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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00444457
First received: March 5, 2007
Last updated: October 10, 2012
Last verified: October 2012
History of Changes
Results First Received: June 11, 2010  
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: Vaccines, Pneumococcal
Interventions: Biological: 13-valent Pneumococcal Conjugate Vaccine
Biological: 7vPnC

  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
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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 (Pilot Lot 1) Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
13vPnC (Pilot Lot 2) Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
13vPnC (Manufacturing Lot) Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
7vPnC Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.

Participant Flow for 3 periods

 Period 1:   Infant Series
    13vPnC (Pilot Lot 1)     13vPnC (Pilot Lot 2)     13vPnC (Manufacturing Lot)     7vPnC  
STARTED     489     488     489     246  
Vaccinated Dose 1     486     484     485     244  
Vaccinated Dose 2     455     447     455     228  
Vaccinated Dose 3     442     435     438     225  
COMPLETED     435     427     428     218  
NOT COMPLETED     54     61     61     28  
Unknown                 0                 1                 0                 0  
Parent or legal guardian request                 18                 29                 34                 14  
Lost to Follow-up                 10                 11                 7                 6  
Protocol Violation                 16                 8                 6                 3  
Failed to return                 5                 4                 4                 2  
Investigator request                 4                 3                 3                 2  
Unspecified                 0                 2                 4                 0  
Adverse Event                 1                 2                 2                 0  
Death                 0                 1                 1                 1  

Period 2:   After Infant Series
    13vPnC (Pilot Lot 1)     13vPnC (Pilot Lot 2)     13vPnC (Manufacturing Lot)     7vPnC  
STARTED     435     427     427     218  
COMPLETED     415 [1]   397 [1]   408 [1]   208 [1]
NOT COMPLETED     20     30     19     10  
Unknown                 0                 1                 1                 1  
Parent or legal guardian request                 4                 11                 6                 3  
Failed to return                 7                 6                 5                 1  
Lost to Follow-up                 5                 5                 5                 2  
Protocol Violation                 2                 4                 2                 2  
Adverse Event                 2                 2                 0                 0  
Investigator request                 0                 0                 0                 1  
Unspecified                 0                 1                 0                 0  
[1] Not completed=Withdrawn after infant series

Period 3:   Toddler Dose
    13vPnC (Pilot Lot 1)     13vPnC (Pilot Lot 2)     13vPnC (Manufacturing Lot)     7vPnC  
STARTED     415 [1]   397 [1]   408 [1]   208 [1]
COMPLETED     408     391     404     200  
NOT COMPLETED     7     6     4     8  
Lost to Follow-up                 4                 1                 1                 3  
Failed to return                 2                 2                 1                 3  
Parent or legal guardian request                 0                 3                 2                 1  
Protocol Violation                 1                 0                 0                 1  
[1] Vaccinated toddler dose



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
13vPnC (Pilot Lot 1) Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
13vPnC (Pilot Lot 2) Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
13vPnC (Manufacturing Lot) Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
7vPnC Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
Total Total of all reporting groups

Baseline Measures
    13vPnC (Pilot Lot 1)     13vPnC (Pilot Lot 2)     13vPnC (Manufacturing Lot)     7vPnC     Total  
Number of Participants  
[units: participants]
 		  489     488     489     246     1712  
Age  
[units: months]
Mean ± Standard Deviation 		  2.2  ± 0.3     2.2  ± 0.3     2.2  ± 0.3     2.2  ± 0.3     2.2  ± 0.3  
Gender, Customized  
[units: participants]
 		         
Female     230     226     213     115     784  
Male     259     260     275     131     925  
Unknown     0     2     1     0     3  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series   [ Time Frame: 1 Month after the infant series (7 Months of age) ]
  Show Outcome Measure 1

2.  Primary:   Percentage of Participants Achieving Predefined Antibody Level ≥0.1 International Units Per Milliliter (IU/mL) for Tetanus Toxoid in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series   [ Time Frame: 1 month after the infant series (7 months of age) ]
  Show Outcome Measure 2

3.  Primary:   Percentage of Participants Achieving Predefined Antibody Level ≥1:8 for Poliovirus in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series   [ Time Frame: 1 month after the infant series (7 months of age) ]
  Show Outcome Measure 3

4.  Primary:   Percentage of Participants Achieving Predefined Antibody Level ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series   [ Time Frame: 1 month after the infant series (7 months of age) ]
  Show Outcome Measure 4

5.  Secondary:   Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series   [ Time Frame: 1 month after the infant series (7 months of age) ]
  Show Outcome Measure 5

6.  Secondary:   Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose   [ Time Frame: 1 month after the toddler dose (13 months of age) ]
  Show Outcome Measure 6

7.  Secondary:   Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series   [ Time Frame: 1 month after the infant series (7 months of age) ]
  Show Outcome Measure 7

8.  Secondary:   Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose   [ Time Frame: 1 month after the toddler dose (13 months of age) ]
  Show Outcome Measure 8

9.  Secondary:   Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose   [ Time Frame: 1 month after the toddler dose (13 months of age) ]
  Show Outcome Measure 9

10.  Other Pre-specified:   Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)   [ Time Frame: Within 7 days after dose (2 months of age) ]
  Show Outcome Measure 10

11.  Other Pre-specified:   Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)   [ Time Frame: Within 7 days after dose (4 months of age) ]
  Show Outcome Measure 11

12.  Other Pre-specified:   Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)   [ Time Frame: Within 7 days after dose (6 months of age) ]
  Show Outcome Measure 12

13.  Other Pre-specified:   Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age)   [ Time Frame: Within 7 days after dose (12 months of age) ]
  Show Outcome Measure 13

14.  Other Pre-specified:   Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)   [ Time Frame: Within 7 days after dose (2 months of age) ]
  Show Outcome Measure 14

15.  Other Pre-specified:   Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)   [ Time Frame: Within 7 days after dose (4 months of age) ]
  Show Outcome Measure 15

16.  Other Pre-specified:   Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)   [ Time Frame: Within 7 days after dose (6 months of age) ]
  Show Outcome Measure 16

17.  Other Pre-specified:   Percentage of Participants Reporting Systemic Events in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age)   [ Time Frame: Within 7 days after dose (12 months of age) ]
  Show Outcome Measure 17


  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
Commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella) was not available as planned; the alternate of a commercially available MMR and a commercially available varicella vaccine was administered in separate injections.  


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 by Wyeth is now a wholly owned subsidiary of Pfizer

Publications automatically indexed to this study:


Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00444457     History of Changes
Other Study ID Numbers: 6096A1-3005
Study First Received: March 5, 2007
Results First Received: June 11, 2010
Last Updated: October 10, 2012
Health Authority: United States: Food and Drug Administration