Immunogenicity and Safety of Human Papillomavirus (HPV)-16/18 Vaccine in Healthy Females (NCT02740790) | Clinical Trial Compass
CompletedPhase 2
Immunogenicity and Safety of Human Papillomavirus (HPV)-16/18 Vaccine in Healthy Females
China1,200 participantsStarted 2013-09
Plain-language summary
Evaluate immunogenicity and safety of recombinant human papillomavirus bivalent ( types 16 and 18 ) vaccine ( Yeast )in different age group. And evaluate persistence of immune response in 9-17years age group. To demonstrate that 9-17years age group was non-inferior to 18-26 years age group and 27-45 years age group in terms of immunogenicity.
Who can participate
Age range9 Years – 45 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Previous administration of any HPV vaccine
* 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 abnor…
What they're measuring
1
The neutralizing antibody responses of HPV 16/18 after vaccination by measuring Geometric Mean Titer (GMT).