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Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Adolescents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00387725
First received: October 11, 2006
Last updated: November 14, 2014
Last verified: November 2014
Results First Received: November 14, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Healthy
Intervention: Biological: rLP2086

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Twinrix Given on a 0, 1-, 6- month schedule
Initial Formulation rLP2086 20 mcg Given on a 0, 1-, 6- month schedule
Initial Formulation rLP2086 60 mcg Given on a 0, 1-, 6- month schedule
Initial Formulation rLP2086 200 mcg Given on a 0, 1-, 6- month schedule

Participant Flow:   Overall Study
    Twinrix     Initial Formulation rLP2086 20 mcg     Initial Formulation rLP2086 60 mcg     Initial Formulation rLP2086 200 mcg  
STARTED     21     16     45     45  
COMPLETED     20     15     43     43  
NOT COMPLETED     1     1     2     2  
Adverse Event                 0                 0                 0                 1  
Protocol Violation                 0                 1                 0                 0  
Withdrawal by Subject                 1                 0                 1                 0  
Parent/legal guardian request                 0                 0                 1                 1  



  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
Twinrix Given on a 0, 1-, 6- month schedule
Initial Formulation rLP2086 20 mcg Given on a 0, 1-, 6- month schedule
Initial Formulation rLP2086 60 mcg Given on a 0, 1-, 6- month schedule
Initial Formulation rLP2086 200 mcg Given on a 0, 1-, 6- month schedule
Total Total of all reporting groups

Baseline Measures
    Twinrix     Initial Formulation rLP2086 20 mcg     Initial Formulation rLP2086 60 mcg     Initial Formulation rLP2086 200 mcg     Total  
Number of Participants  
[units: participants]
  21     16     45     45     127  
Age  
[units: years]
Mean ± Standard Deviation
  10.19  ± 1.44     10.69  ± 0.95     10.31  ± 1.24     10.31  ± 1.29     10.34  ± 1.25  
Gender  
[units: participants]
         
Female     10     9     22     28     69  
Male     11     7     23     17     58  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2   [ Time Frame: 1 month after Dose 2 ]

2.  Primary:   Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3   [ Time Frame: 1 month after Dose 3 ]

3.  Primary:   Percentage of Participants With at Least One Adverse Event (AE)   [ Time Frame: Dose 1 up to 1 month after Dose 3 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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.


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: Pfizer
ClinicalTrials.gov Identifier: NCT00387725     History of Changes
Other Study ID Numbers: 6108A1-501, B1971006
Study First Received: October 11, 2006
Results First Received: November 14, 2014
Last Updated: November 14, 2014
Health Authority: Australia: Human Research Ethics Committee