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A Study to Evaluate the Safety and Immunogenicity of the Hepatitis A Virus Vaccine HAVpur in Healthy Young Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01349829
First Posted: May 9, 2011
Last Update Posted: December 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Crucell Holland BV
Results First Submitted: October 25, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Hepatitis A
Interventions: Biological: HAVpur Junior
Biological: Havrix 720 Junior

  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
Recruitment period: 25 March 2010 to 18 April 2011; outpatient study

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
HAVpur No text entered.
Havrix No text entered.

Participant Flow:   Overall Study
    HAVpur   Havrix
STARTED   126   125 
COMPLETED   117   102 
NOT COMPLETED   9   23 
Lost to Follow-up                4                8 
Consent withdrawal                3                8 
Migrated/moved                2                7 



  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
HAVpur No text entered.
Havrix No text entered.
Total Total of all reporting groups

Baseline Measures
   HAVpur   Havrix   Total 
Overall Participants Analyzed 
[Units: Participants]
 126   125   251 
Age 
[Units: Participants]
     
<=18 years   126   125   251 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Age 
[Units: Months]
Mean (Standard Deviation)
 27.6  (8.45)   27.9  (8.23)   27.8  (8.33) 
Gender 
[Units: Participants]
     
Female   59   68   127 
Male   67   57   124 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Seroprotection at Month 1   [ Time Frame: Month 1 ]

2.  Secondary:   Seroprotection at Month 6   [ Time Frame: Month 6 ]

3.  Secondary:   Seroprotection at Month 7   [ Time Frame: Month 7 ]

4.  Secondary:   Geometric Mean Concentrations (GMCs)   [ Time Frame: Month 1 ]

5.  Secondary:   Geometric Mean Concentrations (GMCs)   [ Time Frame: Month 6 ]

6.  Secondary:   Geometric Mean Concentrations (GMCs)   [ Time Frame: Month 7 ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Medical Affairs Director
Organization: Crucell Switzerland AG
phone: +41(0)319806111
e-mail: info@crucell.com



Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT01349829     History of Changes
Other Study ID Numbers: EPA-V-A008
First Submitted: May 5, 2011
First Posted: May 9, 2011
Results First Submitted: October 25, 2013
Results First Posted: December 17, 2013
Last Update Posted: December 17, 2013