Delving into the Latest Updates on Diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed(GlaxoSmithKline Plc) with Synapse

Hypoxia/bradycardia are common symptoms after vaccination of preterm infants. Adults show diurnal variations in vaccination response, due to circadian regulation of the immune system. The investigators plan to investigate whether preterm infants also show differences in hypoxia/bradycardia rate upon morning vs. evening vaccination.
Hypoxia/bradycardia is recorded by pulse oximetry starting 24 hours before until 48 hours after vaccination; parents also kept a sleep-diary. 24 hours after vaccination interleukin-6, interleukin-1β and C-reactive protein get determined. To control vaccination response, pertussis- and haemophilus-titers are determined before vaccination and at 4 months corrected age.

Start Date01 Mar 2015

Sponsor / Collaborator

University Hospital Tübingen

NCT02447978 / CompletedNot Applicable

Duration of Protection Following Five Doses of GlaxoSmithKline's (GSK's) DTaP Vaccines in School Age Children

The purpose of this study is to assess duration of protection for GSK DTaP vaccines in preventing pertussis.

Start Date01 Feb 2015

Sponsor / Collaborator

GSK Plc

NCT02096263 / CompletedPhase 3

Immunogenicity and Safety Study of GSK Biologicals' Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants

The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' Infanrix hexa vaccine when administered to healthy infants as primary vaccination at 2, 4 and 6 months of age, co-administered with Prevnar and Rotarix with a booster dose of GSK Biologicals' Infanrix and Hiberix vaccines at 15-18 months of age.

Start Date16 Apr 2014

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with Diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed(GlaxoSmithKline Plc)

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100 Translational Medicine associated with Diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed(GlaxoSmithKline Plc)

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100 Patents (Medical) associated with Diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed(GlaxoSmithKline Plc)

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50

Literatures (Medical) associated with Diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed(GlaxoSmithKline Plc)

01 Jan 2020·VaccineQ3 · MEDICINE

Blistering post 4-year old Infanrix® IPV

Q3 · MEDICINE

Article

Author: Crawford, Nigel W ; Harris, Adele ; Lazzaro, Teresa

01 Feb 2019·Human Vaccines & ImmunotherapeuticsQ3 · MEDICINE

Safety and immunogenicity of VAQTA® in children 12-to-23 months of age with and without administration of other US pediatric vaccines

Q3 · MEDICINE

Article

Author: Goveia, Michelle G. ; Kuter, Barbara J. ; Schödel, Florian P. ; Stek, Jon E. ; Acosta, Camilo J. ; Klopfer, Stephanie O. ; Petrecz, Maria ; Lee, Andrew W.

Safety and immunogenicity data from 5 clinical trials conducted in the US in children 12-to-23 months old where HAVi was administered alone or concomitantly with other pediatric vaccines (M-M-R®II, Varivax®, TRIPEDIA®, Prevnar®, ProQuad®, PedvaxHIB®, and INFANRIX®) were combined. Among 4,374 participants receiving ≥ 1 dose of HAVi, 4,222 (97%) had safety follow-up and the proportions reporting adverse events (AE) were comparable when administered alone (69.4%) or concomitantly with other pediatric vaccines (71.1%). The most common solicited injection-site AEs were pain/tenderness (Postdose 1: 25.8%; Postdose 2: 26.1%) and redness (Postdose 1: 13.6%; Postdose 2: 15.1%). The most common vaccine-related systemic AEs were fever (≥ 100.4ºF, 12.2%) and irritability (8.1%). Serious AEs (SAEs) were observed at a rate of 0.4%; 0.1% were considered vaccine-related. No deaths were reported within 14 days following a dose of HAVi. These integrated analyses also showed that protective antibody concentrations were elicited in 100% of toddlers after two doses and 92% after a single dose, regardless of whether HAVi was given concomitantly with other vaccines or alone. These results demonstrate that HAVi was well-tolerated whether given alone or concomitantly with other vaccines, with a low incidence of vaccine-related SAEs. HAVi was immunogenic in this age group regardless of whether administered with or without other pediatric vaccines and whether 1 or 2 doses were administered. HAVi did not impact the immune response to other vaccines. These data continue to support the routine use of HAVi with other pediatric vaccines in children ≥ 12 months of age.

01 Feb 2017·Pediatric DrugsQ4 · MEDICINE

DTaP5-HB-IPV-Hib Vaccine (Vaxelis®): A Review of its Use in Primary and Booster Vaccination

Q4 · MEDICINE

Review

Author: Syed, Yahiya Y

Vaxelis^® is a fully liquid, ready-to-use, hexavalent vaccine approved in the EU for primary and booster vaccination in infants and toddlers from the age of 6 weeks against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and invasive diseases caused by Haemophilus influenzae type b (Hib). It contains diphtheria and tetanus toxoids, five acellular pertussis antigens, recombinant hepatitis B virus surface antigen produced in the yeast, Saccharomyces cerevisiae, inactivated poliovirus, and the Hib polysaccharide (polyribosylribitol phosphate) conjugated to the outer membrane protein complex of Neisseria meningitidis. In pivotal clinical studies, Vaxelis^® was highly immunogenic for all its component toxoids/antigens when administered by three different schedules. Primary endpoints of seroprotection or vaccine response rates with Vaxelis^® met the predefined acceptability criteria and were noninferior to those with comparator vaccines (Infanrix^® hexa or Pentacel^® plus Recombivax HB^®). Limited data indicate that immune responses to Vaxelis^® in preterm infants were generally similar to those seen in the overall population. Vaxelis^® can be coadministered with a number of common childhood vaccines. In clinical studies, Vaxelis^® was generally well tolerated with a tolerability profile similar to that of the comparator vaccines. Available clinical data indicate that Vaxelis^® is a new hexavalent vaccine option for immunization against several serious childhood infectious diseases.

100 Deals associated with Diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed(GlaxoSmithKline Plc)

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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
Diphtheria	US	GlaxoSmithKline LLC	29 Jan 1997
Tetanus	US	GlaxoSmithKline LLC	29 Jan 1997
Whooping Cough	US	GlaxoSmithKline LLC	29 Jan 1997

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Tetanus	NDA/BLA	EU	GlaxoSmithKline Biologicals SA	23 Oct 2000
Tetanus	NDA/BLA	IS	GlaxoSmithKline Biologicals SA	23 Oct 2000
Tetanus	NDA/BLA	NO	GlaxoSmithKline Biologicals SA	23 Oct 2000
Tetanus	NDA/BLA	LI	GlaxoSmithKline Biologicals SA	23 Oct 2000

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02096263 (CTgov)	Phase 3	Diphtheria \| Hepatitis B \| Haemophilus Infections \| Whooping Cough \| Tetanus \| Poliomyelitis	585	Hiberix+Infanrix+Infanrix hexa+Rotarix+Prevnar13 (Infanrix Hexa Group)	leusuaoyjl(dtmgijzprz) = ubtembciok rxsuvhhvht (gsgnaybwjs, tsmqoajhpv - fohkspbnhy) View more	-	01 Aug 2018
				ActHIB+Infanrix+Rotarix+Prevnar13+Pediarix (Pediarix Group)	leusuaoyjl(dtmgijzprz) = levtdbbzkb rxsuvhhvht (gsgnaybwjs, meexykudgd - zqhkkqxnhv) View more
NCT01000974 (CTgov)	Phase 3	Haemophilus Infections	4,003	GSK Biologicals' Haemophilus influenzae type b vaccine (GSK 208108)+Infanrix™+Rotarix™+Prevnar 13™+Pediarix™ (Hiberix Group)	jteqztnpjo(azkrvcbiwe) = szkwqpbtyt jgjmngaciy (iyqkhcjksh, vjscdiozyx - bvcbrfbbho) View more	-	19 Aug 2013
				ActHIB™+Infanrix™+Rotarix™+Prevnar 13™+Pediarix™ (ActHIB Group)	jteqztnpjo(azkrvcbiwe) = egtgmomavg jgjmngaciy (iyqkhcjksh, emkbaluebs - plokjcabsq) View more
NCT01171963 (113808, CTgov)	Phase 3	Rotavirus Infections	3,340	Institute of Medical Biology Chinese Academy of Medical Sciences' Oral poliovirus vaccine (OPV)+Infanrix™+GSK Biologicals' liquid human rotavirus vaccine 444563 (Rotarix Group)	motndyypft(aumuhvzdvv) = irwvjtzmsd knrrqpuwvb (lqxcevhaxy, hqonabsxfp - qdqwpxtvwu) View more	-	24 Jun 2013
				Institute of Medical Biology Chinese Academy of Medical Sciences' Oral poliovirus vaccine (OPV)+Infanrix™ (Placebo Group)	motndyypft(aumuhvzdvv) = vfegvmmzvq knrrqpuwvb (lqxcevhaxy, xpdabumcho - feqjyzcdku) View more
NCT00614614 (CTgov)	Phase 3	Meningococcal Infections	1,558	ActHIB®+Infanrix®+Pediarix® (ActHIB- Infanrix Group)	iddgflztff(ehjpyyievz) = ptiilhnbtj drzdmrsvva (oadpbpbzjm, xhcmgswchf - ruymrckujl) View more	-	20 Jul 2012
				GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix)+Infanrix®+GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix)+Pediarix® (Menhibrix 1 Group)	zppumfagyj(ookxzahiuc) = ouconhposw umoobysihb (kkuqlgadwm, jvfeamycdk - pyzvkwtzyf) View more
NCT01153893 (CTgov)	Phase 3	Streptococcal Infections	105	Pneumococcal vaccine GSK1024850A+InfanrixTM (Synflorix/Infanrix Primed Group)	fikizelbda(kgntnccvcf) = nkofwojpwh clinvmieby (pdxxtgbvyz, ikneojwbqx - fqrsjbjiiy) View more	-	15 Mar 2012
				Pneumococcal vaccine GSK1024850A+InfanrixTM (Synflorix/Infanrix Unprimed Group)	dildvntazg(inztcnnqdf) = wplxgnigvi wquwthoqxw (gzfuykdxkj, khoslmnilf - yedbrsmiie) View more
NCT00696423 (CTgov)	Phase 3	Diphtheria \| Whooping Cough \| Tetanus	467	Hiberix™+Infanrix™ (Infanrix/Hib Single Injection Group)	xqmxwsuhyh(zodbsahedy) = yunhpnxazl rtgfokardj (crffpmfxuw, ovdqqnvxlt - zqfnnrurxj) View more	-	26 Aug 2009
				Hiberix™+Infanrix™ (Infanrix + Hiberix Separate Injection Group)	xqmxwsuhyh(zodbsahedy) = nbogqekezw rtgfokardj (crffpmfxuw, dngqnxxemz - jyhcjlusdd) View more
NCT00197236 (CTgov)	Phase 3	Hepatitis A \| Diphtheria \| Whooping Cough \| Tetanus	468	Havrix™ (Havrix Group)	rssldllpia(iiwaxtaspx) = rmhefvlmqf ioztpgpenr (addunfmirl, pgykeeqdvq - kleslfinbq) View more	-	24 Jul 2009
				ActHIB™+Infanrix™+Havrix™ (Havrix + Infanrix + ActHIB Group)	rssldllpia(iiwaxtaspx) = bhbaetiabc ioztpgpenr (addunfmirl, kehzuhnkay - cpjiubfzvd) View more