Trial jRCT2031210470
Publication Shinkai M, Vaccine, 2022
Dates: 2021-12-03 to 2021-12-22
Funding: Mixed (Shionogi & Co., Ltd.; Ministry of Health, Labour and Welfare (MHLW), Japan; Japan Agency for Medical Research and Development (AMED))
Conflict of interest: Yes
Methods | |
RCT | |
Location :
Single center / Japan Follow-up duration (months): 1 | |
S-268019 booster (n = 101) BNT162b2 booster (n = 103) |
|
Inclusion criteria |
|
Exclusion criteria |
|
Interventions | |
Intervention
1 IM 10 mcg S-268019-b booster, at least 6 months after prime BNT162b2 schedule |
|
Control
1 IM 30 mcg BNT162b2 booster, at least 6 months after prime BNT162b2 schedule | |
Participants | |
Randomized 204 participants | |
Characteristics of participants Type of participants: Adults N=204 143 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 21-59 | |
Description of participants Adults who had received 2 doses of BNT162b2 vaccine at least 6 months earlier with no history of SARS-CoV-2 infection at a single centre in Japan | |
Primary outcome | |
In the register SARS-CoV-2 neutralizing antibody titer on Day 29 | |
In the report day 29 geometric mean titer (GMT) and seroresponse rate (SRR) for SARS-CoV-2 neutralizing antibodies | |
Documents available |
Protocol NR Statistical plan * Data-sharing stated:
Yes |
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 pre-print, 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 outcome in the article reflected that in the registry. The trial (n = 204) achieved its target sample size (n = 204).
This study was updated on September 19th, 2022 after publication of the study report. |