q1 · MEDICINE

ArticleOA

Author: Lai, Xiaozhen ; Qin, Ying ; Yu, Wenzhou ; Zhang, Haijun ; Xu, Tingting ; Jing, Rize ; Fang, Hai ; Yin, Zundong ; Knoll, Maria Deloria ; Garcia, Cristina ; Wahl, Brian

Abstract:

Background:

Globally,Haemophilus influenzaetype b (Hib) vaccine has substantially reduced the burden of Hib invasive disease. However, China remains the only country not to include Hib vaccine into its national immunization program (NIP), although it accounts for 11% of global Hib deaths. We aimed to assess the cost-effectiveness of including Hib vaccine in China’s NIP at the national and provincial levels.

Methods:

Using a decision-tree Markov state transition model, we estimated the cost-effectiveness of Hib vaccine in the NIP compared to thestatus quoof Hib vaccine in the private market for the 2017 birth cohort. Treatment costs and vaccine program costs were calculated from Chinese Center for Disease Control and Prevention (CDC) and national insurance databases. Epidemiological data and other model parameters were obtained from published literature. Cases and deaths averted, quality-adjusted life years (QALYs) gained, and incremental cost-effectiveness ratios (ICER) were predicted by province. Deterministic and probabilistic sensitivity analyses were performed to explore model uncertainty.

Results:

Including Hib vaccine in the NIP was projected to prevent approximately 2700 deaths (93% reduction) and 235,700 cases of Hib disease (92% reduction) for the 2017 birth cohort at the national level. Hib vaccine was cost-effective nationally (US$ 8001 per QALY gained) compared to the GDP per capita and cost-effective in 15 of 31 provinces. One-way and scenario sensitivity analyses indicated results were robust when varying model parameters, and in probabilistic sensitivity analysis, Hib vaccine had a 64% probability of being cost-effective nationally.

Conclusion:

Introducing Hib vaccine in China’s NIP is cost-effective nationally and in many provinces. Less socioeconomically developed provinces with high Hib disease burden and low access to Hib vaccine in the current private market, such as those in the west region, would benefit the most from adding Hib vaccine to the NIP. In the absence of a national policy decision on Hib vaccine, this analysis provides evidence for provincial governments to include Hib vaccine into local immunization programs to substantially reduce disease burden and treatment costs.

01 Nov 2021·Journal of chromatography. B, Analytical technologies in the biomedical and life sciencesQ3 · MEDICINE

A reversed phase HPLC-UV method for the simultaneous determination of residual formaldehyde and Triton X-100 in vaccine products

Q3 · MEDICINE

Article

Author: Kumar Gambheerrao, Sampreeth ; V N Janardhan Reddy, M ; Rajendar, Burki ; N V Suresh, Ch ; Matur, Ramesh V

Many of the inactivated viral vaccines for human and animal use are manufactured using formaldehyde as an inactivating agent. Apart from formaldehyde, Triton X-100 is also one of the chemicals commonly used in viral vaccine manufacturing. Triton X-100 is typically used to extract the cell-associated viruses and / or components during manufacturing process. The concentration of formaldehyde and Triton X-100 in the final bulks are also reduced during vaccine purification process. Here we report a simple RP-HPLC-UV based method for the quantification of residual Triton X-100 and formaldehyde as process impurities in viral vaccines. This method is also adopted for the residual impurity determination of either formaldehyde or Triton X-100 in other non-viral vaccines, multivalent as well as sub-unit vaccines, such as liquid pentavalent, includes TT, DT, Hepatitis B (rDNA) and Haemophilus type b conjugate vaccine (adsorbed). This method is rapid and can quantify both Triton X-100 and formaldehyde in a single preparation with improved peak asymmetry. This new assay has a linearity range starting from 0.0625 to 1 µg/mL for formaldehyde and 0.625-10 µg/mL for Triton X-100. This method would be very useful for viral vaccine manufacturing and release.

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	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	04 Oct 2018
Meningococcal Infections	Phase 3	Puerto Rico	Sanofi Pasteur	04 Oct 2018
Diphtheria	Phase 3	United States	Sanofi Pasteur	01 Nov 2005
Poliomyelitis	Phase 3	United States	Sanofi Pasteur	01 Nov 2005
Whooping Cough	Phase 3	United States	Sanofi Pasteur	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


NCT03691610 (CTgov)	Phase 3	Meningococcal Infections	950	MenACYW conjugate vaccine (Infants: Group 1)	deeamsdhwj = wqcynjqccc ejthhyfxwx (fyxsdqoalh, pghiixgroh - qyodldbhox) View more	-	25 Jun 2024
				MENVEO (Infants: Group 2)	deeamsdhwj = nmfszqrcjs ejthhyfxwx (fyxsdqoalh, oubydepvbn - cpslyvhnma) View more
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))	ansrubhfka = gkfmymuvtn ogmoqxnwoo (rlzfzghfje, btlvzkuqsu - zcoxpmhdsz) 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))	odsbfpgqrb = knfmlxnpxc vppxlvbwnb (pjmswkblyv, gkvkiqyiks - trkyjitjko) View more
NCT00255047 (CTgov)	Phase 3	Diphtheria \| Whooping Cough \| Poliomyelitis	2,167	Pentacel+DTaP-IPV+Hib (Study Group 2: Pentacel®)	sxzgmtteqi = pvagjdhlyb mdnuwwertv (pfzoyhrrlj, klsaxfiiid - ajiffqcqhr) View more	-	10 Nov 2010
				DTaP-IPV (Study Group 3: DTaP-IPV and ActHIB®)	sxzgmtteqi = rlselupmel mdnuwwertv (pfzoyhrrlj, jwejonbtai - ujdsbopczi) View more