Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00475033
First received: May 15, 2007
Last updated: April 18, 2011
Last verified: April 2011
Results First Received: May 4, 2010  
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: Vaccines, Pneumococcal Conjugate Vaccine
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
Subjects were recruited in Canada from June 2007 through November 2007.

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 Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
7vPnC Subjects received 1 single 0.5 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 Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.

Participant Flow for 3 periods

Period 1:   Infant Series
    13vPnC     7vPnC  
STARTED     300     303  
Vaccinated Dose 1     300     303  
Vaccinated Dose 2     297     296  
Vaccinated Dose 3     293     294  
COMPLETED     293     290  
NOT COMPLETED     7     13  
Failed to return                 3                 4  
Parent or legal guardian request                 1                 5  
Protocol Violation                 1                 2  
Lost to Follow-up                 2                 0  
Adverse Event                 0                 2  

Period 2:   After the Infant Series
    13vPnC     7vPnC  
STARTED     293     290  
Withdrawn After Infant Series     6     8  
COMPLETED     287     282  
NOT COMPLETED     6     8  
Adverse Event                 0                 4  
Parent or legal guardian request                 2                 2  
Failed to return                 2                 1  
Protocol Violation                 1                 0  
Lost to Follow-up                 1                 0  
Unspecified                 0                 1  

Period 3:   Toddler Dose
    13vPnC     7vPnC  
STARTED     287 [1]   282 [1]
COMPLETED     283     282  
NOT COMPLETED     4     0  
Parent or legal guardian request                 2                 0  
Failed to return                 1                 0  
Lost to Follow-up                 1                 0  
[1] Vaccinated Toddler Dose



  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.
No text entered.

Reporting Groups
  Description
13vPnC Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
7vPnC Subjects received 1 single 0.5 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 Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
Total Total of all reporting groups

Baseline Measures
    13vPnC     7vPnC     Total  
Number of Participants  
[units: participants]
  300     303     603  
Age [1]
[units: months]
Mean ± Standard Deviation
  2.1  ± 0.3     2.1  ± 0.3     2.1  ± 0.3  
Gender  
[units: participants]
     
Female     143     152     295  
Male     157     151     308  
[1] Age at enrollment



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C Serum Bactericidal Assay (SBA) in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series   [ Time Frame: 1 month after 2 doses of NeisVac-C® in the infant series (7 months of age) ]

2.  Primary:   Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series   [ Time Frame: 1 month after 2 doses of NeisVac-C® in the infant series (7 months of age) ]

3.  Primary:   Percentage of Subjects Achieving Predefined Antibody Level to Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series   [ Time Frame: 1 month after the 3-dose infant series (7 months of age) ]

4.  Primary:   Geometric Mean Concentration (GMC) of Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series   [ Time Frame: 1 month after the 3-dose Infant Series (7 months of age) ]

5.  Primary:   Percentage of Subjects Achieving Predefined Antibody Level ≥0.15 Micrograms Per mL (μg/mL) for Polyribosylribitol Phosphate (PRP) in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series   [ Time Frame: 1 month after the 3-dose infant series (7 months of age) ]

6.  Primary:   Geometric Mean Concentration (GMC) of PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series   [ Time Frame: 1 month after the 3-dose infant series (7 months of age) ]

7.  Secondary:   Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C SBA in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose of NeisVac-C®   [ Time Frame: 1 month after the toddler dose of NeisVac-C® (13 months of age) ]

8.  Secondary:   Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose   [ Time Frame: 1 month after the toddler dose (13 months of age) ]

9.  Secondary:   Percentage of Subjects Achieving Predefined Antibody Level ≥1.0 μg/mL for PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series   [ Time Frame: 1 month after the 3-dose infant series (7 months of age) ]

10.  Other Pre-specified:   Percentage of Subjects Achieving Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 μg/mL in the 13vPnC Group After the 3-dose Infant Series   [ Time Frame: 1 month after the 3-dose infant series (7 months of age) ]

11.  Other Pre-specified:   Geometric Mean Concentration (GMC) for Pneumococcal IgG Antibody in 13vPnC Group After the 3-dose Infant Series   [ Time Frame: 1 month after the 3-dose infant series (7 months of age) ]

12.  Other Pre-specified:   Percentage of Subjects Achieving Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 μg/mL in the 13vPnC Group After the Toddler Dose   [ Time Frame: 1 month after the toddler dose (13 months of age) ]

13.  Other Pre-specified:   Geometric Mean Concentration (GMC) for Pneumococcal IgG Antibody in 13vPnC Group After the Toddler Dose   [ Time Frame: 1 month after the toddler dose (13 months of age) ]

14.  Other Pre-specified:   Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 1 (2 Months of Age)   [ Time Frame: Within 4 days after dose (2 months of age) ]

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

16.  Other Pre-specified:   Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 3 (6 Months of Age)   [ Time Frame: Within 4 days after dose (6 months of age) ]

17.  Other Pre-specified:   Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Toddler Dose (12 Months of Age)   [ Time Frame: Within 4 days after dose (12 months of age) ]

18.  Other Pre-specified:   Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)   [ Time Frame: Within 4 days after dose (2 months of age) ]

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

20.  Other Pre-specified:   Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)   [ Time Frame: Within 4 days after dose (6 months of age) ]

21.  Other Pre-specified:   Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Toddler Dose (12 Months of Age)   [ Time Frame: Within 4 days after dose (12 months of age) ]


  Serious Adverse Events


  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.govCallCenter@pfizer.com


No publications provided


Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00475033     History of Changes
Other Study ID Numbers: 6096A1-3008
Study First Received: May 15, 2007
Results First Received: May 4, 2010
Last Updated: April 18, 2011
Health Authority: Canada: Ethics Review Committee
United States: Food and Drug Administration