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
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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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
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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.
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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
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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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]
  Hide Outcome Measure 12

Measure Type Other Pre-specified
Measure Title Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0)
Measure Description Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).
Time Frame Days 1 through 14 / Year 0  
Safety Issue Yes  

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.
Safety population; N=number of participants who reported any systemic reactogenicity events; (n)=number of participants with known values for 13vPnC and 23vPS (Year 0). Participants may be represented in more than 1 category.

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)

Measured Values
    13vPnC     23vPS  
Number of Participants Analyzed  
[units: participants]
  388     403  
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0)  
[units: percentage¬†of¬†participants]
   
Fever: Any ≥38 degrees C (n=299, 309)     1.0     4.2  
Fever: Mild ≥38 but <38.5 degrees C (n=299, 303)     1.0     2.0  
Fever: Moderate ≥38.5 but <39 degrees C(n=297,301)     0.0     0.0  
Fever: Severe ≥39 but ≤40 degrees C (n=297, 301)     0.0     0.3  
Potentially life-threatening >40C (n=297, 307)     0.0     2.0  
Fatigue (n=350, 367)     34.0     43.3  
Headache (n=329, 331)     23.7     26.0  
Chills (n=305, 312)     7.9     11.2  
Rash (n=303, 323)     7.3     16.4  
Vomiting (n=300, 304)     1.7     1.3  
Decreased appetite (n=317, 313)     10.4     11.5  
New muscle pain (n=345, 358)     36.8     44.7  
Aggravated muscle pain (n=320, 334)     20.6     27.5  
New joint pain (n=310, 323)     12.6     14.9  
Aggravated joint pain (n=310, 322)     11.6     16.5  


Statistical Analysis 1 for Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0)
Groups [1] All groups
Method [2] Chan & Zhang
P Value [3] 0.034
difference in proportions [4] -7.9
95% Confidence Interval ( -15.2 to -0.6 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  New generalized muscle pain: difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.

Statistical Analysis 2 for Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0)
Groups [1] All groups
Method [2] Chan & Zhang
P Value [3] 0.039
difference in proportions [4] -6.9
95% Confidence Interval ( -13.6 to -0.3 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Aggravated generalized muscle pain: difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.



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 ]

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 ]

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 ]

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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information