ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase 3 Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Japanese Elderly Adults Aged 65 Years Old and Older

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01646398
Recruitment Status : Completed
First Posted : July 20, 2012
Results First Posted : September 20, 2013
Last Update Posted : September 20, 2013
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 Pneumococcal Vaccines
Pneumococcal Conjugate Vaccine
Interventions Biological: 13-valent pneumococcal conjugate vaccine
Biological: 23-valent pneumococcal polysaccharide vaccine
Enrollment 764
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 13vPnC 23vPS
Hide Arm/Group Description 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1. 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
Period Title: Overall Study
Started 382 382
Completed 381 382
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title 13vPnC 23vPS Total
Hide Arm/Group Description 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1. 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 382 382 764
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 382 participants 382 participants 764 participants
70.0  (4.08) 69.7  (3.66) 69.9  (3.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 382 participants 382 participants 764 participants
Female
198
  51.8%
187
  49.0%
385
  50.4%
Male
184
  48.2%
195
  51.0%
379
  49.6%
1.Primary Outcome
Title Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination
Hide Description Antibody-mediated serum OPA against each of the 12 pneumococcal serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolony OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
Time Frame One month after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population:eligible participants, received study vaccine to which randomized, received no prohibited vaccines, had at least 1 valid and determinate assay result, had blood drawn within prescribed time frame and had no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.
Arm/Group Title 13vPnC 23vPS
Hide Arm/Group Description:
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
Overall Number of Participants Analyzed 366 367
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
1 (n=366, 366)
103
(84.6 to 125.5)
78
(63.6 to 95.8)
3 (n=365, 367)
44
(38.1 to 51.5)
61
(52.8 to 70.1)
4 (n=360, 362)
1016
(850.7 to 1213.2)
392
(314.7 to 487.1)
5 (n=350, 361)
347
(282.3 to 425.6)
118
(98.4 to 142.5)
6B (n=360, 359)
1995
(1689.3 to 2355.9)
1440
(1223.5 to 1694.2)
7F (n=365, 364)
1901
(1642.8 to 2198.7)
1361
(1153.3 to 1605.6)
9V (n=365,358)
858
(675.7 to 1089.5)
379
(290.2 to 493.9)
14 (n=363, 359)
1028
(866.9 to 1217.9)
1059
(896.6 to 1250.6)
18C (n=366, 362)
2015
(1675.4 to 2424.5)
938
(752.7 to 1170.1)
19A (n=365, 362)
985
(841.5 to 1153.9)
429
(358.0 to 513.2)
19F (n=352, 357)
773
(607.9 to 983.0)
388
(305.6 to 491.8)
23F (n=366, 363)
456
(363.7 to 570.6)
180
(143.1 to 226.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 23vPS
Comments Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
0.99 to 1.75
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 23vPS
Comments Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
0.59 to 0.89
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC, 23vPS
Comments Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 2.6
Confidence Interval (2-Sided) 95%
1.96 to 3.44
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC, 23vPS
Comments Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 2.9
Confidence Interval (2-Sided) 95%
2.22 to 3.86
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC, 23vPS
Comments Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
1.10 to 1.75
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC, 23vPS
Comments Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
1.12 to 1.74
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC, 23vPS
Comments Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 2.3
Confidence Interval (2-Sided) 95%
1.59 to 3.24
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC, 23vPS
Comments Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.77 to 1.23
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 13vPnC, 23vPS
Comments Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 2.1
Confidence Interval (2-Sided) 95%
1.61 to 2.86
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 13vPnC, 23vPS
Comments Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 2.3
Confidence Interval (2-Sided) 95%
1.81 to 2.92
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 13vPnC, 23vPS
Comments Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 2.0
Confidence Interval (2-Sided) 95%
1.42 to 2.79
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 13vPnC, 23vPS
Comments Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 2.5
Confidence Interval (2-Sided) 95%
1.84 to 3.49
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titers for Serotype 6A 1 Month After Vaccination
Hide Description For serotype 6A the percentage of participants achieving at least a 4-fold rise on the serotype-specific antibody titer from pre-vaccination to 1 month post-vaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.
Time Frame One month after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with determinate fold rise of OPA antibody titer to serotype 6A.
Arm/Group Title 13vPnC 23vPS
Hide Arm/Group Description:
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
Overall Number of Participants Analyzed 319 320
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
74.0
(68.8 to 78.7)
47.2
(41.6 to 52.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 23vPS
Comments Difference in proportions (13vPnC – 23vPS) expressed as a percentage presented along with exact, 2-sided 95%CI. Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 26.8
Confidence Interval (2-Sided) 95%
19.3 to 34.0
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination
Hide Description Antibody-mediated serum OPA against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolonoy OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
Time Frame One month after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population:eligible participants, received study vaccine to which randomized, received no prohibited vaccines, had at least 1 valid and determinate assay result, had blood drawn within prescribed time frame and had no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.
Arm/Group Title 13vPnC 23vPS
Hide Arm/Group Description:
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
Overall Number of Participants Analyzed 366 367
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
1 (n=366, 366)
103
(84.6 to 125.5)
78
(63.6 to 95.8)
3 (n=365, 367)
44
(38.1 to 51.5)
61
(52.8 to 70.1)
4 (n=360, 362)
1016
(850.7 to 1213.2)
392
(314.7 to 487.1)
5 (n=350, 361)
347
(282.3 to 425.6)
118
(98.4 to 142.5)
6B (n=360, 359)
1995
(1689.3 to 2355.9)
1440
(1223.5 to 1694.2)
7F (n=365, 364)
1901
(1642.8 to 2198.7)
1361
(1153.3 to 1605.6)
9V (n=365,358)
858
(675.7 to 1089.5)
379
(290.2 to 493.9)
14 (n=363, 359)
1028
(866.9 to 1217.9)
1059
(896.6 to 1250.6)
18C (n=366, 362)
2015
(1675.4 to 2424.5)
938
(752.7 to 1170.1)
19A (n=365, 362)
985
(841.5 to 1153.9)
429
(358.0 to 513.2)
19F (n=352, 357)
773
(607.9 to 983.0)
388
(305.6 to 491.8)
23F (n=366, 363)
456
(363.7 to 570.6)
180
(143.1 to 226.1)
6A (n=360, 349)
2122
(1790.9 to 2515.2)
676
(542.4 to 841.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 23vPS
Comments Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
0.99 to 1.75
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 23vPS
Comments Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
0.59 to 0.89
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC, 23vPS
Comments Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 2.6
Confidence Interval (2-Sided) 95%
1.96 to 3.44
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC, 23vPS
Comments Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 2.9
Confidence Interval (2-Sided) 95%
2.22 to 3.86
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC, 23vPS
Comments Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
1.10 to 1.75
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC, 23vPS
Comments Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
1.12 to 1.74
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC, 23vPS
Comments Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 2.3
Confidence Interval (2-Sided) 95%
1.59 to 3.24
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC, 23vPS
Comments Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.77 to 1.23
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 13vPnC, 23vPS
Comments Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 2.1
Confidence Interval (2-Sided) 95%
1.61 to 2.86
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 13vPnC, 23vPS
Comments Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 2.3
Confidence Interval (2-Sided) 95%
1.81 to 2.92
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 13vPnC, 23vPS
Comments Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 2.0
Confidence Interval (2-Sided) 95%
1.42 to 2.79
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 13vPnC, 23vPS
Comments Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 2.5
Confidence Interval (2-Sided) 95%
1.84 to 3.49
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection 13vPnC, 23vPS
Comments Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 2.0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 3.1
Confidence Interval (2-Sided) 95%
2.38 to 4.14
Estimation Comments [Not Specified]
4.Other Pre-specified Outcome
Title Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination
Hide Description Local reactions reported using an electronic diary. Redness and swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).
Time Frame Within 14 days after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received the study vaccine. 'N' (number of participants analyzed)=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.
Arm/Group Title 13vPnC 23vPS
Hide Arm/Group Description:
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
Overall Number of Participants Analyzed 367 370
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Redness: Any (n=355, 363)
28.7
(24.1 to 33.7)
10.5
(7.5 to 14.1)
Redness: Mild (n=352, 362)
22.2
(17.9 to 26.9)
7.7
(5.2 to 11.0)
Redness: Moderate (n=353, 360)
17.3
(13.5 to 21.6)
3.9
(2.1 to 6.4)
Redness: Severe (n=349, 359)
3.4
(1.8 to 5.9)
0.3
(0.0 to 1.5)
Swelling: Any (n=353, 360)
21.5
(17.4 to 26.2)
6.7
(4.3 to 9.8)
Swelling: Mild (n=351, 360)
16.5
(12.8 to 20.8)
5.0
(3.0 to 7.8)
Swelling: Moderate (n=351, 359)
9.7
(6.8 to 13.3)
2.5
(1.2 to 4.7)
Swelling: Severe (n=349, 359)
1.4
(0.5 to 3.3)
0.3
(0.0 to 1.5)
Pain: Any (n=362, 368)
45.6
(40.4 to 50.9)
38.3
(33.3 to 43.5)
Pain: Mild (n=362, 368)
45.3
(40.1 to 50.6)
37.5
(32.5 to 42.7)
Pain: Moderate (n=349, 361)
2.9
(1.4 to 5.2)
5.5
(3.4 to 8.4)
Pain: Severe (n=348, 359)
0.0
(0.0 to 1.1)
1.4
(0.5 to 3.2)
Limitation of arm movement: Any (n=355, 362)
16.3
(12.6 to 20.6)
16.9
(13.1 to 21.1)
Limitation of arm movement: Mild (n=355, 361)
15.5
(11.9 to 19.7)
15.8
(12.2 to 20.0)
Limitation of arm movement: Moderate(n=348, 360)
1.1
(0.3 to 2.9)
3.6
(1.9 to 6.1)
Limitation of arm movement: Severe (n=348, 359)
0.3
(0.0 to 1.6)
1.7
(0.6 to 3.6)
5.Other Pre-specified Outcome
Title Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination
Hide Description Systemic events reported using an electronic diary. Systemic events are any fever greater than or equal to (>=) 37.5 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new muscle pain, aggravated muscle pain, new joint pain, aggravated joint pain, use of medication to treat fever and use of medication to treat pain. All reports of fever >=39 degrees C in 13vPnC and 23vPS were confirmed as data entry errors.
Time Frame Within 14 days after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received the study vaccine. 'N' (number of participants analyzed)=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.
Arm/Group Title 13vPnC 23vPS
Hide Arm/Group Description:
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
Overall Number of Participants Analyzed 357 366
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Fever >=37.5 to <38.5 degrees C (n=348, 359)
2.6
(1.2 to 4.9)
2.8
(1.3 to 5.1)
Fever >=38.5 to <39 degrees C (n=348, 359)
0.3
(0.0 to 1.6)
0.3
(0.0 to 1.5)
Fever >=39 to <=40 degrees C (n=348, 359)
0.0
(0.0 to 1.1)
0.6
(0.1 to 2.0)
Fever >40 degrees C (n=348, 359)
0.9
(0.2 to 2.5)
0.0
(0.0 to 1.0)
Fatigue (n=352, 362)
17.3
(13.5 to 21.7)
16.0
(12.4 to 20.2)
Headache (n=351, 361)
9.4
(6.6 to 12.9)
11.6
(8.5 to 15.4)
Chills (n=348, 359)
2.9
(1.4 to 5.2)
1.1
(0.3 to 2.8)
Rash (n=350, 359)
8.9
(6.1 to 12.3)
3.6
(1.9 to 6.1)
Vomiting (n=348, 359)
1.1
(0.3 to 2.9)
0.6
(0.1 to 2.0)
Decreased appetite (n=348, 360)
3.7
(2.0 to 6.3)
5.0
(3.0 to 7.8)
New muscle pain (n=354, 362)
18.4
(14.5 to 22.8)
17.4
(13.6 to 21.7)
Aggravated muscle pain (n=350, 359)
4.0
(2.2 to 6.6)
3.9
(2.1 to 6.5)
New joint pain (n=350, 359)
7.7
(5.1 to 11.0)
7.0
(4.6 to 10.1)
Aggravated joint pain (n=349, 359)
2.9
(1.4 to 5.2)
3.1
(1.5 to 5.4)
Use of medication to treat fever (n=348, 360)
0.9
(0.2 to 2.5)
2.2
(1.0 to 4.3)
Use of medication to treat pain (n=348, 360)
1.1
(0.3 to 2.9)
2.8
(1.3 to 5.0)
Time Frame AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 14 days after vaccination).
Adverse Event Reporting Description SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
 
Arm/Group Title 13vPnC 23vPS
Hide Arm/Group Description 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1. 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
All-Cause Mortality
13vPnC 23vPS
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
13vPnC 23vPS
Affected / at Risk (%) Affected / at Risk (%)
Total   1/382 (0.26%)   0/382 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Pancreatic carcinoma * 1  1/382 (0.26%)  0/382 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
13vPnC 23vPS
Affected / at Risk (%) Affected / at Risk (%)
Total   211/382 (55.24%)   166/382 (43.46%) 
Blood and lymphatic system disorders     
Lymphadenopathy * 1  1/382 (0.26%)  0/382 (0.00%) 
Ear and labyrinth disorders     
Meniere's disease * 1  0/382 (0.00%)  1/382 (0.26%) 
Gastrointestinal disorders     
Diarrhoea * 1  1/382 (0.26%)  1/382 (0.26%) 
Abdominal pain upper * 1  1/382 (0.26%)  0/382 (0.00%) 
Constipation * 1  1/382 (0.26%)  0/382 (0.00%) 
Gastrooesophageal reflux disease * 1  1/382 (0.26%)  0/382 (0.00%) 
Nausea * 1  1/382 (0.26%)  0/382 (0.00%) 
Periodontal disease * 1  0/382 (0.00%)  1/382 (0.26%) 
General disorders     
Injection site pain * 1  2/382 (0.52%)  1/382 (0.26%) 
Injection site erythema * 1  2/382 (0.52%)  0/382 (0.00%) 
Chills * 1  1/382 (0.26%)  0/382 (0.00%) 
Feeling hot * 1  0/382 (0.00%)  1/382 (0.26%) 
Injection site haematoma * 1  0/382 (0.00%)  1/382 (0.26%) 
Injection site pruritus * 1  1/382 (0.26%)  0/382 (0.00%) 
Injection site swelling * 1  1/382 (0.26%)  0/382 (0.00%) 
Vaccination site pruritus * 1  1/382 (0.26%)  0/382 (0.00%) 
Fever >=37.5 to <38.5 degrees C  4  9/348 (2.59%)  10/359 (2.79%) 
Fever >=38.5 to <39 degrees C  5  1/348 (0.29%)  1/359 (0.28%) 
Fever >=39 to <=40 degrees C  4 [1]  0/348 (0.00%)  2/359 (0.56%) 
Fever >40 degrees C  4 [1]  3/348 (0.86%)  0/359 (0.00%) 
Fatigue  4  61/352 (17.33%)  58/362 (16.02%) 
Headache  4  33/351 (9.40%)  42/361 (11.63%) 
Chills  4  10/348 (2.87%)  4/359 (1.11%) 
Rash  4  31/350 (8.86%)  13/359 (3.62%) 
Vomiting  4  4/348 (1.15%)  2/359 (0.56%) 
Decreased appetite  4  13/348 (3.74%)  18/360 (5.00%) 
New muscle pain  4  65/354 (18.36%)  63/362 (17.40%) 
Aggravated muscle pain  4  14/350 (4.00%)  14/359 (3.90%) 
New joint pain  4  27/350 (7.71%)  25/359 (6.96%) 
Aggravated joint pain  4  10/349 (2.87%)  11/359 (3.06%) 
Infections and infestations     
Nasopharyngitis * 1  3/382 (0.79%)  8/382 (2.09%) 
Pharyngitis * 1  0/382 (0.00%)  2/382 (0.52%) 
Cellulitis * 1  0/382 (0.00%)  1/382 (0.26%) 
Conjunctivitis bacterial * 1  0/382 (0.00%)  1/382 (0.26%) 
Cystitis * 1  0/382 (0.00%)  1/382 (0.26%) 
Paronychia * 1  0/382 (0.00%)  1/382 (0.26%) 
Injury, poisoning and procedural complications     
Contusion * 1  1/382 (0.26%)  0/382 (0.00%) 
Fall * 1  0/382 (0.00%)  1/382 (0.26%) 
Foot fracture * 1  1/382 (0.26%)  0/382 (0.00%) 
Lip injury * 1  0/382 (0.00%)  1/382 (0.26%) 
Rib fracture * 1  1/382 (0.26%)  0/382 (0.00%) 
Tooth fracture * 1  0/382 (0.00%)  1/382 (0.26%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  1/382 (0.26%)  1/382 (0.26%) 
Arthralgia * 1  0/382 (0.00%)  1/382 (0.26%) 
Arthritis * 1  1/382 (0.26%)  0/382 (0.00%) 
Intervertebral disc protrusion * 1  1/382 (0.26%)  0/382 (0.00%) 
Periarthritis * 1  1/382 (0.26%)  0/382 (0.00%) 
Spinal column stenosis * 1  0/382 (0.00%)  1/382 (0.26%) 
Nervous system disorders     
Headache * 1  2/382 (0.52%)  0/382 (0.00%) 
Intercostal neuralgia * 1  1/382 (0.26%)  0/382 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Rhinitis allergic * 1  1/382 (0.26%)  0/382 (0.00%) 
Upper respiratory tract inflammation * 1  0/382 (0.00%)  1/382 (0.26%) 
Skin and subcutaneous tissue disorders     
Dermatitis contact * 1  0/382 (0.00%)  1/382 (0.26%) 
Eczema * 1  1/382 (0.26%)  0/382 (0.00%) 
Haemorrhage subcutaneous * 1  0/382 (0.00%)  1/382 (0.26%) 
Prurigo * 1  1/382 (0.26%)  0/382 (0.00%) 
Redness (Any)  2  102/355 (28.73%)  38/363 (10.47%) 
Redness (Mild)  2  78/352 (22.16%)  28/362 (7.73%) 
Redness (Moderate)  2  61/353 (17.28%)  14/360 (3.89%) 
Redness (Severe)  2  12/349 (3.44%)  1/359 (0.28%) 
Swelling (Any)  2  76/353 (21.53%)  24/360 (6.67%) 
Swelling (Mild)  2  58/351 (16.52%)  18/360 (5.00%) 
Swelling (Moderate)  3  34/351 (9.69%)  9/359 (2.51%) 
Swelling (Severe)  3  5/349 (1.43%)  1/359 (0.28%) 
Pain (Any)  3  165/362 (45.58%)  141/368 (38.32%) 
Pain (Mild)  3  164/362 (45.30%)  138/368 (37.50%) 
Pain (Moderate)  3  10/349 (2.87%)  20/361 (5.54%) 
Pain (Severe)  3  0/348 (0.00%)  5/359 (1.39%) 
Limitation of arm movement (Any)  3  58/355 (16.34%)  61/362 (16.85%) 
Limitation of arm movement (Mild)  3  55/355 (15.49%)  57/361 (15.79%) 
Limitation of arm movement (Moderate)  3  4/348 (1.15%)  13/360 (3.61%) 
Limitation of arm movement (Severe)  3  1/348 (0.29%)  6/359 (1.67%) 
Vascular disorders     
Hypertension * 1  2/382 (0.52%)  0/382 (0.00%) 
Orthostatic hypotension * 1  0/382 (0.00%)  1/382 (0.26%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.1
2
Term from vocabulary, Local Reaction
3
Term from vocabulary, Local Reactions
4
Term from vocabulary, Systemic Events
5
Term from vocabulary, Syetemic Events
[1]
All reports of fever >=39 degrees C in 13vPnC and 23vPS were confirmed as data entry errors.
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
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01646398     History of Changes
Other Study ID Numbers: B1851088
First Submitted: May 10, 2012
First Posted: July 20, 2012
Results First Submitted: July 17, 2013
Results First Posted: September 20, 2013
Last Update Posted: September 20, 2013