The study plans to learn more about how the shingles vaccine, Shingrix (SRX), successfully prevents shingles in older people. Two vaccines are currently approved by the Food and Drug Administration (FDA) to prevent shingles. Zostavax is a live virus vaccine which has been available since 2006 and prevents shingles about 50% of the time, though it is less effective the older a person is when they receive it. Shingrix, which was approved by the FDA in 2017, is not a live virus, but has an additive in the vaccine to boost immune response. It is about 97% effective at preventing shingles regardless of a person's age and so far has been effective for at least 4 years after vaccination. Because Zostavax has live virus in it, giving a "challenge" dose of Zostavax - vOka varicella zoster virus - to people who have received both vaccines (Zostavax or Shingrix) in the past, will allow researchers to learn more about how the body works to prevent shingles and how any shingles vaccination helps protect against shingles.

Start Date28 Jul 2020

Sponsor / Collaborator

University of Colorado Denver

[+1]

NCT04016714

/ CompletedPhase 3

A Phase 3, Multicenter, Randomized, Double-blind, Active-comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 3-dose Regimen of V114 in Healthy Infants (PNEU-PED-EU-2)

The purpose of this clinical study is to evaluate the safety and immunogenicity of a 3-dose schedule (2-dose primary series followed by a toddler dose) of pneumococcal conjugate vaccine (PCV) as one of the currently recommended schedules by the World Health Organization (WHO) Strategic Advisory Group of Experts (SAGE) on Immunizations and practiced in many countries.
The primary hypotheses are that V114 is non-inferior to Prevenar 13™ for the 13 shared serotypes based on response rates and on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; that V114 is superior to Prevenar 13™ for the 2 serotypes unique to V114 based on the response rates and on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 3; and that Vaxelis™ administered concomitantly with V114 is non-inferior to Vaxelis™ administered concomitantly with Prevenar 13™ at 30 days following Dose 3 for each antigen included in Vaxelis™.

Start Date28 Aug 2019

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

NCT03192319

/ CompletedNot ApplicableIIT

Comparison of Change in Humoral and Cellular Immunity Induced by Zoster Vaccine According to the Timing of Vaccination After Hematopoietic Stem Cell Transplantation

The purpose of this study is to determine the optimal timing of zoster vaccination to induce both higher cell-mediated immunity and humoral immunity in adult patient aged over 50 with history of hematopoietic stem cell transplantation(HSCT).

Start Date01 Jul 2017

Sponsor / Collaborator

Seoul National University Hospital

100 Clinical Results associated with Zoster vaccine live(Merck Sharp & Dohme Corp.)

100 Translational Medicine associated with Zoster vaccine live(Merck Sharp & Dohme Corp.)

100 Patents (Medical) associated with Zoster vaccine live(Merck Sharp & Dohme Corp.)

336

Literatures (Medical) associated with Zoster vaccine live(Merck Sharp & Dohme Corp.)

31 Dec 2025·Human Vaccines & Immunotherapeutics

Varicella zoster virus mRNA vaccine candidate induced superior cellular immunity and comparable humoral and Fc-mediated immunity compared to the licensed subunit vaccine in a mouse model

Article

Author: Park, Hosun ; Kim, Yunhwa ; Choi, Seok-Tae ; Nam, Jae-Hwan ; Kim, Keunea ; Jang, Eun-Jeong ; Kwak, Hye Won ; Hwang, Ji-Young ; Seo, Ho Seong ; Woo, Chang-Hoon ; Lee, Kyung-Min ; Lim, Jae Hyang ; Xayaheuang, Sivilay ; Yoon, Boomi

The threat of herpes zoster (HZ) is increasing, particularly in the elderly and immunocompromised individuals. Although two platform vaccines are currently available for HZ prevention, the low effectiveness of the live attenuated varicella-zoster virus vaccine (Zostavax®), and the high reactogenicity and limited supply of the AS01 adjuvant gE subunit vaccine (Shingrix®) indicate that, the development of more effective and safe vaccines is required. Compared to conventional vaccines, mRNA vaccines offer the advantages of faster production and generally do not require adjuvants. However, no authorized mRNA vaccine is currently available for HZ. Therefore, we aimed to prepare a gE mRNA vaccine and evaluate the immunogenicity compared with the two commercial vaccines in mice. The gE mRNA vaccine elicited a robust humoral immune response, as measured by an enzyme-linked immunosorbent assay and the fluorescent antibody to membrane antigen test. The mRNA vaccine binding antibody level was comparable to that of Shingrix® and significantly higher than that of Zostavax®. In contrast, in cellular immune responses, which were evaluated by ELISpot assays and intracellular cytokine staining assay, the VZV gE mRNA vaccine induced significantly higher responses than Zostavax® and Shingrix®. In addition, the antibody-dependent cellular phagocytosis activity of the gE mRNA vaccine was comparable to that of the commercial vaccines. However, the highest antibody-dependent cellular cytotoxicity response was achieved by Shingrix®, followed by gE mRNA and then Zostavax®. Our results demonstrate that the mRNA HZ vaccine candidate elicited robust immunogenicity, especially in cellular immunity, and shows a promising potential for HZ prevention.

01 Aug 2025·VACCINE

Long-term immunogenicity of a live attenuated herpes zoster vaccine in patients with systemic lupus erythematosus

Article

Author: Mok, Chi Chiu ; Tse, Sau Mei ; Chan, Kar Li

OBJECTIVES:

To study the 5-year immunogenicity of a live attenuated herpes zoster (HZ) vaccine in systemic lupus erythematosus (SLE).

METHOD:

This is an extended observational study of the immunogenicity of a live HZ vaccine (Zostavax) in adult patients with stable SLE (SLEDAI <6 and immunosuppressive treatment for ≥6 months) who participated in a placebo (PBO)-controlled randomized controlled trial (RCT). Humoral (anti-VZV IgG reactivity) and cell-mediated (VZV-stimulated IFN-γ enzyme-linked ELISPOT assay) responses to HZ at 5 years were reassessed.

RESULTS:

Of the 90 patients in the original RCT, 70 patients consented for this study (32 treated with vaccine; 38 treated with PBO; age 51.9 ± 15.5 vs 50.0 ± 13.2 years; p = 0.59; 91 % vs 97 % women; p = 0.33). The change in anti-VZV IgG reactivity from week 6 to year 5 was -14.5 % (p = 0.06) in the vaccine and - 10.1 % (p = 0.02) in the PBO group, respectively. The anti-VZV IgG reactivity at year 5 was significantly higher in vaccinated than PBO-treated patients, after adjustment for baseline values (3.61 ± 1.56 vs 2.94 ± 1.03; p = 0.01). The number of IFN-γ secreting T-cell spots (per 5 × 10⁵ cells) increased in vaccinated patients (+65.5 %; p = 0.23) from week 6 to year 5 but decreased in PBO-treated patients (-5.3 %; p = 0.83). The T-cell spots number at year 5 was higher in vaccine than PBO treated patients after adjustment for baseline values (58.1 ± 71.5 vs 24.9 ± 23.2; p = 0.06). The proportion of patients who had a reduction in T-cell spots number by ≥20 % was significantly lower in the vaccine (30.8 %) than PBO (61.1 %) groups (p = 0.046). Among vaccinated patients, a trend of higher cumulative prednisolone, more new addition or dosage increase of non-glucocorticoid immunosuppressive drugs was observed in those who had reduction in T-cell or humoral HZ responses by ≥20 %. One vaccinated patient (3.1 %) and three PBO-treated patients (7.9 %) experienced HZ reactivation, but the difference was not significant (p = 0.62).

CONCLUSIONS:

Immunogenicity of Zostavax in stable SLE patients is largely retained at 5 years.

01 Jul 2025·Value in Health Regional Issues

Cost-Utility and Budget Impact Analyses of Herpes Zoster Vaccines in Patients With Human Immunodeficiency Virus in Thailand

Article

Author: Fueymee, Arisa ; Piboonsatsanasakul, Papassara ; Santhaveesook, Chanyanoot ; Hemapanpairoa, Jatapat ; Kulthanachairojana, Nattanichcha

OBJECTIVES:

This study aimed to perform cost-utility and budget impact analyses of zoster vaccine live (ZVL) and recombinant zoster vaccine (RZV) compared with no vaccination in patients infected with human immunodeficiency virus (HIV) in Thailand.

METHODS:

A Markov model was used to estimate costs and outcomes as a quality-adjusted life year from a societal perspective. Costs and outcomes were discounted at 3% per year. Parameters for herpes zoster prevalence and complications were estimated from previous studies. The target population included patients with HIV infection aged ≥18 years with a CD4 count ≥ 200 cells/mm³. Direct medical and nonmedical costs were included in the analysis. Deterministic and probabilistic sensitivity analyses were performed to assess the robustness of the results. A 5-year budget impact analysis of the vaccination program was performed.

RESULTS:

The incremental cost-effectiveness ratios of ZVL and RZV compared with no vaccination for patients with HIV infection were $2908.70 and $4391.36 per quality-adjusted life year gain, respectively. ZVL was more likely to be cost-effective. Threshold analysis revealed that RZV could be cost-effective if the cost per dose of RZV was reduced by 0.86%. An additional budget of $15 276 033 for ZVL and $43 338 761 for RZV was estimated to be needed over 5 years.

CONCLUSIONS:

ZVL is cost-effective at the Thai willingness-to-pay threshold for patients with HIV infection aged ≥18 years with a CD4 count ≥ 200 cells/mm³. RZV needs a 0.86% price reduction to be cost-effective. These findings may be useful in evidence-based policymaking.

News (Medical) associated with Zoster vaccine live(Merck Sharp & Dohme Corp.)

02 Apr 2025

·www.drugs.com

Shingles Vaccine Protects Against Dementia

TUESDAY, April 2, 2025 -- The shingles vaccine can do more than protect seniors from painful, blistering rashes. It also appears to protect older folks from dementia , researchers say. Seniors who got the shingles vaccine when it became available in the U.K. were 20% less likely to develop dementia than those who did not take the jab, according to research published April 2 in the journal Nature . “It was a really striking finding,” senior researcher Dr. Pascal Geldsetzer , an assistant professor of medicine at Stanford University, said in a news release. “This huge protective signal was there, any which way you looked at the data.” These findings came about due to a “natural experiment” that resulted from the way the shingles vaccine was handed out in Wales after it became available in 2013, Geldsetzer said. Shingles is caused by the same virus that causes chicken pox, varicella-zoster . The virus stays dormant in the nerve cells of people who get chicken pox as children, and then re-emerges as folks’ immune systems weaken due to old age or illness. The vaccine works by boosting seniors’ immune response against varicella-zoster, preventing the dormant virus from emerging and causing shingles. However, researchers wondered if the shingles vaccine might protect the brain as well. Recent evidence has indicated that certain viral infections might increase a person’s risk of dementia . To test this theory, researchers looked to Wales. There, on Sept. 1, 2013, public health officials began offering the vaccine to anyone 79 years of age. People could only get the vaccine once they’d turned 79, and only for that year. Once folks turned 80, they were out of luck, including anyone who’d already turned 80 by the start of the vaccine program. The rules were designed to ration a limited supply of vaccine, but they also created a natural randomized trial that could test the vaccine’s effects on people, researchers said. By comparing people who turned 80 just before September 2013 with those who turned 80 just after, researchers could isolate the vaccine’s effects. “We know that if you take a thousand people at random born in one week and a thousand people at random born a week later, there shouldn’t be anything different about them on average. They are similar to each other apart from this tiny difference in age,” Geldsetzer said. “What makes the study so powerful is that it’s essentially like a randomized trial with a control group — those a little bit too old to be eligible for the vaccine — and an intervention group — those just young enough to be eligible,” he added. Researchers tracked health outcomes over the next seven years for people who got the vaccine versus those who didn’t. As expected, shingles cases were 37% lower in people who’d received the vaccine, researchers found. But by 2020, vaccine recipients also were 20% less likely to develop dementia, results show. This finding held even after researchers considered other potential factors that might influence dementia risk like level of education or chronic illnesses such as diabetes , heart disease or cancer. “The signal in our data was so strong, so clear and so persistent,” Geldsetzer said. Results also showed that the protection against dementia was much more pronounced in women than in men. This could be because women on average respond better to vaccination than men, researchers said. Also, shingles is more common in women than in men, so the vaccine’s protection might matter more for them. This research team has since replicated the Wales findings using health records from England, Australia, New Zealand and Canada. “We just keep seeing this strong protective signal for dementia in dataset after dataset,” Geldsetzer said. It’s not clear, however, why the vaccine would protect against dementia at all, researchers said. It might protect the brain by boosting the immune system overall, or by specifically preventing varicella-zoster from having some yet-unknown affect on brain health, researchers speculated. It’s also not known whether the newest version of the vaccine, which is the only one available in the U.S., would confer the same protection, researchers noted. The first vaccine, Zostavax , contained a live but weakened version of the varicella-zoster virus to which the immune system responded. It’s now been replaced by Shingrix, a genetically engineered version of the vaccine that contains only certain proteins from the virus. Shingrix is more effective against varicella-zoster – 97% versus 51% in clinical trials – but might have a different impact on dementia risk than its predecessor, researchers said. Geldsetzer hopes these new findings will inspire others to look into Shingrix’s effectiveness against dementia. “At least investing a subset of our resources into investigating these pathways could lead to breakthroughs in terms of treatment and prevention,” he concluded. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

VaccineClinical Result

25 Mar 2025

·www.pharmaceutical-technology.com

GSK and UK researchers plan to study Shingrix and dementia risk reduction link

More than 55 million people worldwide have dementia, according to the WHO. Credit: Alican Lazutti via Getty Images. GSK is collaborating with the UK Dementia Research Institute (UK DRI) and Health Data Research UK (HDR UK) to investigate whether GSK’s shingles vaccine, Shingrix (zoster vaccine recombinant), could reduce the risk of dementia. The research plan follows multiple retrospective observational studies, which suggest a potential link between shingles vaccination – specifically with Shingrix – and a lower likelihood of developing dementia. However, given unmeasured confounding factors, GSK has cautioned that these studies cannot establish causation. The new study will analyse electronic health records from the UK’s National Health Service (NHS), focusing on approximately 1.4 million individuals who are 65 or 66 years old. Researchers will assess how shingles vaccination affects dementia risk while accounting for variables such as age, sex, and existing medical conditions. The study is expected to take four years to complete. Interest in the potential cognitive benefits of Shingrix was highlighted by a 2024 study published in Nature , which leveraged a natural experiment created by the transition from live to recombinant shingles vaccines. The study found that recipients of the recombinant vaccine had a significantly lower risk of dementia over six years, with a 17% increase in diagnosis-free time – equivalent to 164 additional days without a dementia diagnosis for those eventually affected. The effect observed across various analyses, was more pronounced in women, and was stronger compared to other vaccines commonly administered to older adults, including influenza and tetanus-diphtheria-pertussis vaccines. The study’s authors called for further research into the underlying biological mechanisms and a large-scale randomised controlled trial. In the UK, the recombinant zoster vaccine Shingrix, is offered to all adults turning 65, those aged 70 to 79 years, and those who are 50 years and above with a severely weakened immune system. It is the only US Food and Drug Administration (FDA)-approved shingles vaccine and has dominated the market since its US approval in 2017, outperforming MSD’s now-discontinued Zostavax. In 2020, Zostavax was discontinued in the US given Shingrix’s better effectiveness and safety. The UK Health Security Agency (UKHSA) announced in September 2023 that all newly eligible individuals would receive Shingrix instead of Zostavax. GSK’s vaccine generated £3.36bn ($4.35bn) in sales in 2024, as per the company’s financials. According to GlobalData’s Pharma Intelligence Center, Shingrix sales will surpass $5bn by 2030. GlobalData is the parent company of Pharmaceutical Technology.

VaccineDrug ApprovalClinical StudymRNA

29 Jul 2024

·pmlive.com

Study reveals GSK’s new recombinant shingles vaccine could reduce dementia risk

Researchers from the University of Oxford have revealed that GSK’s new recombinant shingles vaccine, Shingrix, could reduce the risk of dementia compared to Merck & Co’s – known as MSD outside the US and Canada – shingles vaccine, Zostavax. The study was funded by the National Institute for Health and Care Research’s (NIHR) Oxford Health Biomedical Research Centre and published in Nature Medicine. Shingles, a common but serious condition caused by the herpes zoster virus, varicella-zoster virus (VZV), affects up to one in three people in their lifetime, according to a 2023 global survey published by GSK. Utilising the US TriNetx electronic health records network, researchers compared the risk of dementia in more than 200,000 people six years following either Shingrix or Zostavax vaccination, as well as in those who had received vaccines against other infections including flu, tetanus, diphtheria and pertussis. Results showed that the Shingrix vaccine was more protective against dementia compared to Zostavax, as well as being more protective than vaccines against other infections. In total, the team found a 17% reduction in dementia diagnoses in the six years after the new recombinant shingles vaccination, totalling around 164 or more additional days lived without dementia, compared to Zostavax and up to 27% less than with other vaccines. Researchers intend to conduct further research before suggesting Shingrix to identify how and why, as well as whether it could have additional value in terms of protection against dementia. John Todd, professor of precision medicine, University of Oxford’s Nuffield Department of Medicine, suggested that this happens because the VZV infection “might increase the risk of dementia” or because chemicals in the vaccine “might have separate beneficial effects on brain health”. Affecting more than 944,000 people in the UK, dementia is a neurodegenerative condition that affects the ability to remember, think or make decisions in everyday life, and around a third of those living with the disease in England do not have a diagnosis, according to new data published by NHS England. Dr Maxime Taquet, NIHR academic clinical lecturer, department of psychiatry, University of Oxford, who led the study, commented: “If validated in clinical trials, these findings could have significant implications for older adults, health services and public health.”

VaccineClinical Result

100 Deals associated with Zoster vaccine live(Merck Sharp & Dohme Corp.)

External Link

KEGG	Wiki	ATC	Drug Bank
-	Zoster vaccine live(Merck Sharp & Dohme Corp.)	J07BK02	DB10318

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Herpes Zoster	European Union	Merck Sharp & Dohme BV	19 May 2006
Herpes Zoster	Iceland	Merck Sharp & Dohme BV	19 May 2006
Herpes Zoster	Liechtenstein	Merck Sharp & Dohme BV	19 May 2006
Herpes Zoster	Norway	Merck Sharp & Dohme BV	19 May 2006
Neuralgia, Postherpetic	European Union	Merck Sharp & Dohme BV	19 May 2006
Neuralgia, Postherpetic	Iceland	Merck Sharp & Dohme BV	19 May 2006
Neuralgia, Postherpetic	Liechtenstein	Merck Sharp & Dohme BV	19 May 2006
Neuralgia, Postherpetic	Norway	Merck Sharp & Dohme BV	19 May 2006

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Varicella Zoster Virus Infection	Phase 3	-	Merck Sharp & Dohme Corp.	01 Mar 2007
Influenza, Human	Phase 3	-	Merck Sharp & Dohme LLC	01 Sep 2005
Chickenpox	Phase 3	-	Merck Sharp & Dohme Corp.	01 Aug 2005
HIV Infections	Phase 2	United States	Merck Sharp & Dohme Corp.	29 Apr 2009
Bruton Type Agammaglobulinemia	Clinical	United States	Merck Sharp & Dohme Corp.	01 Dec 2015
Common Variable Immunodeficiency	Clinical	United States	Merck Sharp & Dohme Corp.	01 Dec 2015
Immunoglobulin deficiency	Clinical	United States	Merck Sharp & Dohme Corp.	01 Dec 2015

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04169009 (CTgov)	Phase 4	Herpes Zoster	105	vOka varicella zoster virus (ZVL)+Zostavax (ZVL) (ZVL >5 Years Previously (Cohort 1))	bqowtrzaov(iwuvwqrtdh) = dtncijktzp htiuywkxkb (gnhwhefxay, NA) View more	-	15 Oct 2024
				ZVL (ZVL 6-12 Months Previously (Cohort 3))	bqowtrzaov(iwuvwqrtdh) = unolylueul htiuywkxkb (gnhwhefxay, NA) View more
NCT02624375 (CTgov)	Phase 4	Herpes Zoster	10	Zostavax	hvqmrnpphx(onlfzebhsr) = kqnhncolyz kvthbelord (lmmvwchdat, mqfnoslcdj - uqaglnshtc) View more	-	05 Dec 2019
NCT02704572 (Pubmed \| Infect Chemother)	Not Applicable	Herpes Zoster	60	Live Zoster Vaccine (6-12 months group)	mzbmnbradf(dpuorlgghl) = zdgoxwhklz lzosveeaqk (qslcxpwxom )	-	01 Dec 2018
				Live Zoster Vaccine (1-5 years group)	mzbmnbradf(dpuorlgghl) = cuuwktilmy lzosveeaqk (qslcxpwxom )
NCT00561080 (V211-043, CTgov)	Phase 3	Herpes Zoster	759	Zostavax (Group 2: Zostavax - Day 0 and Month 1)	ewbyasvtcm(fzamrmnhuw) = bgvshetlah zuwvhunfqv (eyiybvrups, krbbszztgk - rpepgypids) View more	-	22 Dec 2017
				Zostavax (Group 3: Zostavax - Day 0 and Month 3)	ewbyasvtcm(fzamrmnhuw) = ytsdqommje zuwvhunfqv (eyiybvrups, fihlhoiyay - ofcmamndua) View more
NCT01391546 (V211-045, CTgov)	Phase 3	Herpes Zoster	354	ZOSTAVAX (ZOSTAVAX Intramuscular (IM) Route)	xglikrrkma(ujwcqthiny) = vuqvkliixc ilszskjnkw (oybkfyzpoc, fhksxsyjqy - mjqjzvxjwm) View more	-	20 Nov 2017
				ZOSTAVAX (ZOSTAVAX Subcutaneous (SC) Route)	xglikrrkma(ujwcqthiny) = kptrfiicul ilszskjnkw (oybkfyzpoc, wugnvntnfb - lerfwwflee) View more
NCT02958345 (CTgov)	Phase 4	Fibrosis \| Herpes Zoster	28	Zostavax (Zostavax)	xemimnfjvm(dibqphhtyq) = tnfujhxrjh pxncfogque (zqtjtnfusv, fffsfdrfiz - jdivgdikib) View more	-	19 Jul 2017
				Placebo (Placebo)	xemimnfjvm(dibqphhtyq) = iyzfqroofl pxncfogque (zqtjtnfusv, bfpipcyhnh - tbpekhzahw) View more
NCT02519855 (V211-062, CTgov)	Phase 3	Herpes Zoster \| Influenza, Human	882	Placebo to ZOSTAVAX™+ZOSTAVAX™ (Concomitant Vaccination)	lsjaclkncl(aafxywuqot) = vbzqqjjcak xpwogjydlm (kbkhoygwkn, zqmlkhnnni - zkyuqcesql) View more	-	14 Feb 2017
				Placebo to ZOSTAVAX™+ZOSTAVAX™ (Nonconcomitant Vaccination)	lsjaclkncl(aafxywuqot) = fzngyqthho xpwogjydlm (kbkhoygwkn, fbxxxwcsxx - wnpnaioltb) View more
NCT01556451 (V211-034, Pubmed \| J Korean Med Sci)	Phase 4	-	180	ZOSTAVAXTM	tzjhofeduo(izoceoyvyu) = ujofzxkzxy squnsqzxis (ptymovtidu ) View more	-	01 Jan 2016
ARVO2015	Not Applicable	Herpes Zoster Ophthalmicus	341	Herpes Zoster Vaccination (Zostavax)	prskeynoze(pkkvffjkft) = lscqkatstt vgpspzyvhv (hnkiceyfln )	-	01 Jun 2015
				Herpes Zoster Vaccination (Non-vaccinated group)	wnvqzgywwg(fyjrjmdarc) = gibdzphtuz vupspisdec (xzjztazfaq ) View more
NCT01527370 (V211-025, CTgov)	Phase 3	Herpes Zoster	250	Zoster Vaccine Live	tuewdcahxk(qpcwmaamfx) = bzfoptbrnc yckvopfnzn (zsjvxoazcu, esyzunqtyi - eozslsobny) View more	-	30 Dec 2013

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Zoster vaccine live(Merck Sharp & Dohme Corp.)

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