A Phase 4, Randomized, Open Label Clinical Trial to Determine Efficacy and Immunomodulation of Simultaneous HPV/HBV Vaccination Tango-trial)
Phase 4
11 Years
12 Years
11 Years
12 Years
Not Enrolling
Female
Human Papillomavirus Infection
Female
Human Papillomavirus Infection
Trial Information
A Phase 4, Randomized, Open Label Clinical Trial to Determine Efficacy and Immunomodulation of Simultaneous HPV/HBV Vaccination Tango-trial)
Inclusion Criteria:
1. Female pre-adolescents born in 1998, eligible for HPV vaccination in 2011.
2. Able to fulfill all study requirements.
Exclusion Criteria:
1. Previous vaccination with any licensed or experimental HPV or HBV vaccine.
2. Contraindication for vaccination with Cervarix®.
3. Contraindication for vaccination with Engerix-B®.
4. Use of investigational vaccine or medication within 30 days before study
5. History of severe adverse reaction associated with a vaccine or vaccine component.
6. Heart disease
7. Liver disease
8. Spleen removal
9. Asthma
10. Immune deficiency or suppression
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Antibody seroprotection proportion for HBV in groups 1, 2 and 3 measured in Sample 2.
Outcome Time Frame:
Month 7
Safety Issue:
No
Authority:
Netherlands: Central Committee on Research inv. Human Subjects
Study ID:
LIS144
NCT ID:
NCT01082861
Start Date:
September 2010
Completion Date:
April 2011
Related Keywords:
- Human Papillomavirus Infection
- 1998 female birth cohort eligible for HPV vaccination in 2011 within the Dutch NIP
- Warts
- Papillomavirus Infections
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