Delving into the Latest Updates on Tetanus toxoid reduced diphtheria toxoid and acellular pertussis vaccine adsorbed(GlaxoSmithKline Plc) with Synapse

Author: Berlanda Scorza, Francesco ; Nigro, Simona ; De Coster, Ilse ; Rondini, Simona ; Massai, Luisa ; Conti, Valentino ; Rossi, Omar ; Serry-Bangura, Alimamy ; La Gaetana, Rita ; Luna Cilio, Giulia ; AbdelGhany, Mohammad ; Fineschi, Chiara ; Withanage, Kanchanamala ; Carducci, Martina ; Tessitore, Pietro ; Van Damme, Pierre ; Sarakinou, Eleanna ; Micoli, Francesca ; Nakakana, Usman N ; Kumar Arora, Ashwani ; Marchetti, Elisa

BACKGROUND:

Enteric fever caused by Salmonella enterica serovars Typhi and Paratyphi A remains a major concern. No vaccines are licensed against Salmonella Paratyphi A. We aimed to assess the safety and immunogenicity of an investigational conjugate vaccine against Salmonella Typhi and Paratyphi A (Vi-CRM₁₉₇+O:2-CRM₁₉₇).

METHODS:

In this observer-masked, randomised, controlled, dose-escalation, single-centre, phase 1 trial done during Nov 28, 2022, to April 2, 2024, at the Centre for Evaluation of Vaccination in Belgium, healthy adults (aged 18-50 years) were randomly assigned (2:1 or 2:2:1 across different steps using sealed envelopes following a randomisation schedule generated by an independent statistician) to receive two intramuscular doses (on day 1 and day 169) of one of four Vi-CRM₁₉₇+O:2-CRM₁₉₇ formulations (low dose or full dose, with or without aluminium hydroxide) or a control vaccine (Vi capsular polysaccharide vaccine and diphtheria toxoid-tetanus toxoid-acellular pertussis vaccine for first and second dose). The primary outcome was vaccine safety (solicited events during 7 days and unsolicited adverse events during 28 days after vaccination, serious adverse events [SAEs], and adverse events or SAEs leading to study withdrawal or withholding of further study intervention administration from day 1 to day 197, and deviations from normal or baseline laboratory test values 7 days after vaccination). Secondary outcomes included long-term vaccine safety (SAEs and adverse events or SAEs leading to study withdrawal from day 197 to day 337), and immunogenicity, including anti-Vi and anti-O:2 IgG antibody geometric mean concentrations and geometric mean ratios (GMRs) by ELISA, and seroresponses (percentages of participants with anti-Vi IgG concentrations ≥4·3 μg/mL and ≥2·0 μg/mL; ≥4-fold anti-O:2 IgG concentration increase from baseline) at day 1 (as applicable), day 29, day 169, day 176, and day 197. Safety analyses were done on the solicited safety set, unsolicited safety set, and the exposed set. The primary immunogenicity analysis was done on the per-protocol set defined by timepoint. The trial is registered with ClinicalTrials.gov (NCT05613205) and gsk-studyregister.com (205480), and is completed.

FINDINGS:

96 participants were randomly assigned, 12 to each low-dose group, 24 to each full-dose group, and 24 to the control group. The incidence of solicited administration-site events (mostly pain) ranged from six (50% [95% CI 21·1-78·9]) of 12 participants in the low-dose without aluminium hydroxide group to 23 (96% [78·9-99·9]) of 24 in the full-dose with aluminium hydroxide group, versus 22 (92% [73·0-99·0]) of 24 in the control group. Solicited systemic events (mostly fatigue, headache, and myalgia) ranged from eight (67% [34·9-90·1]) of 12 in the low-dose groups to 20 (83% [62·6-95·3]) of 24 in the full-dose with aluminium hydroxide group, versus 21 (88% [67·6-97·3]) of 24 in the control group. The incidence of unsolicited adverse events (mostly nasopharyngitis) ranged from seven (58% [27·7-84·8]) of 12 in the low-dose without aluminium hydroxide group to ten (83% [51·6-97·9]) of 12 in the low-dose with aluminium hydroxide group, versus 14 (58% [36·6-77·9]) of 24 in the control group. Most safety laboratory results were within reference ranges. No SAEs occurred. After dose 1 (ie, at day 29), full-dose without aluminium hydroxide and full-dose with aluminium hydroxide induced the highest anti-Vi IgG responses (GMR 53·01 [95% CI 31·94-87·99] and 31·55 [18·74-53·11], respectively) versus control (4·50 [2·93-6·90]). Full-dose without aluminium hydroxide and low-dose without aluminium hydroxide induced the highest anti-O:2 IgG responses after dose 1 (GMR 162·61 [91·17-290·04] and 114·19 [44·83-290·86], respectively), versus control (1·27 [1·02-1·60]). 89-100% and 82-100% of participants (lowest percentages for low-dose with aluminium hydroxide) had anti-Vi IgG ≥4·3 μg/mL at day 29 (in initially seronegative participants) and ≥4-fold anti-O:2 IgG increase from baseline, respectively, versus 13 (54% [95% CI 32·8-74·4]) and one (4% [0·1-21·1]) of 24 participants in the control group, respectively. The second dose did not boost the responses.

INTERPRETATION:

Vi-CRM₁₉₇+O:2-CRM₁₉₇ formulations did not raise safety concerns and showed immunogenicity with a single dose, supporting further clinical assessment of the full-dose without aluminium hydroxide in target populations (infants and older age groups) in endemic regions.

FUNDING:

Wellcome Trust.

01 Feb 2026·VACCINE

Impact of pregnancy on longitudinal pertussis antibody responses to Tdap vaccine in Guatemala

Article

Author: Sundaram, Maria ; Bednarczyk, Robert A ; Maldonado, Herberth ; McCracken, John P ; Phadke, Varun K ; Omer, Saad B

Maternal immunization with tetanus, diphtheria, and acellular pertussis (Tdap) vaccine is recommended in many countries, but coverage in many low-income countries remains suboptimal. Targeted vaccination of women of child-bearing age could be a supplemental strategy to address this gap, but there are limited longitudinal immunogenicity data in this population outside of high-income countries. We compared antibody responses to Tdap between 30 non-pregnant women and 156 pregnant women enrolled in a clinical trial of maternal Tdap vaccination in Guatemala. Pre-vaccination antibody concentrations among both groups were similar for all vaccine antigens. At 2 months post-vaccination, antibody concentrations against vaccine antigens increased in both groups and were higher among non-pregnant women. By 9 months, antibody concentrations had decayed and were no longer different by study group. These findings reinforce existing recommendations for Tdap vaccination with every pregnancy. Vaccination of non-pregnant women may be considered in settings where maternal Tdap coverage is low.

31 Dec 2025·Human Vaccines & Immunotherapeutics

Economic evaluation of the second booster dose of diphtheria-tetanus-acellular pertussis vaccine for children aged 6 years in Zhejiang Province: A cost-utility analysis

Article

Author: Zheng, Shuhan ; Zhou, Yang ; Su, Ying ; He, Hanqing ; Zhu, Yao ; Tang, Xuewen ; Luo, Feng

Despite increasing pertussis breakthroughs and waning immunity, this study evaluates the cost-effectiveness of replacing the DT booster with DTaP in 6-year-olds in Zhejiang, China. While implemented in high-income regions, this strategy's cost-effectiveness remains unassessed in diverse Chinese settings. We address this gap using local data.Using surveillance data from the Zhejiang Provincial Center for Disease Control and Prevention, literature reviews, and a 10-year simulation timeframe, a decision tree-Markov model was constructed from a societal perspective. The study cohort was 6-year-old children in Zhejiang Province in 2022. Comprehensive evaluation indicators, including Incremental Cost Effectiveness Ratio (ICER) and Incremental Cost-Utility Ratio (ICUR), were used. Robustness was assessed via Deterministic Sensitivity Analysis (DSA) and Probabilistic Sensitivity Analysis (PSA). Simulating 10 years after implementing the DTaP strategy for 628,619 children in 2022, under lower background incidence, DTaP could prevent 1,886 pertussis cases, reduce costs by 1.7 billion CNY, and gain 0.09 QALYs (ICUR = 3,096.15 CNY/QALY). Under higher incidence, it could prevent 8,743 cases, reduce costs by 1.6 billion CNY, and gain 0.084 QALYs (ICUR = 3,081.86 CNY/QALY). Both ICUR values are significantly lower than Zhejiang's per capita GDP (118,496 CNY). Our findings indicate that administering a second booster dose of DTaP to 6-year-old children is cost-effective, particularly with high incidence of pertussis.

20

News (Medical) associated with Tetanus toxoid reduced diphtheria toxoid and acellular pertussis vaccine adsorbed(GlaxoSmithKline Plc)

11 Mar 2026

·www.einpresswire.com

Whooping Cough Continues Wyoming Spread

March 11, 2026 Wyoming Department of Health (WDH) officials are concerned about the ongoing, active spread of pertussis (whooping cough) across the state. Kaylyn Friesen, vaccine-preventable disease epidemiologist with WDH, said there have been 26 confirmed pertussis cases in Wyoming so far this year. “While roughly two-thirds of the reported cases have been among Fremont County residents, pertussis has also been identified in other counties,” Friesen said. Friesen noted that 148 cases were reported in Wyoming in 2025, the highest since 1951. “We are continuing to see outbreaks and high monthly case counts,” Friesen said. Actual case numbers are likely higher because many illnesses are not recognized as pertussis, and others may not be reported. Pertussis typically begins with cold-like symptoms and perhaps a mild cough. Pertussis is often not suspected or diagnosed until a persistent cough with spasms develops after 1 to 2 weeks. Infants and children can cough violently and rapidly with a loud “whooping” sound. Dr. Alexia Harrist, state health officer with WDH, said, “One-third of infants less than 1 year of age who become ill with pertussis need to be hospitalized, and we know, in some cases, it can be deadly for these babies. Pertussis in the youngest babies can cause them to have pauses in breathing. Infants are simply more vulnerable and don’t yet have all the protection pertussis vaccines offer.” Harrist said the Tdap adolescent/adult pertussis booster vaccine is especially important for those spending time with new infants, such as parents, grandparents, and other people who take care of them. “Also, if you are pregnant or planning on becoming pregnant, you should talk to your doctor about a Tdap vaccine because that can also help protect newborns,” she said. Harrist recommends that all residents stay up to date with pertussis vaccines, as those who still become ill with pertussis after vaccination are less likely to have a severe experience. “In addition, people should consider seeing a medical professional for antibiotics if they have symptoms consistent with pertussis,” she said. More information about pertussis can be found online at https://health.wyo.gov/publichealth/infectious-disease-epidemiology-unit/disease/pertussis/ . Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Vaccine

09 Jan 2026

·www.drugs.com

Maternal Flu, Tdap Shots May Lower Rates of Infant Hospitalization, ED Visits

FRIDAY, Jan. 9, 2026 -- Maternal influenza and tetanus-diphtheria-acellular pertussis (Tdap) vaccinations are associated with a lower risk for influenza- and pertussis-related hospitalization or emergency department (ED) visits in infants younger than 6 months, according to a study published online Jan. 8 in JAMA Network Open . Gabriella Morabito, from the National Centre for Healthcare Research and Pharmacoepidemiology at the University of Milano-Bicocca Milan in Italy, and colleagues conducted a population-based cohort study using health care utilization databases from the Lombardy region of Italy to examine the association of maternal influenza and Tdap vaccinations with influenza- and pertussis-related hospitalizations and ED visits among infants aged younger than 6 months. A total of 53,448 pregnant individuals who received the Tdap vaccine and 5,347 who received the influenza vaccine were included in the study. Maternal vaccination coverage was 6.4 and 41.0 percent for influenza and Tdap, respectively. The researchers found that the risk for hospitalization or ED visits for influenza and pertussis was lower among infants born to mothers who received the influenza and Tdap vaccines (vaccine effectiveness, 69.7 and 88.6 percent, respectively). "These results support the current recommendations for administering these vaccines during pregnancy and highlight the urgent need to implement strategies aimed to increase their acceptance," the authors write. One author disclosed ties to the pharmaceutical industry. Abstract/Full Text

VaccineClinical Result

20 Nov 2025

·www.drugs.com

Whooping Cough Surges Nationwide as Vaccinations Fall

THURSDAY, Nov. 20, 2025 — Whooping cough is making a major comeback in the United States, with sharp increases now seen in Texas, Florida, California, Oregon and many other places. Health officials say the latest rise in pertussis cases is being driven by falling vaccination rates, waning immunity and slower public health tracking systems. What's more, officials say, is that babies remain the most vulnerable. "Pertussis cases increase in a cyclical fashion driven by waning immunity," Dr. Demetre Daskalakis , former head of the U.S. Centers for Disease Control and Prevention's (CDC) immunization program, told CBS News . "But the size of the outbreak and the potential for severe outcomes in children who cannot be vaccinated can be mitigated by high coverage and good communication to folks at risk," he added. Before a vaccine was introduced in the early 1900s, whooping cough was one of the leading causes of childhood death in the United States. Today, routine vaccination starts at 2 months old and continues through adulthood with booster shots. But the pandemic brought a drop in vaccine uptake and nonmedical exemptions in some states have widened immunity gaps. Texas illustrates how quickly case numbers have grown. The state reported 1,928 cases in 2024. By October 2025, that number had already climbed past 3,500. National trends are just as shocking. In the first three months of 2025, the United States counted 6,600 pertussis cases, four times last year’s pace and 25 times the pace in 2023. Outbreaks in places like Louisiana, South Dakota and Idaho show the problem is not limited to just one region of the country. Texas recently made it easier for parents to claim exemptions by letting them download forms online, and Dallas County Health Director Dr. Phil Huang said he has already seen a drop in families coming in for routine shots. He also worries that some families, especially in Dallas County’s 40% Hispanic population, may be avoiding vaccinations because of immigration enforcement concerns. Another issue is that protection from the current “acellular” pertussis vaccine wears off over time, leaving many adults without strong immunity. This makes it easier for adults to unknowingly spread the illness to infants. Babies face the highest risk: about 1 in 5 infants with pertussis develop pneumonia , and about 1% die from the infection, according to the CDC. The CDC stresses that pregnant women should get a Tdap vaccine during every pregnancy so their newborns receive antibodies before birth. More cases are also being found because clinics now use modern PCR testing that checks for several respiratory infections at once, including pertussis. Even so, the number of infant hospitalizations shows that true transmission is increasing. Doctors usually treat pertussis with macrolide antibiotics, but resistant strains have been rising in other countries such as China and Peru, reports CBS News . Resistant cases remain rare in the United States, although officials caution that international travel could change that. Health experts say the best strategy now is early detection and vaccination. Clinicians are being urged to consider pertussis whenever a patient has a persistent cough, especially if the patient is an infant or a caregiver of a baby. Families are also encouraged to make sure children, teens and adults are up to date on their vaccines and to keep sick visitors away from newborns. Sources CBS News, Nov. 19, 2025

Vaccine

100 Deals associated with Tetanus toxoid reduced diphtheria toxoid and acellular pertussis vaccine adsorbed(GlaxoSmithKline Plc)

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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Diphtheria	Austria	GlaxoSmithKline GmbH & Co. KG	03 Oct 2000
Diphtheria	Belgium	GlaxoSmithKline GmbH & Co. KG	03 Oct 2000
Diphtheria	Bulgaria	GlaxoSmithKline GmbH & Co. KG	03 Oct 2000
Diphtheria	Croatia	GlaxoSmithKline GmbH & Co. KG	03 Oct 2000
Diphtheria	Cyprus	GlaxoSmithKline GmbH & Co. KG	03 Oct 2000
Diphtheria	Czechia	GlaxoSmithKline GmbH & Co. KG	03 Oct 2000
Diphtheria	Denmark	GlaxoSmithKline GmbH & Co. KG	03 Oct 2000
Diphtheria	Estonia	GlaxoSmithKline GmbH & Co. KG	03 Oct 2000
Diphtheria	Finland	GlaxoSmithKline GmbH & Co. KG	03 Oct 2000
Diphtheria	France	GlaxoSmithKline GmbH & Co. KG	03 Oct 2000
Diphtheria	Germany	GlaxoSmithKline GmbH & Co. KG	03 Oct 2000
Diphtheria	Greece	GlaxoSmithKline GmbH & Co. KG	03 Oct 2000
Diphtheria	Hungary	GlaxoSmithKline GmbH & Co. KG	03 Oct 2000
Diphtheria	Iceland	GlaxoSmithKline GmbH & Co. KG	03 Oct 2000
Diphtheria	Ireland	GlaxoSmithKline GmbH & Co. KG	03 Oct 2000
Diphtheria	Italy	GlaxoSmithKline GmbH & Co. KG	03 Oct 2000
Diphtheria	Latvia	GlaxoSmithKline GmbH & Co. KG	03 Oct 2000
Diphtheria	Lithuania	GlaxoSmithKline GmbH & Co. KG	03 Oct 2000
Diphtheria	Luxembourg	GlaxoSmithKline GmbH & Co. KG	03 Oct 2000
Diphtheria	Malta	GlaxoSmithKline GmbH & Co. KG	03 Oct 2000

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Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05169905 (CTgov)	Phase 3	Respiratory Syncytial Virus Infections	9	RSV MAT vaccine+dTpa vaccine (RSV_dTpa-P Group)	wuxjwbsqfp = ukhdmlpdru ftyifsbztf (ltcpxinnns, jeyjezwhtn - amvzsggnpd) View more	-	07 Apr 2023
				RSV MAT vaccine+dTpa vaccine (RSV_dTpa-A Group)	wuxjwbsqfp = isffxfghue ftyifsbztf (ltcpxinnns, rbzpecmlkj - hjzniiacfl) View more
NCT03589768 (CTgov)	Phase 2	Diphtheria \| Whooping Cough \| Clostridium difficile colitis ... View more	399	BOOSTRIX (BOOSTRIX - Maternal)	qimeiqiveo = eiipjoqzoi cfsfcjdquo (mlzrpeedws, xidebgfqgm - drkankbucf) View more	-	20 Jan 2023
				Td (Td - Maternal)	qimeiqiveo = uevpirrlpx cfsfcjdquo (mlzrpeedws, fasofjlfak - bxffxjacri) View more
NCT03311659 (CTgov)	Phase 3	Diphtheria \| Whooping Cough \| Tetanus	448	Boostrix	rqvfjqaegv = yowxicwqle jgbbqwpbqj (nlxsivneje, nsxfocttmw - oxvqxdhejb) View more	-	23 Oct 2019
NCT02377349 (CTgov)	Phase 4	Diphtheria \| Whooping Cough \| Tetanus	688	dTpa (dTpa Group - Mother)	ocexrizixs(kddtfpdnot) = efipzqimvu ugaucuuhoo (naznbiwvsa, rqpxbbgkme - jpuiyvwmyw) View more	-	28 Jan 2019
				placebo+Boostrix (Control Group - Mother)	ocexrizixs(kddtfpdnot) = lmktbsoeeh ugaucuuhoo (naznbiwvsa, dutyvdcfzj - ueacdjaefq) View more
NCT00548171 (CTgov)	Phase 4	Diphtheria \| Whooping Cough \| Tetanus	203	Boostrix™ (Boostrix I Group)	kfebjhfonf = rcqpudcmzz hftohndawi (xnnkcolimt, skltvcxxxs - hiafnpygji) View more	-	15 Jan 2019
				Boostrix™ (Boostrix II Group)	kfebjhfonf = hxdcbgfqrt hftohndawi (xnnkcolimt, lvrabfnjcf - enatgnxyxz) View more
NCT00385255 (CTgov)	Phase 3	Diphtheria \| Whooping Cough \| Tetanus	1,726	Fluarix®+Boostrix® (Boostrix+Fluarix Group)	ucboxjuxmj(izflptexob) = apxgqjhhys fuakmurfrz (vkmifuxuhq, pletiwydck - seicitbdmi) View more	-	17 Sep 2018
				Fluarix®+Boostrix® (Fluarix Boostrix Group)	ucboxjuxmj(izflptexob) = szakmtaetp fuakmurfrz (vkmifuxuhq, akrajloqyg - jimvbeaspy) View more
NCT00346073 (CTgov)	Phase 3	Diphtheria \| Whooping Cough \| Tetanus	2,337	Boostrix™ (Boostrix Group)	ysqmgtgouo = qwpslfpmqw rkkwalrqcc (yaqfrrbprm, pbofjxsrkh - lfzlehcupr) View more	-	07 Aug 2018
				ADACEL® (Adacel Group)	ysqmgtgouo = srqjoacwga rkkwalrqcc (yaqfrrbprm, zlfupvvoyy - hkhkxybugn) View more
NCT01755689 (Pubmed \| Vaccine) Manual	Phase 3	Meningococcal Infections	1,300	MenACWY-TT+human papillomavirus 16/18 AS04-adjuvanted vaccine+tetanus-diphtheria-acellular pertussis vaccine	nvjqkinslo(xhpxzsevif) = No safety concerns were identified hecjrbxatj (uumusofsak ) View more	Positive	22 Jun 2018
NCT01738477 (CTgov)	Phase 3	Diphtheria \| Whooping Cough \| Tetanus	165	Boostrix (Boostrix Group 1)	ivhgtdatbq = hcrzjhxyix yyqgidoaan (vlydrdlfbe, bxtrdexgsg - gmxsnsyinr) View more	-	27 Dec 2017
				Boostrix (Boostrix Group 2)	ivhgtdatbq = ywdfbzzeoy yyqgidoaan (vlydrdlfbe, gvkcylrgow - fbpravdpme) View more
NCT00282295 (CTgov)	Phase 4	Diphtheria \| Meningococcal Infections \| Whooping Cough ... View more	1,344	Menactra™+Boostrix® (Boostrix + Menactra Group)	fnsmpmrnjz = zemvujgabk tckbzsqktq (nrvhzfptks, zjgmifgjbn - xcxuhvyrgq) View more	-	16 Mar 2017
				Menactra™+Boostrix® (Boostrix-Menactra Group)	fnsmpmrnjz = uazydxkvkl tckbzsqktq (nrvhzfptks, kaucsvifgg - gvkqetwpux) View more