This study aims to identify global and local determinants of HPV vaccine acceptability, HPV vaccine uptake and compliance as well as identify logistics and programmatic issues in each country to offer the HPV vaccine, as a potential cervical cancer…
ID
Source
Brief title
Condition
- Other condition
- Viral infectious disorders
- Reproductive neoplasms female malignant and unspecified
Synonym
Health condition
premaligne genitale laesies (cervicaal, vulvair en vaginaal) en genitale wratten (condylomata acuminata)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Vaccine uptake is the primary parameter for this study. This will be estimated
as the percentage of women who get at least one dose of HPV vaccine among all
of those who fill the questionnaire.
Secondary outcome
Vaccine compliance of one, two or three doses is the secondary study parameter.
Background summary
The CoheaHr-WP4 trial is a feasibility study, preparing for the Faster trial.
The Faster trial aims to evaluate a new strategy for the prevention of cervical
cancer that includes: 1. Vaccination of girls (12-15 years); 2. Primary HPV
screening; and 3. Vaccination of women aged 25-45 years with a negative HPV
test.
Study objective
This study aims to identify global and local determinants of HPV vaccine
acceptability, HPV vaccine uptake and compliance as well as identify logistics
and programmatic issues in each country to offer the HPV vaccine, as a
potential cervical cancer prevention strategy, to mid-aged women attending
screening.
Study design
This is an open-label, multinational, multicentre and not controlled study that
will be conducted in 11 European countries.
Intervention
All patients are invited for HPV vaccination with Cervarix. This is optional.
Study burden and risks
Within the first part of this study, participants will be asked to fill in a
questionnaire at home. This will take 10-15 minutes approximately. For those
who accept the vaccine, 3 clinical visits are required for vaccine
administration (free of costs). Side effects that can occur after
administration of Cervarix the following. Frequencies are reported as: Very
common (*1/10); Common (*1/100 to <1/10); Uncommon (*1/1000 to <1/100).:
- Infections and infestations
Uncommon: upper respiratory tract infection
- Blood and lymphatic system disorders
Unknown: Lymphadenopathy
- Immune system disorders
Unknown: Allergic reactions (including anaphylactic and anaphylactoid
reactions), angioedema
- Nervous system disorders
Very common: Headache
Uncommon: Dizziness
Unknown: Syncope or vasovagal responses to injection, sometimes accompanied by
tonic-clonic movements
- Gastrointestinal disorders
Common: gastrointestinal symptoms including nausea, vomiting, diarrhoea and
abdominal pain
- Musculoskeletal and Connective Tissue Disorders
Very common: myalgia
Common: arthralgia
- General disorders and administration site conditions
Very common: injection site reactions including pain, redness, swelling; fatigue
Common: fever (*38°C)
Uncommon: other injection site reactions such as induration, local paraesthesia
- Skin and subcutaneous tissue disorders
Common: itching/pruritus, rash, urticaria
De Boelelaan 1118
Amsterdam 1081 HV
NL
De Boelelaan 1118
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
1) Female aged 30-45 years
2) Participated in the national screening program for cervical cancer in 2015
3) No previous history of HPV vaccine administration.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
1) Known history of severe allergic reaction or hypersensitivty to any of the components of Cervarix: Sodium chloride (NaCl), Sodium dihydrogen phosphate dihydrate (NaH2PO4.2 H2O), AS04: 3-O-desacyl-4*- monophosphoryl lipid A (MPL) or Aluminium hydroxide (Al(OH)3)
2) Known history of immune-related disorders
3) Current acute severe febrile illness, except for minor infections such as a cold, mild upper respiratory infection or low-grade fever. When recovered, the vaccine can be administered
4) Administration of immunoglobulin or blood-derived products within 6 months prior to scheduled HPV vaccine first dose
5) Current pregnancy (reported), breast-feeding or planning to get pregnant in the coming 12 months.
6) Hysterectomized women
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTREUDRACT 2014-0-NL |
| Other | EUDRACT 2014-003177-42 |
| CCMO | NL55480.029.16 |