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Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00373958
First received: September 7, 2006
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
Results First Received: March 26, 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
Interventions: Biological: 13 valent pneumococcal conjugate vaccine
Biological: 7vPnc 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
Participants were recruited in the United States from September 2006 to January 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.

Reporting Groups
  Description
13vPnC Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
7vPnC Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).

Participant Flow for 2 periods

 Period 1:   Infant Series
    13vPnC     7vPnC  
STARTED     334 [1]   332  
Vaccinated Dose 1     332     331  
Vaccinated Dose 2     309     305  
Vaccinated Dose 3     298     300  
COMPLETED     294     290  
NOT COMPLETED     40     42  
Withdrawal by Subject                 13                 15  
Failed to return                 8                 13  
Lost to Follow-up                 6                 5  
Protocol Violation                 3                 7  
Lost Kaiser coverage                 4                 0  
Child relocated                 1                 0  
Consent was not received                 1                 0  
Adverse Event                 3                 1  
Physician Decision                 1                 1  
[1] One participant was prerandomized but not consented.

Period 2:   Toddler Dose
    13vPnC     7vPnC  
STARTED     294     290  
Withdrawn After Infant Series     22     25  
Vaccinated Toddler Dose     272     265  
COMPLETED     264     252  
NOT COMPLETED     30     38  
Lost to Follow-up                 5                 8  
Withdrawal by Subject                 2                 2  
Failed to return                 1                 2  
Protocol Violation                 0                 1  
Withdrawn after infant series                 22                 25  



  Baseline Characteristics
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Reporting Groups
  Description
13vPnC Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
7vPnC Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
Total Total of all reporting groups

Baseline Measures
    13vPnC     7vPnC     Total  
Number of Participants  
[units: participants]
 		  334     332     666  
Age  
[units: months]
Mean ± Standard Deviation 		  2.1  ± 0.3     2.1  ± 0.3     2.1  ± 0.3  
Gender  
[units: patients]
 		     
Female     165     139     304  
Male     169     193     362  



  Outcome Measures
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1.  Primary:   Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series   [ Time Frame: One month after the 3-dose infant series (7 months of age) ]
  Show Outcome Measure 1

2.  Primary:   Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose   [ Time Frame: 1 Month After the Toddler Dose ]
  Show Outcome Measure 2

3.  Primary:   Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series   [ Time Frame: One Month After the Infant Series (7 months of age) ]
  Show Outcome Measure 3

4.  Primary:   Percentage of Participants Reporting Pre-specified Systemic Events   [ Time Frame: Within 7 days after each dose ]
  Show Outcome Measure 4

5.  Primary:   Percentage of Participants Reporting Pre-specified Local Reactions   [ Time Frame: Within 7 days after each dose ]
  Show Outcome Measure 5

6.  Secondary:   Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)   [ Time Frame: One month after toddler dose (13 to 16 months of age) ]
  Show Outcome Measure 6

7.  Secondary:   Geometric Mean Antibody Concentration of Hib PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose   [ Time Frame: one month after the toddler dose ]
  Show Outcome Measure 7

8.  Secondary:   Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose   [ Time Frame: one month after the toddler dose ]
  Show Outcome Measure 8

9.  Secondary:   Geometric Mean Antibody Concentration of Rubella in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose   [ Time Frame: one month after the toddler dose ]
  Show Outcome Measure 9

10.  Secondary:   Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose   [ Time Frame: One month after infant series and one month after toddler dose ]
  Show Outcome Measure 10

11.  Secondary:   Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose   [ Time Frame: one month after the infant series and the toddler dose ]
  Show Outcome Measure 11


  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
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 by Pfizer

Publications automatically indexed to this study:


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00373958     History of Changes
Other Study ID Numbers: 6096A1-004
Study First Received: September 7, 2006
Results First Received: March 26, 2010
Last Updated: January 17, 2013
Health Authority: United States: Food and Drug Administration