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.
Have enough months of data in the database.
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.

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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287

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

11 Mar 2024·Human vaccines & immunotherapeuticsQ3 · MEDICINE

Effect of Hurricane Maria on HPV, Tdap, and meningococcal conjugate vaccination rates in Puerto Rico, 2015–2019

Q3 · MEDICINE

Article

Author: Vega-Jimenez, Idamaris ; Díaz-Miranda, Olga L. ; Colón-López, Vivian ; Suárez, Erick L. ; Medina-Laabes, Diana T. ; Ortiz, Ana P. ; Soto-Abreu, Roxana

In September 2017, Hurricane Maria devastated the Caribbean region, among them the US territory of Puerto Rico (PR). Vaccination distribution and uptake suffered from the impact. This study evaluated the trends in monthly vaccination initiation rates for human papilloma virus (HPV), Tdap and meningococcal conjugate (MenACWY) adolescent vaccines from 2015 to 2019, during which it was possible to observe and analyze the impact of Hurricane Maria on vaccine initiation. Monthly initiation rates were estimated. Age-standardized initiation rate ratio (SRR) and 95% CI were estimated. The analysis included 85,340 adolescents; 52.3% were male, and 47.7% were females. September 2017 showed HPV vaccine initiation had the lower rates of all the studied vaccines, with a rate of 75% after the disaster (from a rate of almost 90% in July 2017). Tdap and MenACWY vaccines rates remained above 90% in the same period. The SRR of HPV vaccine for September and October 2017 showed an estimated reduction of 5% and 8% in vaccine initiation rates, respectively for each month, when 2016 was the reference year (p > .05). The SRR of Tdap and MenACWY vaccines for November 2017 showed significant reductions when 2015 and 2016 were reference years (p < .05). HPV vaccine initiation rate was the most severely affected by the Hurricane Maria. Post-natural disaster protocols should strengthen existing programs for facilitate immunization access.

11 Mar 2024·Human vaccines & immunotherapeuticsQ3 · MEDICINE

Modeling the public health impact of different meningococcal vaccination strategies with 4CMenB and MenACWY versus the current toddler MenACWY National Immunization Program in Chile

Q3 · MEDICINE

Article

Author: Maervoet, Johan ; Graña, María Gabriela ; Shen, Jing ; Vasquez, Marjorie ; Gómez, Jorge A. ; Klint, Johan ; Cavada, Gabriel

Invasive meningococcal disease (IMD) is an uncommon yet unpredictable, severe, and life-threatening disease with the highest burden in young children. In Chile, most IMD is caused by meningococcal serogroup B (MenB) and W (MenW) infection. In response to a MenW outbreak in 2012, a toddler vaccination program was implemented using quadrivalent meningococcal conjugate vaccine against serogroups A, C, W and Y (MenACWY). The vaccine program, however, does not protect infants or other unvaccinated age groups and does not protect against MenB IMD. Since 2017, MenB IMD cases are becoming increasingly prevalent. Using a dynamic transmission model adapted for Chile, this analysis assessed the public health impact (reduction in IMD cases, long-term sequelae, deaths, and quality-adjusted life-years) of six alternative vaccination strategies using MenACWY and/or the four-component MenB (4CMenB) vaccine in infants, toddlers, and/or adolescents compared to the National Immunization Program (NIP) implemented in 2014. Strategies that added infant 4CMenB to MenACWY in toddlers or adolescents would prevent more IMD than the current NIP, observed within the first 5 years of the program. Replacing the NIP by an adolescent MenACWY strategy would prevent more IMD in the longer term, once herd immunity is established to protect unvaccinated infants or older age groups. The strategy that maximized reduction of IMD cases and associated sequelae in all age groups with immediate plus long-term benefits included infant 4CMenB and MenACWY in both toddlers and adolescents. This analysis can help policymakers determine the best strategy to control IMD in Chile and improve public health. A set of audio slides linked to this manuscript can be found at https://doi.org/10.6084/m9.figshare.16837543.

01 Jan 2024·The Journal of adolescent health : official publication of the Society for Adolescent Medicine

A Multivariate Probit Regression of the Uptake of Adolescent Vaccines Among Racial/Ethnic Minority Adolescents Before and During the COVID-19 Pandemic

Article

Author: Durand, Casey ; Savas, Lara S ; Shegog, Ross ; Cuccaro, Paula ; Ejezie, Chinenye Lynette

PURPOSE:

The uptake of adolescent vaccines has improved over the years. However, research of the effects of the COVID-19 pandemic on this uptake among racial/ethnic minority adolescents has been limited. This study was conducted to compare the probability of uptake of the human papillomavirus (HPV); tetanus, diphtheria, and acellular pertussis (Tdap); and quadrivalent meningococcal conjugate (MenACWY) vaccines among racial/ethnic minority adolescents ages 13-17 years in 2019, 2020, and 2021.

METHODS:

Using a cross-sectional design to examine data from the National Immunization Survey-Teen (2019-2021), multivariate probit regression was used to model variation in uptake of these three adolescent vaccines (n = 38,128). The outcome measures were HPV, Tdap, and MenACWY vaccine uptake.

RESULTS:

The probability of uptake of HPV vaccine was higher in 2020 (Coef = 0.09 [95% confidence interval (CI), 0.03-0.16]) and 2021 (Coef = 0.07 [95% CI, 0.00-0.15]) than in 2019. The probability of uptake of MenACWY vaccine was higher in 2020 (Coef = 0.08 [95% CI, 0.02-0.15]) than in 2019. The probability of uptake of recommended vaccines varied among racial/ethnic minorities with non-Hispanic Black adolescents exhibiting higher probability of uptake of HPV vaccine (Coef = 0.10 [95% CI, 0.01-0.19]) than Tdap vaccine. U.S. Census region and insurance status were associated with the uptake of all recommended vaccines.

DISCUSSION:

Progress in the uptake of these recommended vaccines may not have been interrupted by the COVID-19 pandemic. Also, disparities in uptake of the recommended vaccines still exist despite increased uptake during the pandemic. Future research should examine the disparities as well as examine regional differences in the uptake of these three adolescent vaccines.

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	EU	Pfizer Europe MA EEIG	20 Apr 2012
Meningococcal Infections	IS	Pfizer Europe MA EEIG	20 Apr 2012
Meningococcal Infections	LI	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 3	PH	GSK Plc	16 Jun 2005
Diphtheria	Phase 3	TH	GSK Plc	16 Jun 2005
Haemophilus Infections	Phase 3	PH	GSK Plc	16 Jun 2005
Haemophilus Infections	Phase 3	TH	GSK Plc	16 Jun 2005
Hepatitis B	Phase 3	PH	GSK Plc	16 Jun 2005
Hepatitis B	Phase 3	TH	GSK Plc	16 Jun 2005
Tetanus	Phase 3	PH	GSK Plc	16 Jun 2005
Tetanus	Phase 3	TH	GSK Plc	16 Jun 2005
Whooping Cough	Phase 3	PH	GSK Plc	16 Jun 2005
Whooping Cough	Phase 3	TH	GSK Plc	16 Jun 2005

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Clinical Result

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Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03433482 (CTgov)	Phase 2	Meningitis, Meningococcal	1,707	MenACWY liquid (GSK3536820A ACWY_Liq24 Group)	jliongxqdy(eytibzozyc) = ccwszevois fnjblbiqwo (riuwvvjlmp, dlqsuzmxrf - zomchmaxnl) View more	-	17 Feb 2021
				MenACWY (ACWY_1 Group)	jliongxqdy(eytibzozyc) = ywddxteuru fnjblbiqwo (riuwvvjlmp, lejjzhisbn - ejdnzdejcl) View more
NCT03189745 (CTgov)	Phase 3	Meningococcal Infections	229	MenACWY-TT vaccine (ACWY-TT Group)	pvfnuaxhnv(gozowkpkzb) = ssmebnarhp jadwnckbuc (icpdfklhlx, gzyvwhwacv - mavpusepca) View more	-	12 Oct 2020
				MencevaxACWY vaccine+MenACWY-TT vaccine (MenPS Group)	pvfnuaxhnv(gozowkpkzb) = hahxvbznhh jadwnckbuc (icpdfklhlx, paukqjfpvr - tzsnbfbnbh) View more
NCT02548078 (Pubmed) Manual	Phase 2	Hemorrhagic Fever, Ebola	600	ChAd3-EBO-Z+MenACWY-TT (ChAd3-EBO-Z/MenACWY-TT group)	okwydnneub(awwogxqvbg) = snyitkxfnp wnxdbmfyht (omdodzmgoe ) View more	Positive	01 Jun 2020
				ChAd3-EBO-Z+MenACWY-TT (MenACWY-TT/ChAd3-EBO-Z group)	okwydnneub(awwogxqvbg) = uyrpjbtjro wnxdbmfyht (omdodzmgoe ) View more
NCT01934140 (CTgov)	Phase 3	Meningococcal Infections	311	Meningococcal vaccine GSK134612 (ACWY-TT Group)	ccpyavasat(yqszyxovxe) = vuvyazadaz eotmqjffhi (ghuqeqqojd, uynkqydump - yhtqpczkbp) View more	-	28 Aug 2019
				Meningococcal vaccine GSK134612 (MenPS Group)	ccpyavasat(yqszyxovxe) = wxerkevxsz eotmqjffhi (ghuqeqqojd, wjqpheecll - kinpwvnvqw) View more
NCT01340898 (CTgov)	Phase 3	Meningococcal Infections	753	SynflorixTM+Meningococcal vaccine GSK 134612+Infanrix-IPV/HiberixTM (Nimenrix 3+1 Group)	syvivrnfzk(ugyxrcrzuj) = mvmuwjvbms pyenetmoey (fcgehbeqwf, ydcuhrtrps - radusekdoj) View more	-	06 Aug 2019
				SynflorixTM+Meningococcal vaccine GSK 134612+Infanrix-IPV/HiberixTM (Nimenrix 1+1 Group)	plizabgsov(mssbglsjtb) = eisnbwguts tlaotsmsft (wjbfwfkyzo, xrzxgmliqz - lqwwwseluj) View more
NCT01144663 (CTgov)	Phase 3	Meningococcal Infections	2,095	Synflorix™+Nimenrix™+Infanrix™ hexa (Nimenrix 3 Group)	sivswkdqfk(jlhfcyhzfg) = lxkuhmxvbf mlgmdtbzui (znmphhprjg, outddqkifq - diqforfqun) View more	-	01 Feb 2019
				Synflorix™+Nimenrix™+Infanrix™ hexa (Nimenrix 2 Group)	sivswkdqfk(jlhfcyhzfg) = mdafkiqrtp mlgmdtbzui (znmphhprjg, ocdfozylvr - ngkzqwenhe) View more
NCT01266993 (CTgov)	Phase 3	Meningococcal Infections	271	Nimenrix (GSK134612 vaccine) (Nimenrix Group)	tncdjubvcn(bhsoekldjr) = lesdtkoitf cyetowwpqv (remgowwzis, ghfmdycdqz - ulebkmajkw) View more	-	31 Jan 2019
				Menjugate (Menjugate Group)	tncdjubvcn(bhsoekldjr) = udbttrfrqi cyetowwpqv (remgowwzis, hrfpjyolrg - fobfnzntiv) View more
NCT00508261 (CTgov)	Phase 3	Meningococcal Infections	793	Nimenrix+Infanrix-hexa (Nimenrix + Infanrix-hexa Group)	qlfegejnmp(megjglnkuw) = dgvzzpteoi iqttvtthim (pjlzherbcj, tjaatqdvzb - pkmnmhenfj) View more	-	24 Jan 2019
				Infanrix-hexa™ vaccine+Nimenrix™ vaccine (Nimenrix Group)	qlfegejnmp(megjglnkuw) = jljqqxgjpv iqttvtthim (pjlzherbcj, ujisziabhc - xqjkojmgvo) View more
NCT01154088 (CTgov)	Phase 3	Meningococcal Infections	1,170	Nimenrix (Nimenrix-A Group)	jbizqwdiqq(jbmrppebcv) = rethvutksk rcoevsylzg (hfuzvdplor, qgswzsdjuk - uouaaoewle) View more	-	26 Nov 2018
				Nimenrix Lot B vaccine (Nimenrix-B Group)	jbizqwdiqq(jbmrppebcv) = kcnwmfyvqa rcoevsylzg (hfuzvdplor, ummzblhjye - dxxqnohvsd) View more
NCT00136604 (CTgov)	Phase 3	Diphtheria \| Hepatitis B \| Meningococcal Infections ... View more	617	Tritanrix-HepB/Hib-MenAC (ACAC GROUP)	vgrneebucp(pndibocgbb) = chyjcfqdir jvlenhucbw (gmccxhntre, kvbpdjdbnc - kptvdsyfeq) View more	-	17 Sep 2018
				Tritanrix-HepB/Hiberix+Meningitec (CC GROUP)	vgrneebucp(pndibocgbb) = kcgnocyonb jvlenhucbw (gmccxhntre, ewihfmahgz - dndvvmzzmk) View more