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Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00384059
First received: October 2, 2006
Last updated: January 22, 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 (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Vaccines, Pneumococcal
Interventions: Biological: 13-valent Pneumococcal Conjugate Vaccine
Biological: 7vPnC
Biological: Pediacel
Biological: NeisVac-C
Biological: Menitorix

  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 Kingdom (UK) from October 2006 to June 2007.

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 meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
7vPnC Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).

Participant Flow for 3 periods

 Period 1:   Infant Series
    13vPnC     7vPnC  
STARTED     141     145  
Vaccinated Dose 1     139     139  
Vaccinated Dose 2     136     135  
COMPLETED     135     132  
NOT COMPLETED     6     13  
Not consented                 2                 6  
Withdrawal by Subject                 2                 2  
Adverse Event                 1                 2  
Protocol Violation                 1                 2  
Lost to Follow-up                 0                 1  

Period 2:   After Infant Series
    13vPnC     7vPnC  
STARTED     135     132  
COMPLETED     131     122  
NOT COMPLETED     4     10  
Protocol Violation                 2                 3  
Withdrawal by Subject                 2                 2  
Failed to Return                 0                 2  
Adverse Event                 0                 1  
Physician Decision                 0                 1  
Lost to Follow-up                 0                 1  

Period 3:   Toddler Dose
    13vPnC     7vPnC  
STARTED     131     122  
COMPLETED     130     120  
NOT COMPLETED     1     2  
Lost to Follow-up                 1                 1  
Failed to return                 0                 1  



  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 meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
7vPnC Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
Total Total of all reporting groups

Baseline Measures
    13vPnC     7vPnC     Total  
Number of Participants  
[units: participants]
 		  120     118     238  
Age  
[units: months]
Mean ± Standard Deviation 		  2.1  ± 0.3     2.1  ± 0.2     2.1  ± 0.3  
Gender  
[units: participants]
 		     
Female     55     57     112  
Male     65     61     126  



  Outcome Measures
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1.  Primary:   Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series.   [ Time Frame: One month after infant series dose 2 (5 months of age) ]
  Show Outcome Measure 1

2.  Primary:   Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series   [ Time Frame: one month after infant series dose 2 (5 months of age) ]
  Show Outcome Measure 2

3.  Primary:   Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series   [ Time Frame: one month after infant series dose 2 (5 months of age) ]
  Show Outcome Measure 3

4.  Primary:   Geometric Mean Antibody Concentration of Pertusis Filamentous Haemagglutinin (FHA), Pertussis Toxoid (PT), Pertactin (PRN), and Fimbrial Agglutinogens (FIM) as Measured by ELISA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series   [ Time Frame: one month after infant series dose 2 (5 months of age) ]
  Show Outcome Measure 4

5.  Primary:   Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose   [ Time Frame: one month after infant series dose 2 (5 months of age), before and after toddler dose (12 months of age) ]
  Show Outcome Measure 5

6.  Primary:   Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose.   [ Time Frame: one month after infant series dose 2 (5 months of age) and before and after toddler dose (12 months of age) ]
  Show Outcome Measure 6

7.  Secondary:   Percentage of Participants Achieving an SBA Titer ≥1:8 for Meningococcal C in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose.   [ Time Frame: one month after the toddler dose (13 months of age) ]
  Show Outcome Measure 7

8.  Secondary:   Percentage of Participants Achieving a Predefined Antibody Level for Haemophilus Influenzae Type b in the 13vPnC Group Relative to the 7vPnC Group After the Toddler Dose.   [ Time Frame: one month after toddler dose (13 months of age) ]
  Show Outcome Measure 8

9.  Secondary:   Geometric Mean Antibody Concentration for Haemophilus Influenzae Type b PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose.   [ Time Frame: one month after toddler dose (13 months of age) ]
  Show Outcome Measure 9

10.  Secondary:   Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose   [ Time Frame: one month after toddler dose (13 months of age) ]
  Show Outcome Measure 10

11.  Other Pre-specified:   Percentage of Participants Reporting Pre-Specified Local Reactions   [ Time Frame: During the 4-day period after each dose ]
  Show Outcome Measure 11

12.  Other Pre-specified:   Percentage of Participants Reporting Pre-Specified Systemic Events   [ Time Frame: During the 4-day period after each dose ]
  Show Outcome Measure 12


  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 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: NCT00384059     History of Changes
Other Study ID Numbers: 6096A1-007
Study First Received: October 2, 2006
Results First Received: March 26, 2010
Last Updated: January 22, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration