To assess potential hazards, including immediate adverse events after bivalent and quadrivalent HPV vaccines immunizations in healthy Indian women aged 18-25 years.
- Conditions
- To prevent cervical cancer
- Registration Number
- CTRI/2013/11/004140
- Lead Sponsor
- Madhusudan B Vakharia
- Brief Summary
Cervical cancer (CaCx) is one of the leadingcauses of morbidity and mortality among the gynecological cancer worldwide.Each year approximately 529,409 women are diagnosed with cervical cancer. In2008, mortality is staggering at 274,883 lives lost each year. About 86% of thecases occur in developing countries and may constitute up to 25% of all femalecancers.
In India this cervical cancer is reported tobe responsible for almost 20 percent of all female deaths and takes the livesof 8 women in India every hour. India with a population of 365.71 million haswomen aged between 15 years and above who stand at the risk of developingcervical cancer. India recorded 134420 new cases out of these cases 72825cases lost their lives. Cervical cancer age-standardized incidence rate of 30.7per 100,000 is more than 300% higher than rates in the United States and othercountries including United Kingdom and Canada. Cervical cancer mortality at18.6 per 100,000 is more than 8 times higher than the United States and almost11 times higher than Australia.
Numerous clinical evidences have established thehuman papillomavirus (HPV) as a necessary cause of cervical cancer. Knowledgeof this association has spurred research on HPV based strategies for cervicalcancer prevention, including primary prevention of HPV, HPV vaccines, and the useof HPV testing. At thesame time it is crucial to conduct post marketing surveillance in orderto decide whether it is important to implement this HPV vaccine for publichealth and whether the adverse events reported after vaccination with prophylacticbivalent and quadrivalent HPV vaccines the same as those expected and listed in thepackage insert.
**AIMS AND OBJECTIVES****: -**
This study iscarried out among medical personnel to assess-
**1.** To evaluate potential local injection site reactions andserious adverse events within7 and 30 days after each dose of prophylacticbivalent and quadrivalent HPV vaccine.
**2.** To determine the occurrence, nature,duration, severity and relationship to vaccination of any local injection site reactions and seriousadverse events.
**3.** To monitor whether the adverse events reported after vaccinationwith prophylacticbivalent and quadrivalent HPV vaccines the same as those expected and listed in thepackage insert.
**MATERIAL& METHODS: -**
***Study Design:***
This is observational cohortstudy of participants who are immunized with prophylactic bivalent and quadrivalent HPVvaccine and followed actively for safety outcomes during 7 and 30 days aftereach dose of prophylacticbivalent andquadrivalentHPV vaccine. In order to achieve the study objectives, the protocol will becarried out in several settings using the same design. The invitation toparticipate and conduct these studies will be extended to health departmentsand healthcare facilities that routinely conduct HPV vaccine immunization.
Written consent from eligible women will beobtained. Participants will be made to read an information sheet about theproject and the project will be explained to them in the language theyunderstand. The investigatorwill provide a copy of the signed informed consent to the subject, and willmaintain the original in the investigator’s study file. A person who isqualified according to applicable local regulations will conduct the informedconsent discussion. The subject should be given the opportunity to inquireabout details of the study and to consider participation. These women will be asked few questionsrelated 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 inthe entire phase of the study. The subject shouldbe informed in a timely manner if new information becomes available that mightaffect the decision to participate in the study. The communication of thisinformation should be documented.
Prior toimmunization any injection site clinical findings that could impact on theassessment of local l injection site reactions will be documented (such asexisting rash, bruising and so on). While in the immunization clinic, subjectswill be shown how to complete all subject report forms and taught the correctmethod for taking an oral temperature daily using a digital thermometer and forusing the plastic template (containing 5 circles of increasing diameter from 1to 5 cm) to measure the size of any injection side redness, swelling, indurationor bruising. In addition, subjects will be instructed to repeat the temperaturemeasurement any time they feel feverish and to record the value and time takenon the diary card.
Subjects will bekept under observation for a time period in accordance with local standard of practice.It is preferable that subjects be reexamined 30 minutes after immunization forany local or systemic reactions. In health care situations where employeeswould normally return to work before the 30 minute time point, phone follow-upto record the 30 minute observations is acceptable but arrangements should bemade 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 daysfollowing immunization include-
· daily assessment of the presence or absence,and if the former, the maximal
severityof 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 todo 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 5cm will be provided.
**Reactogenicity**
Subjects will use aseparate diary cards to record theoccurrence of unsolicited signs after each vaccine dose. SAEs, MSCs (defined asAEs prompting emergency room or physician visits that wil not related to commondiseases or SAEs that will not related to common diseases), pregnancy outcomesand withdrawals due to AEs/SAEs will be reported throughout the entire studyperiod. Examples of common diseases not included in the definition of MSC willbe upper respiratory infections, sinusitis, pharyngitis, gastroenteritis,urinary tract infections, cervicovaginal yeast infections, menstrual cycleabnormalities and injury. Decisions relating adverse events to vaccination willbe based on the judgment of the investigator at the study site reporting theevent.
All data are to becaptured using the paper case report form. Any AE/SAE will be documented to respectivevaccine adverse event reporting system.
**SELECTION OF CASES: -**
Inclusion/ExclusionCriteria
**1.** Inclusion:
**Subjects eligible for enrolment into thisstudy are healthy female adult volunteers who are:**
1. able to attend all scheduled visits
2. able to give written informed consent prior to study entry.
**2.** Exclusion:
**Individuals are not to be enrolled into thestudy if:**
1. No hospitalization within 21 daysprior 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 ornon-registered product (drug or vaccine) other than the study vaccine(s) within30 days preceding the first dose of study vaccine, or planned use during thestudy period.
5. They have surgery planned during the study period
6. Pregnant or immune compromised women should be avoided.
7. Any other condition including abuseof alcohol, drug addiction of imposed confinement that may interfere withability to comply with trial procedures
**ADVERSE EVENTS/ RISKS/ ETHICAL CONSIDERATIONS****:-**
Risks to confidentiality will be minimized byde-identifying patient information and assigning a unique number to eachpatient. This data would be stored on a password-protected computer and beaccessible only to the study personnel. All patient data including consentforms will be kept in a locked filing cabinet accessible only to the projectpersonnel. To assure confidentiality, all the survey results will be recordedby study ID number only and will not be recorded directly in the studyparticipant’s chart, to avoid inadvertent release of confidential information.All computer entry and networking programs will be done with coded numbersonly. Electronic data will be kept in a password-protected computer with accessprovided only to the study personnel.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 70
- Able to fill the questionnaires used in this study.
- Able to give a written informed consent.
- Able to attend all scheduled visits.
- No hospitalization within 21 days prior to study entry.
- Oral temperature of 38.3 C (101 F) or greater within 72 hours prior to each study vaccination.
- Hypersensitivity to latex.
- 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.
- They have surgery planned during the study period.
- Any other condition including abuse of alcohol, drug addiction of imposed confinement that may interfere with ability to comply with trial procedures.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. 1 year
- Secondary Outcome Measures
Name Time Method 1. To determine the occurrence, nature, duration, severity and relationship to vaccination of any local injection site reactions and serious adverse events. 2. 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.
Trial Locations
- Locations (1)
B. J. Govt. Medical college and Sassoon General Hospitals, Pune
🇮🇳Pune, MAHARASHTRA, India
B. J. Govt. Medical college and Sassoon General Hospitals, Pune🇮🇳Pune, MAHARASHTRA, IndiaDr B B GhonganePrincipal investigator9922925590ghongane.phdguide@gmail.com