A Phase III Study of Human Papillomavirus (HPV)-16/18 Vaccine. (NCT02733068) | Clinical Trial Compass
CompletedPhase 3
A Phase III Study of Human Papillomavirus (HPV)-16/18 Vaccine.
12,000 participantsStarted 2014-11-02
Plain-language summary
A Phase III Double Blinded, Randomized Controlled Study to Evaluate Efficacy of Protection Against HPV-16 and 18 Related Diseases, Immunogenicity and Safety of Recombinant Human Papillomavirus Virus-like Particle Vaccine (Type 16 and 18 L1 Proteins, Yeast) in Healthy Females Aged 18-30 Years.
Who can participate
Age range18 Years – 30 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18-30 healthy female
* enable to provide an legal identification
* have the ability to understand and sign the Informed Consent Form
* confirmed by the investigator that the participant has the ability to comply with the protocol requirements
* agreed to use effective contraceptive method in 7 months or has no plan of pregnancy
* can avoid vaginal sex within two days (48 hours) before every interview; don't employ a vaginal douche or any other intervention which can influence the gynecological examination and sample collection
Exclusion Criteria:
* has received HPV vaccine previously; have received other research or unregistered product (drug or vaccine) within 30 days before the first injection
* within three months before the first injection, has had received a whole-blood, plasma or immunoglobulin treatment, or planed to receive such treatments during the research period; within 28 days before the research, has had received attenuated live vaccine; or within 14 days has had received inactivated vaccine
* has a history of allergic reaction which requires medical intervention; has allergic reaction for vaccine or vaccine-containing elements; has serious adverse effect history for vaccine
* has a history of epilepsy, convulsion or has a family history of mental diseases
* has immunodeficiency diseases including: AIDS, HIV infection, lymphoma, leukemia, Systemic Lupus Erythematosus, rheumatoid arthritis, Juvenile Rheumatoid Arthritis, inflammatory bowe…
What they're measuring
1
Cervical intraepithelial neoplasia grade 2 or more (CIN 2+) caused by HPV type 16 and/or 18.