Phase 3 study, to evaluate the safety and immunogenicity of 10 mcg HXP-GPOVac COVID-19 vaccine boost in comparison to a viral vector-based COVID-19 vaccines

The Government Pharmaceutical Organization0 sites4,000 target enrollmentOctober 26, 2022

ConditionsHealthy male and female subjects

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Healthy male and female subjects
Sponsor: The Government Pharmaceutical Organization
Enrollment: 4000
Status: Enrolling By Invitation
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 26, 2022

End Date

January 23, 2024

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

The Government Pharmaceutical Organization

Eligibility Criteria

Inclusion Criteria

•1\. Willingness to provide a signed and dated informed consent form.
•2\. Stated willingness to comply with all study procedures and availability for entire duration of the study.
•3\. Be a Thai male or female 18 years of age or older who were previously vaccinated with two intramuscular doses of Pfizer\-BioNTech or AstraZeneca or Sinovac vaccine with a minimum of 4 months from their second dose vaccination.
•4\. For females: Be of non\-childbearing potential or willing to use appropriate contraceptive measures for 30 days prior to vaccination through two months after complete vaccination. Non\-childbearing potential means being surgically sterilized or at least one year post\-menopausal. Appropriate measures to prevent pregnancy include abstinence or adequate contraceptive precautions (intrauterine or implantable contraceptive device, oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam).
•5\. For healthy participants with pre\-existing medical conditions: Be in stable condition that has not worsened over the three months before enrollment to require hospitalization or significant changes in therapy.

Exclusion Criteria

•1\. Prior or planned administration of a non\-study vaccine (licensed or investigational) within 30 days before and after vaccination.
•2\. History of allergic reactions or anaphylaxis to any previous immunizations.
•3\. History of allergies to eggs, chicken, or any components of the study vaccine.
•4\. Fever (greater than or equal to 38\.0 Celsius) within the past 24 hours.
•5\. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the study vaccine.
•6\. Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban).
•7\. History of COVID\-19 infection within the three months preceding the planned administration of the study vaccine.
•8\. History of bleeding disorder (exempli gratia: factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following intramuscular (IM) injections or venipuncture.
•9\. History of cerebral venous sinus thrombosis, antiphospholipid syndrome or heparin induced thrombocytopenia and thrombosis (HITT or HIT type 2\).
•10\. Any other significant disease, disorder or finding which in the opinion of the investigator may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study or impair interpretation of the study data.