Delving into the Latest Updates on Meningococcal group A, C, W 135 and Y conjugate vaccine(GlaxoSmithKline Plc) with Synapse

Brief Summary:
The main purpose of the study is to learn about how well Trumenba vaccine shot works against gonorrhea infection. This study looks at data records from a database in the United States.
This study includes patient's data from the database who:
* Are 15-30 years old.
* Have received at least one dose of Trumenba and a MenACWY vaccine or who have received only MenACWY vaccine.
This data has already been collected in the past and is being studied between April and June of 2023.

Start Date24 Apr 2023

Sponsor / Collaborator

Pfizer Inc.

NCT04819113 / CompletedPhase 3

A PHASE 3B, OPEN-LABEL, STUDY TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF NIMENRIX(Registered) IN HEALTHY INFANTS, GIVEN AT 3 AND 12 MONTHS OF AGE

This study will evaluate the safety and immunogenicity of a single dose of Nimenrix in infants at 3 months of age, followed by a second dose at 12 months of age. Current posology allows for 2 doses of Nimenrix before 6 months of age, where the first dose is administered from 6 weeks onwards with a second dose at least 2 months later, with a booster at 12 months; and in infants from 6 months of age, a single dose at 6 months, with a booster dose at 12 months. This study will provide valuable immunogenicity and safety data for a single dose in healthy infants <6 months of age, followed by the booster at 12 months

Start Date09 Apr 2021

Sponsor / Collaborator

Pfizer Inc.

NL-OMON20287 / SuspendedNot Applicable

Primary and booster meningococcal vaccination in Dutch elderly: study to investigate the immune response and determine functional antibodies after the tetravalent MenACWY-TT conjugate vaccine in the elderly population’

Start Date01 Jan 2021

Sponsor / Collaborator

National Institute For Health & Welfare

100 Clinical Results associated with Meningococcal group A, C, W 135 and Y conjugate vaccine(GlaxoSmithKline Plc)

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100 Translational Medicine associated with Meningococcal group A, C, W 135 and Y conjugate vaccine(GlaxoSmithKline Plc)

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100 Patents (Medical) associated with Meningococcal group A, C, W 135 and Y conjugate vaccine(GlaxoSmithKline Plc)

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303

Literatures (Medical) associated with Meningococcal group A, C, W 135 and Y conjugate vaccine(GlaxoSmithKline Plc)

31 Dec 2024·Human Vaccines & Immunotherapeutics

Impact of the COVID-19 pandemic on social media utilization, influences related to parental vaccine decision making, and opinions on trustworthy social media vaccination campaigns: A qualitative analysis

Article

Author: Fontenot, Holly B ; Glauberman, Gary ; Zimet, Gregory ; Michel, Alexandra ; Quist, Kevin M

There is a continued need for research to better understand the influence social media has on parental vaccination attitudes and behaviors, especially research capturing the effects of the COVID-19 pandemic. The goal of this study was to explore parents' perspectives related to the impact the pandemic had on 1) social media engagement, 2) vaccine messaging on social media, and 3) factors to guide future intervention development. Between February and March 2022, 6 online, synchronous, text-based focus groups were conducted with parents of adolescents aged 11 to 17 years. Participants who all utilized social media were recruited from across the United States. Qualitative data were analyzed using content analysis. A total of 64 parents participated. Average age was 47 years, and participants were predominantly White (71.9%), female (84.3%), and engaged with social media multiple times per day (51.6%). Participants (95.3%) viewed obtaining all recommended vaccines as important or very important; however, overall vaccination rates for their adolescents were varied (50% ≥1 dose HPV; 59.4% MenACWY; 78.1% Tdap; 65.6% Flu; 81.3% COVID-19). Three themes emerged highlighting the pandemic's impact on parent's (1) general patterns of social media use, (2) engagement about vaccines on social media and off-line behaviors related to vaccination, and (3) perspectives for developing a credible and trustworthy social media intervention about vaccination. Participants reported fatigue from contentious vaccine-related content on social media and desired future messaging to be from recognizable health institutions/associations with links to reputable resources. Plus, providers should continue to provide strong vaccine recommendations in clinic.

31 Dec 2024·Expert Review of Vaccines

Antibody persistence and revaccination recommendations of MenACWY-TT: a review of clinical studies assessing antibody persistence up to 10 years after vaccination

Review

Author: Findlow, Jamie ; Knuf, Markus ; Burman, Cynthia ; Sáfadi, Marco Aurelio P

INTRODUCTIONInvasive meningococcal disease (IMD) is potentially fatal and associated with severe sequelae among survivors. It is preventable by several vaccines, including meningococcal vaccines targeting the most common disease-causing serogroups (A, B, C, W, Y). The meningococcal ACWY tetanus toxoid conjugate vaccine (MenACWY-TT [Nimenrix]) is indicated from 6 weeks of age in the European Union and >50 additional countries.AREAS COVEREDUsing PubMed, Google Scholar, ClinicalTrials.gov and ad hoc searches for publications to June 2023, we review evidence of antibody persistence for up to 10 years after primary vaccination and up to 6 years after MenACWY-TT revaccination. We also review global MenACWY revaccination recommendations and real-world impact of vaccination policies, focusing on how these data can be considered alongside antibody persistence data to inform future IMD prevention strategies.EXPERT OPINIONBased on clear evidence that immunogenicity data (demonstrated antibody titers above established correlates of protection) are correlated with real-world effectiveness, long-term persistence of antibodies after MenACWY-TT vaccination suggests continuing protection against IMD. Optimal timing of primary and subsequent vaccinations is critical to maximize direct and indirect protection. Recommending bodies should carefully consider factors such as age at vaccination and long-term immune responses associated with the specific vaccine being used.

01 Sep 2024·Infectious Diseases and Therapy

Quantifying Stated Preferences for Meningococcal Vaccines Among Adolescents/Young Adults and Parents of Adolescents in the United States: A Discrete Choice Experiment

Article

Author: Burman, Cindy ; Shah, Hiral ; Cabrera, Eliazar Sabater ; Kuylen, Elise ; Kocaata, Zeki ; Sohn, Woo-Yun ; Restrepo, Oscar Herrera ; Begum, Shahina

INTRODUCTIONInvasive meningococcal disease (IMD) is a severe and life-threatening disease. In the United States (US), vaccine coverage with MenACWY and MenB meningococcal vaccines is suboptimal among adolescents/young adults aged 16-23 years. A combined meningococcal vaccine (MenABCWY) could increase convenience (e.g., fewer injections) and improve coverage. The objective was to quantify preferences for hypothetical meningococcal vaccine profiles among adolescents/young adults and parents.METHODSAn online discrete choice experiment was conducted among 16- to 23-year-olds, and parents of 16- to 18-year-olds. Attributes (3 × 4) and levels (1 × 2) were based on the literature and focus groups. Participants made ten pair-wise forced trade-off choices, systematically varied using a D-optimal design. Random parameter logit quantified the relative importance of vaccination attributes and estimated the trade-offs. Differences in preferences by subgroups were assessed.RESULTSTotals of 300 adolescents and young adults (median age 20 years) and 300 parents (median age 46 years) completed the survey. Overall, 89.6% of 16- to 23-year-olds and 69.1% of parents preferred a simplified hypothetical meningococcal vaccination profile, e.g., with fewer injections (3 vs. 4) and fewer healthcare provider (HCP) visits (2-3 vs. 4). Having HCP advice and clear Centers for Disease Control and Prevention recommendations impacted vaccination choice, with both groups reporting high trust in HCP information (83.3% among 16- to 23-year-olds; 98.7% among parents). Barriers to vaccination included lack of HCP advice or awareness of meningococcal vaccines, and income level and out-of-pocket costs for parents.CONCLUSIONSAdolescents/young adults and parents demonstrated a significant preference for a meningococcal vaccine that is more convenient (such as combined MenABCWY). Parents' vaccination preferences differed by income level and out-of-pocket costs, suggesting financial barriers to vaccination may exist which could result in IMD prevention inequalities. Findings from this study provide important information to support patient-facing informed policy discussions. A simplified vaccination schedule and strong recommendation could help improve vaccine uptake, schedule compliance, disease prevention, and reduce inequalities in IMD risk and prevention. A graphical abstract is available with this article.

19

News (Medical) associated with Meningococcal group A, C, W 135 and Y conjugate vaccine(GlaxoSmithKline Plc)

16 Jun 2024

·www.drugs.com

International Travel: Don't Forget Your Child's Vaccinations

SUNDAY, June 16, 2024 -- Exploring Europe, taking an African safari, going on a trip to the tropics: In many cases, vaccines are needed for travel, and that's doubly true for children. According to pediatrician Dr. Lauren Nguyen , researching what vaccines are needed and preparing well before your family's departure is crucial. “I tell my families that it’s best to come in about six weeks prior to international travel,” said Nguyen, who's based in Torrance, Calif. and is affiliated with the Children’s Hospital Los Angeles Care Network. Meet with your child's pediatrician to review travel plans, figure out what vaccines are required or recommended based on your travel destination and arrange to get any shots needed. That consultation is probably best done with an in-person visit, not a phone call, Nguyen noted. Not sure what shots the country you're visiting requires? Head to the U.S. Centers for Disease Control and Prevention's Travelers’ Health website for up to date info for countries worldwide. "The CDC website tells you about any current outbreaks, as well as the recommended vaccines for that country,” Nguyen said in a hospital news release. Besides any special vaccines required by the country you're visiting, make sure your child is up to date on routine shots for seasonal infections like COVID, flu and RSV. Planning ahead is crucial because many vaccines require multiple doses given weeks apart, Nguyen noted. Pediatricians may also not have large supplies of vaccines for diseases like yellow fever or typhoid, and may need time to order them. Then there's time needed for vaccines to give your child's immune system a full boost. “It takes about two to four weeks to respond to the vaccine and develop the antibodies,” Nguyen explained. And it's not just about needles: Daily dose malaria pills, for example, need to be started up to two weeks before departure, taken the entire period that you're in a malaria zone, and then taken for a month after you return home. Vaccine schedules also vary by age, Ngyuen noted. Measles outbreaks are occuring worldwide with greater frequency, and measles vaccine recommendations are different for babies versus older children. Children typically wait to get the first dose of the measles vaccine between the ages of 12 and 15 months and the second dose between 4 and 6 years of age. However, for infants “that changes for international travel,” Nguyen said. “Children between 6 and 12 months of age should get a first dose of the measles vaccine prior to travel.” That first dose should still be followed up by a second dose between the ages of 4 and 6, she added. Hepatitis A is typically contracted through contaminated water or food. Again, routine vaccination recommendations suggest that a child get their first hep A shot between 12 and 23 months of age. However, “infants 6 to 11 months old should be vaccinated when protection against hepatitis A is recommended for the destination," Nguyen said. And if your baby is very young -- under 2 months of age -- you probably shouldn't travel internationally unless it’s absolutely necessary, she added. Another key shot is the meningitis A (MenACWY) vaccine. It's easily transmitted and Nguyen suggests that kids be vaccinated against meningitis A before travel, especially when people are circulating in close quarters, such as on cruise ships. Kids ages 16 and older should also be immunized against the meningitis B vaccine. Cruise ships can be hotbeds of infection, so don't forget vaccinations even if you aren't docking at exotic locales. “The people you’ll be on the ship with might have been vacationing all over the world,” she explained. "Vaccines can protect your children from a wide range of illnesses these passengers might bring on board." Besides shots and pills, you can take other steps to keep you and your family safe while abroad. According to Nguyen, these include bringing: Last but not least, make sure you have adequate travel health insurance so you can access care should any health emergencies arise. SOURCE: Children’s Hospital Los Angeles Care Network, news release, June 13, 2024 Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Vaccine

23 Oct 2023

·www.pmlive.com

Pfizer’s pentavalent meningococcal vaccine granted FDA approval

Pfizer’s Penbraya has been approved by the US Food and Drug Administration (FDA) as the first pentavalent vaccine that provides protection against the five most common serogroups causing meningococcal disease in individuals aged ten to 25 years. Meningococcal disease is an uncommon but serious illness that can lead to death within 24 hours and can result in life-altering, significant long-term disabilities for survivors. Pfizer currently has two vaccines authorised to protect against the disease, with Trumenba targeting meningococcal group B and Nimenrix protecting against groups A, C, W and Y. Penbraya combines the components from both vaccines and simplifies the meningococcal vaccination schedule by reducing the total number of doses needed to be fully protected against the five serogroups, potentially increasing the number of vaccinated adolescents and young adults. The FDA’s decision was supported by positive results from mid- and late-stage trials, including a phase 3 study evaluating the safety, tolerability and immunogenicity of Penbraya compared to currently US-licensed meningococcal vaccines. Annaliesa Anderson, senior vice president and head of vaccine research and development at Pfizer, said: “[The approval] marks an important step forward in the prevention of meningococcal disease in the US. "In a single vaccine, Penbraya has the potential to protect more adolescents and young adults from this severe and unpredictable disease by providing the broadest meningococcal coverage in the fewest shots.” The US Centers for Disease Control and Prevention, which has noted that combining vaccines may mean that more adolescents and young adults get their recommended vaccines on time, will now meet to discuss recommendations for the appropriate use of Penbraya. “Nearly nine out of ten adolescents have incomplete protection against invasive meningococcal disease caused by the leading serogroups,” said Jana Shaw, paediatrics infectious disease specialist at Upstate Golisano Children's Hospital in Syracuse, US. She continued: “For the first time, we have a single vaccine that helps protect against the five most common serogroups and has the potential to improve coverage and increase protection among adolescents and young adults.” GSK is also developing a pentavalent vaccine against meningococcal disease, which combines the antigenic components of its approved Bexsero (MenB) and Menveo (MenACWY) meningococcal vaccines.

Drug ApprovalPhase 3VaccineClinical ResultQualified Infectious Disease Product

22 Oct 2023

·medcitynews.com

Pfizer Meningococcal Vaccine Nabs FDA Nod, Offering More Convenient Dosing

The FDA has approved a new Pfizer meningococcal vaccine whose simpler dosing schedule is expected to make it easier for children and young adults to get fully vaccinated to protect against a rare infection that can quickly become fatal within 24 hours. Five groups of Neisseria meningitidis bacteria are the most common cause of meningococcal disease, which causes infections of the lining of the brain and spinal cord as well as the blood. For those who survive serious cases of the infection, the effects can still be long lasting. Pfizer already had four of the culprit bacterial groups covered with a vaccine called Nimenrix. Another Pfizer vaccine called Trumenba covers the fifth group of bacteria. Penbraya, the meningococcal vaccine approved by the FDA on Friday, combines Nimenrix and Trumenba in a single shot. The regulatory decision covers use of this new vaccine in those ages 10 through 25. Penbraya is administered as two intramuscular injections given six months apart. Penbraya is a bacterial vaccine. It works by what’s called active immunization, in which the immune system is prompted to produce antibodies against target pathogens. FDA approval of the new Pfizer vaccine is based on the results of clinical trials that compared Penbraya to currently available meningococcal vaccines. Results showed this vaccine was “noninferior,” meaning it was not worse at eliciting an immune response versus the comparator vaccines. “In a single vaccine, Penbraya has the potential to protect more adolescents and young adults from this severe and unpredictable disease by providing the broadest meningococcal coverage in the fewest shots,” Annaliesa Anderson, senior vice president and head, vaccine research and development at Pfizer, said in a prepared statement. The Phase 3 study for Penbraya enrolled more than 2,400 patients from the U.S. and Europe. The most common adverse reactions were pain at the injection site, fatigue, headache, injection site redness, muscle pain, injection site swelling, joint pain, and chills. The vaccine’s label also cautions that Guillain-Barré syndrome, an immune response that damages nerves, has been reported after dosing of other meningococcal vaccines. The next step for Penbraya is a recommendation from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices. This vaccine is the first agenda item for the committee’s next meeting, scheduled for this Wednesday. Pfizer isn’t the only company trying to offer protection against meningococcal infection with fewer shots. GSK’s pentavalent meningococcal vaccine candidate is a combination of that company’s approved vaccines, Bexsero and Menveo. In March of this year, the British pharmaceutical giant reported Phase 3 results showing this vaccine candidate, administered as two doses six months apart, was non-inferior to the two approved GSK meningococcal vaccines.

Phase 3Clinical ResultVaccineDrug Approval

100 Deals associated with Meningococcal group A, C, W 135 and Y conjugate vaccine(GlaxoSmithKline Plc)

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-	Meningococcal group A, C, W 135 and Y conjugate vaccine(GlaxoSmithKline Plc)	J07AH08	-

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Meningococcal Infections	IS	Pfizer Europe MA EEIG	20 Apr 2012
Meningococcal Infections	LI	Pfizer Europe MA EEIG	20 Apr 2012
Meningococcal Infections	EU	Pfizer Europe MA EEIG	20 Apr 2012
Meningococcal Infections	NO	Pfizer Europe MA EEIG	20 Apr 2012

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diphtheria	Phase 1	TH	GSK Plc	16 Jun 2005
Haemophilus Infections	Phase 1	TH	GSK Plc	16 Jun 2005
Haemophilus Infections	Phase 1	PH	GSK Plc	16 Jun 2005
Hepatitis B	Phase 1	PH	GSK Plc	16 Jun 2005
Hepatitis B	Phase 1	TH	GSK Plc	16 Jun 2005
Diphtheria	Discovery	PH	GSK Plc	16 Jun 2005
Meningococcal Infections	Discovery	PH	GSK Plc	16 Jun 2005
Meningococcal Infections	Discovery	TH	GSK Plc	16 Jun 2005
Tetanus	Discovery	TH	GSK Plc	16 Jun 2005
Tetanus	Discovery	PH	GSK Plc	16 Jun 2005

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04819113 (CTgov)	Phase 3	Meningococcal Infections	149	Nimenrix	fntshbsmvx(nzlrqfilll) = hnicqluerw fpqxhrcnml (huavdpnubl, qpaybqfysi - xtaxjqwevp) View more	-	18 Mar 2024
NCT03606512 (CTgov)	Phase 1/2	Respiratory Syncytial Virus Infections	38	Placebo+Nimenrix (Placebo/Nimenrix)	iwzcysfrgq(dskikaxcum) = sulnoxrtpz rtmoowbbaf (vaurcgyfwq, hfcjcugvqi - jgvshkxadx) View more	-	30 Nov 2022
				Ad26.RSV.preF (Ad26.RSV.preF)	iwzcysfrgq(dskikaxcum) = lxvvclvmss rtmoowbbaf (vaurcgyfwq, rtzfshpzhq - qsdtqmrvox) View more
NCT01939158 (CTgov)	Phase 3	Meningococcal Infections	803	Meningococcal vaccine GSK134612 (ACWY1d Group)	pkggpbpzrb(ebpvbmbrca) = ixcpiaksoo czahznsakf (tcwisgiaaq, sfxcrcdvsq - ubktkuvyqh) View more	-	05 Oct 2021
				Meningococcal vaccine GSK134612 (ACWY2d Group)	pkggpbpzrb(ebpvbmbrca) = dxjcjfmgsp czahznsakf (tcwisgiaaq, vgdkiihwoh - tikcimitbe) View more
NCT03433482 (CTgov)	Phase 2	Meningitis, Meningococcal	1,707	MenACWY liquid (GSK3536820A ACWY_Liq24 Group)	staoclqbqs(uxtqsxsxid) = sijkvkjhjb cbbirkhtth (ubaijzvjpr, vloexhonmy - yrkttyyjsp) View more	-	17 Feb 2021
				MenACWY (ACWY_1 Group)	staoclqbqs(uxtqsxsxid) = idfnyqqiah cbbirkhtth (ubaijzvjpr, lnxxuahapb - azfvgcteiy) View more
NCT03189745 (CTgov)	Phase 3	Meningococcal Infections	229	MenACWY-TT vaccine (ACWY-TT Group)	sakdjnnztv(rzfggngmue) = hizzqtbfso zsfonwztkt (ksjrwppvnt, qrtcnkkmza - xznjybdqye) View more	-	12 Oct 2020
				MencevaxACWY vaccine+MenACWY-TT vaccine (MenPS Group)	sakdjnnztv(rzfggngmue) = lmejhvwzov zsfonwztkt (ksjrwppvnt, lbqafcoxoe - fvuucypmhf) View more
NCT01934140 (CTgov)	Phase 3	Meningococcal Infections	311	Meningococcal vaccine GSK134612 (ACWY-TT Group)	pogbppjpfj(dwtxynpzct) = mzukpusbxv aofiwkzkdr (zihrhrkeru, apymtztnvu - isvuhjvpcn) View more	-	28 Aug 2019
				Meningococcal vaccine GSK134612 (MenPS Group)	pogbppjpfj(dwtxynpzct) = edacmfkhct aofiwkzkdr (zihrhrkeru, hnmqicjbcy - xjspgynwlk) View more
NCT01340898 (CTgov)	Phase 3	Meningococcal Infections	753	SynflorixTM+Meningococcal vaccine GSK 134612+Infanrix-IPV/HiberixTM (Nimenrix 3+1 Group)	tbhbyrawah(vcdhnbyyjy) = vljbfrymxu ungiavenjo (uymvddljzf, webumzcabs - tlbrfvmjfv) View more	-	06 Aug 2019
				SynflorixTM+Meningococcal vaccine GSK 134612+Infanrix-IPV/HiberixTM (Nimenrix 1+1 Group)	bjmoqbpslk(wigsfrmywu) = vzqoevumdy uuiymasjfd (yjgejaerjy, klwpufqmek - fzdidksisi) View more
NCT01144663 (CTgov)	Phase 3	Meningococcal Infections	2,095	Synflorix™+Nimenrix™+Infanrix™ hexa (Nimenrix 3 Group)	cjudvdwfcz(uvkqswthiv) = awzvzlojry ghwfwamutz (nyplxvnhti, sskcgvvuuw - qzpztvhsff) View more	-	01 Feb 2019
				Synflorix™+Nimenrix™+Infanrix™ hexa (Nimenrix 2 Group)	cjudvdwfcz(uvkqswthiv) = sneewjlfbb ghwfwamutz (nyplxvnhti, zrmnlgnbci - jekbgndrvl) View more
NCT01266993 (CTgov)	Phase 3	Meningococcal Infections	271	Nimenrix (GSK134612 vaccine) (Nimenrix Group)	mtsrujaapt(ihydkwwaua) = iczxsgtudo liddfmfekx (mxpfpnslcm, qkerqgonjs - kbltoyrgms) View more	-	31 Jan 2019
				Menjugate (Menjugate Group)	mtsrujaapt(ihydkwwaua) = slxxowtudt liddfmfekx (mxpfpnslcm, nbuvhohfqo - mqgkfenuxb) View more
NCT01777308 (CTgov)	Phase 3	Meningococcal Infections	156	Meningococcal conjugate vaccine GSK134612 (Menitorix Group)	zdbnzdbgnh(fuxobezmbh) = vimnvccjny zsgnbmedzy (vfgxhsupee, uweeuqzstj - ludhhlouvd) View more	-	25 Jan 2019
				Meningococcal conjugate vaccine GSK134612 (Meningitec + Hiberix Group)	zdbnzdbgnh(fuxobezmbh) = apkxfdgvyj zsgnbmedzy (vfgxhsupee, pyenunbvif - qxxxqpqivx) View more