VAXNEUVANCE Demonstrated Robust Immune Responses in a Variety of Adults at Increased Risk for IPD

STUDY POPULATIONS AT INCREASED RISK

VAXNEUVANCE Demonstrated Robust Immune Responses in a Variety of Adults at Increased Risk for IPD

The clinical development program for VAXNEUVANCE included seven randomized, double-blind clinical trials in a variety of populations and clinical circumstances, including adults at increased risk.

Adults With HIV (Study 7)a

Among pneumococcal vaccine–naïve, HIV-infected adults (n=302) who received VAXNEUVANCE or PCV13, immune responses were higher after administration of VAXNEUVANCE, compared with prevaccination, for the 15 serotypes contained in VAXNEUVANCE.

After sequential administration with PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) two months later, immune responses were numerically similar between the two vaccination groups for all 15 serotypes contained in VAXNEUVANCE.

Design
aStudy 7 was a double-blind, descriptive study, in which the safety and immunogenicity of VAXNEUVANCE were evaluated in pneumococcal vaccine–naïve adults ≥18 years of age living with HIV, with CD4+ cell count ≥50 cells per microliter and plasma HIV RNA value <50,000 copies/mL. Participants were randomized to receive VAXNEUVANCE (N=152) or PCV13 (N=150), followed by PNEUMOVAX 23 two months later. Immune response was assessed by OPA GMTs at 30 days following vaccination.

Chronic Conditions (Study 4)b

VAXNEUVANCE elicited immune responses to all 15 serotypes among adults 18-49 years of age with no history of pneumococcal vaccination who received VAXNEUVANCE or PCV13, including individuals at increased risk of developing pneumococcal disease (n=1515).

This included people with stable underlying medical conditions (eg, diabetes mellitus, renal disorders, chronic heart disease, chronic liver disease, chronic lung disease, including asthma) and/or behavioral risk factors (eg, smoking, increased alcohol use) that increased their risk of developing pneumococcal disease.

Design
bStudy 4 was a double-blind, descriptive study of adults 18 through 49 years of age. It included individuals with increased risk of developing pneumococcal disease who were randomized to receive VAXNEUVANCE (N=1135) or PCV13 (N=380), followed by PNEUMOVAX 23 six months later. Among those who received VAXNEUVANCE, 620 participants had one risk factor and 228 participants had two or more risk factors for pneumococcal disease. Immune response was assessed by OPA GMTs at 30 days following vaccination.

Older Adults (Study 3)

Adults 50 years of age and older (Study 3)c

Among pneumococcal vaccine–naïve adults 50 years of age or older who received VAXNEUVANCE or PCV13 followed by PNEUMOVAX 23 one year later, immune responses were numerically similar between the two vaccination groups for the 15 serotypes in VAXNEUVANCE.

Design
cStudy 3 was a double-blind, active comparator-controlled, descriptive study of pneumococcal vaccine–naïve adults 50 years of age and older. Patients were randomized to receive either VAXNEUVANCE (N=327) or PCV13 (N=325), followed by PNEUMOVAX 23 one year later. Following vaccination with PNEUMOVAX 23, OPA GMTs were assessed. Immune response was assessed by OPA GMTs at 30 days following vaccination.

Adults 65 years of age and olderd

There were no clinically meaningful differences in immune responses observed in older individuals (65 to 74 years and 75 years of age and older) who received VAXNEUVANCE when compared to younger individuals.

Design
dOf the 4389 individuals aged 50 years and older who received VAXNEUVANCE in clinical trials, 2478 (56.5%) were 65 years and older, and 479 (10.9%) were 75 years and older. Immune response was assessed by OPA GMTs at 30 days following vaccination.

GMT, geometric mean titer; HIV, human immunodeficiency virus; IPD, invasive pneumococcal disease; OPA, opsonophagocytic activity; PCV13, 13-valent pneumococcal conjugate vaccine.

How Was the Safety Profile of VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) Assessed?

How was the safety profile of VAXNEUVANCE assessed?

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