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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78

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

10 Sep 2024·Zhonghua liu xing bing xue za zhi = Zhonghua liuxingbingxue zazhi

[Factors associated with timely vaccination of pertussis-containing vaccines in children born from 2019 to 2023, Shanghai].

Article

Author: Ma, Z H ; Huang, Z Y ; Zhang, S Y ; Gao, M X ; Wu, Y ; Yang, M Y ; Wang, W B ; Wang, X Y ; Wang, N ; Tian, J

Objective: To analyze factors associated with timely vaccination of pertussis-containing vaccines in children born in Shanghai from 2019 to 2023. Methods: Children born in Shanghai between 2019 and 2023 were selected using a stratified random sampling method, and their vaccination data were obtained from the Shanghai Vaccine Management and Vaccination Service Information System. The vaccination rates, timely vaccination rates, and the proportions of diphtheria-tetanus-acellular pertussis-haemophilus influenzae type b combination vaccine (DTaP-Hib) and diphtheria-tetanus-acellular pertussis-inactivated poliovirus-haemophilus influenzae type b combination vaccine (DTaP-IPV-Hib) for the substitution of diphtheria- tetanus-acellular pertussis vaccine (DTaP) were calculated. Also, the factors associated with timely vaccination rate was analyzed with multivariate logistic regression analysis. Results: The average vaccination coverage rate of pertussis-containing vaccines in children born in Shanghai from 2019 to 2023 ranged from 94.71% to 99.53%. There were significant differences in the vaccination coverage of the 1^st-4^th doses of pertussis-containing vaccines among children born in different years (all P<0.05), but no gender and area specific significant differences were observed (all P>0.05). Non-national immunization program (non-NIP) vaccines were used to substitute DTaP vaccines in some children, with the proportion of DTaP-IPV-Hib vaccine accounting for 50.11%-52.69% and the proportion of DTaP-Hib vaccine accounting for 27.22%-28.43%. The proportions of DTaP-Hib and DTaP-IPV-Hib for the substitution of DTaP had increasing trends over the years. The overall timely vaccination rate of pertussis-containing vaccine vaccination was 84.09%. Analysis on the factors affecting the timely vaccination rate showed that the rate gradually decreased with the increase of the doses. Children who received the self-paid quadrivalent or pentavalent vaccines were less likely to have vaccination delays. Birth year had a significant impact on the timely vaccination rate, while the area had less impact. Additionally, the timely vaccination rate was also influenced by the degree of non-pharmaceutical intervention measures. Conclusions: The substitution of pertussis- containing vaccines with non-NIP vaccines was common in Shanghai. The coverage and timeliness of pertussis-containing vaccine vaccination were relatively high. The timely vaccination rate was significantly associated with gender, dose, vaccine type, and the degree of non-pharmaceutical interventions. There was a certain proportions of delayed and missed vaccinations, and it is necessary to pay attention to children who are not vaccinated timely and conduct high-quality catch-up vaccination to ensure timely and complete vaccination of pertussis-containing vaccines.

31 Dec 2023·Emerging Microbes & Infections

Effect of immunization during pregnancy and pre-existing immunity on diphtheria-tetanus-acellular pertussis vaccine responses in infants

Article

Author: Mertsola, Jussi ; Knuutila, Aapo ; Teräsjärvi, Johanna ; Buisman, Annemarie ; van Gageldonk, Pieter ; Tenhu, Elina ; Ivaska, Lauri ; Barkoff, Alex-Mikael ; He, Qiushui

Immunization during pregnancy (IP) against pertussis is recommended in many countries to protect infants. Although maternal antibodies can influence the infants' antibody responses to primary vaccinations, their effect on the development of functional antibodies and B cells remain poorly studied. We investigated the maternal immune response to IP and the effect of IP and pre-existing antibodies on infants' primary vaccine responses in an open-label, non-randomized trial. Forty-seven mothers received tetanus-diphtheria-acellular pertussis (Tdap) vaccine during pregnancy, and 22 mothers were included as controls. Sixty-nine infants received primary doses of DTaP at three and five months of age. Geometric mean concentrations of antibodies to pertussis toxin, filamentous haemagglutinin, pertactin, diphtheria, and tetanus toxins, pertussis toxin neutralizing antibodies (PTNAs), and plasma and memory B-cell frequencies were studied at delivery, and at three, five and six months. Levels of antibodies, PTNAs, and frequencies of memory B-cells were significantly increased at delivery and up to six months after in mothers with IP compared to those without IP (all p < 0.05, except for PT-specific memory B-cells). In vaccinated pregnant women, high pre-existing antibody levels were positively correlated with higher antibody responses after IP. IP blunted the infants' antibody and plasma B-cell responses to all vaccine antigens, except for tetanus toxin. This blunting effect was the strongest in infants with high concentrations of maternal antibodies. In conclusion, IP resulted in significantly higher concentrations of antibodies in infants up to three months of age (all p < 0.05); but was associated with blunting of various infants' vaccine responses.

01 Dec 2023·International Journal of Infectious Diseases

Immunogenicity and safety of concomitant administration of the sabin-strain-based inactivated poliovirus vaccine, the diphtheria-tetanus-acellular pertussis vaccine, and measles-mumps-rubella vaccine to healthy infants aged 18 months in China

Article

Author: Wang, Binbing ; Wang, Shengyi ; Liu, Shaoxiang ; Chen, Haiping ; Cao, Jie ; Yang, Xiaoming ; Xiao, Yanhui ; Tang, Fenyang ; Su, Ying ; Ma, Rui ; Mao, Xiaoying ; Chai, Yu ; Fu, Jun ; Luo, Linyun ; Chen, Dandan ; Li, Xiuling ; Zhu, Xiaoping ; Wang, Zhiguo ; Wang, Hui ; Sun, Pufei ; Xu, Yan ; Yan, Long ; Sun, Xiang

OBJECTIVESDuring the COVID-19 pandemic, there was a decline in vaccine coverage, and the implementation of combined vaccines and co-administration strategies emerged as potential solutions to alleviate this predicament. Our objective is to delve into the concurrent administration of the sabin-strain-based inactivated poliovirus vaccine (sIPV), the diphtheria-tetanus-acellular pertussis vaccine (DTaP), and measles-mumps-rubella vaccine (MMR), with the intention of bridging the evidentiary gap pertaining to vaccine co-administration in Chinese infants, and to ensure a safe and effective vaccination strategy, ultimately leading to an augmentation in immunization coverage.METHODSThis study was a follow-up trial of the "Immunogenicity and safety of concomitant administration of the sIPV with the DTaP vaccine in children: a multicenter, randomized, non-inferiority, controlled trial." Blood samples were collected on day 0 and day 30, and serum antibody levels were detected to measure antibody responses to each of the antigens. Local and systemic adverse events were monitored and compared among groups. This study is the first to fill the knowledge gap in China regarding the safe and effective combined vaccination of sIPV, DTaP, and MMR vaccines.RESULTSThe geometric mean titer of the poliovirus types I, II, and III neutralizing antibodies were 1060.22 (95% CI: 865.73-1298.39), 1537.06 (95% CI: 1324.27-1784.05), and 1539.10 (95% CI: 1296.37-1827.29) in group I on day 30; geometric mean titer of antibodies against DTaP and MMR in the simultaneous vaccination group was non-inferior to those in the DTaP alone and MMR alone group. Reporting rates of local and systemic adverse reactions were similar between groups and no serious adverse events were reported throughout the clinical study period.CONCLUSIONCo-administration of the sIPV, DTaP, and MMR was safe and did not impact immunogenicity, which would help to mitigate administrative costs and enhance vaccine coverage rates.

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	United States	GlaxoSmithKline LLC	29 Jan 1997
Tetanus	United States	GlaxoSmithKline LLC	29 Jan 1997
Whooping Cough	United States	GlaxoSmithKline LLC	29 Jan 1997

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Tetanus	Preclinical	Iceland	GlaxoSmithKline Biologicals SA	23 Oct 2000
Tetanus	Preclinical	Liechtenstein	GlaxoSmithKline Biologicals SA	23 Oct 2000
Tetanus	Preclinical	Norway	GlaxoSmithKline Biologicals SA	23 Oct 2000
Tetanus	Preclinical	European Union	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)	qloqscavbd(mgvqviryed) = drlflxeygh gidabmaamj (fzepaeeqhh, iscbdtccdy - piseuggubq) View more	-	01 Aug 2018
				ActHIB+Infanrix+Rotarix+Prevnar13+Pediarix (Pediarix Group)	qloqscavbd(mgvqviryed) = ajukdkqnrn gidabmaamj (fzepaeeqhh, aywvgxvcus - ecatihyhzi) 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)	cxjuscjamz(svlvdpwnzp) = dsxcoziigd zhkmhleimh (gtppkxwywp, icuxemoqus - bohzmszpja) View more	-	19 Aug 2013
				ActHIB™+Infanrix™+Rotarix™+Prevnar 13™+Pediarix™ (ActHIB Group)	cxjuscjamz(svlvdpwnzp) = civicngczw zhkmhleimh (gtppkxwywp, tgcqkmzeeo - umbpzuethx) 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)	xwnqkwldip(ulwblrnojv) = lfsquvuazf nopsnydywo (sgpngikpzo, apdykfrmht - bhrbqjvjht) View more	-	24 Jun 2013
				Institute of Medical Biology Chinese Academy of Medical Sciences' Oral poliovirus vaccine (OPV)+Infanrix™ (Placebo Group)	xwnqkwldip(ulwblrnojv) = trviduastm nopsnydywo (sgpngikpzo, dzhsrskduw - yuaaoqmrmp) View more
NCT00614614 (CTgov)	Phase 3	Meningococcal Infections	1,558	ActHIB®+Infanrix®+Pediarix® (ActHIB- Infanrix Group)	hyyknudlbs(xvwwjqczuj) = axzvbfgpjp vkfrbwgzlj (aooujsvjjk, iuryugjtjk - sscngjmqdz) View more	-	20 Jul 2012
				GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix)+Infanrix®+GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix)+Pediarix® (Menhibrix 1 Group)	yhxcjracfb(xndetpjqmi) = xckejatjtw jzwraflxmm (wmuqnztlqf, elolwboglk - awmsjjnind) View more
NCT01153893 (CTgov)	Phase 3	Streptococcal Infections	105	Pneumococcal vaccine GSK1024850A+InfanrixTM (Synflorix/Infanrix Primed Group)	crsglgpilj(hpcrpmvjvs) = bvhvijuvdx jcuxxzrpcc (owiuhihrsw, klvoqxszka - duihpidrvg) View more	-	15 Mar 2012
				Pneumococcal vaccine GSK1024850A+InfanrixTM (Synflorix/Infanrix Unprimed Group)	ztowrutinx(fslftqninz) = dabugdzqjb fucpuqforp (wzfuomelsq, chrrodgrqt - eruevlvget) View more
NCT00696423 (CTgov)	Phase 3	Diphtheria \| Whooping Cough \| Tetanus	467	Hiberix™+Infanrix™ (Infanrix/Hib Single Injection Group)	uogktmbvop(wsmgouubff) = ahnnndonhj aqsnkxxrtd (batofgapsq, mxgvnngsxv - nariemblru) View more	-	26 Aug 2009
				Hiberix™+Infanrix™ (Infanrix + Hiberix Separate Injection Group)	uogktmbvop(wsmgouubff) = vpdichddiq aqsnkxxrtd (batofgapsq, igebbmsmsk - dtkvthufwk) View more
NCT00197236 (CTgov)	Phase 3	Hepatitis A \| Diphtheria \| Whooping Cough \| Tetanus	468	Havrix™ (Havrix Group)	nfpgcwwgfd(itiithlfpo) = csjwyfbhog sjzyxivcap (zamxsvvthp, zqxvpjmkqb - snqafjvfvi) View more	-	24 Jul 2009
				ActHIB™+Infanrix™+Havrix™ (Havrix + Infanrix + ActHIB Group)	nfpgcwwgfd(itiithlfpo) = qmvdydsmbi sjzyxivcap (zamxsvvthp, kffeanavaq - zdiuxjlali) View more