Clinical Trial of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine

An Open-Label, Single-dose, Non-Randomized, Safety and Tolerability Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine (E.Coli)in Healthy Female Subjects Aged 18 to 55 Years

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01263327

Enrollment

Registered

2010-12-20

Start date

2010-12-31

Completion date

2011-07-31

Last updated

2020-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Keywords

human papillomavirus vaccine

Brief summary

This phase I clinical study was designed to evaluate the safety of novel recombinant HPV 16/18 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO., LTD., in healthy women 18-55 years of age at enrolment. Approximately 30 study subjects will receive the novel HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.

Interventions

BIOLOGICALHPV 16/18

Participants would intramuscularly receive 90mcg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Written informed consent from the subject prior to enrolment; * Female between, and including, 18 and 55 years of age at the time of enrolment; * Subjects must be free of obvious health problems; * Not pregnant and having no plan for pregnancy;

Exclusion criteria

* Pregnant or breastfeeding or having plan for pregnancy during the whole study (Month 0-7); * Previous vaccination against HPV; * Having severe allergic history or other immunodeficiency; * Chemotherapy and other immunosuppressive agents using;

Design outcomes

Primary

Measure	Time frame
Measure injection-site complaints within 7 days after each vaccination; Measure systematic adverse reactions within 1 month after vaccination; Measure serious adverse experience; Measure blood, liver and kidney functions pre- and 3 days post vaccination.	7 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026