Last update 21 Nov 2024

diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and Haemophilus influenzae type b conjugate vaccine, adjuvanted

Last update 21 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Combination vaccine, Prophylactic vaccine, Conjugated vaccine

Synonyms

DTaP2-HepB-Polio-Hib, Hib-DTaP-hepatitis B-poliovirus vaccine, diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and Haemophilus influenzae type b conjugate vaccine, adjuvanted

+ [3]

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesNervous System DiseasesDigestive System Disorders+ [2]

Active Indication-

Inactive Indication

DiphtheriaHaemophilus InfectionsHepatitis B+ [3]

Originator Organization

Sanofi Pasteur MSD AB

Active Organization-

Inactive Organization

Sanofi Pasteur MSD SNC

Drug Highest PhaseWithdrawn

First Approval Date

EU (23 Oct 2000),

DiphtheriaHaemophilus InfectionsHepatitis B+ [3]

Regulation-

Clinical Trials associated with diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and Haemophilus influenzae type b conjugate vaccine, adjuvanted

EUCTR2007-005168-29-IT / Not yet recruitingNot Applicable

An Open-label, randomised, controlled, multi-centre study of the immunogenicity and safety of a booster dose of two different Hepatitis B vaccines to explore the anamnestic immune response in healthy 4 to 7 year-old children previously vaccinated at about 3, 5 and 11 to 13 months of age with either HEXAVAC or INFANRIX-HEXA - ND

Start Date13 Aug 2008

Sponsor / Collaborator

Sanofi Pasteur MSD SNC

EUCTR2005-002578-31-SK / Unknown statusPhase 3

A controlled, double-blind and randomized study, to compare the immunogenicity and safety of HEXAVAC manufactured by an upgraded process to HEXAVAC manufactured by the current process when given to healthy infants at 2, 4 & 6 months of age followed by a booster dose at 12 months of age

Start Date14 Sep 2005

Sponsor / Collaborator

Sanofi Pasteur MSD SNC

EUCTR2005-002578-31-CZ / Not yet recruitingPhase 3

Start Date05 Sep 2005

Sponsor / Collaborator

Sanofi Pasteur MSD SNC

100 Clinical Results associated with diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and Haemophilus influenzae type b conjugate vaccine, adjuvanted

100 Translational Medicine associated with diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and Haemophilus influenzae type b conjugate vaccine, adjuvanted

100 Patents (Medical) associated with diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and Haemophilus influenzae type b conjugate vaccine, adjuvanted

Literatures (Medical) associated with diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and Haemophilus influenzae type b conjugate vaccine, adjuvanted

31 Dec 2024·Human Vaccines & Immunotherapeutics

A phase 4, open-label study to evaluate the safety and immunogenicity of DTaP5-HBV-IPV-Hib in children previously vaccinated with DTaP2-HBV-IPV-Hib or DTaP5-HBV-IPV-Hib (V419-016)

Article

Author: Lumley, Jessie ; Chen, Ziqiang ; Costantino, Claudio ; Johnson, David ; Westerholt, Soeren ; Martinon-Torres, Federico ; Lambeth, Courtney ; Guerra, Andrea ; Marcek, Tomas ; Wilck, Marissa

DTaP5-HBV-IPV-Hib (Vaxelis®) is a hexavalent combination vaccine (HV) indicated in infants and toddlers for the prevention of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and invasive disease due to Haemophilus influenzae type b. Switching between HVs during the childhood vaccination series is sometimes necessary due to, for example, vaccine availability, health-care provider preference, and/or tender awards. The purpose of this study was to describe the safety, tolerability, and immunogenicity of a booster dose of Vaxelis® in participants who previously received a primary infant series of either DTaP2-HBV-IPV-Hib (Hexyon®) or Vaxelis®. Healthy participants approximately 11-13 months of age who previously received a two-dose primary series of Hexyon® (HHV group) or Vaxelis® (VVV group) all received a Vaxelis® booster dose. Immunogenicity was evaluated by measuring antibody levels to individual vaccine antigens approximately 30 days following booster vaccination. Safety was evaluated as the proportion of participants with adverse events (AEs). The proportions of participants with antibody-specific responses for antigens contained in both Vaxelis® and Hexyon® at 30 days post-toddler-booster vaccination with Vaxelis® were comparable between groups, and higher in the VVV group for Vaxelis® antigens PRN and FIM2/3. The overall proportions of participants with AEs were generally comparable between groups. Following a booster dose of Vaxelis®, immune responses were comparable between groups for all shared antigens, and higher in the VVV group for antigens found only in Vaxelis®. The booster was well tolerated in both groups. These data support the use of Vaxelis® as a booster in mixed HV regimens.

01 Jan 2023·Journal of Medical Virology

Cost‐minimization analysis of DTaP‐IPV‐Hib combination vaccine in China: A nationwide cross‐sectional study

Article

Author: Cao, Bing ; Miao, Yudong ; Wang, Chao ; Liu, Bei ; Zhao, Tianshuo ; Sun, Tao ; Zhang, Sihui ; Cui, Fuqiang

AbstractCombination vaccines can reduce the vaccination visit, simplify the vaccination schedule and efficiently improve management. This study was primarily designed to evaluate the economic impact of integrating the diphtheria‐tetanus‐acellular pertussis inactivated poliomyelitis and Haemophilus influenzae type B (DTaP‐IPV‐Hib) combination vaccine into the China National Immunization Program. A cost‐minimization analysis (CMA) compared the costs associated with direct medical, direct nonmedical, and indirect social costs in four schemes was conducted. A budgetary impact analysis assessed the alternative schemes' financial impact on the healthcare budget. Direct medical costs were extracted using a costing questionnaire and an observational time and motion chart. Direct nonmedical (cost for transportation) and indirect costs (loss of productivity) were derived from parents' questionnaires. Replacement of the current vaccination scheme with DTaP‐IPV‐Hib combination vaccine, resulted in net increases in direct medical costs of 77.64% for alternative scheme 1, 146.54% for alternative scheme 2, and 294.67% for alternative scheme 3, respectively. However, the direct nonmedical and indirect costs and the cost of the alternative schemes were 18.18%, 36.36%, and 63.64% lower than the current scheme for alternative scheme 1, alternative scheme 2, and alternative scheme 3, respectively. From the societal perspective, when compared with the current scheme, the budgetary impact of the three alternative schemes were +66 million Chinese Yuan (CNY) (4.81%), +103 million CNY (7.53%), and +305million CNY (22.35%), respectively. The CMA considered a broader perspective of social costs and indicated that the alternative schemes would result in an overall saving of parents' transportation and work loss costs to bring their children for vaccination, translating into a total cost saving of 18.18%, 36.36%, 63.64%, comparing to the current scheme. Thus, fully or partly using the DTaP‐IPV‐Hib combination vaccine is cost‐saving in the context of China.

01 May 2021·Journal of Separation ScienceQ3 · CHEMISTRY

Isolation of saturated alkylresorcinols from rye grains by countercurrent chromatography

Q3 · CHEMISTRY

Article

Author: Hammerschick, Tim ; Wagner, Tim ; Vetter, Walter

AbstractAlkylresorcinols (5‐alkyl‐1,3‐dihydroxybenzenes) are amphiphilic phenolic lipid compounds that are abundant in cereals with highest contents in rye. Alkylresorcinols are suspected to show a wide range of favourable biological activities. For such and further testing, highly pure alkylresorcinol standards are required. Especially, purities >> 98% were partly difficult to obtain in the past. Here, we aimed to isolate the most abundant (saturated) alkylresorcinols from rye using countercurrent chromatography. To achieve very high purity, alkylresorcinol‐containing extract (∼7.14 g) of rye grains (cold extracts with cyclohexane/ethyl acetate (46/54, w/w)) were preparatively transesterified followed by a preparative hydrogenation. Countercurrent chromatography separation of ∼1 g hydrogenated and transesterified rye grain extract using the solvent system n‐hexane–ethyl acetate–methanol–water (9:1:9:1, v/v/v/v) yielded 51.8 mg AR17:0, 77.4 mg AR19:0, 57.2 mg AR21:0, 28.8 mg AR23:0 and 11.5 mg AR25:0 with purities >99% in either case. The isolated alkylresorcinol homologues can be used for subsequent bioassays.

100 Deals associated with diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and Haemophilus influenzae type b conjugate vaccine, adjuvanted

External Link

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