Vaccine Information: VAXNEUVANCE

VAXNEUVANCE- streptococcus pneumoniae type 1 capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 3 capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 4 capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 5 capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 6a capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 6b capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 7f capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 9v capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 14 capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 18c capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 19a capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 19f capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 22f capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 23f capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 33f capsular polysaccharide diphtheria crm197 protein conjugate antigen and corynebacterium diphtheriae crm197 protein injection, suspension
Merck Sharp & Dohme Corp.

1 INDICATIONS AND USAGE

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 adults 18 years of age and older.

2 DOSAGE AND ADMINISTRATION

For intramuscular use only.

2.1 Dosage

Administer a single 0.5 mL dose.

2.2 Administration

Hold the prefilled syringe horizontally and shake vigorously immediately prior to use to obtain an opalescent suspension in the prefilled syringe. Do not use the vaccine if it cannot be resuspended. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use if particulate matter or discoloration is observed.

3 DOSAGE FORMS AND STRENGTHS

VAXNEUVANCE is a suspension for intramuscular injection supplied in a 0.5 mL single-dose prefilled syringe.

4 CONTRAINDICATIONS

Do not administer VAXNEUVANCE to individuals with a severe allergic reaction (e.g., anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid. [See Description (11).]

5 WARNINGS AND PRECAUTIONS

5.1 Altered Immunocompetence

Some individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to VAXNEUVANCE. [See Drug Interactions (7.1) and Use in Specific Populations (8.6).]

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

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%).

Safety Assessment in Clinical Studies

The safety of VAXNEUVANCE was assessed in 7 randomized, double-blind clinical studies conducted in the Americas, Europe and Asia Pacific, in which 5,630 adults 18 years of age and older received VAXNEUVANCE and 1,808 adults received Prevnar 13 [Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)]. In Studies 1-3 (NCT03950622, NCT03950856, and NCT03480763), a total of 3,032 adults 50 years of age and older with no history of pneumococcal vaccination received VAXNEUVANCE and 1,154 participants received Prevnar 13. In Study 4 (NCT03547167), adults 18 through 49 years of age with no history of pneumococcal vaccination, including individuals with increased risk of developing pneumococcal disease, received VAXNEUVANCE (N=1,134) or Prevnar 13 (N=378), followed by PNEUMOVAX 23 six months later. In Study 5 (NCT02573181), adults 65 years of age and older previously vaccinated with PNEUMOVAX 23 (at least 1 year prior to study entry) received VAXNEUVANCE (N=127) or Prevnar 13 (N=126). In Study 6 (NCT03615482), adults 50 years of age and older received VAXNEUVANCE concomitantly with a seasonal inactivated quadrivalent influenza vaccine (Fluarix Quadrivalent; QIV) (Group 1, N=600) or nonconcomitantly 30 days after QIV (Group 2, N=585). In this study population, 20.9% of individuals had a history of prior vaccination with PNEUMOVAX 23. In Study 7 (NCT03480802), HIV-infected adults 18 years of age and older received VAXNEUVANCE (N=152) or Prevnar 13 (N=150), followed by PNEUMOVAX 23 two months later.

The clinical studies included adults with stable underlying medical conditions (e.g., diabetes mellitus, renal disorders, chronic heart disease, chronic liver disease, chronic lung disease including asthma) and/or behavioral risk factors (e.g., smoking, increased alcohol use) that are known to increase the risk of pneumococcal disease. Overall, the mean age of the participants was 58 years and 54.6% were female. The racial distribution was as follows: 72.3% were White, 9.9% were Asian, 8.1% were American Indian or Alaska Native, 7.4% were Black or African American, and 18.1% were of Hispanic or Latino ethnicity.

In all studies, safety was monitored using a Vaccination Report Card (VRC) for up to 14 days postvaccination. Study investigators reviewed the VRC with the participants 15 days postvaccination to ensure consistency with protocol definitions. The analyses presented in Tables 1-3 below reflect the information based on the final assessment by the study investigators. Oral body temperature and injection-site adverse reactions were solicited on Day 1 through Day 5 postvaccination. Systemic adverse reactions were solicited on Day 1 through Day 14 postvaccination. Unsolicited adverse events were reported on Day 1 through Day 14 postvaccination.

The duration of the safety follow-up period for serious adverse events postvaccination with VAXNEUVANCE was 1 month in Study 5; 2 months in Study 7; 6 months in Studies 1, 2, 4 and 6; and 12 months in Study 3.

Solicited Adverse Reactions

The percentage of participants with solicited adverse reactions that occurred within 5 or 14 days following administration of VAXNEUVANCE or Prevnar 13 in 3 studies are shown in Tables 1-3. The majority of solicited adverse reactions lasted ≤3 days.

Table 1: Percentage of Participants with Solicited Local and Systemic Adverse Reactions in Pneumococcal Vaccine-Naïve Adults 50 Years of Age and Older (Study 2)*
VAXNEUVANCE (%)N=2,103 Prevnar 13 (%)N=230
N=Number of participants vaccinated
*
Study 2 (NCT03950856) was a randomized (9:1), double-blind, active comparator-controlled, lot to lot consistency study. Safety was monitored using a Vaccination Report Card (VRC) for up to 14 days postvaccination. The table represents the final assessment by the study investigators upon review of the VRC 15 days postvaccination, to ensure consistency with protocol definitions.
Solicited on Day 1 through Day 5 postvaccination
Any use of narcotic pain reliever or prevents daily activity
§
Solicited on Day 1 through Day 14 postvaccination
Percentages are based on the number of participants with temperature data
Local Reactions
Pain
Any 66.8 52.2
Grade 3 0.9 0.0
Erythema
Any 10.9 9.6
>10 cm 0.6 0.4
Swelling
Any 15.4 14.3
>10 cm 0.2 0.0
Systemic Reactions §
Fatigue
Any 21.5 22.2
Grade 3 0.7 0.9
Headache
Any 18.9 18.7
Grade 3 0.8 0.0
Myalgia
Any 26.9 21.7
Grade 3 0.4 0.0
Arthralgia
Any 7.7 5.7
Grade 3 0.2 0.0
Fever
≥38.0°C and <38.5°C 0.6 0.4
≥38.5°C and <39.0°C 0.1 0.0
≥39.0°C 0.0 0.0
Table 2: Percentage of Participants with Solicited Local and Systemic Adverse Reactions in Pneumococcal Vaccine-Naïve Adults 18 to 49 Years of Age With or Without Risk Factors for Pneumococcal Disease (Study 4)*
VAXNEUVANCE (%)N=1,134 Prevnar 13 (%)N=378
N=Number of participants vaccinated
*
Study 4 (NCT03547167) was a randomized (3:1), double-blind, descriptive study. Safety was monitored using a Vaccination Report Card (VRC) for up to 14 days postvaccination. The table represents the final assessment by the study investigators upon review of the VRC 15 days postvaccination, to ensure consistency with protocol definitions.
Solicited on Day 1 through Day 5 postvaccination
Any use of narcotic pain reliever or prevents daily activity
§
Solicited on Day 1 through Day 14 postvaccination
Percentages are based on the number of participants with temperature data
Local Reactions
Pain
Any 75.8 68.8
Grade 3 1.1 1.6
Erythema
Any 15.1 14.0
>10 cm 0.5 0.3
Swelling
Any 21.7 22.2
>10 cm 0.4 0.5
Systemic Reactions §
Fatigue
Any 34.3 36.8
Grade 3 1.0 0.8
Headache
Any 26.5 24.9
Grade 3 0.8 0.5
Myalgia
Any 28.8 26.5
Grade 3 0.3 0.5
Arthralgia
Any 12.7 11.6
Grade 3 0.4 0.0
Fever
≥38.0°C and <38.5°C 1.0 0.3
≥38.5°C and <39.0°C 0.3 0.0
≥39.0°C 0.2 0.0
Table 3: Percentage of Participants with Solicited Local and Systemic Adverse Reactions in Adults 65 Years of Age and Older with Previous Pneumococcal Vaccination (Study 5)*
VAXNEUVANCE (%)N=127 Prevnar 13 (%)N=126
N=Number of participants vaccinated
*
Study 5 (NCT02573181) was a randomized, double-blind, descriptive study. Safety was monitored using a Vaccination Report Card (VRC) for up to 14 days postvaccination. The table represents the final assessment by the study investigators upon review of the VRC 15 days postvaccination, to ensure consistency with protocol definitions.
Solicited on Day 1 through Day 5 postvaccination
Any use of narcotic pain reliever or prevents daily activity
§
Solicited on Day 1 through Day 14 postvaccination
Percentages are based on the number of participants with temperature data
Local Reactions
Pain
Any 55.1 44.4
Grade 3 0.8 0.0
Erythema
Any 7.9 7.1
>10 cm 0.8 0.0
Swelling
Any 14.2 6.3
>10 cm 0.0 0.0
Systemic Reactions §
Fatigue
Any 18.1 19.0
Grade 3 0.0 0.0
Headache
Any 13.4 15.9
Grade 3 0.0 0.0
Myalgia
Any 15.7 11.1
Grade 3 0.8 0.0
Arthralgia
Any 5.5 8.7
Grade 3 0.0 0.0
Fever
≥38.0°C and <38.5°C 1.6 0.0
≥38.5°C and <39.0°C 0.0 0.0
≥39.0°C 0.0 0.0

Unsolicited Adverse Reactions

Across all studies, injection-site pruritus was reported to occur in up to 2.8% of adults vaccinated with VAXNEUVANCE.

Serious Adverse Events

Across all studies, among participants 18 years of age and older who received VAXNEUVANCE (excluding those who received QIV concomitantly; N=5,030) or Prevnar 13 (N=1,808), serious adverse events within 30 days postvaccination were reported by 0.4% of VAXNEUVANCE recipients and by 0.7% of Prevnar 13 recipients. In a subset of these studies, among those who received VAXNEUVANCE (N=4,751) and Prevnar 13 (N=1,532), serious adverse events within 6 months postvaccination were reported by 2.5% of VAXNEUVANCE recipients and by 2.4% of Prevnar 13 recipients.

There were no notable patterns or numerical imbalances between vaccination groups for specific categories of serious adverse events that would suggest a causal relationship to VAXNEUVANCE.

Safety with Concomitant Influenza Vaccine Administration

The safety profile was similar when VAXNEUVANCE was administered with or without inactivated quadrivalent influenza vaccine.

Page 1 of 3 1 2 3

VxLabels.com provides trustworthy package insert and label information about marketed drugs and vaccines as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VxLabels.com. Every individual vaccine label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Vaccine Sections

Vaccine Information by RSS

As the leading independent provider of trustworthy vaccine information, our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VxLabels.com provides the full vaccine subset of the FDA's repository. Vaccine information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.