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A Trial To Evaluate A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50-85 Years Of Age

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ClinicalTrials.gov Identifier: NCT03313050
Recruitment Status : Completed
First Posted : October 18, 2017
Results First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition Pneumococcal Infections
Interventions Biological: Multivalent
Biological: Tdap
Biological: polysaccharide
Enrollment 511
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Stage 1: c7vPnC (50 to 64 Years of Age) Stage 1: Tdap (50 to 64 Years of Age) Stage 2: c7vPnC (65 to 85 Years of Age) Stage 2: PPSV23 (65 to 85 Years of Age)
Hide Arm/Group Description In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 milliliter (mL) intramuscular injection of complementary 7-valent pneumococcal conjugate vaccine (c7vPnC) on Day 1. Participants were followed up to 6 months after vaccination. In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as control vaccine on Day 1. Participants were followed up to 6 months after vaccination. In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination. In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.
Period Title: Stage 1: 6 Months
Started 34 32 0 0
Vaccinated 34 32 0 0
Completed 34 32 0 0
Not Completed 0 0 0 0
Period Title: Stage 2: 12 Months
Started 0 [1] 0 [1] 221 [2] 224 [2]
Vaccinated 0 0 221 223
Completed 0 0 210 204
Not Completed 0 0 11 20
Reason Not Completed
Adverse Event             0             0             0             1
Death             0             0             3             0
Lost to Follow-up             0             0             1             5
No Longer Meets Eligibility Criteria             0             0             0             3
Protocol deviation             0             0             7             7
Withdrawal by Subject             0             0             0             3
Other             0             0             0             1
[1]
Stage 1 participants did not continue in Stage 2.
[2]
After Stage 1 safety was acceptable then Stage 2 followed with newer participants.
Arm/Group Title Stage 1: c7vPnC (50 to 64 Years of Age) Stage 1: Tdap (50 to 64 Years of Age) Stage 2: c7vPnC (65 to 85 Years of Age) Stage 2: PPSV23 (65 to 85 Years of Age) Total
Hide Arm/Group Description In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1. Participants were followed up to 6 months after vaccination. In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as control vaccine on Day 1. Participants were followed up to 6 months after vaccination. In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination. In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination. Total of all reporting groups
Overall Number of Baseline Participants 34 32 221 223 510
Hide Baseline Analysis Population Description
The safety population included all participants who received at least 1 dose of c7vPnC or Tdap or PPSV23 in the study and had post-vaccination follow-up and participants who lacked any safety data were excluded from the analysis.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 32 participants 221 participants 223 participants 510 participants
58.2  (4.52) 58.1  (4.46) 68.9  (4.72) 68.8  (3.97) 67.5  (5.66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 32 participants 221 participants 223 participants 510 participants
Female
23
  67.6%
21
  65.6%
131
  59.3%
135
  60.5%
310
  60.8%
Male
11
  32.4%
11
  34.4%
90
  40.7%
88
  39.5%
200
  39.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 32 participants 221 participants 223 participants 510 participants
Hispanic or Latino
0
   0.0%
2
   6.3%
4
   1.8%
10
   4.5%
16
   3.1%
Not Hispanic or Latino
34
 100.0%
30
  93.8%
216
  97.7%
213
  95.5%
493
  96.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   0.5%
0
   0.0%
1
   0.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 32 participants 221 participants 223 participants 510 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
6
   2.7%
4
   1.8%
10
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   3.1%
11
   5.0%
9
   4.0%
21
   4.1%
White
34
 100.0%
31
  96.9%
204
  92.3%
210
  94.2%
479
  93.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination
Hide Description Local reactions included pain at injection site, swelling and redness recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild: greater than (>) 2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm and severe: >10.0 cm. Pain at injection site was graded as mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity.
Time Frame within 14 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population of Stage 1 included all participants who received at least 1 dose of c7vPnC or Tdap and had post-vaccination follow-up in Stage 1 and participants who lacked any safety data were excluded from the analysis.
Arm/Group Title Stage 1: c7vPnC (50 to 64 Years of Age) Stage 1: Tdap (50 to 64 Years of Age)
Hide Arm/Group Description:
In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1. Participants were followed up to 6 months after vaccination.
In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as control vaccine on Day 1. Participants were followed up to 6 months after vaccination.
Overall Number of Participants Analyzed 34 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Redness: Any
2.9
(0.1 to 15.3)
12.5
(3.5 to 29.0)
Redness: Mild
2.9
(0.1 to 15.3)
6.3
(0.8 to 20.8)
Redness: Moderate
0
(0.0 to 10.3)
6.3
(0.8 to 20.8)
Redness: Severe
0
(0.0 to 10.3)
0
(0.0 to 10.9)
Swelling: Any
8.8
(1.9 to 23.7)
18.8
(7.2 to 36.4)
Swelling: Mild
5.9
(0.7 to 19.7)
6.3
(0.8 to 20.8)
Swelling: Moderate
2.9
(0.1 to 15.3)
12.5
(3.5 to 29.0)
Swelling: Severe
0
(0.0 to 10.3)
0
(0.0 to 10.9)
Pain at injection site: Any
64.7
(46.5 to 80.3)
71.9
(53.3 to 86.3)
Pain at injection site: Mild
50.0
(32.4 to 67.6)
59.4
(40.6 to 76.3)
Pain at injection site: Moderate
14.7
(5.0 to 31.1)
12.5
(3.5 to 29.0)
Pain at injection site: Severe
0
(0.0 to 10.3)
0
(0.0 to 10.9)
2.Primary Outcome
Title Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination
Hide Description Local reactions included pain at injection site, swelling and redness recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: >2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm and severe: >10.0 cm. Pain at injection site was graded as mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity.
Time Frame within 14 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population of Stage 2 included all participants who received at least 1 dose of c7vPnC or PPSV23 and had post-vaccination follow-up in Stage 2 and participants who lacked any safety data were excluded from the analysis.
Arm/Group Title Stage 2: c7vPnC (65 to 85 Years of Age) Stage 2: PPSV23 (65 to 85 Years of Age)
Hide Arm/Group Description:
In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.
In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.
Overall Number of Participants Analyzed 221 223
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Redness: Any
8.1
(4.9 to 12.6)
17.9
(13.1 to 23.6)
Redness: Mild
5.9
(3.2 to 9.8)
8.1
(4.9 to 12.5)
Redness: Moderate
2.3
(0.7 to 5.2)
4.5
(2.2 to 8.1)
Redness: Severe
0
(0.0 to 1.7)
5.4
(2.8 to 9.2)
Swelling: Any
6.8
(3.8 to 10.9)
16.6
(12.0 to 22.1)
Swelling: Mild
5.9
(3.2 to 9.8)
5.4
(2.8 to 9.2)
Swelling: Moderate
0.9
(0.1 to 3.2)
7.6
(4.5 to 11.9)
Swelling: Severe
0
(0.0 to 1.7)
3.6
(1.6 to 6.9)
Pain at injection site: Any
48.4
(41.7 to 55.2)
61.0
(54.2 to 67.4)
Pain at injection site: Mild
46.6
(39.9 to 53.4)
44.8
(38.2 to 51.6)
Pain at injection site: Moderate
1.8
(0.5 to 4.6)
14.3
(10.0 to 19.6)
Pain at injection site: Severe
0
(0.0 to 1.7)
1.8
(0.5 to 4.5)
3.Primary Outcome
Title Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination
Hide Description Systemic events included fever, fatigue, headache, muscle pain and joint pain recorded by participants in an e-diary. Fever was categorized as: >=38.0 degrees Celsius (C), >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as any, mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity.
Time Frame within 14 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population of Stage 1 included all participants who received at least 1 dose of c7vPnC or Tdap and had post-vaccination follow-up in Stage 1 and participants who lacked any safety data were excluded from the analysis.
Arm/Group Title Stage 1: c7vPnC (50 to 64 Years of Age) Stage 1: Tdap (50 to 64 Years of Age)
Hide Arm/Group Description:
In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1. Participants were followed up to 6 months after vaccination.
In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as control vaccine on Day 1. Participants were followed up to 6 months after vaccination.
Overall Number of Participants Analyzed 34 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Fever: >=38.0 degree C
0
(0.0 to 10.3)
0
(0.0 to 10.9)
Fever: >=38.0 to 38.4 degree C
0
(0.0 to 10.3)
0
(0.0 to 10.9)
Fever: >38.4 to 38.9 degree C
0
(0.0 to 10.3)
0
(0.0 to 10.9)
Fever: >38.9 to 40.0 degree C
0
(0.0 to 10.3)
0
(0.0 to 10.9)
Fever: >40.0 degree C
0
(0.0 to 10.3)
0
(0.0 to 10.9)
Fatigue: Any
29.4
(15.1 to 47.5)
28.1
(13.7 to 46.7)
Fatigue: Mild
29.4
(15.1 to 47.5)
9.4
(2.0 to 25.0)
Fatigue: Moderate
0
(0.0 to 10.3)
18.8
(7.2 to 36.4)
Fatigue: Severe
0
(0.0 to 10.3)
0
(0.0 to 10.9)
Headache: Any
38.2
(22.2 to 56.4)
34.4
(18.6 to 53.2)
Headache: Mild
23.5
(10.7 to 41.2)
18.8
(7.2 to 36.4)
Headache: Moderate
14.7
(5.0 to 31.1)
15.6
(5.3 to 32.8)
Headache: Severe
0
(0.0 to 10.3)
0
(0.0 to 10.9)
Muscle pain: Any
38.2
(22.2 to 56.4)
56.3
(37.7 to 73.6)
Muscle pain: Mild
26.5
(12.9 to 44.4)
43.8
(26.4 to 62.3)
Muscle pain: Moderate
11.8
(3.3 to 27.5)
12.5
(3.5 to 29.0)
Muscle pain: Severe
0
(0.0 to 10.3)
0
(0.0 to 10.9)
Joint pain: Any
11.8
(3.3 to 27.5)
15.6
(5.3 to 32.8)
Joint pain: Mild
11.8
(3.3 to 27.5)
12.5
(3.5 to 29.0)
Joint pain: Moderate
0
(0.0 to 10.3)
3.1
(0.1 to 16.2)
Joint pain: Severe
0
(0.0 to 10.3)
0
(0.0 to 10.9)
4.Primary Outcome
Title Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination
Hide Description Systemic events included fever, fatigue, headache, muscle pain and joint pain recorded by participants in an e-diary. Fever was categorized as: >=38.0 degrees C, >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as any, mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity.
Time Frame within 14 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population of Stage 2 included all participants who received at least 1 dose of c7vPnC or PPSV23 and had post-vaccination follow-up in Stage 2 and participants who lacked any safety data were excluded from the analysis.
Arm/Group Title Stage 2: c7vPnC (65 to 85 Years of Age) Stage 2: PPSV23 (65 to 85 Years of Age)
Hide Arm/Group Description:
In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.
In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.
Overall Number of Participants Analyzed 221 223
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Fever: >=38.0 degree C
0.5
(0.0 to 2.5)
0.9
(0.1 to 3.2)
Fever: >=38.0 to 38.4 degree C
0.5
(0.0 to 2.5)
0
(0.0 to 1.6)
Fever: >38.4 to 38.9 degree C
0
(0.0 to 1.7)
0.4
(0.0 to 2.5)
Fever: >38.9 to 40.0 degree C
0
(0.0 to 1.7)
0.4
(0.0 to 2.5)
Fever: >40.0 degree C
0
(0.0 to 1.7)
0
(0.0 to 1.6)
Fatigue: Any
34.4
(28.1 to 41.1)
33.2
(27.0 to 39.8)
Fatigue: Mild
24.9
(19.3 to 31.1)
17.5
(12.7 to 23.1)
Fatigue: Moderate
7.7
(4.5 to 12.0)
13.9
(9.6 to 19.1)
Fatigue: Severe
1.8
(0.5 to 4.6)
1.8
(0.5 to 4.5)
Headache: Any
24.4
(18.9 to 30.6)
20.2
(15.1 to 26.1)
Headache: Mild
20.4
(15.3 to 26.3)
14.3
(10.0 to 19.6)
Headache: Moderate
3.6
(1.6 to 7.0)
5.4
(2.8 to 9.2)
Headache: Severe
0.5
(0.0 to 2.5)
0.4
(0.0 to 2.5)
Muscle pain: Any
38.5
(32.0 to 45.2)
46.6
(39.9 to 53.4)
Muscle pain: Mild
31.7
(25.6 to 38.2)
29.1
(23.3 to 35.6)
Muscle pain: Moderate
6.3
(3.5 to 10.4)
16.6
(12.0 to 22.1)
Muscle pain: Severe
0.5
(0.0 to 2.5)
0.9
(0.1 to 3.2)
Joint pain: Any
14.9
(10.5 to 20.3)
19.7
(14.7 to 25.6)
Joint pain: Mild
9.5
(6.0 to 14.2)
12.6
(8.5 to 17.6)
Joint pain: Moderate
5.4
(2.8 to 9.3)
7.2
(4.2 to 11.4)
Joint pain: Severe
0
(0.0 to 1.7)
0
(0.0 to 1.6)
5.Primary Outcome
Title Stage 1: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
Hide Description An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both AEs and Non-SAEs.
Time Frame within 1 month after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population of Stage 1 included all participants who received at least 1 dose of c7vPnC or Tdap and had post-vaccination follow-up in Stage 1 and participants who lacked any safety data were excluded from the analysis.
Arm/Group Title Stage 1: c7vPnC (50 to 64 Years of Age) Stage 1: Tdap (50 to 64 Years of Age)
Hide Arm/Group Description:
In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1. Participants were followed up to 6 months after vaccination.
In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as control vaccine on Day 1. Participants were followed up to 6 months after vaccination.
Overall Number of Participants Analyzed 34 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8.8
(1.9 to 23.7)
9.4
(2.0 to 25.0)
6.Primary Outcome
Title Stage 2: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
Hide Description An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both AEs and Non-SAEs.
Time Frame within 1 month after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population of Stage 2 included all participants who received at least 1 dose of c7vPnC or PPSV23 and had post-vaccination follow-up in Stage 2 and participants who lacked any safety data were excluded from the analysis.
Arm/Group Title Stage 2: c7vPnC (65 to 85 Years of Age) Stage 2: PPSV23 (65 to 85 Years of Age)
Hide Arm/Group Description:
In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.
In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.
Overall Number of Participants Analyzed 221 223
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
10.0
(6.3 to 14.7)
13.5
(9.3 to 18.6)
7.Primary Outcome
Title Stage 1: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame within 6 months after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population of Stage 1 included all participants who received at least 1 dose of c7vPnC or Tdap and had post-vaccination follow-up in Stage 1 and participants who lacked any safety data were excluded from the analysis.
Arm/Group Title Stage 1: c7vPnC (50 to 64 Years of Age) Stage 1: Tdap (50 to 64 Years of Age)
Hide Arm/Group Description:
In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1. Participants were followed up to 6 months after vaccination.
In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as control vaccine on Day 1. Participants were followed up to 6 months after vaccination.
Overall Number of Participants Analyzed 34 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
5.9
(0.7 to 19.7)
0
(0.0 to 10.9)
8.Primary Outcome
Title Stage 2: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame within 6 months after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population of Stage 2 included all participants who received at least 1 dose of c7vPnC or PPSV23 and had post-vaccination follow-up in Stage 2 and participants who lacked any safety data were excluded from the analysis.
Arm/Group Title Stage 2: c7vPnC (65 to 85 Years of Age) Stage 2: PPSV23 (65 to 85 Years of Age)
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In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.
In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.
Overall Number of Participants Analyzed 221 223
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
2.3
(0.7 to 5.2)
2.7
(1.0 to 5.8)
9.Primary Outcome
Title Stage 1: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination
Hide Description An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects.
Time Frame within 6 months after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population of Stage 1 included all participants who received at least 1 dose of c7vPnC or Tdap and had post-vaccination follow-up in Stage 1 and participants who lacked any safety data were excluded from the analysis.
Arm/Group Title Stage 1: c7vPnC (50 to 64 Years of Age) Stage 1: Tdap (50 to 64 Years of Age)
Hide Arm/Group Description:
In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1. Participants were followed up to 6 months after vaccination.
In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as control vaccine on Day 1. Participants were followed up to 6 months after vaccination.
Overall Number of Participants Analyzed 34 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 10.3)
6.3
(0.8 to 20.8)
10.Primary Outcome
Title Stage 2: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination
Hide Description An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects.
Time Frame within 6 months after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population of Stage 2 included all participants who received at least 1 dose of c7vPnC or PPSV23 and had post-vaccination follow-up in Stage 2 and participants who lacked any safety data were excluded from the analysis.
Arm/Group Title Stage 2: c7vPnC (65 to 85 Years of Age) Stage 2: PPSV23 (65 to 85 Years of Age)
Hide Arm/Group Description:
In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.
In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.
Overall Number of Participants Analyzed 221 223
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3.2
(1.3 to 6.4)
4.5
(2.2 to 8.1)
11.Primary Outcome
Title Stage 2: Percentage of Participants With Serious Adverse Events (SAEs) Within 12 Months After Vaccination
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame within 12 months after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population of Stage 2 included all participants who received at least 1 dose of c7vPnC or PPSV23 and had post-vaccination follow-up in Stage 2 and participants who lacked any safety data were excluded from the analysis.
Arm/Group Title Stage 2: c7vPnC (65 to 85 Years of Age) Stage 2: PPSV23 (65 to 85 Years of Age)
Hide Arm/Group Description:
In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.
In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.
Overall Number of Participants Analyzed 221 223
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
4.1
(1.9 to 7.6)
3.6
(1.6 to 6.9)
12.Primary Outcome
Title Stage 2: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 12 Months After Vaccination
Hide Description An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects.
Time Frame within 12 months after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population of Stage 2 included all participants who received at least 1 dose of c7vPnC or PPSV23 and had post-vaccination follow-up in Stage 2 and participants who lacked any safety data were excluded from the analysis.
Arm/Group Title Stage 2: c7vPnC (65 to 85 Years of Age) Stage 2: PPSV23 (65 to 85 Years of Age)
Hide Arm/Group Description:
In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.
In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.
Overall Number of Participants Analyzed 221 223
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
6.8
(3.8 to 10.9)
6.3
(3.5 to 10.3)
13.Secondary Outcome
Title Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination
Hide Description Antibody-mediated serum OPA against the 7 pneumococcal serotypes specific to c7vPnC (serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ in the analysis. Evaluable immunogenicity population = EIP.
Time Frame 1 month after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
EIP Stage 1:eligible participants with no major protocol deviations, received assigned vaccine, blood collected was within 27-49 days post vaccination, had at least 1 valid and determinate assay result for at least 1 serotype for 1 month after vaccination. 'Number Analyzed' = participants evaluable for this outcome measure at specified rows.
Arm/Group Title Stage 1: c7vPnC (50 to 64 Years of Age) Stage 1: Tdap (50 to 64 Years of Age)
Hide Arm/Group Description:
In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1. Participants were followed up to 6 months after vaccination.
In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as control vaccine on Day 1. Participants were followed up to 6 months after vaccination.
Overall Number of Participants Analyzed 33 32
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer (1/dilution)
Serotype 8 Number Analyzed 33 participants 32 participants
1401
(913.4 to 2147.9)
16
(9.3 to 26.4)
Serotype 10A Number Analyzed 30 participants 28 participants
6622
(3705.5 to 11833.0)
92
(35.3 to 239.3)
Serotype 11A Number Analyzed 29 participants 30 participants
3154
(1890.7 to 5262.8)
604
(302.2 to 1206.4)
Serotype 12F Number Analyzed 25 participants 30 participants
9558
(4114.7 to 22202.0)
90
(39.6 to 202.8)
Serotype 15B Number Analyzed 28 participants 30 participants
3926
(1526.1 to 10100.2)
30
(17.9 to 49.7)
Serotype 22F Number Analyzed 30 participants 32 participants
5932
(3625.8 to 9705.6)
167
(74.4 to 374.3)
Serotype 33F Number Analyzed 27 participants 30 participants
8432
(4116.7 to 17271.3)
433
(204.7 to 915.4)
14.Secondary Outcome
Title Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination
Hide Description Antibody-mediated serum OPA against the 7 common pneumococcal serotypes specific to c7vPnC (serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis.
Time Frame within 1 month after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
EIP Stage 2:eligible participants with no major protocol deviations, received assigned vaccine, blood collected was within 27-49 days post vaccination, had at least 1 valid and determinate assay result for at least 1 serotype for 1 month after vaccination. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified rows.
Arm/Group Title Stage 2: c7vPnC (65 to 85 Years of Age) Stage 2: PPSV23 (65 to 85 Years of Age)
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In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.
In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.
Overall Number of Participants Analyzed 219 217
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer (1/dilution)
Serotype 8 Number Analyzed 215 participants 217 participants
528
(423.2 to 658.6)
639
(511.9 to 798.3)
Serotype 10A Number Analyzed 209 participants 212 participants
2297
(1842.9 to 2863.4)
1052
(802.5 to 1378.9)
Serotype 11A Number Analyzed 215 participants 209 participants
2290
(1854.0 to 2828.7)
2673
(2182.7 to 3274.6)
Serotype 12F Number Analyzed 210 participants 210 participants
3684
(2926.5 to 4638.6)
2416
(1852.8 to 3151.0)
Serotype 15B Number Analyzed 216 participants 208 participants
1381
(1019.2 to 1872.2)
586
(426.0 to 807.2)
Serotype 22F Number Analyzed 211 participants 206 participants
4775
(3889.1 to 5862.2)
2723
(2123.9 to 3491.1)
Serotype 33F Number Analyzed 209 participants 209 participants
4250
(3403.2 to 5307.2)
4043
(3082.4 to 5304.3)
15.Secondary Outcome
Title Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-vaccination to 1 Month After Vaccination
Hide Description GMFR for the 7 pneumococcal serotypes (serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) from before Vaccination to one month after Vaccination. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis.
Time Frame before Vaccination to 1 month after Vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
EIP Stage 1:eligible participants with no major protocol deviations, received assigned vaccine, blood collected was within 27-49 days post vaccination, had at least 1 valid and determinate assay result for at least 1 serotype for 1 month after vaccination. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified rows.
Arm/Group Title Stage 1: c7vPnC (50 to 64 Years of Age) Stage 1: Tdap (50 to 64 Years of Age)
Hide Arm/Group Description:
In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1. Participants were followed up to 6 months after vaccination.
In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as control vaccine on Day 1. Participants were followed up to 6 months after vaccination.
Overall Number of Participants Analyzed 33 32
Geometric Mean (95% Confidence Interval)
Unit of Measure: fold rise
Serotype 8 Number Analyzed 32 participants 31 participants
106.2
(56.7 to 198.9)
1.1
(1.0 to 1.3)
Serotype 10A Number Analyzed 29 participants 27 participants
64.7
(28.5 to 146.9)
1.2
(0.8 to 1.7)
Serotype 11A Number Analyzed 28 participants 28 participants
6.5
(3.0 to 14.2)
1.0
(0.7 to 1.5)
Serotype 12F Number Analyzed 24 participants 29 participants
261.8
(106.1 to 646.2)
1.2
(1.0 to 1.4)
Serotype 15B Number Analyzed 28 participants 30 participants
100.2
(32.1 to 312.7)
1.1
(0.9 to 1.3)
Serotype 22F Number Analyzed 30 participants 31 participants
58.6
(25.0 to 137.3)
1.4
(1.1 to 1.8)
Serotype 33F Number Analyzed 23 participants 24 participants
27.9
(10.4 to 74.6)
0.9
(0.6 to 1.5)
16.Secondary Outcome
Title Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-Vaccination to 1 Month After Vaccination
Hide Description GMFR for the 7 pneumococcal serotypes (serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) from before Vaccination to one month after Vaccination. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis.
Time Frame before Vaccination to 1 month after Vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
EIP Stage 2:eligible participants with no major protocol deviations, received assigned vaccine, blood collected was within 27-49 days post vaccination, had at least 1 valid and determinate assay result for at least 1 serotype for 1 month after vaccination. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified rows.
Arm/Group Title Stage 2: c7vPnC (65 to 85 Years of Age) Stage 2: PPSV23 (65 to 85 Years of Age)
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In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.
In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.
Overall Number of Participants Analyzed 219 217
Geometric Mean (95% Confidence Interval)
Unit of Measure: fold rise
Serotype 8 Number Analyzed 209 participants 212 participants
30.2
(23.0 to 39.6)
40.5
(30.4 to 53.8)
Serotype 10A Number Analyzed 200 participants 201 participants
30.6
(21.3 to 43.8)
15.2
(11.0 to 20.9)
Serotype 11A Number Analyzed 198 participants 181 participants
7.5
(5.6 to 10.1)
7.0
(5.2 to 9.4)
Serotype 12F Number Analyzed 200 participants 196 participants
64.0
(47.3 to 86.8)
37.6
(27.2 to 52.0)
Serotype 15B Number Analyzed 210 participants 201 participants
31.7
(22.6 to 44.4)
16.4
(11.6 to 23.0)
Serotype 22F Number Analyzed 196 participants 192 participants
30.0
(21.1 to 42.7)
18.6
(13.4 to 25.9)
Serotype 33F Number Analyzed 195 participants 194 participants
10.0
(7.0 to 14.2)
8.7
(6.3 to 11.9)
Time Frame Local reactions and systemic events: within 14 days after vaccination; Non serious AEs: Stage 1 and 2- baseline up to 1 month after vaccination (approximately up to 35 days); SAEs: Stage 1- baseline up to 6 months after vaccination (approximately up to 196 days), Stage 2- baseline up to 12 months after vaccination (approximately up to 378 days)
Adverse Event Reporting Description Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population evaluated.
 
Arm/Group Title Stage 1: c7vPnC (50 to 64 Years of Age) Stage 1: Tdap (50 to 64 Years of Age) Stage 2: c7vPnC (65 to 85 Years of Age) Stage 2: PPSV23 (65 to 85 Years of Age)
Hide Arm/Group Description In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1. Participants were followed up to 6 months after vaccination. In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as control vaccine on Day 1. Participants were followed up to 6 months after vaccination. In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination. In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.
All-Cause Mortality
Stage 1: c7vPnC (50 to 64 Years of Age) Stage 1: Tdap (50 to 64 Years of Age) Stage 2: c7vPnC (65 to 85 Years of Age) Stage 2: PPSV23 (65 to 85 Years of Age)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/32 (0.00%)   3/221 (1.36%)   0/223 (0.00%) 
Hide Serious Adverse Events
Stage 1: c7vPnC (50 to 64 Years of Age) Stage 1: Tdap (50 to 64 Years of Age) Stage 2: c7vPnC (65 to 85 Years of Age) Stage 2: PPSV23 (65 to 85 Years of Age)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/34 (5.88%)   0/32 (0.00%)   9/221 (4.07%)   8/223 (3.59%) 
Cardiac disorders         
Aortic valve stenosis * 1  0/34 (0.00%)  0/32 (0.00%)  1/221 (0.45%)  0/223 (0.00%) 
Arrhythmia * 1  0/34 (0.00%)  0/32 (0.00%)  0/221 (0.00%)  1/223 (0.45%) 
Coronary artery disease * 1  0/34 (0.00%)  0/32 (0.00%)  1/221 (0.45%)  0/223 (0.00%) 
Myocardial infarction * 1  0/34 (0.00%)  0/32 (0.00%)  1/221 (0.45%)  0/223 (0.00%) 
Ventricular arrhythmia * 1  0/34 (0.00%)  0/32 (0.00%)  0/221 (0.00%)  1/223 (0.45%) 
Gastrointestinal disorders         
Diverticulum intestinal * 1  0/34 (0.00%)  0/32 (0.00%)  0/221 (0.00%)  1/223 (0.45%) 
Intestinal obstruction * 1  1/34 (2.94%)  0/32 (0.00%)  0/221 (0.00%)  0/223 (0.00%) 
Small intestinal obstruction * 1  0/34 (0.00%)  0/32 (0.00%)  1/221 (0.45%)  0/223 (0.00%) 
General disorders         
Oedema peripheral * 1  0/34 (0.00%)  0/32 (0.00%)  1/221 (0.45%)  0/223 (0.00%) 
Hepatobiliary disorders         
Cholecystitis * 1  1/34 (2.94%)  0/32 (0.00%)  0/221 (0.00%)  0/223 (0.00%) 
Infections and infestations         
Septic shock * 1  0/34 (0.00%)  0/32 (0.00%)  0/221 (0.00%)  1/223 (0.45%) 
Musculoskeletal and connective tissue disorders         
Lumbar spinal stenosis * 1  0/34 (0.00%)  0/32 (0.00%)  0/221 (0.00%)  1/223 (0.45%) 
Osteoarthritis * 1  0/34 (0.00%)  0/32 (0.00%)  2/221 (0.90%)  0/223 (0.00%) 
Polymyalgia rheumatica * 1  0/34 (0.00%)  0/32 (0.00%)  0/221 (0.00%)  1/223 (0.45%) 
Spinal synovial cyst * 1  0/34 (0.00%)  0/32 (0.00%)  0/221 (0.00%)  1/223 (0.45%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Acute myeloid leukaemia * 1  0/34 (0.00%)  0/32 (0.00%)  1/221 (0.45%)  0/223 (0.00%) 
Lung neoplasm malignant * 1  0/34 (0.00%)  0/32 (0.00%)  1/221 (0.45%)  0/223 (0.00%) 
Prostate cancer * 1  0/34 (0.00%)  0/32 (0.00%)  0/221 (0.00%)  1/223 (0.45%) 
Reproductive system and breast disorders         
Vaginal prolapse * 1  0/34 (0.00%)  0/32 (0.00%)  0/221 (0.00%)  1/223 (0.45%) 
Respiratory, thoracic and mediastinal disorders         
Acute respiratory distress syndrome * 1  0/34 (0.00%)  0/32 (0.00%)  1/221 (0.45%)  0/223 (0.00%) 
Acute respiratory failure * 1  0/34 (0.00%)  0/32 (0.00%)  0/221 (0.00%)  1/223 (0.45%) 
Chronic obstructive pulmonary disease * 1  0/34 (0.00%)  0/32 (0.00%)  1/221 (0.45%)  0/223 (0.00%) 
Lung infiltration * 1  0/34 (0.00%)  0/32 (0.00%)  0/221 (0.00%)  1/223 (0.45%) 
Pneumothorax * 1  0/34 (0.00%)  0/32 (0.00%)  1/221 (0.45%)  0/223 (0.00%) 
Surgical and medical procedures         
Hernia hiatus repair * 1  0/34 (0.00%)  0/32 (0.00%)  0/221 (0.00%)  1/223 (0.45%) 
Vascular disorders         
Arteriosclerosis * 1  0/34 (0.00%)  0/32 (0.00%)  1/221 (0.45%)  0/223 (0.00%) 
1
Term from vocabulary, MedDRA v22.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Stage 1: c7vPnC (50 to 64 Years of Age) Stage 1: Tdap (50 to 64 Years of Age) Stage 2: c7vPnC (65 to 85 Years of Age) Stage 2: PPSV23 (65 to 85 Years of Age)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   27/34 (79.41%)   28/32 (87.50%)   161/221 (72.85%)   171/223 (76.68%) 
General disorders         
Injection site erythema  1  1/34 (2.94%)  4/32 (12.50%)  18/221 (8.14%)  40/223 (17.94%) 
Injection site swelling  1  3/34 (8.82%)  6/32 (18.75%)  15/221 (6.79%)  37/223 (16.59%) 
Fatigue  1  10/34 (29.41%)  9/32 (28.13%)  76/221 (34.39%)  74/223 (33.18%) 
Injection site pain  1  22/34 (64.71%)  23/32 (71.88%)  107/221 (48.42%)  136/223 (60.99%) 
Infections and infestations         
Cellulitis * 1  0/34 (0.00%)  0/32 (0.00%)  0/221 (0.00%)  3/223 (1.35%) 
Cystitis * 1  1/34 (2.94%)  0/32 (0.00%)  0/221 (0.00%)  0/223 (0.00%) 
Gastroenteritis * 1  0/34 (0.00%)  1/32 (3.13%)  1/221 (0.45%)  1/223 (0.45%) 
Helicobacter gastritis * 1  1/34 (2.94%)  0/32 (0.00%)  1/221 (0.45%)  0/223 (0.00%) 
Nasopharyngitis * 1  1/34 (2.94%)  2/32 (6.25%)  2/221 (0.90%)  2/223 (0.90%) 
Injury, poisoning and procedural complications         
Procedural nausea * 1  1/34 (2.94%)  0/32 (0.00%)  0/221 (0.00%)  0/223 (0.00%) 
Procedural pain * 1  1/34 (2.94%)  0/32 (0.00%)  1/221 (0.45%)  1/223 (0.45%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  4/34 (11.76%)  5/32 (15.63%)  33/221 (14.93%)  44/223 (19.73%) 
Arthralgia * 1  0/34 (0.00%)  0/32 (0.00%)  1/221 (0.45%)  5/223 (2.24%) 
Myalgia  1  13/34 (38.24%)  18/32 (56.25%)  85/221 (38.46%)  104/223 (46.64%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Skin papilloma * 1  1/34 (2.94%)  0/32 (0.00%)  0/221 (0.00%)  0/223 (0.00%) 
Nervous system disorders         
Headache  1  13/34 (38.24%)  11/32 (34.38%)  54/221 (24.43%)  45/223 (20.18%) 
1
Term from vocabulary, MedDRA v22.0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03313050    
Other Study ID Numbers: C3571001
First Submitted: October 10, 2017
First Posted: October 18, 2017
Results First Submitted: May 15, 2020
Results First Posted: June 4, 2020
Last Update Posted: June 4, 2020