Status and phase
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About
The primary objective of the study is to measure the anti-SARS-CoV-2 neutralizing antibody titres in adult participants, in particular elderly, so as to demonstrate immunogenic superiority of MVC-COV1901 to the active control, AZD1222 vaccine, in terms of the GMT of neutralizing antibodies at 14 days after the second dose of the study intervention. This study also assesses the safety and tolerability of the study intervention and explores the immunogenicity in terms of antigen-specific immunoglobulin as well as the potential efficacy of MVC-COV1901 in preventing COVID-19.
Full description
This is a Phase III, parallel-group, prospective, randomized, double-blind, active-controlled, two- arm study to be conducted in approximately 250 participants aged 18 years and above who are generally healthy or with stable pre-existing medical conditions. The participants, investigators, the site personnel and the Sponsor staff who are involved in the blinded conduct of the study will be blinded to the study intervention assignment. Preparation and administration of the study intervention will be performed by authorized unblinded site personnel who do not participate in the evaluation of the participants.
Eligible participants will be randomized to receive either MVC-COV1901 or AZD1222 vaccine in a 1:1 ratio. Randomization of participants will be stratified by study site and age (≥ 18 to < 65 years and ≥ 65 years), at least 40% of the participants shall be ≥ 65 years.
Approximately 30 participants in the age 18 to <65 group and 10 participants in the age ≥ 65 years will be included in the CMI Subset for CMI assessments.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Male or female participant aged 18 years and above at randomization.
Healthy adult or adult with pre-existing medical conditions who is in a stable condition. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease 3 months before enrollment and expected to remain stable for the duration of the study.
Female participant:
i. Implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine hormonal-releasing system ii. Established use of hormonal methods (injectable, pill, patch or ring) combined with barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository iii. Azoospermic partner (vasectomized or due to medical cause), provided the partner is the sole sexual partner of the female participant and the absence of sperm has been confirmed (from medical records/examination/history).
c. Have a negative pregnancy test
Participant is willing and able to comply with all required study visits and follow-up required by this protocol.
Participant or the participant's legal representative must understand the procedures of the study and provide written informed consent.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
200 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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