A Global Multi-center, Randomized, Blinded, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine for the Prevention of COVID-19 in Participants Aged 18 Years and Older

Status: Recruiting
Location: See location...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

A Global Multi-center, Randomized, Blinded, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (LVRNA009) for the Prevention of COVID-19 in Participants Aged 18 Years and Older

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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• Adults aged 18 years and older.

• Understand the content of the Informed Consent Form (ICF), and voluntarily sign the ICF (If the participant is unable to sign the ICF on his/her own due to illiteracy, an impartial witness is needed).

• Participants who are willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests, and other study procedures.

• Female participants of childbearing potential or partners of male participants:

• voluntarily agree to use effective contraception with their partners prior to the first vaccination and must agree to continue such precautions during the study until 3 months after full vaccination (including the initial set of vaccination and crossover set of vaccination). \[Effective contraception includes oral contraceptives, injectable or implantable contraception, extended-release topical contraceptives, hormonal patches, intrauterine devices (IUDs), sterilization, abstinence, condoms (for male), diaphragms, cervical caps, etc.\].

• For female participants: without childbearing potential (amenorrhea for at least 1 year or documented surgical sterilization) or have used effective contraception with a negative pregnancy test before each vaccination in this study.

• On the day of 1st dose of vaccination and 24 hours prior to vaccination, axillary temperatures \<37.3°C/99.1°F.

• Healthy participants or participants with mild underlying disease \[in a stable state without exacerbation (no admission to hospital or no major adjustment to treatment regimen, etc.) for at least 3 months prior to enrollment in this study\].

Locations
Other Locations
Kenya
KEMRI CRDR Research Annex, Siaya Country Referral Hospital
RECRUITING
Siaya
Contact Information
Primary
Videlis Nduba, PHD
vnduba@gmail.com
254-724-52247
Time Frame
Start Date: 2023-01-30
Estimated Completion Date: 2025-12
Participants
Target number of participants: 34000
Treatments
Experimental: Vaccine group
Phase 3(Base the result of Phase 1 and Phase 2, intervent 100μg): initial vaccination stage- LVRNA009; crossover vaccination stage- placebo
Placebo_comparator: Control group
Phase 3: initial vaccination stage- placebo; crossover vaccination stage- LVRNA009
Related Therapeutic Areas
Sponsors
Leads: AIM Vaccine Co., Ltd.
Collaborators: AIM Innovation Biotechnology (Shanghai) Co., Ltd, LiveRNA Therapeutics Inc., Ningbo Rongan Biological Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov