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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Brazil

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00676091
First received: April 8, 2008
Last updated: August 4, 2011
Last verified: August 2011
History of Changes
Results First Received: September 22, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Prevention
Condition: Vaccines, Pneumococcal Conjugate Vaccine
Interventions: Biological: 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)
Biological: 7-Valent Pneumococcal Conjugate Vaccine (7vPnc)

  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 (IM) 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 IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).

Participant Flow for 3 periods

 Period 1:   Infant Series
    13vPnC     7vPnC  
STARTED     177     177  
Vaccinated Dose 1     163     162  
Vaccinated Dose 2     159     162  
Vaccinated Dose 3     158     161  
COMPLETED     157     159  
NOT COMPLETED     20     18  
Parent or legal guardian request                 10                 8  
Protocol Violation                 6                 3  
Adverse Event                 2                 3  
Failed to return                 1                 3  
Lost to Follow-up                 1                 0  
Died prior to receiving 7vPnC                 0                 1  

Period 2:   After Infant Series
    13vPnC     7vPnC  
STARTED     157     159  
COMPLETED     156     156  
NOT COMPLETED     1     3  
Adverse Event                 0                 1  
Protocol Violation                 0                 1  
Failed to return                 1                 1  

Period 3:   Toddler Dose
    13vPnC     7vPnC  
STARTED     156     156  
COMPLETED     153     156  
NOT COMPLETED     3     0  
Failed to return                 2                 0  
Parent or legal guardian request                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
13vPnC 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) 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 IM 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]
 		  163     162     325  
Age  
[units: months]
Mean ± Standard Deviation 		  2.2  ± 0.2     2.2  ± 0.2     2.2  ± 0.2  
Gender  
[units: participants]
 		     
Female     89     76     165  
Male     74     86     160  



  Outcome Measures
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1.  Primary:   Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series   [ Time Frame: 1 Month after the infant series (7 Months of age) ]

Measure Type Primary
Measure Title Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series
Measure Description Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time Frame 1 Month after the infant series (7 Months of age)  
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: treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. N=number of participants with a determinate IgG antibody concentration to the given serotype.

Reporting Groups
  Description
13vPnC 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) 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 IM 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]
 		  156     158  
Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series  
[units: percentage of participants]
Number ( 95% Confidence Interval ) 		   
Common serotypes - serotype 4     100.0  
  ( 97.7 to 100.0 )   		  100.0  
  ( 97.7 to 100.0 )  
Common serotypes - serotype 6B     96.8  
  ( 92.7 to 99.0 )   		  95.6  
  ( 91.1 to 98.2 )  
Common serotypes - serotype 9V     98.7  
  ( 95.4 to 99.8 )   		  100.0  
  ( 97.7 to 100.0 )  
Common serotypes - serotype 14     98.1  
  ( 94.5 to 99.6 )   		  97.5  
  ( 93.6 to 99.3 )  
Common serotypes - serotype 18C     97.4  
  ( 93.6 to 99.3 )   		  98.1  
  ( 94.5 to 99.6 )  
Common serotypes - serotype 19F     94.2  
  ( 89.3 to 97.3 )   		  98.7  
  ( 95.5 to 99.8 )  
Common serotypes - serotype 23F     96.8  
  ( 92.7 to 99.0 )   		  93.0  
  ( 87.8 to 96.5 )  
Additional serotypes - serotype 1     99.4  
  ( 96.5 to 100.0 )   		  2.5  
  ( 0.7 to 6.4 )  
Additional serotypes - serotype 3     87.1  
  ( 80.8 to 91.9 )   		  4.4  
  ( 1.8 to 8.9 )  
Additional serotypes - serotype 5     98.7  
  ( 95.4 to 99.8 )   		  38.2  
  ( 30.4 to 46.4 )  
Additional serotypes - serotype 6A     97.4  
  ( 93.6 to 99.3 )   		  52.6  
  ( 44.4 to 60.6 )  
Additional serotypes - serotype 7F     100.0  
  ( 97.7 to 100.0 )   		  1.3  
  ( 0.2 to 4.6 )  
Additional serotypes - serotype 19A     99.4  
  ( 96.5 to 100.0 )   		  98.7  
  ( 95.4 to 99.8 )  

No statistical analysis provided for Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series



2.  Primary:   Percentage of Participants Achieving Antibody Level ≥5 Enzyme-linked Immunosorbent Assay (ELISA) Units Per mL (EU/mL) for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series   [ Time Frame: 1 month after the infant series (7 months of age) ]

Measure Type Primary
Measure Title Percentage of Participants Achieving Antibody Level ≥5 Enzyme-linked Immunosorbent Assay (ELISA) Units Per mL (EU/mL) for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series
Measure Description Percentage of participants achieving predefined antibody threshold ≥5 enzyme-linked immunosorbent assay (ELISA) units per mL (EU/mL) along with the corresponding 95% CI for concomitant antigen pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], and pertactin [PRN]) are presented.
Time Frame 1 month after the infant series (7 months of age)  
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 antibody concentration to the given concomitant vaccine component.

Reporting Groups
  Description
13vPnC 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) 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 IM 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]
 		  156     158  
Percentage of Participants Achieving Antibody Level ≥5 Enzyme-linked Immunosorbent Assay (ELISA) Units Per mL (EU/mL) for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series  
[units: percentage of participants]
Number ( 95% Confidence Interval ) 		   
PT ≥5 EU/mL     35.9  
  ( 28.4 to 44.0 )   		  32.3  
  ( 25.1 to 40.2 )  
FHA ≥5 EU/mL     70.1  
  ( 62.2 to 77.2 )   		  71.5  
  ( 63.8 to 78.4 )  
PRN ≥5 EU/mL     93.5  
  ( 88.5 to 96.9 )   		  96.2  
  ( 91.9 to 98.6 )  

No statistical analysis provided for Percentage of Participants Achieving Antibody Level ≥5 Enzyme-linked Immunosorbent Assay (ELISA) Units Per mL (EU/mL) for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series



3.  Secondary:   Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose   [ Time Frame: 1 month after the toddler dose (13 months of age) ]

Measure Type Secondary
Measure Title Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
Measure Description Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time Frame 1 month after the toddler dose (13 months of age)  
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 IgG antibody concentration to the given serotype.

Reporting Groups
  Description
13vPnC 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) 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 IM 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]
 		  152     152  
Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose  
[units: percentage of participants]
Number ( 95% Confidence Interval ) 		   
Common serotypes - serotype 4     100.0  
  ( 97.6 to 100.0 )   		  100.0  
  ( 97.6 to 100.0 )  
Common serotypes - serotype 6B     97.4  
  ( 93.4 to 99.3 )   		  98.7  
  ( 95.3 to 99.8 )  
Common serotypes - serotype 9V     100.0  
  ( 97.6 to 100.0 )   		  100.0  
  ( 97.6 to 100.0 )  
Common serotypes - serotype 14     100.0  
  ( 97.6 to 100.0 )   		  99.3  
  ( 96.4 to 100.0 )  
Common serotypes - serotype 18C     99.3  
  ( 96.4 to 100.0 )   		  100.0  
  ( 97.6 to 100.0 )  
Common serotypes - serotype 19F     99.3  
  ( 96.4 to 100.0 )   		  98.7  
  ( 95.3 to 99.8 )  
Common serotypes - serotype 23F     98.7  
  ( 95.3 to 99.8 )   		  99.3  
  ( 96.4 to 100.0 )  
Additional serotypes - serotype 1     100.0  
  ( 97.6 to 100.0 )   		  2.7  
  ( 0.7 to 6.7 )  
Additional serotypes - serotype 3     92.1  
  ( 86.5 to 95.8 )   		  7.5  
  ( 3.8 to 13.0 )  
Additional serotypes - serotype 5     100.0  
  ( 97.6 to 100.0 )   		  72.1  
  ( 63.9 to 79.4 )  
Additional serotypes - serotype 6A     100.0  
  ( 97.6 to 100.0 )   		  92.1  
  ( 86.5 to 95.8 )  
Additional serotypes - serotype 7F     100.0  
  ( 97.6 to 100.0 )   		  4.2  
  ( 1.5 to 8.8 )  
Additional serotypes - serotype 19A     100.0  
  ( 97.6 to 100.0 )   		  100.0  
  ( 97.6 to 100.0 )  

No statistical analysis provided for Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose



4.  Secondary:   Percentage of Participants Achieving Antibody Level ≥5 EU/mL for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose   [ Time Frame: 1 month after the toddler dose (13 months of age) ]

Measure Type Secondary
Measure Title Percentage of Participants Achieving Antibody Level ≥5 EU/mL for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
Measure Description Percentage of participants achieving predefined antibody threshold ≥5 EU/mL along with the corresponding 95% CI for concomitant antigen pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], and pertactin [PRN]) are presented.
Time Frame 1 month after the toddler dose (13 months of age)  
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 antibody concentration to the given concomitant vaccine component.

Reporting Groups
  Description
13vPnC 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) 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 IM 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]
 		  152     152  
Percentage of Participants Achieving Antibody Level ≥5 EU/mL for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose  
[units: percentage of participants]
Number ( 95% Confidence Interval ) 		   
PT ≥5 EU/mL     50.7  
  ( 42.4 to 58.9 )   		  49.3  
  ( 41.1 to 57.6 )  
FHA ≥5 EU/mL     91.4  
  ( 85.8 to 95.4 )   		  88.8  
  ( 82.7 to 93.3 )  
PRN ≥5 EU/mL     99.3  
  ( 96.4 to 100.0 )   		  98.7  
  ( 95.3 to 99.8 )  

No statistical analysis provided for Percentage of Participants Achieving Antibody Level ≥5 EU/mL for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose



5.  Other Pre-specified:   Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)   [ Time Frame: Within 4 days after dose 1 (2 months of age) ]

Measure Type Other Pre-specified
Measure Title Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)
Measure Description Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Time Frame Within 4 days after dose 1 (2 months of age)  
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: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.

Reporting Groups
  Description
13vPnC 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) 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 IM 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]
 		  145     156  
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)  
[units: percentage of participants]
 		   
Tenderness: Any     60.0     59.4  
Tenderness: Significant     14.0     12.8  
Swelling: Any     13.9     15.0  
Swelling: Mild     10.3     13.6  
Swelling: Moderate     5.9     1.4  
Swelling: Severe     0.0     0.0  
Redness: Any     10.3     13.4  
Redness: Mild     8.8     11.4  
Redness: Moderate     2.9     2.1  
Redness: Severe     0.0     0.0  

No statistical analysis provided for Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)



6.  Other Pre-specified:   Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)   [ Time Frame: Within 4 days after dose 2 (4 months of age) ]

Measure Type Other Pre-specified
Measure Title Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)
Measure Description Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Time Frame Within 4 days after dose 2 (4 months of age)  
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: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.

Reporting Groups
  Description
13vPnC 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) 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 IM 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]
 		  137     145  
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)  
[units: percentage of participants]
 		   
Tenderness: Any     53.3     53.8  
Tenderness: Significant     9.4     11.9  
Swelling: Any     12.1     13.8  
Swelling: Mild     10.5     10.0  
Swelling: Moderate     2.4     3.9  
Swelling: Severe     0.0     0.0  
Redness: Any     9.3     12.4  
Redness: Mild     9.3     11.6  
Redness: Moderate     0.0     1.6  
Redness: Severe     0.0     0.0  

No statistical analysis provided for Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)



7.  Other Pre-specified:   Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)   [ Time Frame: Within 4 days after dose 3 (6 months of age) ]

Measure Type Other Pre-specified
Measure Title Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)
Measure Description Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Time Frame Within 4 days after dose 3 (6 months of age)  
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: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.

Reporting Groups
  Description
13vPnC 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) 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 IM 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]
 		  134     134  
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)  
[units: percentage of participants]
 		   
Tenderness: Any     48.1     47.4  
Tenderness: Significant     10.9     8.8  
Swelling: Any     14.6     9.7  
Swelling: Mild     12.2     9.7  
Swelling: Moderate     4.2     0.9  
Swelling: Severe     0.0     0.0  
Redness: Any     10.7     14.0  
Redness: Mild     10.7     13.3  
Redness: Moderate     0.8     0.9  
Redness: Severe     0.0     0.0  

No statistical analysis provided for Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)



8.  Other Pre-specified:   Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)   [ Time Frame: Within 4 days after toddler dose (12 months of age) ]

Measure Type Other Pre-specified
Measure Title Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)
Measure Description Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Time Frame Within 4 days after toddler dose (12 months of age)  
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: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.

Reporting Groups
  Description
13vPnC 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) 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 IM 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]
 		  128     128  
Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)  
[units: percentage of participants]
 		   
Tenderness: Any     64.3     53.2  
Tenderness: Significant     18.3     13.3  
Swelling: Any     11.5     10.5  
Swelling: Mild     8.1     8.7  
Swelling: Moderate     5.3     3.9  
Swelling: Severe     0.0     0.0  
Redness: Any     13.3     8.7  
Redness: Mild     12.4     7.8  
Redness: Moderate     0.9     1.0  
Redness: Severe     0.0     0.0  

No statistical analysis provided for Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)



9.  Other Pre-specified:   Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)   [ Time Frame: Within 4 days after dose 1 (2 months of age) ]

Measure Type Other Pre-specified
Measure Title Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)
Measure Description Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time Frame Within 4 days after dose 1 (2 months of age)  
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: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.

Reporting Groups
  Description
13vPnC 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) 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 IM 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]
 		  154     154  
Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)  
[units: percentage of participants]
 		   
Fever ≥38 but ≤39 degrees C     18.0     19.9  
Fever >39 but ≤40 degrees C     0.0     0.7  
Fever >40 degrees C     0.0     0.0  
Decreased appetite     26.6     28.0  
Irritability     80.3     77.9  
Increased sleep     56.6     52.4  
Decreased sleep     39.7     27.5  

No statistical analysis provided for Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)



10.  Other Pre-specified:   Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)   [ Time Frame: Within 4 days after dose 2 (4 months of age) ]

Measure Type Other Pre-specified
Measure Title Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)
Measure Description Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time Frame Within 4 days after dose 2 (4 months of age)  
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: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.

Reporting Groups
  Description
13vPnC 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) 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 IM 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]
 		  145     157  
Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)  
[units: percentage of participants]
 		   
Fever ≥38 but ≤39 degrees C     23.8     23.0  
Fever >39 but ≤40 degrees C     3.2     0.8  
Fever >40 degrees C     0.0     0.0  
Decreased appetite     33.8     29.6  
Irritability     80.4     79.2  
Increased sleep     32.8     38.7  
Decreased sleep     25.8     36.0  

No statistical analysis provided for Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)



11.  Other Pre-specified:   Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)   [ Time Frame: Within 4 days after dose 3 (6 months of age) ]

Measure Type Other Pre-specified
Measure Title Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)
Measure Description Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time Frame Within 4 days after dose 3 (6 months of age)  
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: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.

Reporting Groups
  Description
13vPnC 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) 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 IM 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]
 		  148     144  
Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)  
[units: percentage of participants]
 		   
Fever ≥38 but ≤39 degrees C     22.6     22.4  
Fever >39 but ≤40 degrees C     4.2     3.5  
Fever >40 degrees C     0.8     0.9  
Decreased appetite     37.9     32.2  
Irritability     76.9     71.2  
Increased sleep     35.7     36.9  
Decreased sleep     27.6     34.1  

No statistical analysis provided for Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)



12.  Other Pre-specified:   Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age)   [ Time Frame: Within 4 days after toddler dose (12 months of age) ]

Measure Type Other Pre-specified
Measure Title Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age)
Measure Description Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time Frame Within 4 days after toddler dose (12 months of age)  
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: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.

Reporting Groups
  Description
13vPnC 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) 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 IM 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]
 		  136     133  
Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age)  
[units: percentage of participants]
 		   
Fever ≥38 but ≤39 degrees C     31.0     29.9  
Fever >39 but ≤40 degrees C     1.8     3.0  
Fever >40 degrees C     0.9     0.0  
Decreased appetite     33.3     39.0  
Irritability     67.2     68.8  
Increased sleep     30.8     24.1  
Decreased sleep     22.7     20.6  

No statistical analysis provided for Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age)




  Serious Adverse Events
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  Other Adverse Events
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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: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00676091     History of Changes
Other Study ID Numbers: 6096A1-012
Study First Received: April 8, 2008
Results First Received: September 22, 2010
Last Updated: August 4, 2011
Health Authority: United States: Food and Drug Administration