Publication Khobragade A, Lancet , 2022
Dates: 2021-01-16 to 2021-06-23
Funding: Mixed (National Biopharma Mission, Department of Biotechnology, Government of India; Cadila Healthcare, Ahmedabad, Gujarat India; PharmaJet provided the PharmaJet Tropis needle-free injection system for vaccine delivery.)
Conflict of interest: Yes
Multicenter / India |
Follow-up duration (months): 5.2
|2 mg ZyCov-D (n=13851)
3 intradermal doses of 2mg ZyCoV-D, 28 days apart
3 intradermal doses of placebo, 28 days apart
|Characteristics of participants|
Type of participants: Adolescents and adults
Pregnant women: 0
Immunocompromized patients: 0
Age range: 12-88
|Description of participants|
Healthy adults and adolescents aged (≥12 years) with no previous history of COVID-19 at 49 centers in India.
|In the register|
To demonstrate the efficacy of ZyCoV-D in the prevention of virologically confirmed symptomatic COVID-19 cases as compared to placebo. Timepoint Day 84 to Day 364.
|In the report|
The number of participants with first occurrence of symptomatic RT-PCR-positive COVID-19, 28 days after the third dose of ZyCoV-D vaccine, until the targeted number of cases (n=158) had been achieved.
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
|General comment||In addition to the published article, the prospective study registry and supplementary appendices were used in data extraction and risk of bias assessment. The protocol and statistical analysis plan were not available. The article reports an interim analysis triggered when 50% of COVID-19 events had been detected and thus the study (n = 27703) had not yet achieved its target sample size (n = 28216). There were no important differences between protocol/registry and published report in population, procedures, interventions or outcomes.|