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Study Evaluating the Impact of a 13-valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Colonization

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00508742
First received: July 26, 2007
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
Results First Received: June 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Pneumococcal Infections
Interventions: Biological: 13-valent Pneumococcal Conjugate Vaccine
Biological: 7 valent pneumococcal conjugate vaccine

  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
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 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
7vPnC 7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).

Participant Flow for 3 periods

 Period 1:   Period 1: Infant Series
    13vPnC     7vPnC  
STARTED     932     934  
Vaccinated Dose 1 (at 2 Months of Age)     930     933  
Vaccinated Dose 2 (at 4 Months of Age)     904     902  
Vaccinated Dose 3 (at 6 Months of Age)     898     892  
COMPLETED     890     889  
NOT COMPLETED     42     45  
Adverse Event                 5                 4  
Protocol Violation                 1                 0  
Parent/Legal Guardian Request                 31                 40  
Physician Decision                 1                 0  
Unspecified                 4                 1  

Period 2:   Period 2: After Infant Series
    13vPnC     7vPnC  
STARTED     890     889  
COMPLETED     883     878  
NOT COMPLETED     7     11  
Adverse Event                 2                 6  
Lost to Follow-up                 1                 1  
Protocol Violation                 1                 0  
Parent/Legal Guardian Request                 0                 3  
Failed to Return                 1                 0  
Unspecified                 2                 1  

Period 3:   Period 3: Toddler Dose
    13vPnC     7vPnC  
STARTED     883     878  
COMPLETED     858     863  
NOT COMPLETED     25     15  
Adverse Event                 1                 0  
Lost to Follow-up                 2                 3  
Parent/Legal Guardian Request                 17                 8  
Unspecified                 5                 4  



  Baseline Characteristics
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Reporting Groups
  Description
13vPnC 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
7vPnC 7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
Total Total of all reporting groups

Baseline Measures
    13vPnC     7vPnC     Total  
Number of Participants  
[units: participants]
 		  932     934     1866  
Age  
[units: years]
Mean ± Standard Deviation 		  2.2  ± 0.3     2.2  ± 0.3     2.2  ± 0.3  
Gender  
[units: participants]
 		     
Female     474     471     945  
Male     458     463     921  



  Outcome Measures
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1.  Primary:   Percentage of Participants With a New Acquisition of Serotype 6A' (6A + 6C) or 19A Combined 1 Month After the Infant Series to 24 Months of Age   [ Time Frame: Month 7 through Month 24 ]

Measure Type Primary
Measure Title Percentage of Participants With a New Acquisition of Serotype 6A' (6A + 6C) or 19A Combined 1 Month After the Infant Series to 24 Months of Age
Measure Description A new acquisition was defined as the detection of a serotype (here 6A’ [6A + 6C] or 19A), once a participant was fully vaccinated (one month after dose 3), that had not been detected previously in the baseline samples at 2, 4, 6 months of age.
Time Frame Month 7 through Month 24  
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 culture population included all participants who adhered to protocol requirements; received the treatment to which they were randomized; had at least 1 nasopharyngeal swab for the proposed analysis and no major protocol violations.

Reporting Groups
  Description
13vPnC 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
7vPnC 7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).

Measured Values
    13vPnC     7vPnC  
Number of Participants Analyzed  
[units: participants]
 		  881     873  
Percentage of Participants With a New Acquisition of Serotype 6A' (6A + 6C) or 19A Combined 1 Month After the Infant Series to 24 Months of Age  
[units: percentage of participants]
Number ( 95% Confidence Interval ) 		  20.0  
  ( 17.4 to 22.8 )   		  36.0  
  ( 32.8 to 39.3 )  


Statistical Analysis 1 for Percentage of Participants With a New Acquisition of Serotype 6A' (6A + 6C) or 19A Combined 1 Month After the Infant Series to 24 Months of Age
Groups [1] All groups
Rate Ratio [2] 0.56
95% Confidence Interval ( 0.47 to 0.65 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.



2.  Secondary:   Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age   [ Time Frame: Month 7, 12, 13, 18, 24 ]

Measure Type Secondary
Measure Title Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age
Measure Description No text entered.
Time Frame Month 7, 12, 13, 18, 24  
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 culture population; 'n' is number of participants with at least 1 determinate nasopharyngeal culture result for given serotype combination at specified time points for each arm group respectively.

Reporting Groups
  Description
13vPnC 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
7vPnC 7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).

Measured Values
    13vPnC     7vPnC  
Number of Participants Analyzed  
[units: participants]
 		  881     873  
Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age  
[units: percentage of participants]
Number ( 95% Confidence Interval ) 		   
Month 7 (n= 881, 871)     7.3  
  ( 5.6 to 9.2 )   		  10.9  
  ( 8.9 to 13.2 )  
Month 12 (n= 881, 873)     8.1  
  ( 6.3 to 10.1 )   		  13.7  
  ( 11.5 to 16.2 )  
Month 13 (n= 871, 870)     5.4  
  ( 4.0 to 7.1 )   		  13.6  
  ( 11.4 to 16.0 )  
Month 18 (n= 864, 864)     7.1  
  ( 5.4 to 9.0 )   		  13.5  
  ( 11.3 to 16.0 )  
Month 24 (n= 855, 856)     6.2  
  ( 4.7 to 8.0 )   		  10.7  
  ( 8.8 to 13.0 )  


Statistical Analysis 1 for Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age
Groups [1] All groups
Odds Ratio (OR) [2] 0.6
95% Confidence Interval ( 0.5 to 0.9 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Month 7: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age
Groups [1] All groups
Odds Ratio (OR) [2] 0.6
95% Confidence Interval ( 0.4 to 0.7 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Month 12: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age
Groups [1] All groups
Odds Ratio (OR) [2] 0.4
95% Confidence Interval ( 0.3 to 0.5 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Month 13: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age
Groups [1] All groups
Odds Ratio (OR) [2] 0.5
95% Confidence Interval ( 0.4 to 0.7 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Month 18: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 5 for Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age
Groups [1] All groups
Odds Ratio (OR) [2] 0.5
95% Confidence Interval ( 0.4 to 0.8 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Month 24: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.
[2] Other relevant estimation information:
  No text entered.




  Serious Adverse Events
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  Other Adverse Events
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  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
Study designated analysis of effect of 13vPnC on serotypes 6A+19A, changed prior to unblinding, to effect on 6A’+19A. Serotype 6A found to include serotype 6A isolates and isolates of newly identified serotype 6C. Serotype 6A assessed as 6A+6C (6A’).  


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: Pfizer
ClinicalTrials.gov Identifier: NCT00508742     History of Changes
Other Study ID Numbers: 6096A1-3006, B1851007
Study First Received: July 26, 2007
Results First Received: June 12, 2012
Last Updated: May 6, 2013
Health Authority: United States: Food and Drug Administration