A Phase 3a, Open-Label, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of Intramuscular Administration of an Investigational Varicella Vaccine and Priorix Compared With Subcutaneous Administration of Varivax and Priorix, When Given as a First Dose to Healthy Children 12 to 15 Months of Age

This study aims to assess the immune response and safety of GSKs candidate chickenpox and marketed MMR vaccines when given to children 12 to 15 months of age via a muscle injection. It compares the GSK vaccines to Mercks chickenpox vaccine, administered just under the skin, to determine which method is more effective. Additionally, the study will evaluate the immune response and safety of giving the GSK vaccines along with other childhood vaccines through a muscle injection.

Start Date21 Apr 2025

Sponsor / Collaborator

GSK Plc

NCT06824181

/ RecruitingPhase 3

A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, 4-arm Study to Investigate the Mixed Vaccination Schedules of a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers

This study is a Phase 3, randomized, modified double-blind study which aims to measure whether the investigational pneumococcal conjugate vaccine PCV21 is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) when it is given after 1 dose, 2 doses, or 3 doses of a licensed 20-valent pneumococcal vaccine compared to when 20-valent pneumococcal vaccine is given as a complete series in infants aged from approximately 2 months (42 to 89 days).
The study duration per participant will be up to approximately 19 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 to 15 months of age (MoA). Routine pediatric vaccines will be given as per local recommendations.
There will be 6 study visits:
Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age until 15 months of age, V06 separated from V05 by 30 days.

Start Date27 Feb 2025

Sponsor / Collaborator

Sanofi

CTRI/2024/11/077318

/ Not yet recruitingPhase 4

A phase IV, double blind, randomized, active control clinical studycomparing safety and immunogenicity of SII-Measles-Mumps-Rubella vaccine with PRIORIX (GSK) in healthy infants in India - MMR01/23

Start Date10 Dec 2024

Sponsor / Collaborator

Serum Institute of India Pvt Ltd.

100 Clinical Results associated with Measles, Mumps and Rubella Vaccine(GlaxoSmithKline Plc)

100 Translational Medicine associated with Measles, Mumps and Rubella Vaccine(GlaxoSmithKline Plc)

100 Patents (Medical) associated with Measles, Mumps and Rubella Vaccine(GlaxoSmithKline Plc)

105

Literatures (Medical) associated with Measles, Mumps and Rubella Vaccine(GlaxoSmithKline Plc)

01 Jan 2023·Dermatology (Basel, Switzerland)

Intralesional Measles, Mumps, Rubella Vaccine versus Tuberculin Purified Protein Derivative Injections in the Treatment of Palmoplantar and Periungual Warts: A Double-Blind Randomized Controlled Trial

Article

Author: Anuntrangsee, Tanaporn ; Pomsoong, Cherrin ; Kositkuljorn, Chaninan ; Rutnin, Suthinee ; Thadanipon, Kunlawat ; Namasondhi, Amornrut

Background: Palmoplantar and periungual warts tend to be recalcitrant. Intralesional immunotherapy can provide high efficacy with additional benefit to distant warts. However, evidence on comparative effects between intralesional immunotherapy with measles, mumps, rubella vaccine (MMR) and tuberculin purified protein derivative (PPD) and roles of dermoscopy in predicting treatment outcomes in palmoplantar/periungual warts is limited. Objectives: The study aimed to compare efficacy and safety of intralesional MMR and PPD injections in treatment of palmoplantar/periungual warts and explore associations between dermoscopic findings and treatment outcomes. Methods: We conducted a double-blind randomized controlled trial involving 40 patients with palmoplantar/periungual warts who were equally assigned to receive MMR or PPD. Intralesional injection was done every 2 weeks until clearance or maximum of 5 treatments. Results: Complete resolution was higher in MMR than PPD group (90.0% vs. 80.0% in index lesion and 81.3% vs. 54.6% in distant lesions, respectively), although the differences were statistically nonsignificant. Dermoscopic findings were not significantly associated with complete resolution. Local swelling, i.e., the most common adverse event, occurred more frequently in PPD (40.0%) than MMR group (10.0%). Conclusion: This study suggests that intralesional immunotherapy with either MMR or PPD is efficacious in palmoplantar/periungual warts, with MMR showing a trend toward higher clearance and lower adverse events.

01 Dec 2022·Public health in practice (Oxford, England)

Design and implementation of tailored intervention to increase vaccine acceptance in a Somali community in Stockholm, Sweden - based on the Tailoring Immunization Programmes approach

Article

Author: Kulane, Asli ; Rubin, Johanna ; Godoy-Ramirez, Karina ; Habersaat, Katrine Bach ; Lindstrand, Ann ; Nejat, Sahar ; Appelqvist, Emma ; Jama, Asha ; Karregård, Susanne ; Jackson, Cath ; Butler, Robb

Objectives:

Sweden has had a high and stable vaccination coverage for measles-mumps-rubella (MMR) vaccine (>96%) through the national immunization program (NIP), but coverage rates highlight local pockets of lower vaccination coverage. This project addressed low MMR vaccine acceptance among parents in a Somali community, in Stockholm. The objective of the intervention was to increase vaccine confidence and MMR-vaccine uptake and also to inform practices addressing vaccine acceptance.

Study design:

This paper describes the design and implementation of a multi-component intervention based on the Tailoring Immunization Programmes (TIP) approach, developed by the WHO European Regional Office.

Methods:

The theoretical underpinning of TIP is the Capability, Opportunity, and Motivation Model (COM-B model) and Behaviour Change Wheel framework (BCW), adapted for vaccination. The COM-model was used to identify barriers and drivers to vaccination and intervention types. The TIP-phases described in this paper are: pre-TIP (planning), three succeeding TIP phases (situational analysis, formative research, intervention design) and the post-TIP phase (implementation).

Results:

The situation analysis and formative research revealed that parents feared the MMR vaccine due to autism or that their child would stop talking following vaccination, despite lack of scientific evidence for an association between autism and MMR vaccines. Barriers were linked to their associated COM-B factors and mapped to appropriate intervention types for two target groups: Somali parents and nurses at the Child Health Centres (CHC). Selected intervention types targeting parents were education, persuasion and modelling whereas education and training were selected for CHC nurses. The intervention activities included community engagement for parents, while the activities for nurses focused on improving encounters and dialogue with parents having low vaccine acceptance. Following the intervention design the activities were developed, pilot tested and implemented.

Conclusion:

This study confirm that the TIP approach is valuable for guiding a stepwise working process for a thorough understanding of barriers and drivers for MMR vaccination among parents in this Somali community. It facilitated the design of a theory and evidence-informed intervention targeting parents and nurses.

01 Nov 2021·The Pediatric infectious disease journalQ4 · MEDICINE

Evaluation of the Safety and Immunogenicity of M-M-RII (Combination Measles-mumps-rubella Vaccine)

Q4 · MEDICINE

Review

Author: Nyaku, Mawuli ; Richardson, Elizabeth ; Kuter, Barbara J ; Martinon-Torres, Federico

Background::

The safety and immunogenicity of M-M-RII (measles, mumps and rubella virus vaccine live, Merck & Co., Inc., West Point, PA)—the only combined measles, mumps and rubella vaccine licensed for use in the United States—were previously reported in pre- and postlicensure clinical trials conducted from 1988 to 2009. M-M-RII continues to be evaluated as a comparator in clinical trials of other vaccines. Here, we review safety and efficacy data from more recent clinical trials of M-M-RII.

Methods::

We performed a systematic literature review of trials using M-M-RII published from 2010 to 2019.

Results::

In the 15 studies that met the inclusion criteria, a total of 12,032 subjects were vaccinated: 7667 persons received a first dose only, 2137 participated in 2-dose studies (128 received 1 dose and 2009 received both) and 2063 received a single dose of M-M-RII as their second dose. Dose number was not specified for 165 participants, ≥6 years old, in 2 studies in which a single dose of M-M-RII was administered. Similar to previous reports, M-M-RII was well tolerated and immunogenic when administered alone or concomitantly with other routinely recommended vaccinations. The most common adverse events included transient injection site pain and fever. Serious adverse events were extremely rare, with only 4 probable or potential vaccine-related events reported among the 12,032 participating subjects.

Conclusions::

In trials published from 2010 to 2019, M-M-RII continued to be safe and immunogenic in all age groups studied. These data, along with the results of earlier trials, indicate that the performance of the vaccine has been consistent across more than 30 years of postlicensure studies.

News (Medical) associated with Measles, Mumps and Rubella Vaccine(GlaxoSmithKline Plc)

08 Apr 2025

·www.fiercepharma.com

RFK Jr. promotes measles vaccine as Texas outbreak continues

Both Merck and GSK make measles, mumps and rubella (MMR) vaccines in the U.S., crucial offerings as a measles outbreak in Texas continues. Following a second measles-related death in Texas, Robert F. Kennedy Jr., head of the federal Department of Health and Human Services, endorsed the measles, mumps, and rubella (MMR) vaccine in a lengthy social media post—seemingly reversing some of his previous comments about vaccines and the outbreak.“The most effective way to prevent the spread of measles is the MMR vaccine,” RFK Jr. wrote on the social media website X on April 6. Both children who died during the recent measles outbreak were unvaccinated, according to Texas officials.The current outbreak is centralized in Texas, with 499 of the 642 confirmed U.S. measles cases coming from the state as of April 6, according to RFK Jr. In March, the health secretary deployed a CDC team to "bolster local and state capacity" for responding across multiple regions in Texas, supply pharmacies with MMR vaccines, and support schools and facilities with contact investigations and community outreach. CDC teams are now back in Texas at the governor's request. Measles vaccine makers are also on the case.Merck, which brought the first MMR vaccine to the U.S. in the 1970s with its M-M-R II, is “committed to providing help to support the current outbreak response efforts,” a Merck spokesperson said in a statement to Fierce Pharma. The company is focused on ensuring the availability of its vaccine for “those who need it most,” and it is “closely monitoring the situation” including outbreak trends and the potential demand for its MMR vaccine.“Based upon current known demand, there is an adequate supply of Merck’s M-M-R II vaccine to support appropriate vaccination of eligible patients,” the company representative said. “Adherence to recommended pediatric vaccination schedules and regular health visits is critical to protecting public health and mitigating outbreaks of these preventable diseases."Since the MMR vaccines were introduced, measles cases have substantially declined in the U.S. The latest outbreak has already resulted in more cases than the total reported in all of 2024, when 285 measles cases were documented. The measles spread hit a high in 2019 with 1,274 cases reported, but quickly quelled in 2020 with just 13, according to the CDC.For context, measles in the U.S. peaked at over 27,000 reported cases in 1990 before the widespread implementation of MMR vaccine. Two doses of the MMR vaccine are proven to be 97% effective against measles. Still, measles vaccination rates for young children are steadily decreasing, according to a recent report by Truveta Research. RFK Jr. has previously held a questionable stance on the MMR vaccine, telling Fox News’ Sean Hannity in early March that the measles vaccine “wanes” for some people and that the measles infection itself offers “lifetime immunity.” He further noted that the MMR vaccine “causes deaths every year” and “all the illnesses that measles itself causes,” CNN reported from the Fox interview.According to the CDC, serious risks of MMR vaccination are rare. There is a “very remote chance” of the vaccine causing a severe allergic reaction, serious injury or death, the CDC points out.Along with promoting the MMR vaccine, RFK Jr. has touted alternative regimens that include aerosolized budesonite and clarithromycin. Hours after writing his recent X post, the health secretary also pointed to two “extraordinary healers” in a separate post who have “treated and health some 300 measles-stricken Mennonite children” using the alternative treatment. There is currently no FDA-approved treatment or cure for measles, but vitamin A has been recommended for treating severe cases.Merck’s family of measles vaccines includes a ProQuad shot, which lumps chicken pox (varicella) protection into an MMR vaccine (MMRV). The company’s MMRV vaccine franchise brought in $2.5 billion in 2024, reflecting sales slightly up from 2023.GSK also markets Priorix, another MMR vaccine. The drugmaker brought its offering to the U.S. in 2022 after introducing it years ago in Europe, adding a key option to the country’s MMR arsenal. Priorix and M-M-R II are both recommended by the CDC’s vaccine committee for routine vaccination.

VaccineClinical Study

24 Jan 2025

·www.drugs.com

COVID Vaccine Hesitancy Reducing Childhood Vaccinations

FRIDAY, Jan. 24, 2025 -- Hesitancy over the COVID-19 vaccine is leading some parents to skip important vaccinations for their children. Young children of parents who declined the COVID vaccine are about 25% less likely to get the standard measles/mumps/rubella (MMR) vaccine, researchers reported in a new study published recently in the American Journal of Public Health . Public health officials are worried that a decline in vaccine coverage will cause an increase in highly contagious childhood diseases like measles . Last year, 16 measles outbreaks were reported, compared with four outbreaks reported in 2023, according to the U.S. Centers for Disease Control and Prevention (CDC). “In the United States, we are experiencing a concerning resurgence of childhood vaccine-preventable diseases,” researcher Dr. Ben Rader , a computational epidemiologist with Boston Children’s Hospital, said in a news release. “Our research suggests that COVID-19 vaccine hesitancy has fueled increasing MMR vaccine hesitancy, leaving children more vulnerable to highly contagious and life-threatening illnesses like measles,” he added. For the study, researchers analyzed responses from nearly 20,000 parents of children younger than 5 to a digital health survey conducted from July 2023 to April 2024. Children of parents who got at least one COVID jab had higher MMR vaccination rates -- nearly 81%, compared to just under 61% for children of unvaccinated parents, researchers found. Politics also played a role in childhood vaccinations. Republican parents were 27% less likely to have their kids get the MMR vaccine than Democratic parents. “Our research highlights the link between parental characteristics and MMR vaccine uptake, showing how pandemic-related hesitancy may affect other routine vaccines,” lead researcher Eric Zhou , a pediatrics instructor at the Icahn School of Medicine at Mount Sinai in New York City, said in a news release. Overall, MMR vaccination rates were higher in the Midwest and Northeast than in the South or West. Parents on Medicare or Medicaid were about 15% less likely to have their kids get the MMR jab than parents with private insurance, results show. “Addressing these disparities, through equitable access and fostering trust and transparency in vaccine safety, is key to protecting children from preventable diseases like measles,” Zhou concluded. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Vaccine

02 Dec 2024

·endpts.com

Scott Gottlieb says he’s against RFK Jr. for HHS: ‘It will cost lives in this country’

Former FDA Commissioner Scott Gottlieb opposed President-elect Donald Trump’s choice to lead the Department of Health and Human Services, saying Robert F. Kennedy Jr.’s policies would lead to a resurgence of preventable diseases and cost lives. Gottlieb led the FDA in the first Trump administration. In comments on CNBC Friday, he called Kennedy (widely known as RFK Jr.) a “committed” anti-vaccine advocate who, if confirmed by the Senate, could easily take steps to decrease the use of vaccines in the US. “I have deep concerns about Kennedy’s stated intentions to roll back core public health protections, particularly as it relates to childhood vaccines,” Gottlieb said. “I think if RFK follows through on his intentions, and I believe he will and I believe he can, it will cost lives in this country.” He said he had raised his objections with Republican senators who will vote on the selection of Kennedy, who Trump announced last month . Trump’s pick of Kennedy has been followed by a series of announcements that would put skeptics of longstanding US healthcare and public health policy in positions of power. Along with Kennedy, that includes Trump’s choice to lead the National Institutes of Health (Stanford researcher and Covid policy skeptic Jay Bhattacharya) and the CDC (former congressman Dave Weldon). While in Congress, Weldon pushed for significant changes to vaccine policy that have been sought by vaccine skeptics. Kennedy has questioned the use of childhood vaccines for years, attempting to link them to the rise of autism and raising other questions about their safety. While his remarks on his exact plans have shifted over time, at their core is the idea that he wants to push away from a policy of vaccine requirements — meant to create widespread immunity and protect those who can’t be vaccinated or who have immune issues — and create a policy of individual choice. “I’m not going to take away anybody’s vaccines,” Kennedy said in a television interview last month. “People can make individual assessments about whether that product is good for them.” The Trump transition team didn’t immediately respond to a request for comment. Gottlieb in particular warned about a resurgence of measles, a highly infectious disease that can be deadly in young children. Vaccination rates of the measles, mumps and rubella (MMR) vaccine have fallen in some parts of the country, and been followed by occasional outbreaks. Nationally, kindergarten vaccination rates are around 92% with two doses of MMR vaccine, according to a CDC study published this year . But in some states, they are far lower. In Idaho, only about 80% of children have received the vaccine. In Wisconsin, the rate is 85%. Those rates are below the 95% target the CDC says is a benchmark for creating population-level immunity to the disease. “If we lose another 5%, we’re going to see a situation where we see distributed outbreaks,” Gottlieb said. “What I worry about is that we’re at a tipping point where we’re going to see epidemics of diseases that have long been vanquished.”

Vaccine

100 Deals associated with Measles, Mumps and Rubella Vaccine(GlaxoSmithKline Plc)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	J07BX	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Measles	United States	GlaxoSmithKline LLC	03 Jun 2022
Mumps	United States	GlaxoSmithKline LLC	03 Jun 2022
Rubella	United States	GlaxoSmithKline LLC	03 Jun 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Haemophilus Infections	Phase 3	Australia	GSK Plc	01 Jun 2006
Meningitis	Phase 3	Australia	GSK Plc	01 Jun 2006
Chickenpox	Phase 3	Austria	GSK Plc	01 Jul 2004
Chickenpox	Phase 3	Germany	GSK Plc	01 Jul 2004
Hepatitis A	Phase 2	United States	GSK Plc	03 Jun 2009
Hepatitis A	Phase 2	Puerto Rico	GSK Plc	03 Jun 2009

Clinical Result

Indication

Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00226499 (CTgov)	Phase 3	Rubella \| Mumps \| Measles ... View more	5,803	Priorix-tetra™ (MMRV Group)	qbwgwcyyum = xbzkmyddob dkzwfwqspp (gfabyjwbrd, ayzomdbnsp - wsbmidbqdl) View more	-	23 Sep 2019
				Varilrix™+Priorix™ (OKAH Group)	qbwgwcyyum = lgbriyrmoh dkzwfwqspp (gfabyjwbrd, ogwygojlid - jgjlonoowc) View more
NCT01681992 (CTgov)	Phase 3	Rubella \| Mumps \| Measles	4,538	Priorix+Varivax+Havrix+Prevnar 13 (Inv_MMR_Min Group)	xgsxiqfwzn = rpjgmgtpaw lxjdbratng (rmsbmyzikm, nlnpwwlnfs - zbuyionxtm) View more	-	17 Aug 2018
				Priorix+Varivax+Havrix+Prevnar 13 (Inv_MMR_Med Group)	xgsxiqfwzn = qepbyasvqb lxjdbratng (rmsbmyzikm, uoynsfavyl - ekocawqefz) View more
NCT02184572 (CTgov)	Phase 3	Rubella \| Mumps \| Measles	1,742	Priorix+Varivax+Havrix+Prevnar 13 (INV_MMR)	ejztpvhxep = ykvzwmdemy cagtzlfjfq (sartgnqggw, jppmkypgtb - sbysbvcpxv)	-	03 Jul 2018
				Varivax+Havrix+Prevnar 13+M-M-R II (COM_MMR)	ejztpvhxep = kenatcmlyu cagtzlfjfq (sartgnqggw, qtiuzilelp - xeemijvfgx)
NCT00969436 (CTgov)	Phase 3	Rubella \| Mumps \| Measles ... View more	450	GSK Biological's investigational MMRV vaccine 208136 (Priorix-Tetra Group)	rbdnqmaepp = hqikoekuik axubsklmkn (quqjqhjxre, lmwmkvjqcp - jdsxyiagsv) View more	-	25 Sep 2017
				GSK Biological's investigational MMRV vaccine 208136+Priorix™ (Priorix/ Priorix-Tetra Group)	rbdnqmaepp = ioltthjgvw axubsklmkn (quqjqhjxre, cbllzwchzg - wpbqvyqyey) View more
NCT01621802 (CTgov)	Phase 3	Rubella \| Mumps \| Measles	4,011	ProQuad+Kinrix+M-M-R II (Com_MMR_CO Group)	yweukaqpmy = sexmvyxuyy adjapxtgtp (hyrlsyxsps, kvneltrjsq - ruhvdipgaz) View more	-	13 Sep 2017
				Priorix (Inv_MMR_I Group)	yweukaqpmy = smxagtqcug adjapxtgtp (hyrlsyxsps, ujdbhbgtju - wbenqkffnr) View more
NCT02058563 (CTgov)	Phase 3	Rubella \| Mumps \| Measles	996	Priorix® (INV_MMR Group)	ydfwlixfzy(reckbeqsje) = mfxxpjgjfz mvcnvgdvqh (fleowbmpsy, lahiqsompb - hjpofcihrz) View more	-	10 Apr 2017
				Merck's M-M-R®II, Measles, Mumps, (COM_MMR Group)	ydfwlixfzy(reckbeqsje) = pchjqssdxs mvcnvgdvqh (fleowbmpsy, xpdfworxgc - sgmpyewpfm) View more
NCT00381615 (CTgov)	Phase 2	-	147	rMenB+DTaP-Hib-IPV+MenC-CRM+MMR+MenC-Hib+PC7 (rMenB)	anbwwebrmv = gbsjgyymxm gfevuzcfeg (jbtbaczkup, ktuebovqtq - qsvgamtgrw) View more	-	09 Oct 2015
				DTaP-Hib-IPV+rMenB+OMV+MenC-CRM+MMR+MenC-Hib+PC7 (rMenB+OMV)	anbwwebrmv = wguhxlompf gfevuzcfeg (jbtbaczkup, nejnxvmcsb - lnnalsftyi) View more
NCT00861744 (CTgov)	Phase 2	Hepatitis A \| Rubella \| Mumps ... View more	1,259	GSK Biological's investigational vaccine 209762+Varivax®+Havrix®+Prevnar® (Priorix 1 Group)	xedwfgktvz = atngrzhalu lqjbvryhdk (ugvsdofckh, jxeumoogur - aviapthedh) View more	-	04 Nov 2011
				GSK Biological's investigational vaccine 209762+Varivax®+Havrix®+Prevnar® (Priorix 2 Group)	xedwfgktvz = fhytoptbhu lqjbvryhdk (ugvsdofckh, nwskqljuaa - idlsxomtoa) View more
NCT00326118 (CTgov)	Phase 3	Meningitis \| Haemophilus Infections	433	Priorix™+Haemophilus influenzae type b (Menitorix Group)	zurttgxxqr = prdawhiihm qdooshwfpn (pwxmmrajru, jelkvpirfk - jaerradxqy) View more	-	23 Oct 2009
				Hiberix™+Priorix™+Meningitec™ (Meningitec + Hiberix Group)	zurttgxxqr = alfmxvnabg qdooshwfpn (pwxmmrajru, nhncdoacyy - qikpgpocgi) View more

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Measles, Mumps and Rubella Vaccine(GlaxoSmithKline Plc)

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