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:
Information provided by (Responsible Party):
Crucell Holland BV
ClinicalTrials.gov Identifier:
NCT01349829
First received: May 5, 2011
Last updated: October 25, 2013
Last verified: August 2013
Results First Received: October 25, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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
None

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  
Number of Participants  
[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
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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


  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.


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: Medical Affairs Director
Organization: Crucell Switzerland AG
phone: +41(0)319806111
e-mail: info@crucell.com


No publications provided


Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT01349829     History of Changes
Other Study ID Numbers: EPA-V-A008
Study First Received: May 5, 2011
Results First Received: October 25, 2013
Last Updated: October 25, 2013
Health Authority: India: Drugs Controller General of India