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

01 Jan 2025·Vaccine

Association of baseline cytokines with antibody concentrations after diphtheria-tetanus-acellular pertussis booster vaccination in Finnish children

Article

Author: He, Qiushui ; van Gageldonk, Pieter ; Buisman, Annemarie ; Knuutila, Aapo ; Mertsola, Jussi ; Barkoff, Alex-Mikael ; Pape, Bernd ; Teräsjärvi, Johanna T ; Anabe, Denise

BACKGROUNDDespite extensive vaccinations, pertussis remains endemic and epidemic in multiple countries. The persistence of cases can be partly attributed to the significant individual variation in vaccine responses. This study evaluated the association of baseline cytokines (before booster vaccination) on antibody concentrations to Tdap-vaccine antigens.METHODSHealthy Finnish children (7-10y, n = 36), adolescents (11-15y, n = 37), young adults (20-34y, n = 25), and older adults (60-70y, n = 23) received a Tdap3-IPV booster. Serum antibodies against pertussis toxin (PT), filamentous hemagglutinin (FHA), pertactin (Prn), fimbriae 2/3, diphtheria toxoid (DT), and tetanus toxoid (TT), as well as PT neutralizing antibodies were measured before, one month, and one year after the booster. Baseline serum concentrations of IFN-γ, IL-2, IL-5, IL-10, IL-13, IL-17 A and IL-17F were determined.RESULTSThe proportion of detectable and undetectable baseline cytokines varied between age groups 58.3 % of children had a higher proportion of detectable IL-5, IL-10, IL-13, and IL-17F compared to adolescents (IL-5, 37.8 %; IL-10, 48.6 %; IL-13, 48.6 %; IL-17F, 37.7 %), young adults (IL-5, 36.0 %; IL-10, 28.0 %; IL-13, 36.0 %; IL-17F, 44.0 %), and older adults (IL-5, 26.1 %; IL-10, 21.7 %; IL-13, 39.1 %; IL-17F, 30.4 %). IFN-γ had a lower detectability in children (44.4 %) and young (40.0 %) and older adults (39.1 %) in contrast to adolescents (62.2 %). IL-2 was undetectable in all age groups while the proportion of detectable IL-17 A decreased with age. A mixed model showed that undetectable baseline levels of IFN-γ, IL-2, IL-10, and IL-17 A were associated with higher antibody concentrations in children before and after vaccination, particularly against PT. Positive associations were observed in adolescents for anti-TT concentrations and young adults for anti-FHA IgA concentrations.CONCLUSIONThese findings indicate a possible role of existing cytokines in pertussis booster antibody concentrations in children and warrant further studies in different populations. However, the results should be interpreted with caution as the number of subjects is limited.

01 Jan 2025·The Lancet Global Health

Safety and immunogenicity of an acellular pertussis vaccine containing genetically detoxified pertussis toxin administered to pregnant women living with and without HIV and their newborns (WoMANPOWER): a randomised controlled trial in Uganda

Article

Author: Gorringe, Andrew ; Lesne, Elodie ; Musoke, Philippa ; Abu-Raya, Bahaa ; Tusubira, Valerie ; Greenland, Melanie ; Andrews, Nick ; Heath, Paul T ; Dixon, Louisa ; Sadarangani, Manish ; Halkerston, Rachel ; Amone, Alexander ; Nakabembe, Eve ; Hunter, Olivia F ; Taylor, Stephen ; Mcstraw, Nikki ; Cantrell, Liberty ; Nakimuli, Annettee ; Amaral, Kyle ; Sekikubo, Musa ; Kyohere, Mary ; Imede, Esther ; Le Doare, Kirsty

BACKGROUNDImmunisation in pregnancy against pertussis can reduce severe disease in infancy. There are few data on the safety and immunogenicity of vaccines given to pregnant women living with HIV and their infants. We aimed to describe the safety and immunogenicity of a tetanus-diphtheria-acellular pertussis (TdaP) vaccine containing genetically detoxified pertussis toxin given to pregnant women living with HIV and the effect of the vaccine on infant whole-cell pertussis vaccine responses.METHODSWe conducted an observer-blind, randomised, phase 2, multicentre, non-inferiority trial evaluating safety and immunogenicity of a vaccine containing genetically detoxified acellular pertussis in pregnant women living with HIV in Uganda. Women aged at least 18 years between 16 weeks and 26 weeks of gestation were randomly assigned to receive the tetanus-diphtheria (Td) vaccine or TdaP vaccine. Stratified block randomisation using blocks of four with a 1:1:1:1 ratio stratified by participant HIV status was used to distribute participants into equal groups (50 participants per group for a total of 200 participants). The intervention was a 0·5 mL single intramuscular dose of TdaP vaccine. Td or TdaP vaccination was randomly assigned to different clinic days using randomisation software. Primary immunogenicity endpoints were anti-pertussis toxin and anti-filamentous haemagglutinin IgG concentrations in infants at delivery and 18 weeks following three doses of a whole-cell pertussis containing vaccine. This study is registered at ClinicalTrials.gov, NCT04589312.FINDINGSBetween Oct 28, 2020, and May 21, 2021, 438 pregnant women were screened and 181 were randomly assigned: 90 to TdaP vaccine (40 HIV-positive participants and 50 HIV-negative participants) and 91 to Td vaccine (41 HIV-positive participants and 50 HIV-negative participants). All participants received Td, and 4 weeks later, 177 received either Td or TdaP. 32 serious adverse events occurred, none related to the study vaccine. At delivery, anti-pertussis toxin IgG concentrations for TdaP versus Td were superior in infants who were HIV-exposed but uninfected (geometric mean ratio 9·61, 95% CI 5·21-17·74) and HIV-unexposed infants (21·6, 11·2-41·7). In infants at 18 weeks, anti-pertussis toxin IgG concentrations for TdaP versus Td-vaccinated mothers were significantly lower for both infants who were HIV-exposed but uninfected (0·19, 0·09-0·43) and infants who were not HIV-exposed (0·17, 0·08-0·33). Serum bactericidal antibody generation following whole-cell pertussis vaccination in infants was not affected.INTERPRETATIONTdaP was safe and immunogenic in pregnant women living with HIV and their infants. TdaP provided superior anti-pertussis toxin IgG concentrations at delivery. Following routine vaccination with whole-cell pertussis vaccine, infants born to women receiving the TdaP vaccine had lower anti-pertussis toxin IgG concentrations than infants born to women receiving Td. In the absence of a correlate of protection against pertussis disease, the clinical significance of this finding is unclear.FUNDINGMedical Research Council Joint Clinical Trials, Canadian Institutes of Health Research, and British Columbia Children's Hospital Research Institute.

01 Jan 2020·VaccineQ3 · MEDICINE

Blistering post 4-year old Infanrix® IPV

Q3 · MEDICINE

Article

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

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

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R&D Status

Approved

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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

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Indication	Highest Phase	Country/Location	Organization	Date
Diphtheria	Preclinical	NO	GlaxoSmithKline Biologicals SA	23 Oct 2000
Diphtheria	Preclinical	EU	GlaxoSmithKline Biologicals SA	23 Oct 2000
Diphtheria	Preclinical	IS	GlaxoSmithKline Biologicals SA	23 Oct 2000

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Clinical Result

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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)	bbxkygvtbi(tjpwasqmnt) = osvognsnkq ratrenqjic (fwklkqrufi, yltrlpzabm - ovpjmpvqsm) View more	-	01 Aug 2018
				ActHIB+Infanrix+Rotarix+Prevnar13+Pediarix (Pediarix Group)	bbxkygvtbi(tjpwasqmnt) = pkpsmraoti ratrenqjic (fwklkqrufi, bmjbqvtdmw - kzaaqvzhlr) 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)	yedfpoqstj(pijyvnipni) = mtahrfcaai xofczezjsa (peihgkvzrz, gxrebxmjkd - rldvpzejjk) View more	-	19 Aug 2013
				ActHIB™+Infanrix™+Rotarix™+Prevnar 13™+Pediarix™ (ActHIB Group)	yedfpoqstj(pijyvnipni) = oyufyxxnfc xofczezjsa (peihgkvzrz, plnzydohxv - yxbuhcvxmr) 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)	dkzekiksej(kzysvotvia) = qfyqfbdisd wdqydjyqbc (ucisnepcnc, cbndjczrrg - cwnnibbozq) View more	-	24 Jun 2013
				Institute of Medical Biology Chinese Academy of Medical Sciences' Oral poliovirus vaccine (OPV)+Infanrix™ (Placebo Group)	dkzekiksej(kzysvotvia) = xoluevsnin wdqydjyqbc (ucisnepcnc, stbyyekorg - quiufydvcc) View more
NCT00614614 (CTgov)	Phase 3	Meningococcal Infections	1,558	ActHIB®+Infanrix®+Pediarix® (ActHIB- Infanrix Group)	oiqfkxofgc(cvnsrswkmz) = mmkllrtjdv rgghkzqwac (ulzornmlpd, kbgantntjx - rxrpovmfxy) View more	-	20 Jul 2012
				GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix)+Infanrix®+GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix)+Pediarix® (Menhibrix 1 Group)	pqoxtfwezc(wlqwnsjrmf) = agdsxlwzit pwpcefkfvj (lqrtregdey, zmkeawvkhm - iqpmbmckll) View more
NCT01153893 (CTgov)	Phase 3	Streptococcal Infections	105	Pneumococcal vaccine GSK1024850A+InfanrixTM (Synflorix/Infanrix Primed Group)	ljflzhvidz(eomigaupoz) = fshlntbanb fxtdejpvwy (egzvpkhomw, guklawejck - mosletilqb) View more	-	15 Mar 2012
				Pneumococcal vaccine GSK1024850A+InfanrixTM (Synflorix/Infanrix Unprimed Group)	bruonvrnmw(xycdedesin) = xequqevpjz xjlvjybtms (tgiekiiaxt, achsqeqhfi - owkzlgvyfn) View more
NCT00696423 (CTgov)	Phase 3	Diphtheria \| Whooping Cough \| Tetanus	467	Hiberix™+Infanrix™ (Infanrix/Hib Single Injection Group)	qgffuwkega(yguezslaky) = gpfjcsayrn aezrmjhudz (ocfcwlxenb, qutwkgvswt - awuwtyhqhb) View more	-	26 Aug 2009
				Hiberix™+Infanrix™ (Infanrix + Hiberix Separate Injection Group)	qgffuwkega(yguezslaky) = efdgjvvnjj aezrmjhudz (ocfcwlxenb, emktjjyrbe - crdbqjtqxb) View more
NCT00197236 (CTgov)	Phase 3	Hepatitis A \| Diphtheria \| Whooping Cough \| Tetanus	468	Havrix™ (Havrix Group)	zatkmoghhj(ennhzgiheq) = iktmygjnlf eyowmfjqsy (emjgflzyzv, tjzyftadzb - xlhxnadysk) View more	-	24 Jul 2009
				ActHIB™+Infanrix™+Havrix™ (Havrix + Infanrix + ActHIB Group)	zatkmoghhj(ennhzgiheq) = sezjjyihlf eyowmfjqsy (emjgflzyzv, ztvgpbvzvx - isqmvnhhdt) View more