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Follow-up Study 16-20 Years After Primary Vaccination Against Hepatitis B of Newborns From HBeAg+ & HBsAg+ Mothers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00240500
First received: October 13, 2005
Last updated: November 3, 2016
Last verified: November 2016
Results First Received: October 30, 2008  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Hepatitis B
Intervention: Biological: Engerix™-B

  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
HBV 5 Group neonates born to Hepatitis B surface antigen negative (HBsAg-) and Hepatitis B e antigen negative (HBeAg-) mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
HBV 2 Group neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
HBV 1 Group neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
HBV 4 Group neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
HBV 3 Group neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
HBV 6 Group neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)

Participant Flow:   Overall Study
    HBV 5 Group   HBV 2 Group   HBV 1 Group   HBV 4 Group   HBV 3 Group   HBV 6 Group
STARTED   17   20   17   23   29   3 
COMPLETED   16   17   14   19   26   2 
NOT COMPLETED   1   3   3   4   3   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
HBV 5 Group neonates born to Hepatitis B surface antigen negative (HBsAg-) and Hepatitis B e antigen negative (HBeAg-) mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
HBV 2 Group neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
HBV 1 Group neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
HBV 4 Group neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
HBV 3 Group neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
HBV 6 Group neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
Total Total of all reporting groups

Baseline Measures
   HBV 5 Group   HBV 2 Group   HBV 1 Group   HBV 4 Group   HBV 3 Group   HBV 6 Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   20   17   23   29   3   109 
Age 
[Units: Years]
Mean (Standard Deviation)
 16.5  (0.51)   16.6  (0.5)   16.5  (0.51)   16.4  (0.51)   16.8  (0.44)   16.7  (0.58)   16.6  (0.50) 
Gender 
[Units: Participants]
Count of Participants
             
Female      7  41.2%      9  45.0%      11  64.7%      7  30.4%      18  62.1%      1  33.3%      53  48.6% 
Male      10  58.8%      11  55.0%      6  35.3%      16  69.6%      11  37.9%      2  66.7%      56  51.4% 


  Outcome Measures
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1.  Primary:   Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations   [ Time Frame: Years 17, 18, 19 and 20. ]

2.  Primary:   Prevalence of Serological Markers for Hepatitis B Infection   [ Time Frame: Years 17, 18, 19 and 20. ]

3.  Primary:   Clinical Review for Hepatitis B Infection Status   [ Time Frame: Over the entire 4 year follow up period (17 - 20 years) ]


  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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00240500     History of Changes
Other Study ID Numbers: 100448
Study First Received: October 13, 2005
Results First Received: October 30, 2008
Last Updated: November 3, 2016