Trial Outcomes & Findings for A Phase IIb, Open-Label, Dose Ranging Study of 13-Valent Pneumococcal Conjugate Vaccine in Adults 55 Through 74 Years of Age Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine (NCT NCT01654263)
NCT ID: NCT01654263
Last Updated: 2017-03-27
Results Overview
Participants maintained a memory aid to record daily the occurrence of local injection site reactions and systemic reactions for 8 days after vaccination based on their interference with daily activities for subjective symptoms or quantitative measurement of the reaction. All participants reporting events of any severity (mild, moderate, or severe) are counted. For measured reactions, participants are included if the reaction is \>0mm.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
884 participants
Primary outcome timeframe
Days 0 to Day 7 post vaccination
Results posted on
2017-03-27
Participant Flow
Participants were healthy adult males and females, 55 through 74 years of age, recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 10OCT2012 and 03MAR2015.
Participant milestones
| Measure |
IA: Pneumococcal Vaccine-naive, Age 55-64, Single Injection
Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-64.
|
IB: Pneumococcal Vaccine-naive, Age 65-74, Single Injection
Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 65-74.
|
IIA: Age 55-64, Previous PPSV23, Single Injection
Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
|
IIB: Age 65-74, Previous PPSV23, Single Injection
Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
|
IIAA: Age 55-64, Previous PPSV23, Two Injections
Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
|
IIBB: Age 65 - 74, Previous PPSV23, Two Injections
Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
164
|
147
|
139
|
145
|
140
|
149
|
|
Overall Study
COMPLETED
|
164
|
147
|
137
|
144
|
139
|
148
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
1
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase IIb, Open-Label, Dose Ranging Study of 13-Valent Pneumococcal Conjugate Vaccine in Adults 55 Through 74 Years of Age Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine
Baseline characteristics by cohort
| Measure |
IA: Pneumococcal Vaccine-naive, Age 55-64, Single Injection
n=164 Participants
Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-64.
|
IB: Pneumococcal Vaccine-naive, Age 65-74, Single Injection
n=147 Participants
Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 65-74.
|
IIA: Age 55-64, Previous PPSV23, Single Injection
n=139 Participants
Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
|
IIB: Age 65-74, Previous PPSV23, Single Injection
n=145 Participants
Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
|
IIAA: Age 55-64, Previous PPSV23, Two Injections
n=140 Participants
Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
|
IIBB: Age 65-74, Previous PPSV23, Two Injections
n=149 Participants
Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
|
Total
n=884 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
164 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
140 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
443 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
145 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
149 Participants
n=10 Participants
|
441 Participants
n=115 Participants
|
|
Age, Continuous
|
59.7 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
67.6 years
STANDARD_DEVIATION 2.6 • n=7 Participants
|
60.8 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
70.5 years
STANDARD_DEVIATION 2.0 • n=4 Participants
|
61.0 years
STANDARD_DEVIATION 2.8 • n=21 Participants
|
70.3 years
STANDARD_DEVIATION 2.0 • n=10 Participants
|
65.0 years
STANDARD_DEVIATION 5.3 • n=115 Participants
|
|
Sex: Female, Male
Female
|
128 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
78 Participants
n=10 Participants
|
512 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
71 Participants
n=10 Participants
|
372 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
159 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
143 Participants
n=4 Participants
|
138 Participants
n=21 Participants
|
147 Participants
n=10 Participants
|
863 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
61 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
154 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
132 Participants
n=4 Participants
|
116 Participants
n=21 Participants
|
138 Participants
n=10 Participants
|
794 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
164 participants
n=5 Participants
|
147 participants
n=7 Participants
|
139 participants
n=5 Participants
|
145 participants
n=4 Participants
|
140 participants
n=21 Participants
|
149 participants
n=10 Participants
|
884 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Days 0 to Day 7 post vaccinationPopulation: All participants who received vaccination are included. Data were analyzed regardless of age strata as pre-specified in the study protocol.
Participants maintained a memory aid to record daily the occurrence of local injection site reactions and systemic reactions for 8 days after vaccination based on their interference with daily activities for subjective symptoms or quantitative measurement of the reaction. All participants reporting events of any severity (mild, moderate, or severe) are counted. For measured reactions, participants are included if the reaction is \>0mm.
Outcome measures
| Measure |
Group IA/B: Pneumococcal Vaccine-naive, Single Injection
n=311 Participants
Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-74.
|
Group IIA/B: Previous PPSV23, Single Injection
n=284 Participants
Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
|
Group IIAA/BB: Previous PPSV23, Two Injections
n=288 Participants
Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
|
|---|---|---|---|
|
Number of Participants Reporting Solicited Local and Systemic Adverse Events
Pain
|
148 participants
|
153 participants
|
187 participants
|
|
Number of Participants Reporting Solicited Local and Systemic Adverse Events
Swelling (measurement)
|
39 participants
|
48 participants
|
45 participants
|
|
Number of Participants Reporting Solicited Local and Systemic Adverse Events
Elevated oral temperature
|
5 participants
|
3 participants
|
7 participants
|
|
Number of Participants Reporting Solicited Local and Systemic Adverse Events
Feverishness
|
18 participants
|
25 participants
|
29 participants
|
|
Number of Participants Reporting Solicited Local and Systemic Adverse Events
Malaise
|
53 participants
|
56 participants
|
86 participants
|
|
Number of Participants Reporting Solicited Local and Systemic Adverse Events
Headache
|
44 participants
|
43 participants
|
63 participants
|
|
Number of Participants Reporting Solicited Local and Systemic Adverse Events
Nausea
|
13 participants
|
14 participants
|
15 participants
|
|
Number of Participants Reporting Solicited Local and Systemic Adverse Events
Tenderness
|
213 participants
|
180 participants
|
214 participants
|
|
Number of Participants Reporting Solicited Local and Systemic Adverse Events
Redness (measurement)
|
40 participants
|
47 participants
|
53 participants
|
|
Number of Participants Reporting Solicited Local and Systemic Adverse Events
Swelling
|
39 participants
|
49 participants
|
45 participants
|
|
Number of Participants Reporting Solicited Local and Systemic Adverse Events
Chills
|
17 participants
|
11 participants
|
26 participants
|
|
Number of Participants Reporting Solicited Local and Systemic Adverse Events
New muscle pain
|
26 participants
|
26 participants
|
36 participants
|
|
Number of Participants Reporting Solicited Local and Systemic Adverse Events
Aggravated muscle pain
|
9 participants
|
11 participants
|
21 participants
|
|
Number of Participants Reporting Solicited Local and Systemic Adverse Events
New joint pain
|
11 participants
|
15 participants
|
16 participants
|
|
Number of Participants Reporting Solicited Local and Systemic Adverse Events
Aggravated joint pain
|
11 participants
|
15 participants
|
21 participants
|
PRIMARY outcome
Timeframe: Up to Day 28 post vaccinationPopulation: All participants who received vaccination are included. Data were analyzed regardless of age strata as pre-specified in the study protocol.
Association with PCV13 was determined by the investigator and defined as "Related", meaning there was a known temporal relationship, or the event was known to occur in association with study product or with a product in a similar class of study products and no alternate etiology was identified.
Outcome measures
| Measure |
Group IA/B: Pneumococcal Vaccine-naive, Single Injection
n=311 Participants
Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-74.
|
Group IIA/B: Previous PPSV23, Single Injection
n=284 Participants
Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
|
Group IIAA/BB: Previous PPSV23, Two Injections
n=288 Participants
Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
|
|---|---|---|---|
|
Number of Participants Reporting Unsolicited Vaccine-related Adverse Events.
|
19 participants
|
14 participants
|
22 participants
|
PRIMARY outcome
Timeframe: Up to Day 180 post vaccinationPopulation: All participants who received vaccination are included. Data were analyzed regardless of age strata as pre-specified in the study protocol.
Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof; was a congenital anomaly/birth defect; or may have jeopardized the participant, or required intervention to prevent one of the outcomes. Association with PCV13 was determined by the investigator and defined as "Related", meaning there was a known temporal relationship, or the event was known to occur in association with study product or with a product in a similar class of study products and no alternate etiology was identified.
Outcome measures
| Measure |
Group IA/B: Pneumococcal Vaccine-naive, Single Injection
n=311 Participants
Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-74.
|
Group IIA/B: Previous PPSV23, Single Injection
n=284 Participants
Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
|
Group IIAA/BB: Previous PPSV23, Two Injections
n=288 Participants
Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
|
|---|---|---|---|
|
Number of Participants Reporting Vaccine-related Serious Adverse Events.
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Day 0 and Day 28 post vaccinationPopulation: All participants who received vaccination and had immunology samples obtained within the protocol-defined windows for Days 0, 28, and 180 are included. Three additional subjects were excluded for not meeting eligibility criteria or receipt of a non-study vaccine. Data were analyzed regardless of age strata as pre-specified in the study protocol.
Blood was collected from all participants at Day 0 and Day 28 after receipt of vaccination. The geometric mean for each group was then assessed by serotype-specific opsonophagocytic antibody (OPA).
Outcome measures
| Measure |
Group IA/B: Pneumococcal Vaccine-naive, Single Injection
n=307 Participants
Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-74.
|
Group IIA/B: Previous PPSV23, Single Injection
n=277 Participants
Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
|
Group IIAA/BB: Previous PPSV23, Two Injections
n=283 Participants
Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
|
|---|---|---|---|
|
Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.
Serotype 1, Day 0
|
6.8 Titer
Interval 6.0 to 7.7
|
20.9 Titer
Interval 16.9 to 25.7
|
20.4 Titer
Interval 16.9 to 24.6
|
|
Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.
Serotype 1, Day 28
|
216.0 Titer
Interval 177.5 to 262.7
|
75.2 Titer
Interval 61.4 to 92.1
|
95.1 Titer
Interval 78.6 to 115.0
|
|
Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.
Serotype 4, Day 0
|
20.6 Titer
Interval 16.6 to 25.5
|
92.3 Titer
Interval 72.2 to 117.9
|
81.3 Titer
Interval 63.7 to 103.7
|
|
Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.
Serotype 4, Day 28
|
1808.9 Titer
Interval 1570.4 to 2083.5
|
926.6 Titer
Interval 787.5 to 1090.3
|
1451.3 Titer
Interval 1277.3 to 1649.0
|
|
Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.
Serotype 5, Day 0
|
8.8 Titer
Interval 7.6 to 10.2
|
53.0 Titer
Interval 41.7 to 67.4
|
36.8 Titer
Interval 29.3 to 46.1
|
|
Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.
Serotype 5, Day 28
|
509.8 Titer
Interval 416.4 to 624.2
|
287.8 Titer
Interval 237.1 to 349.4
|
302.8 Titer
Interval 249.5 to 367.5
|
|
Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.
Serotype 6A, Day 0
|
24.1 Titer
Interval 19.0 to 30.5
|
47.5 Titer
Interval 35.9 to 62.8
|
53.8 Titer
Interval 41.1 to 70.5
|
|
Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.
Serotype 6A, Day 28
|
3222.1 Titer
Interval 2697.1 to 3849.5
|
2256.7 Titer
Interval 1867.1 to 2727.6
|
2903.1 Titer
Interval 2364.5 to 3564.5
|
|
Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.
Serotype 6B, Day 0
|
48.8 Titer
Interval 37.9 to 62.7
|
106.5 Titer
Interval 80.9 to 140.2
|
145.4 Titer
Interval 111.1 to 190.4
|
|
Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.
Serotype 6B, Day 28
|
2950.8 Titer
Interval 2453.0 to 3549.6
|
1767.8 Titer
Interval 1421.2 to 2199.0
|
2562.7 Titer
Interval 2095.5 to 3134.0
|
|
Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.
Serotype 7F, Day 0
|
74.6 Titer
Interval 57.1 to 97.4
|
284.2 Titer
Interval 225.0 to 359.0
|
313.4 Titer
Interval 250.1 to 392.8
|
|
Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.
Serotype 7F, Day 28
|
4670.1 Titer
Interval 4064.9 to 5365.3
|
1692.4 Titer
Interval 1445.1 to 1982.0
|
2144.2 Titer
Interval 1870.2 to 2458.4
|
|
Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.
Serotype 9V, Day 0
|
91.1 Titer
Interval 71.7 to 115.8
|
210.8 Titer
Interval 164.5 to 270.2
|
246.6 Titer
Interval 193.3 to 314.5
|
|
Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.
Serotype 9V, Day 28
|
2337.5 Titer
Interval 2004.9 to 2725.3
|
1067.5 Titer
Interval 895.8 to 1272.2
|
1824.9 Titer
Interval 1566.0 to 2126.6
|
|
Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.
Serotype 14, Day 0
|
120.8 Titer
Interval 94.1 to 155.0
|
370.5 Titer
Interval 288.4 to 476.0
|
452.1 Titer
Interval 358.6 to 570.0
|
|
Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.
Serotype 14, Day 28
|
1667.3 Titer
Interval 1400.6 to 1984.8
|
1102.2 Titer
Interval 916.4 to 1325.7
|
1342.5 Titer
Interval 1149.1 to 1568.4
|
|
Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.
Serotype 18C, Day 0
|
41.3 Titer
Interval 33.4 to 51.1
|
206.5 Titer
Interval 164.0 to 260.0
|
200.8 Titer
Interval 157.2 to 256.5
|
|
Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.
Serotype 18C, Day 28
|
2133.1 Titer
Interval 1801.8 to 2525.3
|
948.3 Titer
Interval 796.1 to 1129.6
|
1373.2 Titer
Interval 1181.6 to 1596.0
|
|
Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.
Serotype 19A, Day 0
|
159.2 Titer
Interval 131.4 to 193.0
|
540.4 Titer
Interval 446.4 to 654.1
|
499.8 Titer
Interval 407.9 to 612.4
|
|
Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.
Serotype 19A, Day 28
|
2981.9 Titer
Interval 2610.4 to 3406.3
|
1828.8 Titer
Interval 1608.6 to 2079.1
|
2316.3 Titer
Interval 2046.2 to 2622.1
|
|
Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.
Serotype 19F, Day 0
|
64.8 Titer
Interval 52.6 to 80.0
|
153.4 Titer
Interval 123.7 to 190.2
|
169.4 Titer
Interval 138.8 to 206.6
|
|
Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.
Serotype 19F, Day 28
|
1415.5 Titer
Interval 1237.2 to 1619.6
|
727.6 Titer
Interval 622.2 to 850.9
|
1050.7 Titer
Interval 912.1 to 1210.3
|
|
Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.
Serotype 23F, Day 0
|
17.8 Titer
Interval 14.1 to 22.3
|
52.6 Titer
Interval 40.7 to 68.0
|
50.6 Titer
Interval 39.3 to 65.3
|
|
Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.
Serotype 23F, Day 28
|
947.4 Titer
Interval 762.2 to 1177.4
|
652.7 Titer
Interval 515.2 to 827.0
|
834.4 Titer
Interval 674.5 to 1032.2
|
SECONDARY outcome
Timeframe: Day 0 and Day 180 post vaccinationPopulation: All participants who received vaccination and had immunology samples obtained within the protocol-defined windows for Days 0, 28, and 180 are included. Three additional subjects were excluded for not meeting eligibility criteria or receipt of a non-study vaccine. Data were analyzed regardless of age strata as pre-specified in the study protocol.
Blood was collected from all participants at Days 0 and 180 after receipt of vaccination. The geometric mean for each group was then assessed by serotype-specific opsonophagocytic antibody (OPA).
Outcome measures
| Measure |
Group IA/B: Pneumococcal Vaccine-naive, Single Injection
n=307 Participants
Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-74.
|
Group IIA/B: Previous PPSV23, Single Injection
n=277 Participants
Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
|
Group IIAA/BB: Previous PPSV23, Two Injections
n=283 Participants
Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
|
|---|---|---|---|
|
Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.
Serotype 6B, Day 0
|
48.8 Titer
Interval 37.9 to 62.7
|
106.5 Titer
Interval 80.9 to 140.2
|
145.4 Titer
Interval 111.1 to 190.4
|
|
Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.
Serotype 1, Day 0
|
6.8 Titer
Interval 6.0 to 7.7
|
20.9 Titer
Interval 16.9 to 25.7
|
20.4 Titer
Interval 16.9 to 24.6
|
|
Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.
Serotype 1, Day 180
|
93.4 Titer
Interval 76.4 to 141.1
|
45.4 Titer
Interval 36.9 to 55.9
|
54.4 Titer
Interval 45.1 to 65.7
|
|
Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.
Serotype 4, Day 0
|
20.6 Titer
Interval 16.6 to 25.5
|
92.3 Titer
Interval 72.2 to 117.9
|
81.3 Titer
Interval 63.7 to 103.7
|
|
Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.
Serotype 4, Day 180
|
718.3 Titer
Interval 619.4 to 833.1
|
483.9 Titer
Interval 407.4 to 574.6
|
734.9 Titer
Interval 641.8 to 841.6
|
|
Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.
Serotype 5, Day 0
|
8.8 Titer
Interval 7.6 to 10.2
|
53.0 Titer
Interval 41.7 to 67.4
|
36.8 Titer
Interval 29.3 to 46.1
|
|
Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.
Serotype 5, Day 180
|
234.6 Titer
Interval 190.7 to 288.6
|
185.4 Titer
Interval 151.6 to 226.8
|
167.6 Titer
Interval 136.4 to 205.8
|
|
Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.
Serotype 6A, Day 0
|
24.1 Titer
Interval 19.0 to 30.5
|
47.5 Titer
Interval 35.9 to 62.8
|
53.8 Titer
Interval 41.1 to 70.5
|
|
Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.
Serotype 6A, Day 180
|
1568.5 Titer
Interval 1321.6 to 1861.6
|
1155.8 Titer
Interval 962.2 to 1388.4
|
1384.4 Titer
Interval 1132.5 to 1692.4
|
|
Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.
Serotype 6B, Day 180
|
1425.1 Titer
Interval 1188.9 to 1708.2
|
996.1 Titer
Interval 806.8 to 1229.9
|
1335.8 Titer
Interval 1084.0 to 1646.2
|
|
Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.
Serotype 7F, Day 0
|
74.6 Titer
Interval 57.1 to 97.4
|
284.2 Titer
Interval 225.0 to 359.0
|
313.4 Titer
Interval 250.1 to 392.8
|
|
Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.
Serotype 7F, Day 180
|
2329.0 Titer
Interval 2053.3 to 2641.8
|
1063.3 Titer
Interval 913.6 to 1237.6
|
1386.9 Titer
Interval 1224.5 to 1570.8
|
|
Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.
Serotype 9V, Day 0
|
91.1 Titer
Interval 71.7 to 115.8
|
210.8 Titer
Interval 164.5 to 270.2
|
246.6 Titer
Interval 193.3 to 314.5
|
|
Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.
Serotype 9V, Day 180
|
1191.7 Titer
Interval 1016.9 to 1396.5
|
722.4 Titer
Interval 602.3 to 866.5
|
1142.8 Titer
Interval 979.2 to 1333.7
|
|
Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.
Serotype 14, Day 0
|
120.8 Titer
Interval 94.1 to 155.0
|
370.5 Titer
Interval 288.4 to 476.0
|
452.1 Titer
Interval 358.6 to 570.0
|
|
Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.
Serotype 14, Day 180
|
992.3 Titer
Interval 844.3 to 1166.1
|
838.3 Titer
Interval 692.2 to 1015.3
|
1056.5 Titer
Interval 908.3 to 1229.0
|
|
Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.
Serotype 18C, Day 0
|
41.3 Titer
Interval 33.4 to 51.1
|
206.5 Titer
Interval 164.0 to 260.0
|
200.8 Titer
Interval 157.2 to 256.5
|
|
Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.
Serotype 18C, Day 180
|
964.7 Titer
Interval 806.2 to 1154.5
|
590.9 Titer
Interval 490.7 to 711.5
|
778.4 Titer
Interval 655.0 to 925.2
|
|
Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.
Serotype 19A, Day 0
|
159.2 Titer
Interval 131.4 to 193.0
|
540.4 Titer
Interval 446.4 to 654.1
|
499.8 Titer
Interval 407.9 to 612.4
|
|
Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.
Serotype 19A, Day 180
|
1522.3 Titer
Interval 1340.3 to 1728.9
|
1272.1 Titer
Interval 1120.7 to 1444.1
|
1508.3 Titer
Interval 1326.3 to 1715.3
|
|
Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.
Serotype 19F, Day 0
|
64.8 Titer
Interval 52.6 to 80.0
|
153.4 Titer
Interval 123.7 to 190.2
|
169.4 Titer
Interval 138.8 to 206.6
|
|
Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.
Serotype 19F, Day 180
|
702.3 Titer
Interval 612.2 to 805.5
|
481.4 Titer
Interval 412.3 to 562.0
|
607.1 Titer
Interval 524.9 to 702.2
|
|
Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.
Serotype 23F, Day 0
|
17.8 Titer
Interval 14.1 to 22.3
|
52.6 Titer
Interval 40.7 to 68.0
|
50.6 Titer
Interval 39.3 to 65.3
|
|
Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.
Serotype 23F, Day 180
|
490.7 Titer
Interval 394.1 to 611.0
|
353.7 Titer
Interval 277.2 to 451.4
|
435.7 Titer
Interval 349.2 to 543.5
|
Adverse Events
IA: Pneumococcal Vaccine-naive, Age 55-64, Single Injection
Serious events: 7 serious events
Other events: 146 other events
Deaths: 0 deaths
IB: Pneumococcal Vaccine-naive, Age 65-74, Single Injection
Serious events: 4 serious events
Other events: 113 other events
Deaths: 0 deaths
IIA: Previous PPSV23, Age 55-64, Single Injection
Serious events: 2 serious events
Other events: 124 other events
Deaths: 0 deaths
IIB: Previous PPSV23, Age 65-74, Single Injection
Serious events: 3 serious events
Other events: 115 other events
Deaths: 0 deaths
IIAA: Previous PPSV23, Age 55-64, Two Injections
Serious events: 4 serious events
Other events: 126 other events
Deaths: 0 deaths
IIBB: Previous PPSV23, Age 65-74, Two Injections
Serious events: 5 serious events
Other events: 131 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IA: Pneumococcal Vaccine-naive, Age 55-64, Single Injection
n=164 participants at risk
Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-64.
|
IB: Pneumococcal Vaccine-naive, Age 65-74, Single Injection
n=147 participants at risk
Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 65-74.
|
IIA: Previous PPSV23, Age 55-64, Single Injection
n=139 participants at risk
Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
|
IIB: Previous PPSV23, Age 65-74, Single Injection
n=145 participants at risk
Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
|
IIAA: Previous PPSV23, Age 55-64, Two Injections
n=140 participants at risk
Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
|
IIBB: Previous PPSV23, Age 65-74, Two Injections
n=149 participants at risk
Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.61%
1/164 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/147 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/139 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/145 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/140 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/149 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.61%
1/164 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/147 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/139 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/145 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/140 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/149 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
Gastrointestinal disorders
Colitis
|
0.61%
1/164 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/147 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/139 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/145 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/140 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/149 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.61%
1/164 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/147 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/139 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/145 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/140 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/149 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
Psychiatric disorders
Alcoholism
|
0.61%
1/164 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/147 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/139 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/145 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/140 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/149 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.61%
1/164 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/147 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/139 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/145 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/140 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/149 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
Infections and infestations
Pneumonia
|
0.61%
1/164 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/147 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/139 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/145 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/140 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/149 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
0.61%
1/164 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/147 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/139 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/145 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/140 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/149 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/164 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.68%
1/147 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/139 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/145 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/140 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.67%
1/149 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/164 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.68%
1/147 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/139 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/145 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/140 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/149 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the vulva
|
0.00%
0/164 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.68%
1/147 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/139 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/145 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/140 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/149 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/164 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.68%
1/147 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/139 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.69%
1/145 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/140 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/149 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/164 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/147 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.72%
1/139 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/145 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/140 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/149 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/164 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/147 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.72%
1/139 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/145 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/140 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/149 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/164 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/147 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/139 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.69%
1/145 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/140 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/149 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/164 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/147 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/139 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.69%
1/145 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.71%
1/140 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/149 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/164 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/147 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/139 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/145 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.71%
1/140 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/149 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
Vascular disorders
Hypotension
|
0.00%
0/164 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/147 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/139 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/145 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.71%
1/140 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/149 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/164 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/147 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/139 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/145 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.71%
1/140 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/149 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/164 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/147 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/139 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/145 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.71%
1/140 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/149 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/164 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/147 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/139 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/145 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/140 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.67%
1/149 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/164 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/147 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/139 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/145 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/140 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.67%
1/149 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/164 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/147 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/139 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/145 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/140 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.67%
1/149 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/164 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/147 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/139 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/145 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.00%
0/140 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
0.67%
1/149 • Number of events 1 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
Other adverse events
| Measure |
IA: Pneumococcal Vaccine-naive, Age 55-64, Single Injection
n=164 participants at risk
Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-64.
|
IB: Pneumococcal Vaccine-naive, Age 65-74, Single Injection
n=147 participants at risk
Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 65-74.
|
IIA: Previous PPSV23, Age 55-64, Single Injection
n=139 participants at risk
Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
|
IIB: Previous PPSV23, Age 65-74, Single Injection
n=145 participants at risk
Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
|
IIAA: Previous PPSV23, Age 55-64, Two Injections
n=140 participants at risk
Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
|
IIBB: Previous PPSV23, Age 65-74, Two Injections
n=149 participants at risk
Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
11/164 • Number of events 11 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
3.4%
5/147 • Number of events 5 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
2.2%
3/139 • Number of events 3 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
7.6%
11/145 • Number of events 11 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
6.4%
9/140 • Number of events 9 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
12.1%
18/149 • Number of events 18 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
General disorders
Vaccination site bruising
|
0.00%
0/164 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
1.4%
2/147 • Number of events 2 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
2.2%
3/139 • Number of events 3 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
2.8%
4/145 • Number of events 4 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
5.0%
7/140 • Number of events 7 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
4.0%
6/149 • Number of events 6 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
General disorders
Feeling hot
|
5.5%
9/164 • Number of events 9 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
6.1%
9/147 • Number of events 9 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
12.2%
17/139 • Number of events 17 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
5.5%
8/145 • Number of events 8 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
11.4%
16/140 • Number of events 16 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
8.7%
13/149 • Number of events 13 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
General disorders
Malaise
|
18.3%
30/164 • Number of events 30 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
15.6%
23/147 • Number of events 23 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
21.6%
30/139 • Number of events 30 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
17.9%
26/145 • Number of events 26 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
30.7%
43/140 • Number of events 43 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
28.9%
43/149 • Number of events 43 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
Nervous system disorders
Headache
|
17.7%
29/164 • Number of events 29 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
10.2%
15/147 • Number of events 15 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
18.0%
25/139 • Number of events 25 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
12.4%
18/145 • Number of events 18 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
25.7%
36/140 • Number of events 36 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
18.1%
27/149 • Number of events 27 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
Gastrointestinal disorders
Nausea
|
5.5%
9/164 • Number of events 9 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
2.7%
4/147 • Number of events 4 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
7.9%
11/139 • Number of events 11 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
2.1%
3/145 • Number of events 3 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
5.7%
8/140 • Number of events 8 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
4.7%
7/149 • Number of events 7 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
General disorders
Chills
|
7.3%
12/164 • Number of events 12 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
3.4%
5/147 • Number of events 5 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
3.6%
5/139 • Number of events 5 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
4.1%
6/145 • Number of events 6 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
9.3%
13/140 • Number of events 13 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
8.7%
13/149 • Number of events 13 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.4%
4/164 • Number of events 4 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
3.4%
5/147 • Number of events 5 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
3.6%
5/139 • Number of events 5 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
4.1%
6/145 • Number of events 6 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
12.1%
17/140 • Number of events 17 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
2.7%
4/149 • Number of events 4 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.7%
6/164 • Number of events 6 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
3.4%
5/147 • Number of events 5 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
4.3%
6/139 • Number of events 6 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
6.2%
9/145 • Number of events 9 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
11.4%
16/140 • Number of events 16 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
3.4%
5/149 • Number of events 5 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
General disorders
Injection site pain
|
73.2%
120/164 • Number of events 120 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
63.3%
93/147 • Number of events 93 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
63.3%
88/139 • Number of events 88 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
63.4%
92/145 • Number of events 92 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
77.9%
109/140 • Number of events 109 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
70.5%
105/149 • Number of events 105 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
General disorders
Injection site erythema
|
14.0%
23/164 • Number of events 23 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
11.6%
17/147 • Number of events 17 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
15.8%
22/139 • Number of events 22 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
17.2%
25/145 • Number of events 25 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
22.1%
31/140 • Number of events 31 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
14.8%
22/149 • Number of events 22 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
|
General disorders
Injection site swelling
|
12.8%
21/164 • Number of events 21 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
12.2%
18/147 • Number of events 18 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
17.3%
24/139 • Number of events 24 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
16.6%
24/145 • Number of events 24 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
16.4%
23/140 • Number of events 23 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
14.8%
22/149 • Number of events 22 • Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.
|
Additional Information
Lisa A. Jackson, MD, MPH
Group Health Research Institute
Phone: 206-442-5216
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60