A Phase 4, Randomized, Open Label Clinical Trial to Determine Efficacy and Immunomodulation of Simultaneous HPV/HBV Vaccination Tango-trial)
1. Female pre-adolescents born in 1998, eligible for HPV vaccination in 2011.
2. Able to fulfill all study requirements.
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
10. Immune deficiency or suppression
Type of Study:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Antibody seroprotection proportion for HBV in groups 1, 2 and 3 measured in Sample 2.
Outcome Time Frame:
Netherlands: Central Committee on Research inv. Human Subjects
- Human Papillomavirus Infection
- 1998 female birth cohort eligible for HPV vaccination in 2011 within the Dutch NIP
- Papillomavirus Infections