Cervical cancer (CaCx) is one of the leading
causes of morbidity and mortality among the gynecological cancer worldwide.
Each year approximately 529,409 women are diagnosed with cervical cancer. In
2008, mortality is staggering at 274,883 lives lost each year. About 86% of the
cases occur in developing countries and may constitute up to 25% of all female
cancers.
In India this cervical cancer is reported to
be responsible for almost 20 percent of all female deaths and takes the lives
of 8 women in India every hour. India with a population of 365.71 million has
women aged between 15 years and above who stand at the risk of developing
cervical cancer. India recorded 134420 new cases out of these cases 72825
cases lost their lives. Cervical cancer age-standardized incidence rate of 30.7
per 100,000 is more than 300% higher than rates in the United States and other
countries including United Kingdom and Canada. Cervical cancer mortality at
18.6 per 100,000 is more than 8 times higher than the United States and almost
11 times higher than Australia.
Numerous clinical evidences have established the
human papillomavirus (HPV) as a necessary cause of cervical cancer. Knowledge
of this association has spurred research on HPV based strategies for cervical
cancer prevention, including primary prevention of HPV, HPV vaccines, and the use
of HPV testing. At the
same time it is crucial to conduct post marketing surveillance in order
to decide whether it is important to implement this HPV vaccine for public
health and whether the adverse events reported after vaccination with prophylactic
bivalent and quadrivalent HPV vaccines the same as those expected and listed in the
package insert.
AIMS AND OBJECTIVES: -
This study is
carried out among medical personnel to assess-
1. To evaluate potential local injection site reactions and
serious adverse events within
7 and 30 days after each dose of prophylactic
bivalent and quadrivalent HPV vaccine.
2. To determine the occurrence, nature,
duration, severity and relationship to vaccination of any local injection site reactions and serious
adverse events.
3. To monitor whether the adverse events reported after vaccination
with prophylactic
bivalent and quadrivalent HPV vaccines the same as those expected and listed in the
package insert.
MATERIAL
& METHODS: -
Study Design:
This is observational cohort
study of participants who are immunized with prophylactic bivalent and quadrivalent HPV
vaccine and followed actively for safety outcomes during 7 and 30 days after
each dose of prophylactic
bivalent and
quadrivalent
HPV vaccine. In order to achieve the study objectives, the protocol will be
carried out in several settings using the same design. The invitation to
participate and conduct these studies will be extended to health departments
and healthcare facilities that routinely conduct HPV vaccine immunization.
Written consent from eligible women will be
obtained. Participants will be made to read an information sheet about the
project and the project will be explained to them in the language they
understand. The investigator
will provide a copy of the signed informed consent to the subject, and will
maintain the original in the investigator’s study file. A person who is
qualified according to applicable local regulations will conduct the informed
consent discussion. The subject should be given the opportunity to inquire
about details of the study and to consider participation. These women will be asked few questions
related to cervical cancer and HPV vaccines and answers will be noted.
Reproductive tract infections related history would be taken from participants.
Strict privacy and confidentiality will be maintained during interview and in
the entire phase of the study. The subject should
be informed in a timely manner if new information becomes available that might
affect the decision to participate in the study. The communication of this
information should be documented.
Prior to
immunization any injection site clinical findings that could impact on the
assessment of local l injection site reactions will be documented (such as
existing rash, bruising and so on). While in the immunization clinic, subjects
will be shown how to complete all subject report forms and taught the correct
method for taking an oral temperature daily using a digital thermometer and for
using the plastic template (containing 5 circles of increasing diameter from 1
to 5 cm) to measure the size of any injection side redness, swelling, induration
or bruising. In addition, subjects will be instructed to repeat the temperature
measurement any time they feel feverish and to record the value and time taken
on the diary card.
Subjects will be
kept under observation for a time period in accordance with local standard of practice.
It is preferable that subjects be reexamined 30 minutes after immunization for
any local or systemic reactions. In health care situations where employees
would normally return to work before the 30 minute time point, phone follow-up
to record the 30 minute observations is acceptable but arrangements should be
made to examine any who report moderate to severe local or systemic reactions. Other observations to be recorded in the diary card each day for the 7 days
following immunization include-
·
daily assessment of the presence or absence,
and if the former, the maximal
severity
of pain at the injection site, headache, feeling unwell, aches/pains or chills/
shivering. Levels of severity are defined as:
mild- present but doesn’t interfere with daily activities
moderate- interferes with daily activities
severe- unable to
do daily activities
- daily measurement of the maximum diameter of any
redness, swelling,
inducrtion or bruising at the injection site(<1cm; 1to<2cm;
2to<3 cm; 3to<4 cm; 4to<5 cm; ≥5 cm).
For these purpose templates with 5 circles of diameters 1, 2, 3, 4 and 5
cm will be provided.
Reactogenicity
Subjects will use a
separate diary cards to record the
occurrence of unsolicited signs after each vaccine dose. SAEs, MSCs (defined as
AEs prompting emergency room or physician visits that wil not related to common
diseases or SAEs that will not related to common diseases), pregnancy outcomes
and withdrawals due to AEs/SAEs will be reported throughout the entire study
period. Examples of common diseases not included in the definition of MSC will
be upper respiratory infections, sinusitis, pharyngitis, gastroenteritis,
urinary tract infections, cervicovaginal yeast infections, menstrual cycle
abnormalities and injury. Decisions relating adverse events to vaccination will
be based on the judgment of the investigator at the study site reporting the
event.
All data are to be
captured using the paper case report form. Any AE/SAE will be documented to respective
vaccine adverse event reporting system.
SELECTION OF CASES: -
Inclusion/Exclusion
Criteria
1. Inclusion:
Subjects eligible for enrolment into this
study are healthy female adult volunteers who are:
- able to attend all scheduled
visits
- able to give written informed consent prior to
study entry.
2. Exclusion:
Individuals are not to be enrolled into the
study if:
1. No hospitalization within 21 days
prior to study entry.
2. Oral temperature of 38.3 C (101 F)
or greater within 72 hours prior to each study vaccination.
3. Hypersensitivity to latex.
4. Use of any investigational or
non-registered product (drug or vaccine) other than the study vaccine(s) within
30 days preceding the first dose of study vaccine, or planned use during the
study period.
5. They have surgery planned during the study period
6. Pregnant or immune compromised women should be avoided.
7. Any other condition including abuse
of alcohol, drug addiction of imposed confinement that may interfere with
ability to comply with trial procedures
ADVERSE EVENTS/ RISKS/ ETHICAL CONSIDERATIONS:
-
Risks to confidentiality will be minimized by
de-identifying patient information and assigning a unique number to each
patient. This data would be stored on a password-protected computer and be
accessible only to the study personnel. All patient data including consent
forms will be kept in a locked filing cabinet accessible only to the project
personnel. To assure confidentiality, all the survey results will be recorded
by study ID number only and will not be recorded directly in the study
participant’s chart, to avoid inadvertent release of confidential information.
All computer entry and networking programs will be done with coded numbers
only. Electronic data will be kept in a password-protected computer with access
provided only to the study personnel.
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