Delving into the Latest Updates on Hib CRM197 vaccine conjugate(Pfizer) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine, Conjugated vaccine

Synonyms

HibTITER

+ [1]

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory DiseasesOther Diseases

Active Indication

Haemophilus InfectionsInfluenza B virus infectionTetanus

Inactive Indication-

Originator Organization

Pfizer Inc.

Active Organization

Wyeth Pharma GmbH

Inactive Organization

Mitsubishi Tanabe Pharma Corp.

License Organization-

Drug Highest PhaseApproved

First Approval Date

United Kingdom (01 Jan 1993),

Haemophilus InfectionsInfluenza B virus infectionTetanus

Regulation-

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A Phase 2, Multicenter, Randomized, Double-Blind, Immunogenicity, Reactogenicity, and Safety Study of NU300 Booster Dose Compared to ActHIB®, Both Co-administered With Prevnar 13® at 12-15 Months of Age, in Healthy Toddlers Who Have Received a Primary Series of a Licensed Hib Vaccine and Prevnar 13®

Evaluate the safety and tolerability of a single booster dose of NU300, co-administered with Prevnar 13® over a 28 day period following the injection compared to a single booster of ACTHIB co-administered with Prevnar 13® over a 28 day period following the injection.
Evaluate the immunogenicity, as determined by anti-PRP polysaccharide response, of a single booster dose of NU300 co-administered with Prevnar 13® compared to a single booster dose of ActHIB® co-administered with Prevnar 13®.
Evaluate the individual IgG antibody quantitative response to the 13 antigens in Prevnar 13® following NU300 co-administration with Prevnar 13® compared to the IgG antibody response to the pneumococcal polysaccharides following ActHIB® co-administration with Prevnar 13® 28 days following injection.

Start Date01 Mar 2013

Sponsor / Collaborator

Nuron Biotech, Inc.

100 Clinical Results associated with Hib CRM197 vaccine conjugate(Pfizer)

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100 Translational Medicine associated with Hib CRM197 vaccine conjugate(Pfizer)

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100 Patents (Medical) associated with Hib CRM197 vaccine conjugate(Pfizer)

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22

Literatures (Medical) associated with Hib CRM197 vaccine conjugate(Pfizer)

01 Nov 2024·International Journal of Risk & Safety in Medicine

Adverse outcome detection of childhood administered thimerosal-free HibTITER^®

Article

Author: Jablonowski, Karl ; Hooker, Brian

Background Haemophilus influenzae type b (HIB) is a gram-negative pathogenic bacterium that mostly impacts the pediatric and geriatric population, sometimes resulting in permanent sequelae or death. Objective In this study we set out to discover adverse outcomes from the thimerosal-free HibTITER® vaccine derived from a Florida Medicaid dataset spanning from January 2003 to June 2007 ( n = 277,484). Methods HIB vaccinated children were isolated from the Florida Medicaid dataset. Using other HIB vaccines as the control, we analyzed diagnoses for statistically significant adverse outcomes related to the HibTITER® vaccine (only the strictest p-value of <0.0001 was used in analyzing this dataset). We simultaneously and independently examined the statistical significance of symptoms reported to VAERS related to HIB vaccines to corroborate our findings ( p-value significance was reported at <0.05, <0.001, and <0.0001). Results The study revealed 19 individual ICD-9 codes positively associated ( p-value<0.0001 post Bonferroni correction) with recipients of the HibTITER® vaccine within 30-days of vaccination. Of these conditions, 14 have VAERS corroborators. The diseases span severity from mild to life-threatening and areas of respiration (e.g., asthma), gastrointestinal, otolaryngologic (e.g., common cold), dermatologic, generalized infections (e.g., tuberculosis), and other conditions. Conclusion Incidence of 19 different medical conditions was significantly higher compared to the control group who received other HIB vaccine formulations. These results were corroborated using the VAERS database, and have profound medical implications for the estimated 35 million Americans between the ages of 16 and 33 who received the vaccine.

01 May 2018·International Journal of Hygiene and Environmental HealthQ2 · MEDICINE

The risk of neurodevelopmental disorders following Thimerosal-containing Hib vaccine in comparison to Thimerosal-free Hib vaccine administered from 1995 to 1999 in the United States

Q2 · MEDICINE

Article

Author: Geier, David A ; Kern, Janet K ; Geier, Mark R ; Homme, Kristin G

Investigators postulated that early-life exposure to organic mercury (Hg) significantly increases the risk of childhood neurodevelopmental disorders (NDs). The Vaccine Adverse Event Reporting System database was utilized to conduct a hypothesis testing case-control study by evaluating 3486 total adverse event reports reported following Haemophilus influenza type b (Hib) vaccination. Exposed subjects received a Thimerosal-containing formulation (HIBTITER™, Wyeth-Lederle), while unexposed subjects received a Thimerosal-free formulation (PEDVAXHIB™, Merck). Subjects were included if they received either of these two Hib vaccine formulations between 1995 and 1999. Cases were defined as adverse event reports with a reported outcome of autism, developmental delay, psychomotor delay, or NDs in general. Cases with reported outcomes of febrile convulsions, pyrexia, or injection site pain, all of which have no biologically plausible relation to Hg exposure, were also examined. Controls were defined as adverse event reports without any mention of the specific case outcome examined. Cases of reported autism (odds ratio (OR) = 2.75, p < 0.02), developmental delay (OR = 5.39, p < 0.01), psychomotor disorder (OR = 2.38, p < 0.03), and neurodevelopmental disorder in general (OR = 2.70, p < 0.001) were each significantly more likely than their respective controls to receive Thimerosal-containing Hib vaccine than Thimerosal-free Hib vaccine. Significant effects for neurodevelopmental disorder in general were observed for males (OR = 2.52, p < 0.005), but not females when separated by gender. For the outcomes that had no biologically plausible relation to Hg exposure, the cases were no more likely than their respective controls to receive Thimerosal-containing Hib vaccine than Thimerosal-free Hib vaccine. This study provides suggestive evidence of an association between Thimerosal and neurodevelopmental outcomes and provides support for carrying out additional well-designed studies examining the association between Thimerosal-containing vaccines and a wide range of neurodevelopmental outcomes.

01 Dec 2005·VaccineQ3 · MEDICINE

Immunogenicity and effectiveness of Haemophilus influenzae type b conjugate vaccine in HIV infected and uninfected African children

Q3 · MEDICINE

Article

Author: Locadiah Kuwanda ; Rosalia Mothupi ; Keith P. Klugman ; Shabir A. Madhi ; Leena Saarinen ; Helena Käyhty ; Clare Cutland

The quantitative (anti-Hib capsular polysaccharide antibody concentrations; anti-HibPS) and qualitative (bactericidal activity and avidity) aspects in immune responses to Haemophilus influenzae type b polyribosyl ribitol phospshate-CRM(197) conjugate vaccine (HibCV; HibTiter) were evaluated in 66 HIV infected children not receiving anti-retroviral therapy and 127 HIV uninfected children. Surveillance was conducted for invasive Hib disease in a cohort of 39,865 (approximately 6.4% of whom were HIV infected) children from March 1998 to June 2004. HIV infected children had lower anti-HibPS geometric mean antibody concentrations 1 month post-immunisation than HIV uninfected children (P<0.00001) and were less likely to have anti-HibPS antibody concentrations of >or=1.0 microg/ml (RR 0.54; 95% CI 0.43-0.69). A lower proportion of HIV infected children than HIV uninfected children (RR 0.78; 95% CI 0.66-0.93) had measurable anti-Hib serum bactericidal activity (SBA) and the HibPS antibody concentration required for 50% killing of Hib bacteria was greater among HIV infected than HIV uninfected children (P=0.001). The estimated risk of HibCV failure was 35.1-fold greater (95% CI 14.6-84.6) amongst HIV infected than HIV uninfected children.

100 Deals associated with Hib CRM197 vaccine conjugate(Pfizer)

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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	Greece	Wyeth Pharma GmbH	01 Jan 1993
Haemophilus Infections	Italy	Wyeth Pharma GmbH	01 Jan 1993
Haemophilus Infections	Portugal	Wyeth Pharma GmbH	01 Jan 1993
Haemophilus Infections	Ireland	Wyeth Pharma GmbH	01 Jan 1993
Haemophilus Infections	Austria	Wyeth Pharma GmbH	01 Jan 1993
Haemophilus Infections	Finland	Wyeth Pharma GmbH	01 Jan 1993
Haemophilus Infections	Germany	Wyeth Pharma GmbH	01 Jan 1993
Haemophilus Infections	France	Wyeth Pharma GmbH	01 Jan 1993
Haemophilus Infections	Spain	Wyeth Pharma GmbH	01 Jan 1993
Tetanus	Denmark	Wyeth Pharma GmbH	01 Jan 1993
Tetanus	Italy	Wyeth Pharma GmbH	01 Jan 1993
Tetanus	Finland	Wyeth Pharma GmbH	01 Jan 1993
Tetanus	Ireland	Wyeth Pharma GmbH	01 Jan 1993
Tetanus	Austria	Wyeth Pharma GmbH	01 Jan 1993
Tetanus	Portugal	Wyeth Pharma GmbH	01 Jan 1993
Tetanus	United Kingdom	Wyeth Pharma GmbH	01 Jan 1993
Tetanus	Spain	Wyeth Pharma GmbH	01 Jan 1993
Tetanus	Germany	Wyeth Pharma GmbH	01 Jan 1993
Tetanus	France	Wyeth Pharma GmbH	01 Jan 1993
Tetanus	Greece	Wyeth Pharma GmbH	01 Jan 1993

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Haemophilus Infections	Phase 3	Japan	Mitsubishi Tanabe Pharma Corp.	01 Apr 2014

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02140047 (CTgov)	Phase 2	Haemophilus Infections	154	Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate+DPT-IPV (MT-2301-Low)	dssjbvcpjv(rckpdpxxot) = jophrsjmti udehbiosjo (ogzzirbzyr, ldfttznlxx - idmjjmtydy) View more	-	19 Sep 2024
				Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate+DPT-IPV (MT-2301-High)	dssjbvcpjv(rckpdpxxot) = tjpinzmlog udehbiosjo (ogzzirbzyr, juvxptxdaj - ctngxouxlo) View more