Publication Thuluva S, Vaccine, 2022
Funding: Mixed (Biological E.Limited, Telangana, India; BIRAC- a division of the Department of Biotechnology, Govt of India; CEPI (Coalition for Epidemic Preparedness Innovation).)
Conflict of interest: Yes
Multicenter / India |
Follow-up duration (months): 1.87
|0.5mL BECOV2 12-18 yo. (n = 234)
Placebo 12-18 yo. (n = 78)
0.5mL BECOV2 5-12 yo. (n = 234)
Placebo 5-12 yo. (n = 78)
2 IM doses of 0.5 mL BECOV2, 28 days apart
2 IM doses adjuvant placebo, 28 days apart2 IM doses adjuvant placebo, 28 days apart
|Characteristics of participants|
Type of participants: children and adolescents
Immunocompromized patients: 0
|Description of participants|
Healthy children and adolescents who were SARS-CoV-2 RT-PCR and anti-SARS-CoV-2 antibody negative in 23 centers in India
|In the register|
Phase II: 1. Occurrence of any adverse reactions within 60 minutes of immediate post vaccination period after each dose. 2.The occurrence of solicited symptoms and their severity 7 consecutive days after each dose. 3. The occurrence of any unsolicited adverse events and their severity till 28 days after each post vaccination period. 4. The occurrence and severity of any SAEs or medically attended AEs or AEs of special interest (AESIs) 28 days after each dose. Phase III: 1. Immune response in terms of geometric mean neutralizing titres and their geometric mean fold rise from baseline, at day 42.
|In the report|
The primary outcome of the phase-2 and secondary outcome of phase-3 part of the study was to assess the safety, tolerability and reactogenicity of CORBEVAX™ vaccine in children and adolescents in comparison to placebo group in terms of occurrence of any solicited and unsolicited AEs for 28 days’ post vaccination. The primary outcome of phase-3 part of the study was demonstration of immunogenic non-inferiority of BE’s CORBEVAX™ vaccine against adult population in terms of geometric mean neutralizing titers and their geometric mean fold rise from baseline, at day 42 (14 days after 2nd dose).
|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
In addition to the published article, the trial registry and supplementary appendices were used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The primary and secondary outcomes in the article reflect those in the registry. The trial (n = 624) its target sample size (n = 624).
This trial was updated on November 10th 2022, after publication of the study report.