Status:
WITHDRAWN
Evaluation of COVID-19 Vaccines Given as a Booster in Healthy Adults in Indonesia (MIACoV Indonesia)
Lead Sponsor:
Murdoch Childrens Research Institute
Collaborating Sponsors:
Universitas Padjadjaran
Health Development Policy Agency, Ministry of Health Republic of Indonesia
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a randomised controlled clinical trial to determine the reactogenicity and immunogenicity of booster doses of SARS-CoV-2 vaccines (Pfizer-BioNTech, AstraZeneca or Moderna) in adults who have p...
Detailed Description
There will be a total of 800 participants in the study, to be randomised and administered booster doses in this study. The study will be conducted at 3 clinics in Bandung. Participants will have prev...
Eligibility Criteria
Inclusion
- Clinically healthy adults aged 18 years and above who had completed the primary series of COVID-19 vaccine with CoronaVac or AstraZeneca more than 6 months prior to enrolment to the study.
- Signed written informed consent form and willing to comply with the instructions of the investigator and the schedule of the trial.
Exclusion
- Those who have already received a third dose of SARS-CoV-2 vaccine
- Concomitantly enrolled or scheduled to be enrolled in another trial.
- Those with fever (temperature ˃ 37.5℃, measured with infrared thermometer/thermal gun), upper respiratory tract infection symptoms such as sneezing, nasal congestion, runny nose, cough, sore throat, loss of taste, chills and shortness of breath within 72 hours before enrolment.
- Blood pressure ˃ 180/110 mmHg.
- History of confirmed COVID-19 within one month prior to study enrolment.
- History of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnoea, and angioneurotic oedema.
- Those with uncontrolled autoimmune disease such as systemic lupus erythematosis.
- History of uncontrolled coagulopathy or blood disorders, immune deficiency.
- History of having received blood derived product/transfusion within 3 months prior to enrolment.
- Those who received immunosuppressant therapy such as high-dose corticosteroid or cancer chemotherapy
- Those with uncontrolled chronic disease, such as severe heart disease, asthma exacerbation
- Those who have history of uncontrolled epilepsy (within the last 2 years) or other progressive neurological disorders, such as Guillain-Barre Syndrome
- Those who have receive any vaccination within 2 weeks before study vaccine administration for this protocol, or intended to receive any vaccination within 2 weeks after study vaccine administration.
- Pregnant woman
- Those aged ≥60 years old with difficulty in climbing 10 steps of stairs, frequently experiencing fatigue, difficulty in walking 100-200 m, or having at least 5 comorbidities (hypertension, diabetes, cancer, chronic lung disease, heart attack, congestive heart failure, chest pain, asthma, joint pain, stroke, and kidney disease).
- Those who are study staff working on the study or the immediate family of study investigators
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05387317
Start Date
April 1 2024
End Date
October 1 2025
Last Update
March 22 2024
Active Locations (3)
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1
Puskesmas Ciumbuleuit
Bandung, West Java, Indonesia
2
Puskesmas Dago
Bandung, West Java, Indonesia
3
Puskesmas Garuda
Bandung, West Java, Indonesia