Trial NCT04383574
Publication Wu Z, 2021
Dates: 5/22/2020 to 6/15/2020
Funding: Public/nonprofit (The National Key Research and Development Program; the Beijing Science and Technology Program)
Conflict of interest: Yes
| Methods | |
| RCT | |
| Location :
Single center / China Follow-up duration (days): 56 | |
| Inclusion criteria | Healthy adults aged 60 years or older. |
| Exclusion criteria | High-risk epidemiological history within 14 days before enrolment (eg, travel to or residence in Wuhan and surrounding areas or other communities with reports of COVID-19 cases, or contact with someone infected with SARS-CoV-2) ; history of severe acute respiratory syndrome or SARS-CoV-2 infection ; axillary temperature of more than 37·0°C ; a history of allergy to any vaccine component. |
| Interventions | |
| Treatment 1 CoronaVac 1.5mcg D0/28 | |
| Control Adjuvant | |
| Treatment 3 CoronaVac 3mcg D0/28 | |
| Treatment 4 CoronaVac 6mcg D0/28 | |
| Participants | |
| Randomized 422 participants | |
| Characteristics of participants Type of participants: Older adults N=422 Adults: 422 Children: 0 Pregnant women: 0 HIV patients: 0 Participants close contacts to COVID-19 patients: 0 Mean age : NR 206 males | |
| Description of participants Healthy adults aged 60 years and older with no history of SARS-CoV-2 infection in a single centre in China | |
| Primary outcome | |
| In the register Safety index-incidence of adverse reactions [ Time Frame: Day 0-28 after each dose vaccination ]; Immunogenicity index-seroconversion rates of neutralizing antibody [ Time Frame: The 30th day after the second dose vaccination ] | |
| In the report Vaccine-related adverse event (adverse reaction) within 28 days after the administration of each dose of vaccine or placebo; Seroconversion rate of neutralising antibodies to live SARS-CoV-2 at day 28 after the second dose | |
| Documents avalaible |
Protocol Yes. In English Statistical plan Yes 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 |
Low |
| General comment | In addition to the published article, the protocol, statistical analysis plan, and study registry were used in data extraction and risk of bias assessment. The units for vaccine doses were different in the trial registration and protocol compared to the published article. The safety data of the phase 1 and phase 2 trial were combined for analysis because the same batches of vaccine and placebo and the same safety observation method were used. Primary outcomes were reported as pre-specified in the registry. Both Phase 1 and 2 trials achieved their pre-stated sample size. This is an early interim analysis of a Phase 1 and a Phase 2 trial in which follow up is continuing. |