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.

Drug Highest PhaseApproved

First Approval Date

Germany (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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21

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

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.

01 Feb 2005·VaccineQ3 · MEDICINE

Double-blind study comparing the immunogenicity of a licensed DTwPHib-CRM197 conjugate vaccine (Quattvaxem™) with three investigational, liquid formulations using lower doses of Hib-CRM197 conjugate

Q3 · MEDICINE

Article

Author: Pantaleo Nacci ; Alessandra Veronese ; Eda Tamm ; Sirli Meriste ; Simonetta Viviani ; Mario Contorni

We performed a double-blind clinical study to evaluate the safety and immunogenicity of four formulations of a DTwPHib full liquid vaccine, three of which contained fractional doses of the 10 microg-dose of CRM197-Hib conjugate vaccine. A total of 261 infants were enrolled and randomised to receive at 3, 4 and 5 months of age, in a double-blind fashion, one of the four DTwPHib vaccine formulations containing 10, 5, 2.5 or 1.25 microg of CRM197-Hib conjugate. Post-immunization reactions were similar in the four vaccine groups, they were mild, transient and resolved without sequelae. The seroconversion rates to anti-PRP titres > or = 0.15 microg/mL were 100%, 98%, 97% and 98% in the groups 10, 5, 2.5 and 1.25 microg, respectively. The seroconversion rates to anti-PRP titres > or =1 microg/mL were 95%, 97%, 88% and 90%, again respectively. Anti-PRP GMTs were 18, 17, 7.82 and 6.94 microg/mL, respectively. All subjects were protected against tetanus and diphtheria, and >80% seroconverted to pertussis. High, and similar, levels of anti-PRP GMTs were elicited by the formulations with 10 and 5 microg of CRM197-Hib conjugate. Although the formulations with 2.5 and 1.25 microg of CRM197-Hib elicited lower levels of anti-PRP GMTs, they were immunogenic and are possible candidates for further development.

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	Germany	Wyeth Pharma GmbH	01 Jan 1993
Influenza B virus infection	Germany	Wyeth Pharma GmbH	01 Jan 1993
Tetanus	Germany	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 1	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)	rukqtuoajw(fpvefcucgv) = uzocvuodmd iwvontzgyd (rcnbkhqggr, xacprxmwup - vzrznyiqlm) View more	-	19 Sep 2024
				Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate+DPT-IPV (MT-2301-High)	rukqtuoajw(fpvefcucgv) = hqniezhngx iwvontzgyd (rcnbkhqggr, gneaokyliw - eblsamayfm) View more