Evaluate the Safety of Recombinant Human Papillomavirus Bivalent (Types 16 and 18) Vaccine (Yeast) in Healthy Females

Human Papillomavirus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01548118
• Other study ID #: 311-HPV-1001
• Status: Unknown status
• Phase: Phase 1
• First received: February 29, 2012
• Last updated: March 5, 2012
• Start date: February 2012
• Est. completion date: December 2012

Study information

• Verified date: March 2012
• Source: Shanghai Zerun Biotechnology Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 160
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 9 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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.

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

Related Conditions & MeSH terms

• Human Papillomavirus

Intervention

Biological:
• HPV 16/18 vaccine, 0,5ml
Subjects were planned to receive HPV vaccine 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
• Placebo control, 0.5ml
Subjects were planned to receive three doses of the placebo control 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule.
• HPV 16/18 vaccine, 1.0ml
Subjects were planned to receive HPV vaccine 1.0ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
• Placebo control, 1.0ml
Subjects were planned to receive three doses of the placebo control 1.0ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule.

Locations

Country	Name	City	State
China	GuangXi Center for Diseases Control and Prevention	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zerun Biotechnology Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence, intensity and relationship to vaccination of any solicited local or systemic reactions.		7 days after each vaccine dose
Primary	Occurrence, intensity and relationship to vaccination of any unsolicited symptom.		30 days after finish vaccinations
Secondary	Neutralizing antibody responses of HPV 16/18 after each vaccine dose.		30 days after finish vaccinations