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Early effects of Vaccine Immunisation (EVI) study

Early effects of Vaccine Immunisation (EVI) study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27917
Enrollment
20
Registered
2019-05-15
Start date
2019-06-03
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Papillomavirus

Interventions

Participants will receive three injections of either the bivalent (Cervarix®) or nonavalent (Gardasil9®) HPV vaccine. In Part I twelve venous blood samples will be drawn and in Part II eight venous bl

Sponsors

Dutch Ministry of Health, welfare and Sports
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ? 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
To obtain insight into signature of immune responses triggered by a bivalent- or nonavalent HPV vaccination.

Secondary

MeasureTime frame
To determine the most informative time-points to study diff

Contacts

Public ContactHella Pasmans

RIVM

hella.pasmans@rivm.nl0302742271

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)