Study 6Prevnar 20® (Pneumococcal 20-valent Conjugate Vaccine) immunogenicity in previously vaccinated adults1
Safety profile for adults with previous pneumococcal vaccination1
Percentage of participants in Study 6 with solicited adverse reactions within 7-10 days after vaccination in adults age 65 or older with prior pneumococcal vaccination1*†
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PRIOR PPSV23‡
PRIOR PCV13‡
PRIOR PCV13 and PPSV23‡
Local reaction§
Prevnar 20 (n ‖‖=253) %
PCV13 (n ‖‖=121) %
Prevnar 20 (n ‖‖=245) %
PPSV23 (n ‖‖=126) %
Prevnar 20
(n ‖‖=125)
%
Pain at injection
site¶
50.2
43.0
61.2
56.3
52.8
Swelling (>2.0 cm)¶**
9.9
6.6
9.4
14.3
4.0
Redness (>2.0 cm)¶**
7.9
2.5
8.6
12.7
4.8
Any local reaction††
53.0
43.8
64.1
57.9
54.4
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PRIOR PPSV23‡
PRIOR PCV13‡
PRIOR PCV13 and PPSV23‡
Systemic reaction§
Prevnar 20 (n ‖=253) %
PCV13 (n ‖=121) %
Prevnar 20 (n ‖=245) %
PPSV23 (n ‖=126) %
Prevnar 20
(n ‖=125)
%
Muscle pain‡‡
32.0
31.4
33.9
46.0
37.6
Fatigue‡‡
28.9
23.3
31.0
33.3
32.8
Headache‡‡
17.8
18.2
13.5
21.4
19.2
Joint pain‡‡
6.7
10.7
11.8
15.9
16.8
Fever (≥38.0 ˚C)
0.8
0.0
0.0
1.6
0.0
Any
systemic reaction§§
51.8
43.8
50.2
59.5
52.8
Use of antipyretic
or pain medication‖‖‖‖
15.8
14.9
17.1
19.8
17.6
PCV13=Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197Protein]); PPSV23=23-valent pneumococcal polysaccharide vaccine.Study 6 was conducted in the U.S. and in Sweden.Open-label administration of Prevnar 20.Includes participants who previously received either PPSV23 ≥1 to ≤5 years before enrollment, PCV13 ≥6 months before enrollment, or PCV13 followed by PPSV23 ≥1 year before enrollment in the study.Local reactions measured within 10 days after vaccination; systemic reactions measured within 7 days after vaccination.n=number of participants with any e-diary data reported after vaccination. This value is the denominator for the percentage calculations.Includes all participants who reported a reaction as mild, moderate, or severe during Day 1 to Day 10 after vaccination.Diameters were measured in caliper units (0.5 cm) of whole numbers from 1 to 21 or 21+. Measurements were rounded up to the nearest whole number. Intensity of redness and swelling was characterized as: mild is >2.0 to 5.0 cm; moderate is >5.0 to 10.0 cm; severe is >10.0 cm.“Any local reaction” includes all participants who reported any injection site reaction (pain, swelling, or redness) as mild, moderate, or severe during Day 1 to Day 10 after vaccination.Includes all participants who reported a reaction as mild, moderate, or severe during Day 1 to Day 7 after vaccination.”Any systemic reaction” includes all participants who reported any fever ≥38 °C or any other systemic reaction (fatigue, headache, joint pain, or muscle pain) as mild, moderate, or severe during Day 1 to Day 7 after vaccination.Severity was not collected for use of antipyretic or pain medication. The numbers listed reflect “yes” responses (ie, number of reactions reported).Reference:Prevnar 20® (Pneumococcal 20-valent Conjugate Vaccine) Prescribing Information, Wyeth Pharmaceuticals LLC, 2023.
Clinical studies
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INDICATION AND SELECT SAFETY INFORMATION
Prevnar 20® is a vaccine approved for:
active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 6 weeks of age and older
active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 18 years of age and older
The indication for the prevention of pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F in individuals 18 years of age and older is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA) assay. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial
SELECT SAFETY INFORMATION
Do not administer Prevnar 20® to individuals with severe allergic reaction (eg, anaphylaxis) to any component of Prevnar 20® or to diphtheria toxoid
Safety and immunogenicity data on Prevnar 20® are not available for individuals in immunocompromised groups and vaccination should be considered on an individual basis. Based on experience with pneumococcal vaccines, individuals with altered immunocompetence may have reduced immune responses to Prevnar 20®
IMPORTANT SAFETY INFORMATION
Do not administer Prevnar 20® to individuals with severe allergic reaction (eg, anaphylaxis) to any component of Prevnar 20® or to diphtheria toxoid
Safety and immunogenicity data on Prevnar 20® are not available for individuals in immunocompromised groups and vaccination should be considered on an individual basis. Based on experience with pneumococcal vaccines, individuals with altered immunocompetence may have reduced immune responses to Prevnar 20®
In individuals 18 years of age and older, the most commonly reported solicited adverse reactions (>10%) were pain at the injection site, muscle pain, fatigue, headache, and arthralgia. Additionally, injection site swelling was also reported (>10%) in individuals 18 through 59 years of age
Patients should always ask their healthcare providers for medical advice about adverse events. You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit http://www.vaers.hhs.gov or call 1-800-822-7967.
Please click for Prevnar 20® Full Prescribing Information.INDICATION
Prevnar 20® is a vaccine approved for:
active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 6 weeks of age and older
active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 18 years of age and older
The indication for the prevention of pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F in individuals 18 years of age and older is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA) assay. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial
