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Study Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00546572
First received: October 18, 2007
Last updated: July 12, 2011
Last verified: July 2011
History of Changes
Results First Received: April 29, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Pneumococcal Infections
Interventions: Biological: 13 valent Pneumococcal Conjugate Vaccine
Biological: 23vPS

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
13vPnC / 13vPnC 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliters (mL) dose intramuscularly (IM) at Year 0 (vaccination 1 [Vax 1]) and 13vPnC 0.5 mL IM at Year 1 (Vax 2)
23vPS / 13vPnC 23-valent pneumococcal polysaccharide conjugate vaccine (23vPS) 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL IM at Year 1 (Vax 2)

Participant Flow for 2 periods

 Period 1:   Vax 1 / Year 0
    13vPnC / 13vPnC     23vPS / 13vPnC  
STARTED     464     474  
Received Vax 1     463     473  
COMPLETED     391     404  
NOT COMPLETED     73     70  
Randomized, not treated                 1                 1  
Withdrawal by Subject                 3                 2  
Protocol Violation                 3                 4  
Death                 2                 2  
Adverse Event                 0                 1  
Lost to Follow-up                 0                 1  
6-Month Contact; withdraw before Vax 2                 64                 59  

Period 2:   Vax 2 / Year 1
    13vPnC / 13vPnC     23vPS / 13vPnC  
STARTED     391     404  
Received Vax 2     391     404  
COMPLETED     387     402  
NOT COMPLETED     4     2  
Unspecified                 1                 1  
Adverse Event                 1                 0  
Vax 2; withdraw before 6-Month Contact                 2                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
13vPnC 13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
23vPS 23vPS 0.5 mL dose IM at Year 0 (Vax 1)
Total Total of all reporting groups

Baseline Measures
    13vPnC     23vPS     Total  
Number of Participants  
[units: participants]
 		  463     473     936  
Age  
[units: years]
Mean ± Standard Deviation 		  76.7  ± 4.6     76.7  ± 4.5     76.7  ± 4.6  
Gender  
[units: participants]
 		     
Female     221     235     456  
Male     242     238     480  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0)   [ Time Frame: 1 month after Vax 1 / Year 0 ]
  Show Outcome Measure 1

2.  Primary:   Percentage of Participants Achieving a ≥ 4-fold Rise for Serotype 6A OPA Titer for 13vPnC Relative to 23vPS (Vax 1 / Year 0)   [ Time Frame: Baseline, 1 month after Vax 1 / Year 0 ]
  Show Outcome Measure 2

3.  Secondary:   Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC Relative to 23vPS (Vax 1 / Year 0)   [ Time Frame: 1 month after Vax 1 / Year 0 ]
  Show Outcome Measure 3

4.  Secondary:   Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0)   [ Time Frame: 1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1 ]
  Hide Outcome Measure 4

Measure Type Secondary
Measure Title Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0)
Measure Description Antibody geometric mean titers as measured by OPA assays for the 13 serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Time Frame 1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the given serotype at both the postvaccination 1 and postvaccination 2 blood draws.

Reporting Groups
  Description
13vPnC 13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
13vPnC / 13vPnC 13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)

Measured Values
    13vPnC     13vPnC / 13vPnC  
Number of Participants Analyzed  
[units: participants]
 		  361     361  
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0)  
[units: geometric mean titer]
Geometric Mean ( 95% Confidence Interval ) 		   
Serotype 1     79  
  ( 65.3 to 94.6 )   		  76  
  ( 64.8 to 89.7 )  
Serotype 3     55  
  ( 47.2 to 64.0 )   		  55  
  ( 48.4 to 63.1 )  
Serotype 4     614  
  ( 489.8 to 768.8 )   		  487  
  ( 393.9 to 603.3 )  
Serotype 5     69  
  ( 56.2 to 84.2 )   		  57  
  ( 46.9 to 68.5 )  
Serotype 6A     971  
  ( 771.0 to 1222.1 )   		  1169  
  ( 974.0 to 1403.0 )  
Serotype 6B     1358  
  ( 1085.4 to 1700.2 )   		  1590  
  ( 1316.9 to 1919.8 )  
Serotype 7F     222  
  ( 170.2 to 290.2 )   		  180  
  ( 138.1 to 233.8 )  
Serotype 9V     187  
  ( 139.3 to 250.4 )   		  166  
  ( 124.2 to 220.8 )  
Serotype 14     265  
  ( 209.9 to 333.6 )   		  241  
  ( 194.4 to 299.1 )  
Serotype 18C     918  
  ( 763.4 to 1104.3 )   		  1003  
  ( 850.2 to 1182.1 )  
Serotype 19A     349  
  ( 299.7 to 405.5 )   		  341  
  ( 297.2 to 390.5 )  
Serotype 19F     329  
  ( 265.6 to 408.6 )   		  322  
  ( 266.3 to 389.6 )  
Serotype 23F     167  
  ( 130.9 to 213.0 )   		  309  
  ( 251.6 to 380.1 )  


Statistical Analysis 1 for Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0)
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
geometric mean fold rise [3] 1.0
95% Confidence Interval ( 0.85 to 1.10 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Serotype 1: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).
[3] Other relevant estimation information:
  Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.

Statistical Analysis 2 for Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0)
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
geometric mean fold rise [3] 1.0
95% Confidence Interval ( 0.91 to 1.11 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Serotype 3: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).
[3] Other relevant estimation information:
  Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.

Statistical Analysis 3 for Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0)
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
geometric mean fold rise [3] 0.8
95% Confidence Interval ( 0.68 to 0.92 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Serotype 4: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).
[3] Other relevant estimation information:
  Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.

Statistical Analysis 4 for Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0)
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
geometric mean fold rise [3] 0.8
95% Confidence Interval ( 0.73 to 0.94 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Serotype 5: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).
[3] Other relevant estimation information:
  Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.

Statistical Analysis 5 for Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0)
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
geometric mean fold rise [3] 1.2
95% Confidence Interval ( 1.03 to 1.40 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Serotype 6A: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).
[3] Other relevant estimation information:
  Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.

Statistical Analysis 6 for Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0)
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
geometric mean fold rise [3] 1.2
95% Confidence Interval ( 1.02 to 1.35 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Serotype 6B: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).
[3] Other relevant estimation information:
  Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.

Statistical Analysis 7 for Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0)
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
geometric mean fold rise [3] 0.8
95% Confidence Interval ( 0.65 to 1.01 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Serotype 7F: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).
[3] Other relevant estimation information:
  Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.

Statistical Analysis 8 for Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0)
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
geometric mean fold rise [3] 0.9
95% Confidence Interval ( 0.69 to 1.15 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Serotype 9V: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).
[3] Other relevant estimation information:
  Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.

Statistical Analysis 9 for Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0)
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
geometric mean fold rise [3] 0.9
95% Confidence Interval ( 0.79 to 1.05 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Serotype 14: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).
[3] Other relevant estimation information:
  Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.

Statistical Analysis 10 for Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0)
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
geometric mean fold rise [3] 1.1
95% Confidence Interval ( 0.97 to 1.23 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Serotype 18C: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).
[3] Other relevant estimation information:
  Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.

Statistical Analysis 11 for Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0)
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
geometric mean fold rise [3] 1.0
95% Confidence Interval ( 0.89 to 1.07 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Serotype 19A: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).
[3] Other relevant estimation information:
  Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.

Statistical Analysis 12 for Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0)
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
geometric mean fold rise [3] 1.0
95% Confidence Interval ( 0.83 to 1.15 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Serotype 19F: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).
[3] Other relevant estimation information:
  Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.

Statistical Analysis 13 for Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0)
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
geometric mean fold rise [3] 1.9
95% Confidence Interval ( 1.60 to 2.14 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Serotype 23F: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).
[3] Other relevant estimation information:
  Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.



5.  Secondary:   Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0)   [ Time Frame: 1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1 ]
  Show Outcome Measure 5

6.  Secondary:   Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0)   [ Time Frame: 1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1 ]
  Show Outcome Measure 6

7.  Other Pre-specified:   Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0)   [ Time Frame: Days 1 through 14 / Year 0 ]
  Show Outcome Measure 7

8.  Other Pre-specified:   Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)   [ Time Frame: Days 1 through 14 / Year 0, Days 1 through 14 / Year 1 ]
  Show Outcome Measure 8

9.  Other Pre-specified:   Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)   [ Time Frame: Days 1 through 14 / Year 0, Days 1 through 14 / Year 1 ]
  Show Outcome Measure 9

10.  Other Pre-specified:   Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 )   [ Time Frame: Days 1 through 14 / Year 1 ]
  Show Outcome Measure 10

11.  Other Pre-specified:   Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1)   [ Time Frame: Days 1 through 14 / Year 0, Days 1 through 14 / Year 1 ]
  Show Outcome Measure 11

12.  Other Pre-specified:   Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0)   [ Time Frame: Days 1 through 14 / Year 0 ]
  Show Outcome Measure 12

13.  Other Pre-specified:   Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)   [ Time Frame: Days 1 through 14 / Year 0, Days 1 through 14 / Year 1 ]
  Show Outcome Measure 13

14.  Other Pre-specified:   Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)   [ Time Frame: Days 1 through 14 / Year 0, Days 1 through 14 / Year 1 ]
  Show Outcome Measure 14

15.  Other Pre-specified:   Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1)   [ Time Frame: Days 1 through 14 / Year 1 ]
  Show Outcome Measure 15

16.  Other Pre-specified:   Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1)   [ Time Frame: Days 1 through 14 / Year 0, Days 1 through 14 / Year 1 ]
  Show Outcome Measure 16


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00546572     History of Changes
Other Study ID Numbers: 6115A1-3005, B1851024
Study First Received: October 18, 2007
Results First Received: April 29, 2011
Last Updated: July 12, 2011
Health Authority: United States: Food and Drug Administration