VAXNEUVANCE Delivered Robust Immunogenicity Against Key Disease-Causing Serotypes

IMMUNOGENICITY

VAXNEUVANCE Delivered Robust Immunogenicity Against Key Disease-Causing Serotypes

Immunogenicity is the capacity of a vaccine to elicit a measurable immune response.6 Clinical trials of VAXNEUVANCE assessed immune response, based on OPA against S. pneumoniae serotypes, as a surrogate measure of protection against invasive pneumococcal disease.

VAXNEUVANCE demonstrated a strong immune response to 15 serotypes, including noninferior immune responses vs PCV13 for the 13 shared serotypes.

VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) Demonstrated a Strong Immune Response to 15 serotypes, Including Noninferior Immune Responses for the 13 Serotypes Shared with PCV13

Serotypes 22F and 33F are included in VAXNEUVANCE but not in PCV13.

VAXNEUVANCE demonstrated superior immune response vs PCV13 for serotype 3, the leading cause of adult IPD in the United States.4

Comparative OPA GMTs for Serotype 3

GMT Ratio: 1.62 (95% CI: 1.40-1.87)

Comparative OPA GMTs for Serotype 3

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


Design

Study 1 assessed serotype-specific OPA responses for each of the 15 serotypes contained in VAXNEUVANCE at 30 days postvaccination in a double-blind, active comparator-controlled study that enrolled pneumococcal vaccine–naïve participants 50 years of age and older. Participants were randomized to receive either VAXNEUVANCE (N=604) or PCV13 (N=601) at sites in the United States, Canada, Spain, Taiwan, and Japan. The mean age of participants was 66 years and 57.3% were female. The racial distribution was as follows: 67.7% were White, 25.1% were Asian, 6.1% were Black or African American, and 22.0% were of Hispanic or Latino ethnicity.

CI, confidence interval; GMT, geometric mean titer; IPD, invasive pneumococcal disease; OPA, opsonophagocytic activity; PCV13, 13-valent pneumococcal conjugate vaccine.

In What Populations Was VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) Studied?

In what populations was VAXNEUVANCE studied?

ref4

Reference

  1. ACIP. Introduction of the pneumococcal work group. Updated October 28, 2020. Accessed December 16, 2021. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-10/pneumo-01-Poehling-Kobayashi-508.pdf
ref6

Reference

  1. WHO. Guidelines on clinical evaluation of vaccines: Regulatory expectations. 2017. Accessed July 9, 2021. who.int/publications/m/item/WHO-TRS-1004-web-annex-9

Indication for VAXNEUVANCE

VAXNEUVANCE(Pneumococcal 15-valent Conjugate Vaccine) 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 adults 18 years of age and older.

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.

Do not administer VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) 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.

The most commonly reported solicited adverse reactions in individuals 18 through 49 years of age were: injection-site pain (75.8%), fatigue (34.3%), myalgia (28.8%), headache (26.5%), injection-site swelling (21.7%), injection-site erythema (15.1%), and arthralgia (12.7%).

The most commonly reported solicited adverse reactions in individuals 50 years of age and older were: injection-site pain (66.8%), myalgia (26.9%), fatigue (21.5%), headache (18.9%), injection-site swelling (15.4%), injection-site erythema (10.9%), and arthralgia (7.7%).

Vaccination with VAXNEUVANCE may not protect all vaccine recipients.

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

VAXNEUVANCE(Pneumococcal 15-valent Conjugate Vaccine) 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 adults 18 years of age and older.

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US-PVC-00163 01/22