A comparative use-result survey by test-negative case-control study for evaluation the effectiveness of FluMist intranasal spray in preventing influenza over time - A comparative use-result survey by test-negative case-control study for evaluation the effectiveness of FluMist intranasal spray in preventing influenza over time

Start Date01 Jan 2025

Sponsor / Collaborator-

NCT06501963 / RecruitingPhase 4IIT

Revealing Protective Immunity to Influenza Using Systems Immunology

The goals of this study are to better understand the human immune response to influenza vaccines, specifically the live attenuated (weakened) influenza vaccine given as a nasal spray. Better understanding why this vaccine does not work as well in adults as it does in children may help design better influenza vaccines.

Start Date14 Oct 2024

Sponsor / Collaborator

Emory University

[+1]

JPRN-jRCT2031240117 / SuspendedNot ApplicableIIT

Use-result survey of FluMist intranasal spray

Start Date01 Sep 2024

Sponsor / Collaborator-

100 Clinical Results associated with Influenza virus vaccine live intranasal (quadrivalent)(MedImmune LLC)

100 Translational Medicine associated with Influenza virus vaccine live intranasal (quadrivalent)(MedImmune LLC)

100 Patents (Medical) associated with Influenza virus vaccine live intranasal (quadrivalent)(MedImmune LLC)

585

Literatures (Medical) associated with Influenza virus vaccine live intranasal (quadrivalent)(MedImmune LLC)

31 Dec 2024·Human Vaccines & Immunotherapeutics

Predictors of parental acceptance to live attenuated influenza vaccine for children

Article

Author: He, Wei ; Qu, Shujuan ; Campy, Kathryn S ; Zhou, Min

To determine the influencing factors of Chinese parents' intention and behavior for children to receive live attenuated influenza vaccine during the 2022-2023 influenza season. A theoretical model was developed and included seven constructs, and structural equation modeling was used to test 11 hypotheses. From October 2022 to December 2023, a survey was conducted across 38 medical institutions in four Chinese cities and their subordinate districts, counties, and rural areas. Parents who accompanied their children for vaccinations were selected through a randomization process based on their child's medical card numbers. Measures were taken to minimize method bias, including a diverse geographical representation and random sampling. The survey resulted in the collection of 936 valid responses, exceeding the recommended sample size for structural equation model analysis and providing robust statistical inferences. During the study period, 936 respondents were included in the study. Perceived ease of use was verified to be a predictor of perceived usefulness and perceived value. Perceived usefulness was verified as a predictor of perceived value and behavioral intention. Knowledge was a significant antecedent of perceived value and risk perception of influenza disease. Risk perception of influenza disease was proved to be a significant predictor of perceived value and self-reported vaccination behavior. Perceived value significantly affected behavioral intention, and behavioral intention significantly affected self-reported vaccination behavior. Six demographic variables significantly moderate the theoretical models. The low vaccination coverage of live attenuated influenza vaccine (LAIV) among children in China suggests a need for a deeper understanding of the factors that influence vaccination rates. Particularly, effective strategies are necessary from policymakers and practitioners to elevate childhood LAIV coverage.

01 Oct 2024·CANCER RESEARCH

A Prime-Boost Vaccination Approach Induces Lung Resident Memory CD8+ T Cells Derived from Central Memory T Cells That Prevent Tumor Lung Metastasis

Article

Author: Tam, Rachel Chun-Yee ; Yue, Ming ; Chen, Bohao ; Chen, Zhiwei ; Wang, Pui ; Huang, Huarong ; Wong, Michael Yik-Chun ; Huang, Haode ; Chen, Honglin ; Liu, Li ; Du, Zhenglong ; Song, Youqiang ; Wang, Jinlin ; Zhou, Biao ; Xu, Haoran ; Tan, Zhiwu ; Zhou, Runhong ; Yuen, Kwok-Yung ; Mo, Yufei

Abstract:

Memory T cells play a key role in immune protection against cancer. Vaccine-induced tissue-resident memory T (TRM) cells in the lung have been shown to protect against lung metastasis. Identifying the source of lung TRM cells can help to improve strategies, preventing tumor metastasis. Here, we found that a prime-boost vaccination approach using intramuscular DNA vaccine priming, followed by intranasal live-attenuated influenza-vectored vaccine (LAIV) boosting induced higher frequencies of lung CD8+ TRM cells compared with other vaccination regimens. Vaccine-induced lung CD8+ TRM cells, but not circulating memory T cells, conferred significant protection against metastatic melanoma and mesothelioma. Central memory T (TCM) cells induced by the DNA vaccination were major precursors of lung TRM cells established after the intranasal LAIV boost. Single-cell RNA sequencing analysis indicated that transcriptional reprogramming of TCM cells for differentiation into TRM cells in the lungs started as early as day 2 post the LAIV boost. Intranasal LAIV altered the mucosal microenvironment to recruit TCM cells via CXCR3-dependent chemotaxis and induced CD8+ TRM-associated transcriptional programs. These results identified TCM cells as the source of vaccine-induced CD8+ TRM cells that protect against lung metastasis.Significance: Prime-boost vaccination shapes the mucosal microenvironment and reprograms central memory T cells to generate lung resident memory T cells that protect against lung metastasis, providing insights for the optimization of vaccine strategies.

01 Oct 2024·VACCINE

Syncope after live attenuated influenza vaccine: Reports to the Vaccine Adverse Event Reporting System (2003–2024)

Article

Author: Miller, Elaine R ; Stroud, Erin ; Woo, Emily Jane ; Miller, Elaine R.

Vasovagal syncope, or fainting, can be triggered by various stimuli, including medical procedures. Syncope after vaccination has been reported, most commonly among adolescents, and can result in injuries. Using the Vaccine Adverse Event Reporting System (VAERS), we reviewed and summarized reports of syncope after live attenuated influenza vaccine, intranasal (LAIV) administered as the sole vaccine (i.e., no concomitant injections). From June 17, 2003 (date of LAIV licensure in the US) through May 31, 2024, VAERS received 50 reports of syncope after LAIV. Nearly half (23; 46 %) pertained to individuals 10-19 years of age. While the vast majority of reports (35; 70 %) did not describe any injuries, 15 people (30 %) were injured, most commonly by falling and hitting their head or face. Twenty-two people (44 %) required evaluation in the emergency department or doctor's office, including an individual who lost consciousness while he was driving home from the vaccination appointment. He did not report any injuries, but the car was severely damaged. Nearly three-quarters of people (37; 74 %) developed syncope within 15 min after vaccination, but fewer than half of reports (24; 48 %) stated that the patient had waited in the observation area for at 15 min. Based on approximately 111.9 million doses of LAIV distributed in the US during the same time period, the reporting rate is approximately 0.4 per million doses, suggesting that syncope following LAIV is rare. The information summarized here may enable clinicians, patients, and caregivers to make a more informed decision regarding preventing injuries that may occur following LAIV-related syncope.

News (Medical) associated with Influenza virus vaccine live intranasal (quadrivalent)(MedImmune LLC)

27 Sep 2024

·www.prnewswire.com

Weekly Recap: 13 Health Press Releases You Might Have Missed

A roundup of the most newsworthy healthcare press releases from PR Newswire this week, including the first nasal spray flu vaccine, upcoming disease awareness campaigns and more. NEW YORK, Sept. 27, 2024 /PRNewswire/ -- With thousands of press releases published each week, it can be difficult to keep up with everything on PR Newswire. To help healthcare journalists and consumers stay on top of the week's most newsworthy and popular releases, here's a recap of some major stories from the week that shouldn't be missed. The list below includes the headline (with a link to the full text) and an excerpt from each story. Click on the press release headlines to access accompanying multimedia assets that are available for download. Continue Reading PR Newswire Weekly Health Press Release Roundup, Sept. 23-27, 2024. Photo provided by ASICS. FDA Approves Nasal Spray Influenza Vaccine for Self- or Caregiver-Administration The U.S. Food and Drug Administration (FDA) approved FluMist for the prevention of influenza disease caused by influenza virus subtypes A and B in individuals 2 through 49 years of age. The vaccine is sprayed into the nose and has been used safely and effectively for many years. Nearly Two-Thirds of Americans Fear Medicare Will Not Be There When They Need It "Concerns about the future of Medicare are adding another layer of uncertainty for Americans as they consider how they'll manage health care costs in retirement," said Kristi Martin Rodriguez, senior vice president of the Nationwide Retirement Institute. "With high living costs already squeezing household budgets, many are worried about having enough saved to cover their long-term health care." Cardinal Health to Acquire Integrated Oncology Network, a Physician-Led Independent Community Oncology Network The transaction demonstrates Cardinal Health's continued investment in specialty and oncology, adding more than 100 providers at more than 50 community-based sites delivering broad-reaching oncology and urology care across 10 states. ADHD Redefined: ADDitude Honors ADHD Empowerment Month with Groundbreaking Campaign Throughout October, ADDitude will highlight a new definition of ADHD each day, sharing inspiring stories of readers who have contributed their personal experiences. The campaign will also feature exclusive profiles of prominent figures in the ADHD community, including novelist Rebecca Makkai, stand-up comedian Rachel Feinstein, and illustrator Hayley Wall, who explain how ADHD shaped their creativity and careers. Halle Berry's Respin and Menopause Pioneer Joylux Announce Strategic Partnership to Advance Intimate Health & Wellness Halle Berry is a passionate advocate for women's health, especially concerning menopause. The collaboration marks a significant milestone for Respin and Joylux as they work together to destigmatize the taboo of intimate health with science-backed solutions that empower women to take control of their health. Hear Powerful Stories of Individuals Living with Familial Hypercholesterolemia in ABC's "Family Heartbeats Unmasked" The new campaign from the Association of Black Cardiologists (ABC) is dedicated to raising awareness about Familial Hypercholesterolemia (FH), a genetic condition that significantly increases the risk of early heart disease and is often underdiagnosed, especially in Black Americans and other minority populations. Flex Confirms Period Discs and Cups Are Free from Harmful Metals and PFAS Amid Concerns Over Toxic Chemicals in Tampons Flex announced that independent third-party lab testing confirmed all Flex menstrual discs and cups are free from harmful PFAS (forever chemicals), lead, arsenic, cadmium, and mercury. This follows the FDA's recent decision to investigate toxic metals found in tampons, fueling discussions about the need for more research and innovation in menstrual health. Brian Cox Warns the World About Workplace Mental Health Threat in PSA for ASICS In the PSA, Brian Cox plays the role of the world's scariest boss to highlight the silent threat to our mental health—the desk we work at every day. The PSA calls on office workers to put their mental health first by taking a Desk Break, a short movement break, during the working day. WebMD Announces 2024 Health Heroes: Visionaries Leveraging AI in Medicine "Artificial Intelligence is reshaping healthcare in profound ways, saving lives and improving patient outcomes," said Dr. John Whyte, Chief Medical Officer of WebMD. "This year's Health Heroes are leading the way in AI innovation, and we are honored to recognize their achievements." Bosley and Lumenis Partner to Introduce Breakthrough Hair Loss Solution, FoLix™, to the U.S. The partnership initiates a new era in hair loss treatment by introducing the first FDA-cleared fractional laser solution for hair loss to U.S. customers for the first time, potentially transforming the lives of millions of people affected by hair loss in the U.S. NYU Langone Health Forms New Partnership to Minimize Deaths from Extreme Heat Amid Rising Global Temperatures Project HEATWAVE (Heat Emergency Avoidance Technologies Working to Adapt to Vulnerabilities Equitably), according to its founders, will be the first-ever initiative to combine advanced climate modeling, public health analysis and policy, and medical and technology innovation to study and help reduce heat-related mortality due to climate change. October is Raynaud's Awareness Month Raynaud's phenomenon is a disorder that affects blood vessels, primarily in the fingers and toes, causing them to constrict in response to cold temperatures or stress. This loss of blood flow can result in episodes of numbness, tingling, and color changes in the affected areas. Seelos Therapeutics Announces the Signing of a Material Transfer Agreement with U.S. Army Medical Materiel Development Activity (USAMMDA) to Evaluate SLS-002 for Treatment of PTSD "Approximately 13 million people in the U.S. live with PTSD and there have been no new drugs approved in the last two decades for people suffering the effects of PTSD," said Raj Mehra, Ph.D., Chief Executive Officer of Seelos. "I believe that the inclusion of SLS-002 in this study is due to the robust amount of anecdotal evidence that ketamine has the potential to be an effective therapeutic for the symptoms of PTSD and other related conditions." For more news like this, check out all of the latest health-related releases from PR Newswire. Do you have a health press release to distribute? Sign up with PR Newswire to share your story with the audiences who matter most. Helping Journalists Stay Up to Date on Industry News These are just a few of the recent press releases that consumers and the media should know about. To be notified of releases relevant to their coverage area, journalists can set up a custom newsfeed with PR Newswire for Journalists. Once they're signed up, reporters, bloggers, and freelancers have access to the following free features: Customization: Users can create customized newsfeeds that will deliver relevant news right to their inbox. Newsfeed results can be targeted by keywords, industry, subject, geography, and more. Photos and Videos: Thousands of multimedia assets are available to download and include in a journalist or blogger's next story. Subject Matter Experts: Journalists will have access to ProfNet, a database of industry experts to connect with as sources or for quotes in their articles. Related Resources: Our journalist- and blogger-focused blog, Beyond Bylines, features regular media news roundups, writing tips, upcoming events, and more. About PR Newswire PR Newswire is the industry's leading press release distribution partner with an unparalleled global reach of more than 440,000 newsrooms, websites, direct feeds, journalists and influencers and is available in more than 170 countries and 40 languages. From our award-winning Content Services offerings, integrated media newsroom and microsite products, Investor Relations suite of services, paid placement and social sharing tools, PR Newswire has a comprehensive catalog of solutions to solve the modern-day challenges PR and communications teams face. For 70 years, PR Newswire has been the preferred destination for brands to share their most important news stories across the world. For questions, contact the team at [email protected]. SOURCE PR Newswire WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalVaccine

23 Sep 2024

·www.pharmaceutical-technology.com

FDA approves AstraZeneca FluMist ‘flu vaccine for self-administration

The influenza vaccine can be self-administered by adults up to 49 years or given by a caregiver to those aged two to 17 years. Credit: directorsuwan/Shutterstock. The US Food and Drug Administration (FDA) has approved AstraZeneca ‘s FluMist, a needle-free nasal spray influenza vaccine for self-administration. The approval makes FluMist the only ‘flu vaccine in the US that can be self-administered by adults up to 49 years or given by a caregiver to people aged two to 17 years. A live attenuated influenza vaccine, FluMist has been recommended by the Advisory Committee on Immunization Practices and the American Academy of Pediatrics. Since its initial US approval in 2003, 200 million doses of FluMist have been distributed globally. The new self-administration option will soon allow individuals aged 18 years and above to have FluMist delivered to their homes through the FluMist Home service. See Also: Teva agrees to pay Baltimore City $80m for fuelling opioid epidemic The service will operate via an online pharmacy where eligible people must complete a questionnaire reviewed by a pharmacist before the vaccine is shipped. FluMist will also remain available at medical offices and pharmacies for administration by healthcare professionals. The FDA’s decision was informed by a comprehensive submission, including a usability study that confirmed individuals over 18 years could correctly self-administer FluMist, as well as administer it to eligible persons aged two to 49 years. The study found that 100% of the intended users successfully administered a full dose. Data indicated that the efficacy, immunogenicity and adverse events associated with self-administration of FluMist are comparable to those observed with healthcare professional-administered vaccinations. The FluMist label has been updated to include additional instructions for ordering and self or caregiver administration. However, children aged two to eight years with an uncertain vaccination history may not qualify for caregiver administration and are advised to consult a healthcare provider. AstraZeneca vaccines and immune therapies executive vice-president Iskra Reic stated: “The approval of FluMist for self-administration is an important step forward in making vaccines more accessible to fight the high annual burden of influenza. “For more than 20 years, FluMist has been the only nasal spray ‘flu vaccine licensed in the US and now it is also the only vaccine to help individuals, families and communities access an influenza vaccine conveniently through self and caregiver administration outside of traditional healthcare settings.”

Drug ApprovalVaccineImmunotherapy

23 Sep 2024

·www.echemi.com

FDA Approves AstraZeneca’s Nasal Vaccine: New Self-Administration Rules Raise Safety Concerns, Prohibited for Children and Adolescents!

The U.S. Food and Drug Administration (FDA) announced Friday that it has officially approved AstraZeneca's new label nasal spray flu vaccine, allowing people to self-administer it. This initiative marks the first time in the field of influenza vaccines that can be self-administered by individuals. The FDA says the vaccine, called FluMist, is the first flu vaccine that can be administered without the intervention of a health care provider. The flu is a common infectious respiratory disease caused by the flu virus that usually circulates during the fall and winter months in the United States. This disease not only affects people's health, but also causes a certain burden on the social economy. To counter this, Astrazeneca plans to offer the FluMist vaccine through third-party online pharmacies. Customers are required to complete a series of screening and eligibility assessments at the time of ordering to ensure the safe use of the vaccine. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said the approval provides individuals and families with a new option that makes it more convenient, flexible and easy for them to get the seasonal flu vaccine. Marks stressed that such a move could lead to higher vaccination rates, which would better protect public health. The FluMist vaccine was first approved by the FDA in 2003, when it could only be administered by healthcare providers. The vaccine contains a weakened form of the live flu strain and can be administered by nasal spray. According to the Centers for Disease Control and Prevention (CDC), between 2010 and 2023, influenza causes an estimated 9.3 million to 41 million illnesses, 100,000 to 710,000 hospitalizations, and 4,900 to 51,000 deaths per year. This data highlights the serious threat influenza poses to public health. However, it is important to note that the Food and Drug Administration states that people between the ages of 2 and 17 should not self-administer the FluMist vaccine. People in this age group should be vaccinated under the guidance of a caregiver to ensure the vaccine is safe and effective. This regulation is to ensure that children and adolescents are properly supervised and guided during the vaccination process. If Burundi's MPOC (Organization of People with Multiple Sclerosis) gets enough resources and does enough to combat the stigma associated with the disease, the outbreak could be brought under control in a matter of weeks. This perspective underscores the importance of resources and education in addressing public health issues.

Drug ApprovalVaccine

100 Deals associated with Influenza virus vaccine live intranasal (quadrivalent)(MedImmune LLC)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	J07BB03	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Influenza, Human	EU	AstraZeneca AB	04 Dec 2013
Influenza, Human	IS	AstraZeneca AB	04 Dec 2013
Influenza, Human	LI	AstraZeneca AB	04 Dec 2013
Influenza, Human	NO	AstraZeneca AB	04 Dec 2013
Influenza A virus infection	US	MedImmune LLC	17 Jun 2003
Influenza B virus infection	US	MedImmune LLC	17 Jun 2003

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Influenza-like symptoms	Phase 3	JP	AstraZeneca PLC	01 Oct 2014
Chronic Disease	Phase 3	US	MedImmune LLC	01 Aug 2009

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03982069 (CTgov)	Phase 4	Influenza, Human	465	FluMist live attenuated influenza vaccine (FluMist Live Attenuated Influenza Vaccine)	pxedyvwaox(josqcqtdru) = ggagwpimgi bqhsnguyva (uqirwvguka, wdcfykneuv - akpghmkcvw) View more	-	14 Oct 2021
				Flucelvax inactivated influenza vaccine (Flucelvax Inactivated Influenza Vaccine)	pxedyvwaox(josqcqtdru) = uhyfkqbtgh bqhsnguyva (uqirwvguka, xylojujyll - gexdvntjqc) View more
ASCO2019	Not Applicable	-	540	Flu vaccination (Patients on ICI)	lkfzkiknfx(pgtfkfbqlh) = tqzlehehcp kirgavswsy (qwytxrffbu )	-	26 May 2019
				Flu vaccination (Patients on non-ICI modalities)	lkfzkiknfx(pgtfkfbqlh) = liqlylduwk kirgavswsy (qwytxrffbu )
NCT03028974 (CTgov)	Phase 4	Influenza, Human	77	FluMist® (Group A: 2-4 yo LAIV4 (Return))	bcmnppnllv(txgjiuvpur) = ospdejabcu rqbrjatzov (kqxaquywuv, rhkefqhyrm - ivefunsrmx) View more	-	14 Dec 2018
				Fluzone® (Group E: 6 - 23 Mos Old IIV4 (Single Yr))	meianaxbmr(btytbvfrfj) = tpnpgrhvvd cwdbnaqppl (ewaathjbxd, annkntssma - lwtscsebab) View more
NCT02474901 (QLAIV, CTgov)	Phase 2	HIV Infections \| Influenza, Human	101	Quadrivalent Live Attenuated Influenza Vaccine (QLAIV, HIV-infected)	vbtvgnsfwm(stqpzmcgrd) = phnnmiberu tkgcuchsvi (btfgvgiosk, msfpgrzzhi - pdvjbtocge) View more	-	16 Oct 2017
				Quadrivalent Live Attenuated Influenza Vaccine (QLAIV, HIV-uninfected)	vbtvgnsfwm(stqpzmcgrd) = wnfwhsozdn tkgcuchsvi (btfgvgiosk, jqzblgvgsh - bjidpacbdr) View more
NCT03028987 (CTgov)	Phase 4	Influenza, Human	10	FluMist® (LAIV Randomized)	ppxgxrftxe(yyvifwxbol) = hxxgelvbtg ixsloubbwm (fcwsqjytfb, jexkqxtzet - ljpzaagazz) View more	-	12 Sep 2017
				Fluzone® (IIV4 Randomized)	ppxgxrftxe(yyvifwxbol) = hqndikykfh ixsloubbwm (fcwsqjytfb, wqrstpzvex - caeaowgqwn) View more
NCT01933048 (SNIF, CTgov)	Phase 4	Influenza, Human	1,077	FluMist (Healthcare Worker Administration)	cuhkybavle(rxqlcnyvcb) = svfquyfyet glafvkzgvp (hglbwswrjn, stchofrymw - jsmkbypdgj) View more	-	12 Sep 2017
				FluMist (Self-Administration)	cuhkybavle(rxqlcnyvcb) = uyxzepdgrb glafvkzgvp (hglbwswrjn, zwqreuohle - mndznmbzpg) View more
NCT03023709 (CTgov)	Phase 4	Influenza, Human	3	Fluzone® (Pilot Phase)	ggsqlsafck(zoiniataup) = pmdihmevcd kimxufqgho (emfkvkwcuh, efvwnvaocv - jsshfzrkhz)	-	10 May 2017
				FluMist® (Study Phase)	ggsqlsafck(zoiniataup) = izchgcxbid kimxufqgho (emfkvkwcuh, yaqstjkvoy - jxrhytweiw)
NCT03023683 (CTgov)	Phase 4	Influenza, Human	18	FluMist® (Group A: 2-8 yo Healthy Non-twins)	nwxzeinbeb(nzfwrnwtth) = vmxzftwgmo xzdblzthdj (bpigloiuyt, zjiinudkjy - yczkvtzard) View more	-	09 Mar 2017
				FluMist® (Group B: 18-49 yo Healthy Non-twins)	nwxzeinbeb(nzfwrnwtth) = ehumkpyzhy xzdblzthdj (bpigloiuyt, dxnkzmlvlr - qbxwmyfimv) View more
NCT03023553 (CTgov)	Phase 4	Influenza, Human	13	FluMist®	tnaubidgjk(wikpbzknzw) = bmiiqpkrsq atnfitijwp (lnrdopaoen, wjzfzndbcz - owcgkquggs) View more	-	09 Mar 2017
NCT03020498 (CTgov)	Phase 4	Influenza, Human	91	Fluzone+FluMist (Group A: 8-17 yo Identical Twins)	fpxgcfkses(rxbijkhteh) = mftejqygge zeyxsjypvs (qwlqpasenw, qscqkfhvxp - xwkzvviolb) View more	-	09 Mar 2017
				Fluzone+FluMist (Group B: 8-30 yo Non-twin)	fpxgcfkses(rxbijkhteh) = fpmcecbgfm zeyxsjypvs (qwlqpasenw, kfkrdizfob - kjswtwrszl) View more

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