{"id":105,"date":"2024-06-26T13:53:17","date_gmt":"2024-06-26T13:53:17","guid":{"rendered":"https:\/\/www.merckvaccines.com\/vaxneuvance\/?page_id=105"},"modified":"2025-12-22T17:09:03","modified_gmt":"2025-12-22T17:09:03","slug":"special-populations","status":"publish","type":"page","link":"https:\/\/www.merckvaccines.com\/vaxneuvance\/special-populations\/","title":{"rendered":"Specific populations"},"content":{"rendered":"\n\n
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VAXNEUVANCE should be considered for your at-risk populations<\/strong><\/strong><\/strong><\/h1>

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There is an increased rate of IPD in children with certain underlying medical conditions, including immunocompromising conditions.1<\/sup><\/strong><\/strong><\/h2><\/div>\n\n\n\n
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Prevalence of select risk conditions<\/strong><\/h2><\/div>\n<\/div><\/div><\/div>\n\n\n\n
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\"HIV:<\/figure><\/div><\/div>\n\n\n\n

At year-end 2022 in the US and 6 dependent areas, the rate of children aged <13 years living with diagnosed HIV infection was 2.2\/100,000 (~1,126 total cases)2,a<\/sup><\/p><\/div><\/div>\n\n\n\n

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\"Sickle<\/figure><\/div><\/div>\n\n\n\n

During 2016\u20132020 in the US, the rate of SCD was approximately 4.8\/10,000 live births (3,305 total cases)3,b<\/sup><\/p><\/div><\/div>\n\n\n\n

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\"Asthma<\/figure><\/div><\/div>\n\n\n\n

In 2021\u20132022, 1.0% of US parents of children with asthma rated the severity of asthma in their children aged \u22645 years as moderate\/severe4,c,d<\/sup><\/p><\/div><\/div>\n\n\n\n

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Study designs<\/strong><\/h2><\/summary>
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Studies 8, 9, and 10:<\/strong> In a descriptive analysis, the safety and immunogenicity of VAXNEUVANCE were evaluated in enrolled preterm infants (<37 weeks gestation at birth). Participants were randomized to receive VAXNEUVANCE (N=142) or PCV13 (N=144) as a 4-dose series administered at 2, 4, 6, and 12 through 15 months of age. Participants in these studies may have received either US-licensed or non-US licensed concomitant vaccines according to the local recommended schedule.<\/p>\n\n\n\n

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Study 13:<\/strong> A double-blind, descriptive study that assessed the safety and immunogenicity of VAXNEUVANCE in children 5 through 17 years of age with SCD. Participants were randomized 2:1 to receive a single dose of VAXNEUVANCE (N=70) or PCV13 (N=34).<\/p>\n\n\n\n

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Study 14:<\/strong> A double-blind, descriptive study that assessed the safety and immunogenicity of VAXNEUVANCE in HIV-infected children 6 through 17 years of age, with CD4+ T-cell count \u2265200 cells per microliter and plasma HIV RNA value <50,000 copies\/mL. Participants were randomized to receive a single dose of VAXNEUVANCE (N=203) or PCV13 (N=204), followed by PPSV23 two months later.<\/p>\n\n\n\n

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Study 15:<\/strong> A double-blind, descriptive study that assessed the safety and immunogenicity of VAXNEUVANCE compared to PCV13 in participants, aged 3 through 74 years of age, who had received an allo-HSCT 3\u20136 months prior to enrollment. Pediatric participants (N=14) were randomized to receive 3 doses of VAXNEUVANCE (N=8) or PCV13 (N=6), administered 1 month apart. Twelve months after allo-HSCT, participants without chronic GVHD received one dose of PPSV23 and those with chronic GVHD received a 4th dose of VAXNEUVANCE or PCV13. All participants had a history of stable engraftment and none had severe GVHD. IgG GMCs and OPA GMTs were measured after dose 3 and 30 days following vaccination with the 4th<\/sup> dose of PCV or the single dose of PPSV23.<\/p>\n\n\n\n

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<\/span>These children may represent a small number of your total patients, but their care requires extra consideration.5-7,e<\/sup><\/mark><\/strong><\/span><\/p><\/blockquote><\/div>\n\n\n\n

a<\/sup>Data for the year 2022 are preliminary and based on deaths reported to CDC as of December 2023. Data are based on address of residence as of December 31, 2022 (ie, most recent known address).2<\/sup>
b<\/sup>The CDC-funded Sickle Cell Data Collection program included 11 state-level surveillance programs from the southern, midwestern, and western United States, and collects and analyzes state newborn screening records.3<\/sup>
c<\/sup>Based on data collected in the National Survey of Children\u2019s Health (NSCH), which is fielded annually by the US Census Bureau. Randomly sampled households were contacted by mail to identify those with one or more children under 18 years old. In each household, one child was randomly selected to be the subject of the survey, which oversampled children with special health care needs and children 0\u20135 years of age. Asthma prevalence is sourced from the 2021\u20132022 combined dataset.4,8<\/sup>
d<\/sup>VAXNEUVANCE Study 12 (Protocol 024) included children with a medical history of asthma (VAXNEUVANCE: n=10; PCV13: n=10).9<\/sup>
e<\/sup>Based on a US analysis of MarketScan Commercial Claims and Medicare data from August 1, 2012, through July 31, 2017, done to explore the prevalence of immunosuppressive conditions. Enrollees with symptomatic HIV\/AIDS or sickle cell disease were among those considered immunosuppressed.7<\/sup><\/p>\n\n\n\n

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VAXNEUVANCE is a CDC recommended option that was proactively studied in certain at-risk populations10,f<\/sup><\/strong><\/h2><\/div>\n\n\n\n
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VAXNEUVANCE is the only CDC recommended PCV with clinical studies that was specifically designed to evaluate immune responses in special populations with a need for pneumococcal disease prevention based on their diagnosed risk condition, such as people living with HIV or SCD.10<\/sup><\/p>\n\n\n\n

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f<\/sup>Pediatric populations with risk conditions were preterm infants, children living with HIV or SCD (immunocompromising diseases), or children who had received an allo-HSCT (an immunocompromising condition): preterm infants, <37 weeks gestation at birth; children living with HIV, 6\u201317 years of age; children living with SCD, 5\u201317 years of age; and recipients of allo-HSCT, 3\u201317 years of age.<\/p>\n\n\n\n

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Choose the robust immunogenicity of VAXNEUVANCE<\/a> for your appropriate pediatric patients\u2014including those with immunocompromising conditions.<\/strong><\/p><\/div><\/div>\n\n\n

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AIDS, acquired immunodeficiency syndrome; allo-HSCT, allogeneic hematopoietic stem cell transplant; CDC, Centers for Disease Control and Prevention; GMC, geometric mean concentration (mcg\/mL); GMT, geometric mean titer; GVHD, graft-versus-host disease; HIV, human immunodeficiency virus; IgG, Immunoglobulin G; IPD, invasive pneumococcal disease; OPA, opsonophagocytic activity; PCV, pneumococcal conjugate vaccine; PCV13, 13-valent pneumococcal conjugate vaccine; PPSV23, 23-valent pneumococcal polysaccharide vaccine; RNA, ribonucleic acid; SCD, sickle cell disease.<\/p>\n\n\n\n

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Review CDC, AAP, and AAFP recommendations<\/strong><\/h3>

Review CDC, AAP, and AAFP recommendations<\/a><\/p><\/div>

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View safety & tolerability data<\/strong><\/h3>

View safety & tolerability data<\/a><\/p><\/div>

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Learn about storage & handling information<\/strong><\/h3>

Learn about storage & handling information<\/a><\/p><\/div>

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See immunogenicity data<\/h3>

See immunogenicity data<\/a><\/p><\/div>

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References:<\/strong><\/h2><\/div>\n\n\n\n\n
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  1. Farrar JL, Gierke R, Andrejko KL, et al. ACIP updates: recommendations for use of 20-valent pneumococcal conjugate vaccine in children \u2014 United States, 2023. MMWR Morb Mortal Wkly Rep<\/em>. 2023;72(39):1072. doi:10.15585\/mmwr.mm7239a5<\/li>\n\n\n\n
  2. Centers for Disease Control and Prevention. HIV surveillance report, volume 35: diagnoses, deaths, and prevalence of HIV in the United States and 6 territories and freely associated states, 2022. Published May 21, 2024. Accessed October 12, 2025. https:\/\/stacks.cdc.gov\/view\/cdc\/156509<\/li>\n\n\n\n
  3. Kayle M, Blewer AL, Pan W, et al. Birth prevalence of sickle cell disease and county-level social vulnerability \u2013 sickle cell data collection program, 11 states, 2016-2020. MMWR Morb Mortal Wkly Rep.<\/em> 2024;73(12):249-254. doi:10.15585\/mmwr.mm7312a1<\/li>\n\n\n\n
  4. National Survey of Children’s Health 2021-2022: Parent rated severity of current asthma, nationwide, age in 3 groups. Data Resource Center for Child and Adolescent Health. Accessed October 12, 2025. https:\/\/www.childhealthdata.org\/browse\/survey\/results?q=10481&r=1&g=1071<\/span><\/li>\n\n\n\n
  5. Pittet LF, Posfay-Barbe KM. Vaccination of immune compromised children – an overview for physicians. Eur J Pediatr.<\/em> 2021;180(7):2035-2047. doi:10.1007\/s00431-021-03997-1<\/li>\n\n\n\n
  6. Quinn CT, Wiedmann RT, Jarovsky D, et al. Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in children with SCD: a V114-023 (PNEU-SICKLE) study. Blood Adv.<\/em> 2023;7(3):414-421. doi:10.1182\/bloodadvances.2022008037<\/li>\n\n\n\n
  7. Patel M, Chen J, Kim S, et al. Analysis of MarketScan Data for immunosuppressive conditions and hospitalizations for acute respiratory illness, United States. Emerg Infect Dis.<\/em> 2020;26(8):1720-1730. doi:10.3201\/eid2608.191493<\/li>\n\n\n\n
  8. Child and Adolescent Health Measurement Initiative. Fast Facts: 2021-2022 National Survey of Children\u2019s Health. Data Resource Center for Child and Adolescent Health. 2023. Accessed October 24, 2025. https:\/\/www.childhealthdata.org\/docs\/default-source\/nsch-docs\/2021-2022-nsch-fast-facts_cahmi.pdf<\/li>\n\n\n\n
  9. Data available on request from the Merck National Service Center via email at daprequests@merck.com. Please specify information package US-PVC-01958<\/span>.<\/li>\n\n\n\n
  10. Centers for Disease Control and Prevention. Recommended child and adolescent immunization schedule for ages 18 years or younger, United States, 2025. Revised October 7, 2025. Accessed October 12, 2025. https:\/\/www.cdc.gov\/vaccines\/hcp\/imz-schedules\/downloads\/child\/0-18yrs-child-combined-schedule.pdf<\/li>\n<\/ol>\n<\/div>\n\n\n\n\n
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    At year-end 2022 in the US and 6 dependent areas, the rate of children aged <13 years living with diagnosed HIV infection…<\/p>\n","protected":false},"author":708,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_trash_the_other_posts":false,"editor_notices":[],"footnotes":""},"ga4_page_audience":[1166],"ga4_page_birn_id":[],"ga4_page_branding":[227],"ga4_page_businessunit":[235],"ga4_page_campaign":[],"ga4_page_content_purpose":[243],"ga4_page_customer_journey_stage":[295],"ga4_page_customer_specialty":[359],"ga4_page_experience":[],"ga4_page_indication":[1215],"ga4_page_material_intent":[575],"ga4_page_product":[777],"ga4_page_region":[1025],"ga4_page_therapeuticarea":[1120],"class_list":["post-105","page","type-page","status-publish"],"yoast_head":"\nEvaluating Special Populations in Clinical Trials for VAXNEUVANCE\u00ae (Pneumococcal 15-valent Conjugate Vaccine)<\/title>\n<meta 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