Early effects of Vaccine Immunisation (EVI) study
- Conditions
- Human Papillomavirus
- Registration Number
- NL-OMON27917
- Lead Sponsor
- Dutch Ministry of Health, welfare and Sports
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
? Seronegative for hr-HPV vaccine types(16,18,31,33,45,52,58)
? Female
? Normal general health
? Pre-menopausal
? Willing to receive HPV vaccination
? Provision of written informed consent
? Willing to adhere to the protocol and be available during the study period
present evidence of serious disease(s) within the last 3 months before inclusion
requiring immunosuppressive or immune modulating medical treatment, such as
systemic corticosteroids, that might interfere with the results of the study;
? chronic infection
? known or suspected immune deficiency;
? history of any neurologic disorder, including epilepsy;
? previous administration of serum products (including immunoglobulins) within 6
months before vaccination and blood sampling
? known or suspected allergy to any of the vaccine components (by medical history)
? previous vaccination with any HPV vaccine
? pregnancy
? participating in another vaccination/ medicine study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To obtain insight into signature of immune responses triggered<br>by a bivalent- or nonavalent HPV vaccination.
- Secondary Outcome Measures
Name Time Method To determine the most informative time-points to study diff