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A Blind, Randomized and Placebo-controlled Clinical Trial With Recombinant HumanPapillomavirus Bivalent (Types 16 and 18) Vaccine (Yeast) in Health Women-Phase I

Phase 1
9 Years
45 Years
Open (Enrolling by invite only)
Human Papillomavirus

Thank you

Trial Information

A Blind, Randomized and Placebo-controlled Clinical Trial With Recombinant HumanPapillomavirus Bivalent (Types 16 and 18) Vaccine (Yeast) in Health Women-Phase I

Inclusion Criteria:

- Healthy female between, and including, 9 and 45 years of age at the time of the first

- 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.

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Outcome Measure:

Occurrence, intensity and relationship to vaccination of any solicited local or systemic reactions.

Outcome Time Frame:

7 days after each vaccine dose

Safety Issue:


Principal Investigator

Yan-ping Li, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Guangxi Centers for Disease Control and Prevention


China: Food and Drug Administration

Study ID:




Start Date:

February 2012

Completion Date:

December 2012

Related Keywords:

  • Human Papillomavirus
  • Human papillomavirus
  • vaccine
  • cervical infection
  • cervical cancer