Immunogenicity and safety of various recombinant acellular pertussis-containing vaccines in healthy women of child bearing age

Phase 2

Completed

• Conditions: Pertussis

• Registration Number: TCTR20180321004
• Lead Sponsor: BioNet-Asia Co.,Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-21
• Study Completion: 2018-08-19
• Results First Posted: 2021-11-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 250

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;
11. Has an active malignancy or recent (<10 years) history of metastatic or hematologic malignancy;
12. Suspected or known alcohol and/or illicit drug abuse within the past 5 years;
13. Administration of immunoglobulins and/or any blood products within 3 months preceding study entry or planned administration during the study period;
14. History of receiving immunosuppressive drugs or systemic corticosteroid (>0.5 mg/kg of prednisolone or equivalent for more than 14 days) within 3 months prior to study entry;
15. Has any active clinically significant finding or life-threatening disease that, in the opinion of the investigator, would increase the risk of the individual's having an adverse outcome by participating in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified