A phase II randomized controlled trial evaluating the immunogenicity and safety of a recombinant aP vaccine and various Tdap vaccine formulations in healthy women of child bearing age

BioNet-Asia Co.,Ltd.0 sites250 target enrollmentMarch 21, 2018

ConditionsPertussis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Pertussis
Sponsor: BioNet-Asia Co.,Ltd.
Enrollment: 250
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

From July 5 to 22, 2018, 250 women with median age of 31 years were enrolled in the study. Seroresponse rates for anti-PT were 92% (95% CI 80.8-97.8) for BioNet ap, 88% (95% CI 75.7-95.5) for BioNet Tdap (low dose), 80% (95% CI 66.3-90.0) for BioNet Tdap (medium dose), 94% (95% CI 83.5-98.8) for Boostagen and 78% (95% CI 64.0-88.5) for Boostrix. All formulations passed the seroresponse criterion and will be further evaluated in pregnant women.

Registry

who.int

Start Date

March 21, 2018

End Date

August 19, 2018

Last Updated

last year

Study Type

Interventional

Sex

Female

Investigators

Sponsor

BioNet-Asia Co.,Ltd.

Eligibility Criteria

Inclusion Criteria

•1\. Female, aged 18\-40 years (inclusive) at the time of enrollment;
•2\. Willing and able to provide written informed consent prior to any study procedure;
•3\. Free of clinically significant health problems, as determined by pertinent medical history and clinical examination at study screening;
•4\. Must have a negative urine pregnancy test at enrollment and willing to take reliable birth control measures for 1 month after vaccination;
•5\. Able to attend all scheduled visits and to understand and comply with the study procedures in the principal investigator's judgment.

Exclusion Criteria

•1\. Acute or chronic, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the Investigator based on medical history, physical exam;
•2\. Pregnant or breast\-feeding women or female who intends to become pregnant during the study period;
•3\. History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions;
•4\. Known hypersensitivity or allergy to diphtheria, tetanus, or pertussis vaccine (including excipients);
•5\. Receipt of investigational product up to 30 days prior to enrollment or ongoing participation in another interventional clinical trial;
•6\. Receipt of licensed vaccines within 30 days prior to enrollment (3 months for live attenuated vaccines) or plan to receive other vaccine during the study period;
•7\. Receipt of diphtheria or tetanus or pertussis vaccine within 1 year prior to enrollment;
•8\. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination;
•9\. Any chronic or active neurologic disorder, including seizures, and epilepsy;
•10\. Has a known history of Guillain\-Barre Syndrome;