To help protect against pediatric IPD, immunogenicity matters through the first year of life and beyond1,2,3,4,5

Consider VAXNEUVANCE for your pediatric patients

Administered as a 4-dose series at 2, 4, 6, and 12 through 15 months of age

Elicited robust immune responses to all 15 serotypes in the vaccine postdose 3 and postdose 4

More reasons to choose VAXNEUVANCE

Protection matters during the first year of life, when pediatric IPD incidence is highest4,6,7,8

The immune response generated postdose 3 is an important measure when evaluating protection against IPD during the first year of life2,5,9

Comparable immune response to PCV13 for 12 shared serotypes following a 4-dose seriesa

Superior immune responses vs PCV13 for shared Serotype 3 and unique Serotypes 22F and 33Fa

Randomized controlled trials assessing the clinical efficacy of VAXNEUVANCE compared to PCV13 have not been conducted.

aStudy Design

Study 8 was a pivotal, double-blind, active comparator-controlled study in which participants were randomized to receive VAXNEUVANCE (N=860) or PCV13 (N=860) in a 4-dose series. The first 3 doses were administered to infants at 2, 4, and 6 months of age and the fourth dose was administered to children at 12 through 15 months of age. Participants also received other licensed pediatric vaccines concomitantly. Immune responses were measured by IgG response rates, IgG GMCs, and OPA GMTs for all 15 serotypes contained in VAXNEUVANCE.

VAXNEUVANCE is CDC, AAP, and AAFP recommended as an option for your pediatric patients9,10,11,12

AAP, American Academy of Pediatrics; AAFP, American Academy of Family Physicians; CDC, Centers for Disease Control and Prevention; GMC, geometric mean concentration (mcg/mL); GMT, geometric mean titer; IgG, Immunoglobulin G; IPD, invasive pneumococcal disease; OPA, opsonophagocytic activity; PCV13, 13-valent pneumococcal conjugate vaccine.

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Reference

  1. Weekly epidemiological record. World Health Organization. 2019;85–104. Accessed January 26, 2024. https://www.who.int/publications/i/item/10665-310968
pediatric-ref2

Reference

  1. Recommendations to assure the quality, safety and efficacy of pneumococcal conjugate vaccines, Annex 3, TRS No 977. World Health Organization. October 19, 2013. Accessed January 26, 2024. https://www.who.int/publications/m/item/pneumococcal-conjugate-vaccines-annex3-trs-977
pediatric-ref3

Reference

  1. Gruber MF, Marshall VB. Chapter 80: Regulation and testing of vaccines in the US. In: Orenstein WA, Offit PA, Edwards KM, Plotkin SA, eds. Plotkin’s Vaccines. 8th ed. Elsevier; 2022;1640-1659.e2.
pediatric-ref4

Reference

  1. Gierke R, Wodi P, Kobayashi M. Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book). 14th edition. Chapter 17: Pneumococcal disease. Centers for Disease Control and Prevention. Last reviewed August 18, 2021. Accessed April 10, 2024. https://www.cdc.gov/vaccines/pubs/pinkbook/pneumo.html
pediatric-ref5

Reference

  1. Guidelines on clinical evaluation of vaccines: regulatory expectations. WHO Technical Report Series 1004, Annex 9, 2017. World Health Organization. Accessed July 18, 2023. https://www.who.int/publications/m/item/WHO-TRS-1004-web-annex-9
pediatric-ref6

Reference

  1. Moraes-Pinto M, Suano-Souza F, Aranda C. Immune system: development and acquisition of immunological competence. J Pediatr (Rio J). 2021; S59-S66. doi:10.1016/j.jped.2020.10.006
pediatric-ref7

Reference

  1. Data available on request from Merck & Co., Inc., Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package US-PVC-01698.
pediatric-ref8

Reference

  1. Wodi AP, Morelli V. Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book). 14th edition. Chapter 1: Principles of vaccination. Centers for Disease Control and Prevention. Last reviewed August 18, 2021. Accessed January 10, 2024. https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/prinvac.pdf
pediatric-ref9

Reference

  1. Centers for Disease Control and Prevention (CDC). Child and adolescent immunization schedule. Last updated November 16, 2023. Accessed November 16, 2023. https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html
pediatric-ref10

Reference

  1. Immunizations. American Academy of Pediatrics (AAP). Last updated July 10, 2023. Accessed January 2, 2024. https://www.aap.org/en/patient-care/immunizations/
pediatric-ref11

Reference

  1. American Academy of Family Physicians (AAFP). Immunization schedules. 2024. Accessed November 29, 2023. https://www.aafp.org/family-physician/patient-care/prevention-wellness/immunizations-vaccines/immunization-schedules.html
pediatric-ref12

Reference

  1. Farrar JL, Gierke R, Andrejko KL, et al. ACIP updates: recommendations for use of 20-valent pneumococcal conjugate vaccine in children–United States, 2023. Supplement. MMWR Morb Mortal Wkly Rep. 2023;72(39):1072. Accessed October 2, 2023. https://stacks.cdc.gov/view/cdc/133252
pediatric-ref13

Reference

  1. Centers for Disease Control and Prevention (CDC). VFC. CDC Vaccine Price List. Updated March 1, 2024. Accessed March 4, 2024. https://www.cdc.gov/vaccines/programs/vfc/awardees/vaccine-management/price-list/index.html
pediatric-ref14

Reference

  1. Centers for Disease Control and Prevention. About VFC. Reviewed December 19, 2023. Accessed February 13, 2024. https://www.cdc.gov/vaccines/programs/vfc/about/index.html
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Indications and Usage for VAXNEUVANCE

VAXNEUVANCE is indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 6 weeks of age and older.

Select Safety Information for VAXNEUVANCE

Do not administer VAXNEUVANCE to individuals with a severe allergic reaction (eg, anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid.

Some individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to VAXNEUVANCE.

Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination of premature infants should be based on the infant’s medical status and the potential benefits and possible risks.

The most commonly reported solicited adverse reactions in children vaccinated at 2, 4, 6, and 12 through 15 months of age, provided as a range across the 4-dose series, were: irritability (57.3% to 63.4%), somnolence (24.2% to 47.5%), injection-site pain (25.9% to 40.3%), fever ≥38.0°C (13.3% to 20.4%), decreased appetite (14.1% to 19.0%), injection-site induration (13.2% to 15.4%), injection-site erythema (13.7% to 21.4%), and injection-site swelling (11.3% to 13.4%).

The most commonly reported solicited adverse reactions in children 2 through 17 years of age vaccinated with a single dose were: injection-site pain (54.8%), myalgia (23.7%), injection-site swelling (20.9%), injection-site erythema (19.2%), fatigue (15.8%), headache (11.9%), and injection-site induration (6.8%).

The reported solicited adverse reactions in children 7 through 11 months of age who received 3 doses of VAXNEUVANCE were: fever ≥38.0°C (21.9%), irritability (32.8%), injection-site erythema (28.1%), somnolence (21.9%), injection-site swelling (18.8%), injection-site pain (18.8%), injection-site induration (17.2%), decreased appetite (15.6%), and urticaria (1.6%).

The reported solicited adverse reactions in children 12 through 23 months of age who received 2 doses of VAXNEUVANCE were: fever ≥38.0°C (11.3%), irritability (35.5%), injection-site pain (33.9%), somnolence (24.2%), decreased appetite (22.6%), injection-site erythema (21.0%), injection-site swelling (14.5%), and injection-site induration (8.1%).

Vaccination with VAXNEUVANCE may not protect all vaccine recipients.

Before administering VAXNEUVANCE, please read the accompanying Prescribing Information. The Patient Information also is available.

Indications and Usage for VAXNEUVANCE® (Pneumococcal 15-valent Conjugate Vaccine)

VAXNEUVANCE is indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 6 weeks of age and older.

VAXNEUVANCE is indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae

VAXNEUVANCE is indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 6 weeks of age and older.

Select Safety Information for VAXNEUVANCE® (Pneumococcal 15-valent Conjugate Vaccine)

Do not administer VAXNEUVANCE to individuals with a severe allergic reaction (eg, anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid.

Some individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to VAXNEUVANCE.

Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination of premature infants should be based on the infant’s medical status and the potential benefits and possible risks.

The most commonly reported solicited adverse reactions in children vaccinated at 2, 4, 6, and 12 through 15 months of age, provided as a range across the 4-dose series, were: irritability (57.3% to 63.4%), somnolence (24.2% to 47.5%), injection-site pain (25.9% to 40.3%), fever ≥38.0°C (13.3% to 20.4%), decreased appetite (14.1% to 19.0%), injection-site induration (13.2% to 15.4%), injection-site erythema (13.7% to 21.4%), and injection-site swelling (11.3% to 13.4%).

The most commonly reported solicited adverse reactions in children 2 through 17 years of age vaccinated with a single dose were: injection-site pain (54.8%), myalgia (23.7%), injection-site swelling (20.9%), injection-site erythema (19.2%), fatigue (15.8%), headache (11.9%), and injection-site induration (6.8%).

The reported solicited adverse reactions in children 7 through 11 months of age who received 3 doses of VAXNEUVANCE were: fever ≥38.0°C (21.9%), irritability (32.8%), injection-site erythema (28.1%), somnolence (21.9%), injection-site swelling (18.8%), injection-site pain (18.8%), injection-site induration (17.2%), decreased appetite (15.6%), and urticaria (1.6%).

The reported solicited adverse reactions in children 12 through 23 months of age who received 2 doses of VAXNEUVANCE were: fever ≥38.0°C (11.3%), irritability (35.5%), injection-site pain (33.9%), somnolence (24.2%), decreased appetite (22.6%), injection-site erythema (21.0%), injection-site swelling (14.5%), and injection-site induration (8.1%).

Vaccination with VAXNEUVANCE may not protect all vaccine recipients.

Before administering VAXNEUVANCE, please read the accompanying Prescribing Information. The Patient Information also is available.

Do not administer VAXNEUVANCE to individuals with a severe allergic reaction (eg, anaphylaxis) to any component of VAXNEUVANCE or

Do not administer VAXNEUVANCE to individuals with a severe allergic reaction (eg, anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid.

Some individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to VAXNEUVANCE.

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