Long-term Persistence of Immunity Against Hepatitis B in 7-8 Years Old Children After Hepatitis B Vaccination.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00519649
First received: August 21, 2007
Last updated: March 14, 2013
Last verified: March 2013
Results First Received: December 17, 2008  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Hepatitis B Vaccine
Intervention: Biological: Engerix™-B Kinder

  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
One additional subject, enrolled but not vaccinated, was not included in the number of subjects under "STARTED"

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
Group Engerix Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)

Participant Flow:   Overall Study
    Group Engerix  
STARTED     300  
COMPLETED     299  
NOT COMPLETED     1  
Withdrawal by Subject                 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.
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Reporting Groups
  Description
Group Engerix Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)

Baseline Measures
    Group Engerix  
Number of Participants  
[units: participants]
  300  
Age  
[units: years]
Mean ± Standard Deviation
  7.7  ± 0.46  
Gender  
[units: participants]
 
Female     136  
Male     164  



  Outcome Measures
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1.  Primary:   Number of Participants With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-off Value   [ Time Frame: One month after the challenge dose of HBV vaccine ]

2.  Secondary:   Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value   [ Time Frame: Before challenge dose of HBV vaccine ]

3.  Secondary:   Number of Participants Reporting Solicited Local Symptoms   [ Time Frame: During the 4-day follow-up period after the challenge dose of HBV vaccine. ]

4.  Secondary:   Number of Participants Reporting Solicited General Symptoms   [ Time Frame: During the 4-day follow-up period after the challenge dose of HBV vaccine. ]

5.  Secondary:   Number of Participants Reporting Unsolicited Adverse Events   [ Time Frame: During the 31-day follow-up period after the challenge dose of HBV vaccine. ]

6.  Secondary:   Number of Participants Reporting Serious Adverse Events (SAE)   [ Time Frame: After the challenge dose of HBV vaccine. ]


  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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications:
Disselhoff J et al. Immune memory against hepatitis B persists in 7-8 year olds primed with 3 doses of HBV vaccine in routine clinical practice. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00519649     History of Changes
Other Study ID Numbers: 110474
Study First Received: August 21, 2007
Results First Received: December 17, 2008
Last Updated: March 14, 2013
Health Authority: Germany: Paul-Ehrlich-Institut