CompletedPhase 1

A Phase I Trial Evaluate the Safety and Tolerability Profile of HPV Vaccine

China160 participantsStarted 2019-09-01

Plain-language summary

This study is to evaluate the safety and tolerability profile of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) in healthy women ages 18-45

Who can participate

Age range18 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

✓. Female subjects 27-45 years of age (inclusive of 27 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 understand and agree to comply with the study procedures and provide written informed consent;
✓. Subjects who are able to comply with protocol-specified requirements;
✓. Subjects with negative urine pregnancy test result at screening;
✓. Subjects with no childbearing potential (e.g. females who have undergone bilateral tubal ligation, hysterectomy, bilateral oophorectomy, etc.), or 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 and throughout the study;
✓. Subjects with axillary temperature≤37.0℃.
✓. Female subjects 18-26 years of age (inclusive of 18 and 26 years of age);

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;
✕. Women who have known allergy history or who 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 two years;
✕. Women who have diabetes mellitus (type I or II), with the exception of gestational diabetes;

What they're measuring

Percentage of adverse reaction(s) within 7 days post any dose of the interventions.

Timeframe: 0-7 months

Trial details

NCT IDNCT05680454

SponsorBeijing Health Guard Biotechnology, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-04-06

View on ClinicalTrials.gov More Human Papillomavirus Infection trials