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Study Evaluating the Effiacy of a 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in Adults (CAPITA)

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ClinicalTrials.gov Identifier: NCT00744263
Recruitment Status : Completed
First Posted : August 29, 2008
Results First Posted : October 6, 2014
Last Update Posted : October 6, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Pneumonia, Pneumococcal
Pneumococcal Infections
13-valent Pneumococcal Vaccine
Interventions Biological: VACCINE: placebo
Biological: VACCINE: 13-valent pneumococcal conjugate vaccine
Enrollment 84496
Recruitment Details Of 84496 participants who were randomized in this study, 2011 participants were included in the immunogenicity subset. Participants in the immunogenicity subset were analyzed for local reactions and systemic events as per planned analysis.
Pre-assignment Details  
Arm/Group Title 13vPnC Placebo
Hide Arm/Group Description Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1. Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
Period Title: Overall Study
Started 42240 42256
Completed 37004 36936
Not Completed 5236 5320
Reason Not Completed
Death             3006             3005
Lost to Follow-up             2038             2135
Withdrawal by Subject             166             150
Physician Decision             20             23
Protocol Violation             3             5
Adverse Event             1             0
Other             2             2
Arm/Group Title 13vPnC Placebo Total
Hide Arm/Group Description Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1. Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 42237 42255 84492
Hide Baseline Analysis Population Description
Safety population included all participants who received study vaccine and who had any safety data.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42237 participants 42255 participants 84492 participants
72.8  (5.7) 72.8  (5.6) 72.8  (5.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42237 participants 42255 participants 84492 participants
Female
18790
  44.5%
18454
  43.7%
37244
  44.1%
Male
23447
  55.5%
23801
  56.3%
47248
  55.9%
1.Primary Outcome
Title Number of Participants With First Episode of Confirmed Vaccine-type Community-acquired Pneumonia (VT-CAP)
Hide Description CAP was defined based on clinical and radiological criteria. Microbiological criteria differentiate different categories of CAP. Clinical criteria: presence of 2 or more criteria from following: cough, production of purulent sputum/change in sputum character, temperature greater than (>) 38.0 degrees Celsius (C) or less than (<) 36.1 degrees C, auscultatory findings consistent with pneumonia including rales and/or evidence of pulmonary consolidation, leukocytosis (>10*10^9 white blood cells/liter or >15 percent (%) bands), C-reactive protein level >3 times upper limit of normal, hypoxemia with partial oxygen pressure <60 millimeter of mercury (mmHg). Radiological criteria: pneumonia confirmation by adjudication committee via lateral, posterior-anterior chest x-ray or anterior-posterior chest x-ray. Microbiological criteria: VT Streptococcus pneumonia culture from blood, pleural fluid or other sterile site and/or positive VT serotype-specific urinary antigen detection (SSUAD).
Time Frame Baseline up to occurrence of first episode of VT-CAP, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol(PP) population: eligible participants who received study vaccine, 65 years or older, identified with CAP(pre-defined criteria) or had invasive pneumococcal disease(IPD); symptom onset at least 14 days after vaccination; immunocompetent at time of episode; no major protocol violations as determined by clinical scientist/medical monitor.
Arm/Group Title 13vPnC Placebo
Hide Arm/Group Description:
Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
Overall Number of Participants Analyzed 42240 42256
Measure Type: Number
Unit of Measure: participants
49 90
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, Placebo
Comments Vaccine efficacy against first event expressed as percentage. Vaccine efficacy = 1 - (proportion of participants who received 13vPnC with confirmed VT-CAP relative to those who received placebo). p-value and confidence intervals were derived using Clopper-Pearson method. The null hypothesis was vaccine efficacy = 0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Clopper-Pearson method
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 45.56
Confidence Interval (2-Sided) 95.2%
21.82 to 62.49
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With First Episode of Nonbacteremic/Noninvasive (NB/NI) Vaccine-type Community-acquired Pneumonia (VT-CAP)
Hide Description CAP was defined based on clinical and radiological criteria. Microbiological criteria differentiate different categories of CAP. Clinical criteria: presence of 2 or more criteria from following: cough, production of purulent sputum/change in sputum character, temperature >38.0 degrees C or <36.1 degrees C, auscultatory findings consistent with pneumonia including rales and/or evidence of pulmonary consolidation, leukocytosis (>10*10^9 white blood cells/liter or >15% bands), C-reactive protein level >3 times upper limit of normal, hypoxemia with partial oxygen pressure <60 mmHg. Radiological criteria: pneumonia confirmation by adjudication committee via lateral, posterior-anterior chest x-ray or anterior-posterior chest x-ray. Microbiological criteria: Confirmed VT pneumococcal CAP (by SSUAD) where a blood culture result was available and was negative and for which any other sterile culture results were negative for Streptococcus pneumoniae.
Time Frame Baseline up to occurrence of first episode of NB/NI VT-CAP, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)
Hide Outcome Measure Data
Hide Analysis Population Description
PP population: eligible participants who received study vaccine, 65 years or older, identified with CAP (pre-defined criteria) or had IPD; symptom onset at least 14 days after vaccination; immunocompetent at time of episode; no major protocol violations as determined by clinical scientist/medical monitor.
Arm/Group Title 13vPnC Placebo
Hide Arm/Group Description:
Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
Overall Number of Participants Analyzed 42240 42256
Measure Type: Number
Unit of Measure: participants
33 60
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, Placebo
Comments Vaccine efficacy against first event expressed as percentage. Vaccine efficacy = 1-(proportion of participants who received 13vPnC with confirmed VT-CAP relative to those who received placebo). p-value and confidence intervals were derived using Clopper-Pearson method. The null hypothesis was vaccine efficacy = 0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0067
Comments [Not Specified]
Method Clopper-Pearson method
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 45.00
Confidence Interval (2-Sided) 95.2%
14.21 to 65.31
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With First Episodes of Vaccine-type Invasive Pneumococcal Disease (VT-IPD) Cases
Hide Description VT-IPD was defined as the presence of Streptococcus pneumoniae in a sterile site (blood, cerebrospinal fluid, pleural fluid, peritoneal fluid, pericardial fluid, surgical aspirate, bone, or joint fluid).
Time Frame Baseline up to occurrence of first episode of VT-IPD, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)
Hide Outcome Measure Data
Hide Analysis Population Description
PP population: eligible participants who received study vaccine, 65 years or older, identified with CAP (pre-defined criteria) or had IPD; symptom onset at least 14 days after vaccination; immunocompetent at time of episode; no major protocol violations as determined by clinical scientist/medical monitor.
Arm/Group Title 13vPnC Placebo
Hide Arm/Group Description:
Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
Overall Number of Participants Analyzed 42240 42256
Measure Type: Number
Unit of Measure: participants
7 28
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, Placebo
Comments Vaccine efficacy against first event expressed as percentage. Vaccine efficacy = 1-(proportion of participants who received 13vPnC with confirmed VT-CAP relative to those who received placebo). p-value and confidence intervals were derived using Clopper-Pearson method. The null hypothesis was vaccine efficacy = 0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Clopper-Pearson method
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 75.00
Confidence Interval (2-Sided) 95%
41.43 to 90.78
Estimation Comments [Not Specified]
4.Other Pre-specified Outcome
Title Percentage of Participants With Pre-specified Local Reactions Within 7 Days After Vaccination
Hide Description Local reactions were reported using electronic diary (e-diary). Redness and swelling scaled as Any (redness or swelling present); Absent (no or minimal); Mild (2.5 centimeter [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Limitation of arm movement scaled as Any (limitation present); Absent (no limitation of arm movement); Mild (some limitation of arm movement); Moderate (unable to move arm above head, but able to move arm above shoulder); Severe (unable to move arm above shoulder). Percentage of participants with local reactions were reported. Participants may be represented in more than 1 category.
Time Frame Within 7 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction.
Arm/Group Title 13vPnC Placebo
Hide Arm/Group Description:
Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
Overall Number of Participants Analyzed 917 867
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Redness: Any (n = 886, 859)
4.9
(3.5 to 6.5)
1.2
(0.6 to 2.1)
Redness: Mild (n = 886, 859)
3.7
(2.6 to 5.2)
0.8
(0.3 to 1.7)
Redness: Moderate (n = 881, 859)
1.7
(1.0 to 2.8)
0.3
(0.1 to 1.0)
Redness: Severe (n = 881, 859)
0.5
(0.1 to 1.2)
0.1
(0.0 to 0.6)
Swelling: Any (n = 888, 859)
6.8
(5.2 to 8.6)
1.2
(0.6 to 2.1)
Swelling: Mild (n = 888, 859)
5.5
(4.1 to 7.2)
0.7
(0.3 to 1.5)
Swelling: Moderate (n = 884, 859)
2.6
(1.7 to 3.9)
0.6
(0.2 to 1.4)
Swelling: Severe (n = 881, 859)
0.1
(0.0 to 0.6)
0.1
(0.0 to 0.6)
Pain: Any (n = 914, 863)
36.1
(33.0 to 39.3)
6.1
(4.6 to 8.0)
Pain: Mild (n = 913, 861)
32.9
(29.8 to 36.0)
5.6
(4.1 to 7.3)
Pain: Moderate (n = 886, 860)
7.7
(6.0 to 9.6)
0.6
(0.2 to 1.4)
Pain: Severe (n = 881, 860)
0.3
(0.1 to 1.0)
0.1
(0.0 to 0.6)
Limitation of arm movement: Any (n = 891, 865)
14.1
(11.9 to 16.6)
3.2
(2.2 to 4.6)
Limitation of arm movement: Mild (n = 888, 863)
12.4
(10.3 to 14.7)
2.5
(1.6 to 3.8)
Limitation of arm movement: Moderate (n =883, 860)
1.7
(1.0 to 2.8)
0.5
(0.1 to 1.2)
Limitation of arm movement: Severe (n = 882, 861)
1.2
(0.6 to 2.2)
0.7
(0.3 to 1.5)
5.Other Pre-specified Outcome
Title Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
Hide Description Systemic events (fever, fatigue, headache, chills, rash, vomiting, decreased appetite, diarrhea, new generalized muscle/joint pain [new muscle/joint pain], aggravated generalized muscle/joint pain [aggravated muscle/joint pain], use of medication to treat pain/fever) reported using an e-diary. Fever scaled as Absent(<38 degrees C); Mild(greater than or equal to [>=]38 to <38.5 degrees C); Moderate(>=38.5 to <39 degrees C); Severe(>=39 to less than or equal to [<=]40 degrees C); Potentially life threatening (>40 degrees C). Fatigue, headache, new/aggravated muscle/joint pain scaled as Mild(no interference); Moderate(some interference); Severe(prevented routine activity). Vomiting scaled as Mild(1-2 times in 24 hours [hrs]); Moderate(>2 times in 24 hrs); Severe(required intravenous hydration). Diarrhea scaled as Mild(2-3 loose stools in 24 hrs); Moderate(4-5 loose stools in 24 hrs); Severe(>=6 loose stools in 24 hrs). Percentage of participants with systemic events were reported.
Time Frame Within 7 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity subset. Participants may be represented in more than 1 category. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event.
Arm/Group Title 13vPnC Placebo
Hide Arm/Group Description:
Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
Overall Number of Participants Analyzed 918 907
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Fever: >=38 to <38.5 degrees C (n = 883, 859)
1.1
(0.5 to 2.1)
0.6
(0.2 to 1.4)
Fever: >=38.5 to <39 degrees C (n = 881, 859)
0.6
(0.2 to 1.3)
0.2
(0.0 to 0.8)
Fever: >=39 to =<40 degrees C (n = 882, 859)
0.7
(0.3 to 1.5)
0.2
(0.0 to 0.8)
Fever: >40 degrees C (n = 882, 860)
0.8
(0.3 to 1.6)
0.3
(0.1 to 1.0)
Fatigue: Mild (n = 892, 871)
13.8
(11.6 to 16.2)
11.7
(9.7 to 14.0)
Fatigue: Moderate (n = 886, 866)
7.8
(6.1 to 9.8)
6.2
(4.7 to 8.1)
Fatigue: Severe (n = 883, 863)
1.4
(0.7 to 2.4)
0.9
(0.4 to 1.8)
Headache: Mild (n = 891, 870)
13.0
(10.9 to 15.4)
13.1
(10.9 to 15.5)
Headache: Moderate (n = 883, 868)
5.2
(3.8 to 6.9)
3.8
(2.6 to 5.3)
Headache: Severe (n = 881, 861)
0.6
(0.2 to 1.3)
0.6
(0.2 to 1.3)
Chills (n = 891, 866)
9.4
(7.6 to 11.5)
8.4
(6.7 to 10.5)
Rash (n = 882, 860)
3.3
(2.2 to 4.7)
0.8
(0.3 to 1.7)
Vomiting: Mild (n = 881, 860)
0.0
(0.0 to 0.4)
0.7
(0.3 to 1.5)
Vomiting: Moderate (n =881, 860)
0.1
(0.0 to 0.6)
0.1
(0.0 to 0.6)
Vomiting: Severe (n = 881, 860)
0.2
(0.0 to 0.8)
0.1
(0.0 to 0.6)
Decreased appetite (n = 886, 865)
5.3
(3.9 to 7.0)
3.7
(2.5 to 5.2)
Diarrhea: Mild (n = 887, 868)
5.1
(3.7 to 6.7)
7.7
(6.0 to 9.7)
Diarrhea: Moderate (n = 882, 863)
1.2
(0.6 to 2.2)
1.0
(0.5 to 2.0)
Diarrhea: Severe (n = 881, 862)
0.7
(0.3 to 1.5)
0.5
(0.1 to 1.2)
New muscle pain: Mild (n = 894, 865)
14.5
(12.3 to 17.0)
6.7
(5.1 to 8.6)
New muscle pain: Moderate (n = 886, 863)
5.9
(4.4 to 7.6)
2.8
(1.8 to 4.1)
New muscle pain: Severe (n = 882, 860)
0.7
(0.3 to 1.5)
0.5
(0.1 to 1.2)
Aggravated muscle pain: Mild (n = 886, 862)
4.6
(3.3 to 6.2)
1.9
(1.1 to 3.0)
Aggravated muscle pain: Moderate (n = 885, 863)
5.1
(3.7 to 6.7)
2.8
(1.8 to 4.1)
Aggravated muscle pain: Severe (n = 882, 860)
0.7
(0.3 to 1.5)
0.1
(0.0 to 0.6)
New joint pain: Mild (n = 884, 862)
5.0
(3.6 to 6.6)
3.9
(2.7 to 5.5)
New joint pain: Moderate (n = 883, 864)
2.9
(1.9 to 4.3)
2.2
(1.3 to 3.4)
New joint pain: Severe (n = 882, 860)
0.3
(0.1 to 1.0)
0.3
(0.1 to 1.0)
Aggravated joint pain: Mild (n = 883, 861)
2.3
(1.4 to 3.5)
1.7
(1.0 to 2.9)
Aggravated joint pain: Moderate (n = 884, 862)
3.2
(2.1 to 4.5)
2.6
(1.6 to 3.8)
Aggravated joint pain: Severe (n = 882, 860)
0.3
(0.1 to 1.0)
0.3
(0.1 to 1.0)
Use of medication to treat pain (n = 887, 872)
8.0
(6.3 to 10.0)
6.2
(4.7 to 8.0)
Use of medication to treat fever (n = 883, 863)
3.2
(2.1 to 4.6)
1.5
(0.8 to 2.6)
6.Other Pre-specified Outcome
Title Percentage of Participants Who Died
Hide Description Deaths collected throughout the case acquisition period were presented.
Time Frame From signing of informed consent form up to case acquisition period defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received study vaccine and who had any safety data.
Arm/Group Title 13vPnC Placebo
Hide Arm/Group Description:
Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
Overall Number of Participants Analyzed 42237 42255
Measure Type: Number
Unit of Measure: percentage of participants
7.1 7.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, Placebo
Comments Fisher exact test, 2-sided, was used to calculate the p-value for the difference between vaccine groups in percentages of participants.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.979
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
7.Other Pre-specified Outcome
Title Percentage of Participants With Newly Diagnosed Chronic Medical Condition
Hide Description Percentage of participants with newly diagnosed chronic medical conditions (including autoimmune or neuroinflammatory disease) in the immunogenicity subset were reported as per planned analysis.
Time Frame From 1 month after vaccination up to 6 months after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures.
Arm/Group Title 13vPnC Placebo
Hide Arm/Group Description:
Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
Overall Number of Participants Analyzed 1006 1005
Measure Type: Number
Unit of Measure: percentage of participants
1.7 1.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, Placebo
Comments Fisher exact test, 2-sided, was used to calculate the p-value for the difference between vaccine groups in percentages of participants.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.455
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
Adverse Event Reporting Description SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
 
Arm/Group Title 13vPnC Safety Set Placebo Safety Set 13vPnC Immunogenicity Subset Placebo Immunogenicity Subset
Hide Arm/Group Description All Participants who received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1, were assessed for serious adverse events (SAEs) from vaccination up to 1 month after vaccination. Safety set included all participants who received study vaccine and who had any safety data. All participants who received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1, were assessed for SAEs from vaccination up to 1 month after vaccination. Safety set included all participants who received study vaccine and who had any safety data. Participants included in immunogenicity subset who received a single 0.5 mL dose of 13vPnC intramuscular injection on Day 1, were assessed for SAEs from 1 month after vaccination up to 6 months after vaccination and for Other adverse events (AEs) from vaccination up to 1 month after vaccination. Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures. Participants included in immunogenicity subset who received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1, were assessed for SAEs from 1 month after vaccination up to 6 months after vaccination and for Other AEs from vaccination up to 1 month after vaccination. Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures.
All-Cause Mortality
13vPnC Safety Set Placebo Safety Set 13vPnC Immunogenicity Subset Placebo Immunogenicity Subset
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
13vPnC Safety Set Placebo Safety Set 13vPnC Immunogenicity Subset Placebo Immunogenicity Subset
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   327/42237 (0.77%)   314/42255 (0.74%)   55/1006 (5.47%)   48/1005 (4.78%) 
Blood and lymphatic system disorders         
Anaemia * 1  2/42237 (0.00%)  0/42255 (0.00%)  1/1006 (0.10%)  0/1005 (0.00%) 
Idiopathic thrombocytopenic purpura * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Iron deficiency anaemia * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Pancytopenia * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Cardiac disorders         
Angina pectoris * 1  19/42237 (0.04%)  19/42255 (0.04%)  3/1006 (0.30%)  1/1005 (0.10%) 
Atrial fibrillation * 1  13/42237 (0.03%)  9/42255 (0.02%)  3/1006 (0.30%)  1/1005 (0.10%) 
Myocardial infarction * 1  12/42237 (0.03%)  6/42255 (0.01%)  0/1006 (0.00%)  1/1005 (0.10%) 
Cardiac failure * 1  7/42237 (0.02%)  10/42255 (0.02%)  4/1006 (0.40%)  0/1005 (0.00%) 
Atrial flutter * 1  5/42237 (0.01%)  2/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Coronary artery disease * 1  3/42237 (0.01%)  4/42255 (0.01%)  0/1006 (0.00%)  0/1005 (0.00%) 
Acute coronary syndrome * 1  2/42237 (0.00%)  3/42255 (0.01%)  1/1006 (0.10%)  0/1005 (0.00%) 
Cardiac asthma * 1  2/42237 (0.00%)  3/42255 (0.01%)  0/1006 (0.00%)  0/1005 (0.00%) 
Angina unstable * 1  2/42237 (0.00%)  2/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Cardiac arrest * 1  2/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  1/1005 (0.10%) 
Sick sinus syndrome * 1  1/42237 (0.00%)  2/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Aortic valve stenosis * 1  1/42237 (0.00%)  1/42255 (0.00%)  1/1006 (0.10%)  0/1005 (0.00%) 
Atrioventricular block * 1  1/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Atrioventricular block complete * 1  1/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Myocardial ischaemia * 1  1/42237 (0.00%)  1/42255 (0.00%)  1/1006 (0.10%)  0/1005 (0.00%) 
Pericarditis * 1  1/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Supraventricular tachycardia * 1  0/42237 (0.00%)  2/42255 (0.00%)  0/1006 (0.00%)  1/1005 (0.10%) 
Acute myocardial infarction * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Arrhythmia * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Atrial tachycardia * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Bradycardia * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Cardio-respiratory arrest * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Coronary artery dissection * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Left ventricular failure * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Mitral valve incompetence * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Palpitations * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Silent myocardial infarction * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Sinus bradycardia * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Ventricular tachycardia * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Atrioventricular block second degree * 1  0/42237 (0.00%)  0/42255 (0.00%)  1/1006 (0.10%)  0/1005 (0.00%) 
Cardiac failure congestive * 1  0/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  1/1005 (0.10%) 
Coronary artery stenosis * 1  0/42237 (0.00%)  0/42255 (0.00%)  1/1006 (0.10%)  0/1005 (0.00%) 
Ear and labyrinth disorders         
Vertigo positional * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Vertigo * 1  0/42237 (0.00%)  0/42255 (0.00%)  1/1006 (0.10%)  0/1005 (0.00%) 
Eye disorders         
Retinal detachment * 1  1/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Retinal artery occlusion * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Macular fibrosis * 1  0/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  1/1005 (0.10%) 
Gastrointestinal disorders         
Ileus * 1  2/42237 (0.00%)  4/42255 (0.01%)  0/1006 (0.00%)  0/1005 (0.00%) 
Constipation * 1  4/42237 (0.01%)  1/42255 (0.00%)  0/1006 (0.00%)  1/1005 (0.10%) 
Rectal haemorrhage * 1  1/42237 (0.00%)  2/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Colitis * 1  1/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Diarrhoea * 1  1/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Gastrooesophageal reflux disease * 1  1/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Pancreatitis acute * 1  2/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Abdominal pain * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Duodenal perforation * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Duodenal ulcer * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Gastric perforation * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Gastritis * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Inguinal hernia, obstructive * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Intestinal obstruction * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Intestinal perforation * 1  1/42237 (0.00%)  0/42255 (0.00%)  1/1006 (0.10%)  0/1005 (0.00%) 
Melaena * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Pancreatitis * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Subileus * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Upper gastrointestinal haemorrhage * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Varices oesophageal * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Abdominal hernia * 1  0/42237 (0.00%)  0/42255 (0.00%)  1/1006 (0.10%)  0/1005 (0.00%) 
Diverticulum intestinal haemorrhagic * 1  0/42237 (0.00%)  0/42255 (0.00%)  1/1006 (0.10%)  0/1005 (0.00%) 
Large intestinal stenosis * 1  0/42237 (0.00%)  0/42255 (0.00%)  1/1006 (0.10%)  0/1005 (0.00%) 
Umbilical hernia * 1  0/42237 (0.00%)  0/42255 (0.00%)  1/1006 (0.10%)  0/1005 (0.00%) 
General disorders         
Non-cardiac chest pain * 1  12/42237 (0.03%)  2/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Chest pain * 1  5/42237 (0.01%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Device dislocation * 1  2/42237 (0.00%)  0/42255 (0.00%)  1/1006 (0.10%)  0/1005 (0.00%) 
Accidental death * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Death * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Device occlusion * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Hernia obstructive * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Malaise * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Medical device complication * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Pyrexia * 1  1/42237 (0.00%)  0/42255 (0.00%)  1/1006 (0.10%)  0/1005 (0.00%) 
Sudden cardiac death * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Implant site fibrosis * 1  0/42237 (0.00%)  0/42255 (0.00%)  1/1006 (0.10%)  0/1005 (0.00%) 
Hepatobiliary disorders         
Cholecystitis * 1  2/42237 (0.00%)  2/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Bile duct stone * 1  0/42237 (0.00%)  2/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Cholangitis * 1  2/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Cholecystitis acute * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Cholelithiasis * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  1/1005 (0.10%) 
Immune system disorders         
Anaphylactic reaction * 1  0/42237 (0.00%)  2/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Anaphylactic shock * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  1/1005 (0.10%) 
Corneal graft rejection * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Infections and infestations         
Pneumonia * 1  14/42237 (0.03%)  6/42255 (0.01%)  4/1006 (0.40%)  1/1005 (0.10%) 
Appendicitis * 1  2/42237 (0.00%)  4/42255 (0.01%)  0/1006 (0.00%)  0/1005 (0.00%) 
Device related infection * 1  3/42237 (0.01%)  2/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Urinary tract infection * 1  2/42237 (0.00%)  3/42255 (0.01%)  0/1006 (0.00%)  0/1005 (0.00%) 
Urosepsis * 1  1/42237 (0.00%)  3/42255 (0.01%)  0/1006 (0.00%)  0/1005 (0.00%) 
Gastroenteritis * 1  0/42237 (0.00%)  3/42255 (0.01%)  1/1006 (0.10%)  0/1005 (0.00%) 
Pneumonia pneumococcal * 1  1/42237 (0.00%)  2/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Diverticulitis * 1  1/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Pneumonia legionella * 1  1/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Wound infection * 1  0/42237 (0.00%)  2/42255 (0.00%)  2/1006 (0.20%)  1/1005 (0.10%) 
Bronchiolitis * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Cholangitis suppurative * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Cystitis * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Erysipelas * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Herpes zoster * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Infective exacerbation of chronic obstructive airways disease * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Meningitis * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Peritonitis * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Peritonsillar abscess * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Respiratory tract infection * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Staphylococcal bacteraemia * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Staphylococcal infection * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Tuberculosis * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Upper respiratory tract infection * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Vestibular neuronitis * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Viral infection * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Viral upper respiratory tract infection * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Abdominal abscess * 1  0/42237 (0.00%)  0/42255 (0.00%)  1/1006 (0.10%)  0/1005 (0.00%) 
Injury, poisoning and procedural complications         
Femur fracture * 1  5/42237 (0.01%)  4/42255 (0.01%)  0/1006 (0.00%)  1/1005 (0.10%) 
Hip fracture * 1  3/42237 (0.01%)  3/42255 (0.01%)  1/1006 (0.10%)  0/1005 (0.00%) 
Femoral neck fracture * 1  3/42237 (0.01%)  2/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Humerus fracture * 1  1/42237 (0.00%)  4/42255 (0.01%)  0/1006 (0.00%)  0/1005 (0.00%) 
Brain contusion * 1  2/42237 (0.00%)  2/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Radius fracture * 1  1/42237 (0.00%)  3/42255 (0.01%)  0/1006 (0.00%)  0/1005 (0.00%) 
Ankle fracture * 1  2/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  2/1005 (0.20%) 
Contusion * 1  0/42237 (0.00%)  3/42255 (0.01%)  0/1006 (0.00%)  0/1005 (0.00%) 
Head injury * 1  1/42237 (0.00%)  2/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Rib fracture * 1  3/42237 (0.01%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Subdural haematoma * 1  2/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Tendon rupture * 1  0/42237 (0.00%)  3/42255 (0.01%)  0/1006 (0.00%)  0/1005 (0.00%) 
Fracture * 1  0/42237 (0.00%)  2/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Pelvic fracture * 1  1/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Ulna fracture * 1  1/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  1/1005 (0.10%) 
Wrist fracture * 1  1/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Accidental overdose * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Anaemia postoperative * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Cardiac valve replacement complication * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Concussion * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Facial bones fracture * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Forearm fracture * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Foreign body aspiration * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Incisional hernia * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Injury * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Joint dislocation * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  1/1005 (0.10%) 
Kidney contusion * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Ligament injury * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Lower limb fracture * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Mental status changes postoperative * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Multiple injuries * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Periprosthetic fracture * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Post laminectomy syndrome * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Procedural intestinal perforation * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Procedural pain * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  1/1005 (0.10%) 
Tendon injury * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Thermal burn * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Urinary retention postoperative * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Vascular graft occlusion * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Wound dehiscence * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Procedural haemorrhage * 1  0/42237 (0.00%)  0/42255 (0.00%)  1/1006 (0.10%)  0/1005 (0.00%) 
Investigations         
Weight decreased * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Metabolism and nutrition disorders         
Electrolyte imbalance * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Hypoglycaemia * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Musculoskeletal and connective tissue disorders         
Finger deformity * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Intervertebral disc protrusion * 1  1/42237 (0.00%)  0/42255 (0.00%)  2/1006 (0.20%)  1/1005 (0.10%) 
Lumbar spinal stenosis * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  1/1005 (0.10%) 
Osteoarthritis * 1  1/42237 (0.00%)  0/42255 (0.00%)  2/1006 (0.20%)  10/1005 (1.00%) 
Arthralgia * 1  0/42237 (0.00%)  0/42255 (0.00%)  2/1006 (0.20%)  0/1005 (0.00%) 
Bone cyst * 1  0/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  1/1005 (0.10%) 
Polymyalgia rheumatica * 1  0/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  1/1005 (0.10%) 
Rotator cuff syndrome * 1  0/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  1/1005 (0.10%) 
Spondylolisthesis * 1  0/42237 (0.00%)  0/42255 (0.00%)  1/1006 (0.10%)  0/1005 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Basal cell carcinoma * 1  22/42237 (0.05%)  16/42255 (0.04%)  0/1006 (0.00%)  0/1005 (0.00%) 
Prostate cancer * 1  10/42237 (0.02%)  7/42255 (0.02%)  0/1006 (0.00%)  2/1005 (0.20%) 
Colon cancer * 1  7/42237 (0.02%)  6/42255 (0.01%)  2/1006 (0.20%)  1/1005 (0.10%) 
Breast cancer * 1  2/42237 (0.00%)  3/42255 (0.01%)  0/1006 (0.00%)  1/1005 (0.10%) 
Malignant melanoma * 1  2/42237 (0.00%)  3/42255 (0.01%)  0/1006 (0.00%)  1/1005 (0.10%) 
Transitional cell carcinoma * 1  2/42237 (0.00%)  2/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Gastric cancer * 1  2/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Adenocarcinoma of colon * 1  0/42237 (0.00%)  2/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Bladder cancer * 1  1/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Colon cancer metastatic * 1  1/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Endometrial adenocarcinoma * 1  1/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Non-small cell lung cancer * 1  2/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Plasma cell myeloma * 1  2/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Rectal cancer * 1  2/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Bladder adenocarcinoma stage unspecified * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Bowen's disease * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Bronchial carcinoma * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Clear cell renal cell carcinoma * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Colorectal cancer metastatic * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Glioblastoma * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Glioma * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Hepatic adenoma * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Hypopharyngeal cancer * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Laryngeal cancer * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Leukaemia * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Lung adenocarcinoma metastatic * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Lung neoplasm malignant * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Malignant neoplasm of renal pelvis * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Melanoma recurrent * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Mesothelioma * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  1/1005 (0.10%) 
Metastasis * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Metastatic gastric cancer * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Metastatic renal cell carcinoma * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Myelodysplastic syndrome * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Neoplasm prostate * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Oesophageal adenocarcinoma * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Oesophageal carcinoma recurrent * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Prostate cancer metastatic * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Prostate cancer recurrent * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Renal cancer * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Renal cell carcinoma * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Small cell lung cancer * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Squamous cell carcinoma * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Squamous cell carcinoma of skin * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Tonsil cancer * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Bile duct adenocarcinoma * 1  0/42237 (0.00%)  0/42255 (0.00%)  1/1006 (0.10%)  0/1005 (0.00%) 
Bladder transitional cell carcinoma * 1  0/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  1/1005 (0.10%) 
Colon neoplasm * 1  0/42237 (0.00%)  0/42255 (0.00%)  1/1006 (0.10%)  0/1005 (0.00%) 
Endometrial cancer * 1  0/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  1/1005 (0.10%) 
Renal cancer recurrent * 1  0/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  1/1005 (0.10%) 
Nervous system disorders         
Cerebrovascular accident * 1  9/42237 (0.02%)  8/42255 (0.02%)  3/1006 (0.30%)  1/1005 (0.10%) 
Cerebral infarction * 1  4/42237 (0.01%)  9/42255 (0.02%)  0/1006 (0.00%)  0/1005 (0.00%) 
Transient ischaemic attack * 1  8/42237 (0.02%)  5/42255 (0.01%)  0/1006 (0.00%)  0/1005 (0.00%) 
Syncope * 1  3/42237 (0.01%)  3/42255 (0.01%)  0/1006 (0.00%)  0/1005 (0.00%) 
Presyncope * 1  1/42237 (0.00%)  3/42255 (0.01%)  0/1006 (0.00%)  0/1005 (0.00%) 
Cerebral haemorrhage * 1  2/42237 (0.00%)  1/42255 (0.00%)  1/1006 (0.10%)  0/1005 (0.00%) 
Subarachnoid haemorrhage * 1  1/42237 (0.00%)  2/42255 (0.00%)  1/1006 (0.10%)  0/1005 (0.00%) 
Dizziness * 1  1/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Epilepsy * 1  0/42237 (0.00%)  2/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Loss of consciousness * 1  1/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Transient global amnesia * 1  0/42237 (0.00%)  2/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Acute disseminated encephalomyelitis * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Cerebral ischaemia * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Convulsion * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Hemiparesis * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Peroneal nerve palsy * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Radicular pain * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Radiculitis lumbosacral * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Trigeminal neuralgia * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Carotid artery stenosis * 1  0/42237 (0.00%)  0/42255 (0.00%)  1/1006 (0.10%)  0/1005 (0.00%) 
Hepatic encephalopathy * 1  0/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  1/1005 (0.10%) 
Ischaemic stroke * 1  0/42237 (0.00%)  0/42255 (0.00%)  1/1006 (0.10%)  0/1005 (0.00%) 
Peripheral nerve lesion * 1  0/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  1/1005 (0.10%) 
Psychiatric disorders         
Bipolar disorder * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Delirium * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Psychotic disorder * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Suicidal ideation * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Renal and urinary disorders         
Calculus bladder * 1  2/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Haematuria * 1  2/42237 (0.00%)  0/42255 (0.00%)  1/1006 (0.10%)  0/1005 (0.00%) 
Cystitis noninfective * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Nephrolithiasis * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Renal impairment * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Ureteric stenosis * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Urethral stenosis * 1  0/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  1/1005 (0.10%) 
Urinary retention * 1  0/42237 (0.00%)  0/42255 (0.00%)  1/1006 (0.10%)  0/1005 (0.00%) 
Reproductive system and breast disorders         
Benign prostatic hyperplasia * 1  0/42237 (0.00%)  2/42255 (0.00%)  1/1006 (0.10%)  1/1005 (0.10%) 
Acquired phimosis * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Female genital tract fistula * 1  0/42237 (0.00%)  0/42255 (0.00%)  1/1006 (0.10%)  0/1005 (0.00%) 
Vaginal prolapse * 1  0/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  1/1005 (0.10%) 
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disease * 1  13/42237 (0.03%)  8/42255 (0.02%)  2/1006 (0.20%)  1/1005 (0.10%) 
Pulmonary embolism * 1  3/42237 (0.01%)  2/42255 (0.00%)  1/1006 (0.10%)  0/1005 (0.00%) 
Pneumothorax * 1  1/42237 (0.00%)  3/42255 (0.01%)  0/1006 (0.00%)  0/1005 (0.00%) 
Epistaxis * 1  2/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Dyspnoea exertional * 1  0/42237 (0.00%)  2/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Sleep apnoea syndrome * 1  1/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Alveolitis allergic * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Asphyxia * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Dyspnoea * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Hydrothorax * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Lung infiltration * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Pleural effusion * 1  0/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  1/1005 (0.10%) 
Skin and subcutaneous tissue disorders         
Skin ulcer * 1  0/42237 (0.00%)  2/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Rash * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Vascular disorders         
Circulatory collapse * 1  3/42237 (0.01%)  2/42255 (0.00%)  1/1006 (0.10%)  0/1005 (0.00%) 
Aortic aneurysm * 1  2/42237 (0.00%)  1/42255 (0.00%)  2/1006 (0.20%)  0/1005 (0.00%) 
Aortic aneurysm rupture * 1  3/42237 (0.01%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Hypertension * 1  1/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  1/1005 (0.10%) 
Hypotension * 1  2/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Deep vein thrombosis * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Haematoma * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Intermittent claudication * 1  0/42237 (0.00%)  1/42255 (0.00%)  2/1006 (0.20%)  1/1005 (0.10%) 
Peripheral arterial occlusive disease * 1  0/42237 (0.00%)  1/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Temporal arteritis * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Thrombophlebitis * 1  1/42237 (0.00%)  0/42255 (0.00%)  0/1006 (0.00%)  0/1005 (0.00%) 
Malignant hypertension * 1  0/42237 (0.00%)  0/42255 (0.00%)  1/1006 (0.10%)  0/1005 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
13vPnC Safety Set Placebo Safety Set 13vPnC Immunogenicity Subset Placebo Immunogenicity Subset
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   363/1006 (36.08%)   315/1005 (31.34%) 
Cardiac disorders         
Angina pectoris * 1  0/0  0/0  0/1006 (0.00%)  2/1005 (0.20%) 
Atrial fibrillation * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Cardiac failure * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Mitral valve incompetence * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Palpitations * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Tachycardia * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Ear and labyrinth disorders         
Vertigo * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Eye disorders         
Conjunctivitis * 1  0/0  0/0  5/1006 (0.50%)  0/1005 (0.00%) 
Cataract * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Conjunctivitis allergic * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Ocular hyperaemia * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Vitreous floaters * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Gastrointestinal disorders         
Diarrhoea * 1  0/0  0/0  3/1006 (0.30%)  5/1005 (0.50%) 
Nausea * 1  0/0  0/0  2/1006 (0.20%)  3/1005 (0.30%) 
Abdominal pain upper * 1  0/0  0/0  2/1006 (0.20%)  1/1005 (0.10%) 
Gastrooesophageal reflux disease * 1  0/0  0/0  0/1006 (0.00%)  2/1005 (0.20%) 
Change of bowel habit * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Eructation * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Gastritis * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Haemorrhoids * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Vomiting * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
General disorders         
Injection site erythema * 1  0/0  0/0  30/1006 (2.98%)  0/1005 (0.00%) 
Injection site pain * 1  0/0  0/0  18/1006 (1.79%)  2/1005 (0.20%) 
Injection site pruritus * 1  0/0  0/0  10/1006 (0.99%)  0/1005 (0.00%) 
Injection site swelling * 1  0/0  0/0  10/1006 (0.99%)  0/1005 (0.00%) 
Malaise * 1  0/0  0/0  4/1006 (0.40%)  3/1005 (0.30%) 
Fatigue * 1  0/0  0/0  2/1006 (0.20%)  4/1005 (0.40%) 
Injection site haematoma * 1  0/0  0/0  1/1006 (0.10%)  2/1005 (0.20%) 
Injection site exfoliation * 1  0/0  0/0  2/1006 (0.20%)  0/1005 (0.00%) 
Pyrexia * 1  0/0  0/0  1/1006 (0.10%)  1/1005 (0.10%) 
Chills * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Cyst * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Device breakage * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Ill-defined disorder * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Injection site rash * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Injection site reaction * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Oedema peripheral * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Vaccination site erythema * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Vessel puncture site haematoma * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Fever: >=38 to <38.5 degrees C  3  0/0  0/0  10/883 (1.13%)  5/859 (0.58%) 
Fever: >=38.5 to <39 degrees C  3  0/0  0/0  5/881 (0.57%)  2/859 (0.23%) 
Fever: >=39 to =<40 degrees C  3  0/0  0/0  6/882 (0.68%)  2/859 (0.23%) 
Fever: >40 degrees C  3  0/0  0/0  7/882 (0.79%)  3/860 (0.35%) 
Fatigue: Mild  3  0/0  0/0  123/892 (13.79%)  102/871 (11.71%) 
Fatigue: Moderate  3  0/0  0/0  69/886 (7.79%)  54/866 (6.24%) 
Fatigue: Severe  3  0/0  0/0  12/883 (1.36%)  8/863 (0.93%) 
Headache: Mild  3  0/0  0/0  116/891 (13.02%)  114/870 (13.10%) 
Headache: Moderate  3  0/0  0/0  46/883 (5.21%)  33/868 (3.80%) 
Headache: Severe  3  0/0  0/0  5/881 (0.57%)  5/861 (0.58%) 
Chills  3  0/0  0/0  84/891 (9.43%)  73/866 (8.43%) 
Rash  3  0/0  0/0  29/882 (3.29%)  7/860 (0.81%) 
Vomiting: Mild  3  0/0  0/0  0/881 (0.00%)  6/860 (0.70%) 
Vomiting: Moderate  3  0/0  0/0  1/881 (0.11%)  1/860 (0.12%) 
Vomiting: Severe  3  0/0  0/0  2/881 (0.23%)  1/860 (0.12%) 
Decreased appetite  3  0/0  0/0  47/886 (5.30%)  32/865 (3.70%) 
Diarrhea: Mild  3  0/0  0/0  45/887 (5.07%)  67/868 (7.72%) 
Diarrhea: Moderate  3  0/0  0/0  11/882 (1.25%)  9/863 (1.04%) 
Diarrhea: Severe  3  0/0  0/0  6/881 (0.68%)  4/862 (0.46%) 
New generalized muscle pain: Mild  3  0/0  0/0  130/894 (14.54%)  58/865 (6.71%) 
New generalized muscle pain: Moderate  3  0/0  0/0  52/886 (5.87%)  24/863 (2.78%) 
New generalized muscle pain: Severe  3  0/0  0/0  6/882 (0.68%)  4/860 (0.47%) 
Aggravated generalized muscle pain: Mild  3  0/0  0/0  41/886 (4.63%)  16/862 (1.86%) 
Aggravated generalized muscle pain: Moderate  3  0/0  0/0  45/885 (5.08%)  24/863 (2.78%) 
Aggravated generalized muscle pain: Severe  3  0/0  0/0  6/882 (0.68%)  1/860 (0.12%) 
New generalized joint pain: Mild  3  0/0  0/0  44/884 (4.98%)  34/862 (3.94%) 
New generalized joint pain: Moderate  3  0/0  0/0  26/883 (2.94%)  19/864 (2.20%) 
New generalized joint pain: Severe  3  0/0  0/0  3/882 (0.34%)  3/860 (0.35%) 
Aggravated generalized joint pain: Mild  3  0/0  0/0  20/883 (2.27%)  15/861 (1.74%) 
Aggravated generalized joint pain: Moderate  3  0/0  0/0  28/884 (3.17%)  22/862 (2.55%) 
Aggravated generalized joint pain: Severe  3  0/0  0/0  3/882 (0.34%)  3/860 (0.35%) 
Hepatobiliary disorders         
Cholelithiasis * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Infections and infestations         
Nasopharyngitis * 1  0/0  0/0  12/1006 (1.19%)  20/1005 (1.99%) 
Upper respiratory tract infection * 1  0/0  0/0  8/1006 (0.80%)  17/1005 (1.69%) 
Cystitis * 1  0/0  0/0  5/1006 (0.50%)  8/1005 (0.80%) 
Gastroenteritis * 1  0/0  0/0  4/1006 (0.40%)  9/1005 (0.90%) 
Bronchitis * 1  0/0  0/0  5/1006 (0.50%)  4/1005 (0.40%) 
Influenza * 1  0/0  0/0  4/1006 (0.40%)  5/1005 (0.50%) 
Herpes zoster * 1  0/0  0/0  2/1006 (0.20%)  1/1005 (0.10%) 
Pneumonia * 1  0/0  0/0  0/1006 (0.00%)  3/1005 (0.30%) 
Sinusitis * 1  0/0  0/0  2/1006 (0.20%)  1/1005 (0.10%) 
Fungal infection * 1  0/0  0/0  2/1006 (0.20%)  0/1005 (0.00%) 
Urinary tract infection * 1  0/0  0/0  1/1006 (0.10%)  1/1005 (0.10%) 
Wound infection * 1  0/0  0/0  0/1006 (0.00%)  2/1005 (0.20%) 
Abscess oral * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Enteritis infectious * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Folliculitis * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Fungal skin infection * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Lower respiratory tract infection * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Oral herpes * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Otitis externa * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Otitis media * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Tinea barbae * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Injury, poisoning and procedural complications         
Limb injury * 1  0/0  0/0  2/1006 (0.20%)  1/1005 (0.10%) 
Contusion * 1  0/0  0/0  1/1006 (0.10%)  1/1005 (0.10%) 
Procedural pain * 1  0/0  0/0  0/1006 (0.00%)  2/1005 (0.20%) 
Bone contusion * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Concussion * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Epicondylitis * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Face injury * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Muscle strain * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Periorbital contusion * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Traumatic haemorrhage * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Investigations         
International normalised ratio decreased * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite * 1  0/0  0/0  1/1006 (0.10%)  3/1005 (0.30%) 
Gout * 1  0/0  0/0  1/1006 (0.10%)  2/1005 (0.20%) 
Musculoskeletal and connective tissue disorders         
Back pain * 1  0/0  0/0  5/1006 (0.50%)  1/1005 (0.10%) 
Myalgia * 1  0/0  0/0  3/1006 (0.30%)  3/1005 (0.30%) 
Arthralgia * 1  0/0  0/0  2/1006 (0.20%)  3/1005 (0.30%) 
Musculoskeletal stiffness * 1  0/0  0/0  4/1006 (0.40%)  1/1005 (0.10%) 
Pain in extremity * 1  0/0  0/0  3/1006 (0.30%)  0/1005 (0.00%) 
Tendonitis * 1  0/0  0/0  1/1006 (0.10%)  2/1005 (0.20%) 
Intervertebral disc protrusion * 1  0/0  0/0  1/1006 (0.10%)  1/1005 (0.10%) 
Fibromyalgia * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Inclusion body myositis * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Joint range of motion decreased * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Joint stiffness * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Muscle spasms * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Muscular weakness * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Musculoskeletal chest pain * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Musculoskeletal discomfort * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Musculoskeletal disorder * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Musculoskeletal pain * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Myositis * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Osteitis * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Pain in jaw * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Keratoacanthoma * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Nervous system disorders         
Headache * 1  0/0  0/0  7/1006 (0.70%)  1/1005 (0.10%) 
Dizziness * 1  0/0  0/0  3/1006 (0.30%)  3/1005 (0.30%) 
Ageusia * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Aphonia * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Cerebrovascular accident * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Neuropathy peripheral * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Paraesthesia * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Sciatica * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Syncope * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Transient ischaemic attack * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Renal and urinary disorders         
Haematuria * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Nephrolithiasis * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Urinary retention * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Epistaxis * 1  0/0  0/0  5/1006 (0.50%)  2/1005 (0.20%) 
Cough * 1  0/0  0/0  2/1006 (0.20%)  1/1005 (0.10%) 
Productive cough * 1  0/0  0/0  3/1006 (0.30%)  0/1005 (0.00%) 
Chronic obstructive pulmonary disease * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Dyspnoea * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Hyperventilation * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Lung disorder * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Rhinalgia * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Rhinorrhoea * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Sneezing * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Skin and subcutaneous tissue disorders         
Rash * 1  0/0  0/0  2/1006 (0.20%)  1/1005 (0.10%) 
Dermatitis allergic * 1  0/0  0/0  1/1006 (0.10%)  1/1005 (0.10%) 
Dry skin * 1  0/0  0/0  1/1006 (0.10%)  1/1005 (0.10%) 
Blood blister * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Eczema * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Pruritus * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Pruritus generalised * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Skin ulcer * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Urticaria * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Redness: Any  2  0/0  0/0  43/886 (4.85%)  10/859 (1.16%) 
Redness: Mild  2  0/0  0/0  33/886 (3.72%)  7/859 (0.81%) 
Redness: Moderate  2  0/0  0/0  15/881 (1.70%)  3/859 (0.35%) 
Redness: Severe  2  0/0  0/0  4/881 (0.45%)  1/859 (0.12%) 
Swelling: Any  2  0/0  0/0  60/888 (6.76%)  10/859 (1.16%) 
Swelling: Mild  2  0/0  0/0  49/888 (5.52%)  6/859 (0.70%) 
Swelling: Moderate  2  0/0  0/0  23/884 (2.60%)  5/859 (0.58%) 
Swelling: Severe  2  0/0  0/0  1/881 (0.11%)  1/859 (0.12%) 
Pain: Any  2  0/0  0/0  330/914 (36.11%)  53/863 (6.14%) 
Pain: Mild  2  0/0  0/0  300/913 (32.86%)  48/861 (5.57%) 
Pain: Moderate  2  0/0  0/0  68/886 (7.67%)  5/860 (0.58%) 
Pain: Severe  2  0/0  0/0  3/881 (0.34%)  1/860 (0.12%) 
Limitation of arm movement: Any  2  0/0  0/0  126/891 (14.14%)  28/865 (3.24%) 
Limitation of arm movement: Mild  2  0/0  0/0  110/888 (12.39%)  22/863 (2.55%) 
Limitation of arm movement: Moderate  2  0/0  0/0  15/883 (1.70%)  4/860 (0.47%) 
Limitation of arm movement: Severe  2  0/0  0/0  11/882 (1.25%)  6/861 (0.70%) 
Vascular disorders         
Hypertension * 1  0/0  0/0  1/1006 (0.10%)  0/1005 (0.00%) 
Peripheral coldness * 1  0/0  0/0  0/1006 (0.00%)  1/1005 (0.10%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
2
Term from vocabulary, Local Reactions
3
Term from vocabulary, Systemic Events
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
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00744263     History of Changes
Other Study ID Numbers: 6115A1-3006
B1851025
First Submitted: August 27, 2008
First Posted: August 29, 2008
Results First Submitted: October 1, 2014
Results First Posted: October 6, 2014
Last Update Posted: October 6, 2014