Trial NCT04677660
Publication Masuda T, Vaccine, 2022
Dates: 2021-01-21 to 2021-02-03
Funding: Mixed (Takeda Pharmaceutical Company Limited and Japan Agency for Medical Research and Development (AMED))
Conflict of interest: Yes

Methods
RCT
Location : Multicenter / Japan
Follow-up duration (months): 1.9
mRNA-1273 (n = 150)
Placebo (n = 50)
Inclusion criteria
  • Japanese adults aged ≥ 20 years
  • in good health as determined by medical history, physical examination (including vital signs and laboratory tests) and clinical judgement of the investigator.
Exclusion criteria
  • Received any other SARS-CoV-2 vaccines or other experimental novel coronavirus vaccine
  • had been in close contact with anyone known to have COVID-19 within 30 days before study vaccination
  • positive for SARS-CoV-2 infection before the trial
Interventions
Intervention
2 IM doses of 100 mcg mRNA-1273, 28 days apart
Control
2 IM doses of saline placebo, 28 days apart
Participants
Randomized
200 participants
Characteristics of participants
Type of participants: Healthy adults
N=200
112 males
Children: 0
Pregnant women: 0
Immunocompromized patients: 0
Mean age:
Age range: 20-77
Description of participants
Healthy adults aged ≥ 20 years with no known history/risk of SARS-CoV-2 infection at 2 centers in Japan.
Primary outcome
In the register
1) Percentage of Participants with Reported Solicited Local Adverse Events (AEs) for 7 Days Following Each Vaccination [ Time Frame: Up to Day 7 after each vaccination ]; 2) Percentage of Participants with Solicited Systemic AEs for 7 Days Following Each Vaccination [ Time Frame: Up to Day 7 after each vaccination ]; 3) Percentage of Participants with Unsolicited AEs for 28 Days After Each Vaccination [ Time Frame: Up to Day 28 after each vaccination ]; 4) Percentage of Participants with Serious AE (SAE) until Day 57 [ Time Frame: Up to Day 57 ]; 5) Percentage of Participants with Medically-Attended Adverse Events (MAAEs) until Day 57 [ Time Frame: Up to Day 57 ]; 6) Percentage of Participants with Any AE Leading to Discontinuation of Vaccination [ Time Frame: Up to Day 57 (up to discontinuation of vaccination) ]; 7) Percentage of Participants with Any AE Leading to Participant's Withdrawal from the Trial until Day 57 [ Time Frame: Up to Day 57 ]; 8) Percentage of Participants with SARS-CoV-2 Infection until Day 57 [ Time Frame: Up to Day 57 ]; 9) Geometric Mean Titers (GMT) of Serum binding antibody (bAb) Against SARS-CoV-2 on Day 57 [ Time Frame: Day 57 ]; 10) Geometric Mean Fold Rise (GMFR) of Serum bAb Against SARS-CoV-2 on Day 57 [ Time Frame: Day 57 ]; 11) Seroconversion Rate (SCR) of Serum bAb Against SARS-CoV-2 on Day 57 [ Time Frame: Day 57 ]
In the report
1) solicited AEs through 7 days after each vaccination; 2) unsolicited AEs through 28 days after each vaccination; 3) MAAEs, SAEs, AEs leading to discontinuation of vaccination and AEs leading to participant withdrawal from the trial through day 57; 4) proportion of participants with SARS-CoV-2 infection through day 57; 5) serum bAb levels against SARS-CoV-2 on day 57
Documents
available

Protocol

NR

Statistical plan

*

Data-sharing stated: Yes, after the publication of the final study results within 3 months from initial request to researchers who provide a methodologically sound proposal
Data accessibility: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement. Corresponding author: taisei.masuda@takeda.com (T. Masuda)
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 prospective trial registry and supplementary appendix were used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The primary outcomes reported in the article reflect those in the registry. The trial achieved its target sample size (n = 200).