A Phase II Trial Evaluate the Immunogenicity and Safety Profile of HPV Vaccine (NCT05694728) | Clinical Trial Compass
CompletedPhase 2
A Phase II Trial Evaluate the Immunogenicity and Safety Profile of HPV Vaccine
China780 participantsStarted 2020-05-23
Plain-language summary
This trail is to evaluate the safety profile of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) in healthy Chinese women ages 20-45 and determine the optimal ratio of the antigens included in the investigational vaccine. Besides, the trail is also to demonstrate that the levels of neutralizing antibodies to vaccine HPV types 31, 33, 45, 52 and 58 elicited by the investigational vaccine with the chosen optimal antigen ratio are superior to those induced by Gardasil.
Who can participate
Age range20 Years – 45 Years
SexFEMALE
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Inclusion criteria
✓. Female subjects ages 20-45 (inclusive of 20 years of age and 45 years of age);
✓. Subjects decided to be healthy by the principal investigator in accordance with such trial subjects' medical history and physical examination results;
✓. Subjects who agree to participate in the trial after being fully informed of the study, and provide a written informed consent;
✓. Trial subjects who are able to comply with protocol-specified requirements;
✓. Trial subjects with negative urine pregnancy test at screening;
✓. Trial subjects with no childbearing potential (e.g. females who have undergone bilateral tubal ligation, hysterectomy, bilateral oophorectomy, etc), or female subjects with childbearing potential who have agreed to abstain from any sexual activity that could result in pregnancy or practice adequate contraception for at least 28 days prior to the first dose of the interventions and throughout the study.
✓. Subjects with axillary temperature≤37.0℃.
Exclusion criteria
✕. Women who are pregnant or breastfeeding, or planning for pregnancy in the following 7 months;
✕. Women who have received other HPV vaccine(s) prior to dose 1 of the interventions;
✕. Women who have received an investigational or unregistered drug or vaccine within 28 days prior to the first dose of the interventions, or plan to receive an investigational or unregistered drug or vaccine during the study;
What they're measuring
1
Percentage of adverse reactions up to Day 7 after each dose of the interventions
Timeframe: 0-7 days after each immunization
2
To determine the optimal ratio of antigens included in the investigational vaccine
✕. Women who have known anaphylaxis history or are allergic to any component of the interventions, such as penicillin and amikacin;
✕. Women with a history of severe adverse reactions to previous vaccinations, such as allergies, urticaria, dyspnea, angioneurotic edema, or abdominal pain;
✕. Women who have an autoimmune disease or immunodeficiency, are HIV positive, or have primary diseases in vital organs;
✕. Women who have asthma that is unstable and requires urgent care, hospitalization and the use of oral or intravenous corticosteroids during the past 2 years;
✕. Women who have diabetes mellitus (type I or II), with the exception of gestational diabetes;