Covid-19 Living Data

Trial NCT04508075 ; INA-WXFM0YX
Publication Fadlyana E, Vaccine, 2021
Dates: 2020-08-11 to 2020-10-21
Funding: Mixed (PT Bio Farma and Sinovac Life Sciences Co., Ltd.)
Conflict of interest:

Methods
	RCT
	Location : Single center / Indonesia Follow-up duration (months): 3
	CoronaVac (n = 810 Placebo (n = 810)
Inclusion criteria	Clinically healthy adults aged 18 - 59 years informed consent commit to comply with the instructions of the investigator and the schedule of the trial.
Exclusion criteria	Evolving mild, moderate, or severe illness, especially infectious disease or fever (body temperature ≥ 37.5℃) positive result from a nasopharyngeal swab RT-PCR test reactive IgG and IgM for SARS-CoV-2 lactating, pregnant or planning to become pregnant during the study period serious chronic diseases (serious cardiovascular disease, uncontrolled hypertension and diabetes, liver and kidney disease, malignant tumors, or any condition which according to the investigator may interfere with the assessment of the trial objectives) uncontrolled coagulopathy or blood disorders history of asthma history of allergy to vaccines or vaccine ingredients history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immune response [intravenous immunoglobulins, blood-derived products, or long-term corticosteroid therapy (>2 weeks)] history of uncontrolled epilepsy or other progressive neurological disorders having received any vaccination within 1 month before or after administration of the study vaccine
Interventions
	Intervention 2 IM doses of 3mcg, 14 days apart
	Control 2 IM doses of placebo, 14 days apart
Participants
	Randomized 1620 participants
	Characteristics of participants Type of participants: Healthy adults N=1620 1046 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: NR
	Description of participants Healthy adults aged 18 - 59 years, seropositive and seronegative, at a single center in Indonesia
Primary outcome
	In the register Incidence of laboratory-confirmed COVID-19 after the second dose [ Time Frame: 14 days to 6 months after the second dose ]
	In the report Incidence of laboratory confirmed-symptomatic COVID-19 cases starting at 14 days following the second dose
Documents available	Protocol NR Statistical plan * Data-sharing stated: No Data accessibility: Corresponding author : eddy.fadlyana@unpad.ac.id (E. Fadlyana)
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to the published article, the trial registry and supplementary materials were used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The primary outcome in the article (laboratory confirmed-symptomatic COVID-19 cases) differed slightly from that in the registry (laboratory confirmed COVID-19 cases). Serious adverse events were not reported per arm, as had been pre-specified in the registry. No other important differences were noted between registry and published report in population, procedures, and interventions. The target sample size specified in the registry was achieved. The article reports early findings after 3 months surveillance. Follow up continued to 6 months. It is unclear whether the immunogenicity and adverse events analyses subset, comprising the first 540 participants, was randomised; the report states that study randomisation was done in a 1:1 ratio (810 vs 810), but the subset had unequal sizes (405 vs 135).