Evaluate the Safety of Recombinant Human Papillomavirus Bivalent (Types 16 and 18) Vaccine (Yeast) in Healthy Females
A Blind, Randomized and Placebo-controlled Clinical Trial With Recombinant HumanPapillomavirus Bivalent (Types 16 and 18) Vaccine (Yeast) in Health Women-Phase I
1 other identifier
interventional
160
1 country
1
Brief Summary
This study will evaluate the safety of a novel recombinant human papillomavirus bivalent ( types 16 and 18 ) vaccine ( Yeast ) with different dose in healthy females between 9-45 years of age at enrollment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 29, 2012
CompletedFirst Posted
Study publicly available on registry
March 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedMarch 8, 2012
March 1, 2012
8 months
February 29, 2012
March 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Occurrence, intensity and relationship to vaccination of any solicited local or systemic reactions.
7 days after each vaccine dose
Occurrence, intensity and relationship to vaccination of any unsolicited symptom.
30 days after finish vaccinations
Secondary Outcomes (1)
Neutralizing antibody responses of HPV 16/18 after each vaccine dose.
30 days after finish vaccinations
Study Arms (8)
Adult Group 1, HPV vaccine 0.5ml
EXPERIMENTAL20 women between 18-45 yeas of age, receiving 0,2,6 month-schedule of 0.5ml experimental HPV vaccines.
Adult Group 1, Placebo 0.5ml
PLACEBO COMPARATOR20 women between 18-45 yeas of age, receiving 0,2,6 month-schedule of 0.5ml aluminum phosphate.
Adult Group 2, HPV vaccine 1.0ml
EXPERIMENTAL20 women between 18-45 yeas of age, receiving 0,2,6 month-schedule of 1.0ml experimental HPV vaccines.
Adult Group 2, Placebo 1.0ml
PLACEBO COMPARATOR20 women between 18-45 yeas of age, receiving 0,2,6 month-schedule of 1.0ml aluminum phosphate.
Children Group 1, HPV vaccine 0.5ml
EXPERIMENTAL20 girls between 9-17 yeas of age, receiving 0,2,6 month-schedule of 0.5ml experimental HPV vaccines.
Children Group 1, Placebo 0.5ml
PLACEBO COMPARATOR20 girls between 9-17 yeas of age, receiving 0,2,6 month-schedule of 0.5ml aluminum phosphate.
Children Group 2, HPV vaccine 1.0ml
EXPERIMENTAL20 girls between 9-17 yeas of age, receiving 0,2,6 month-schedule of 1.0ml experimental HPV vaccines.
Children Group 2, Placebo 1.0ml
PLACEBO COMPARATOR20 girls between 9-17 yeas of age, receiving 0,2,6 month-schedule of 1.0ml aluminum phosphate.
Interventions
Subjects were planned to receive HPV vaccine 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
Subjects were planned to receive three doses of the placebo control 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule.
Subjects were planned to receive HPV vaccine 1.0ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
Subjects were planned to receive three doses of the placebo control 1.0ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule.
Eligibility Criteria
You may qualify if:
- Healthy female between, and including, 9 and 45 years of age at the time of the first vaccination
- Provide legal identification for for the sake of recruitment.
- Be able to understand and sign informed consent prior to enrollment (For subjects below the legal age of consent, informed consent must be signed by parent(s)/legal guardian(s) in addition).
- Subject must be not pregnant at the enrollment and agree to using adequate contraceptive precautions within 7 months.
You may not qualify if:
- History of cervical cancer
- History of severe allergic reaction requiring medical intervention (such as oral and throat swelling, difficulty breathing, hypotension or shock)
- History of allergic to vaccine, or to any ingredient of vaccine.
- History of epilepsy, seizures or convulsions, or family history of mental illness
- Subjects are immunocompromised or have been diagnosed as suffering from congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis inflammation (JRA), inflammatory bowel disease or other autoimmune diseases, administration of immunosuppressants with six months prior to the first vaccine dose.
- History of asthma, thyroidectomy, angioneurotic edema, diabetes or malignant
- Asplenia, functional asplenia, or any circumstances result of asplenia or splenectomy
- Medical diagnosis of coagulation abnormalities (eg, clotting factor deficiency, coagulation disorders, platelet anomaly) or obvious bruising or coagulation disorder
- Acute disease or chronic disease acute exacerbation 7 days prior to vaccination
- Administration of immunoglobulins and/or any blood products within 3 months, or administration of any live attenuated vaccine within 28 days, or administration of any subunit or inactivated vaccines within 14 days.
- Fever or axillary temperature\> 37.0 °C before vaccination
- During menstrual period, breastfeeding, pregnancy(pregnancy test positive), or planned pregnant within 7 month
- History of hypertension, physical examination systolic blood pressure\> 150mmHg and/or diastolic blood pressure\> 100mmHg
- Abnormal laboratory tests parameters
- Any clinical significant disease or findings during study screening that, in the opinion of the Investigator may interfere with the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
GuangXi Center for Diseases Control and Prevention
Nanning, Guangxi, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yan-ping Li, MD
Guangxi Centers for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 29, 2012
First Posted
March 8, 2012
Study Start
February 1, 2012
Primary Completion
October 1, 2012
Study Completion
December 1, 2012
Last Updated
March 8, 2012
Record last verified: 2012-03