Publication Ella R, Lancet, 2021
Dates: 2020-11-16 to 2021-01-07
Funding: Mixed (Bharat Biotech International Limited and the Indian Council of Medical Research.)
Conflict of interest: Yes
Multicenter / India |
Follow-up duration (months): 12
2 IM doses of 6 mcg, 28 days apart
2 IM doses of placebo, 28 days apart
|Characteristics of participants|
Type of participants: Adults
Pregnant women: 0
Immunocompromized patients: 0
Age range: 18-92
|Description of participants|
Adults with no history of SARS-CoV-2 infection who were healthy or had stable chronic medical conditions at 25 centers in India
|In the register|
First occurrence of Virologically confirmed (RT-PCR positive) symptomatic cases of COVID-19. [ Time Frame: Day 42 to Month 12 ] (RT-PCR positive) symptomatic cases of COVID-19.
|In the report|
Efficacy of the BBV152 vaccine in preventing a first occurrence of symptomatic COVID-19(any severity)with onset at least 14 days after the second dose in the per-protocol populationcomposed of participants who were SARS-CoV-2 negative by PCR and serology at baseline,had no major protocol deviations, and followed-up for at least two weeks after the second dose.
Yes. In English
Yes, When the trial is complete upon direct request to the corresponding author with an appropriate research proposal.
|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 pre-print article, the study registry, protocol andstatistical plan were used in the data extraction and risk assessment. Target sample size was achieved. There is not change from the trial registration in the intervention and control treatments. The outcome "The occurrence of enhanced respiratory disease episodes. " is present in the registry but not reported.sAb GMT was not included in the listed outcomes in the registry, but included as an outcome in the detailed description above, along with the small subgroup that immunogenicity was evaluated amongst. ) Mortality was not included in the listed outcomes in the registry, but evaluated as a SAE in the safety population. This trial was updated on Mars 3rd, 2022 after study report publication.|