Immunogenicity and Safety of Co-immunization With Cecolin and Hecolin (NCT05415345) | Clinical Trial Compass
UnknownPhase 4
Immunogenicity and Safety of Co-immunization With Cecolin and Hecolin
China480 participantsStarted 2021-10-25
Plain-language summary
The purpose of this study is to evaluate the immunogenicity and safety of co-immunization with recombinant human papillomavirus bivalent (Types 16,18) vaccine (Escherichia coli) and Hepatitis E vaccine (Escherichia coli)
Who can participate
Age range18 Years – 25 Years
SexFEMALE
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Inclusion Criteria:
* Female, aged between 18 and 25 years (including 18 and 25 years) on the day of enrollment
* Judged as healthy and eligible for vaccination by the investigators through a self- reported medical history and some physical examinations
* Willing to participate in this study and sign informed consent form
* Able to understand this study information and willing to comply with all study requirements
* Axillary temperature ≤37.0 °C
* Negative urine pregnancy test
Exclusion Criteria:
* Women who are pregnant or breastfeeding or who plan to get pregnant within the next seven months
* Use of any investigational product or non-registered product (drug or vaccine) within 30 days preceding the first dose of the study vaccine or plan to use during the study period
* Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, except local treatment
* Administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine,or plan to use during the study period
* Administration of any inactivated vaccines within 14 days preceding the first dose of the study or attenuated live vaccines within 21 days preceding the first dose of the study
* Had a fever (axillary temperature over 38°C) within 3 days or acute illness requiring systemic antibiotics or antiviral treatment within 5 days before vaccination
* Plan to participate in another clinical study a…
What they're measuring
1
evaluate the concentration of IgG antibodies to HPV-16
Timeframe: At 7 months after first dose
2
evaluate the concentration of IgG antibodies to HPV-18
Timeframe: At 7 months after first dose
3
evaluate the concentration of IgG antibodies to HEV