Trial NCT04551547
Publication Han B, Lancet Infect Dis, 2021
Dates: 2020-10-31 to 2020-12-30
Funding: Public/non profit (Chinese National Key Research and Development Program and Beijing Science and Technology Program)
Conflict of interest: Yes

Methods
RCT
Location : Single center / China
Follow-up duration (months): 7.3
• 1.5 mcg CoronaVac (n = 219)
• 3 mcg CoronaVac (n = 219)
• Adjuvant (n = 114)
Inclusion criteria
  • Healthy children and adolescents aged 3-17 years
Exclusion criteria
  • High-risk epidemiology history within 14 days before enrollment (eg, travel or residence history in communities with case reports, or contact history 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℃
  • history of allergy to any vaccine component
Interventions
Intervention
2 IM doses of 1.5 mcg CoronaVac, 28 days apart
2 IM doses of 3.0 mcg CoronaVac, 28 days apart
Control
2 IM doses of adjuvant, 28 days apart
Participants
Randomized
552 participants
Characteristics of participants
Type of participants: Children
N=552
297 males
Children: 552
Pregnant women: 0
Immunocompromized patients: 0
Mean age: NR
Age range: 03-17
Description of participants
Healthy children and adolescents aged 3-17 years 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 28th day after the second dose vaccination ]
In the report
The primary safety endpoint was adverse reactions within 28 days after each injection in all participants who received at least one dose. The primary immunogenicity endpoint was seroconversion rate at 28 days after the second injection
Documents
available

Protocol

NR

Statistical plan

*

Data-sharing stated: Yes, after publication and finalisation of the completed clinical study report for at least 6 months
Data accessibility: Researchers who provide a scientifically sound proposal will be allowed to access to the de-identified individual participant data. Proposals should be sent to the corresponding authors, at gaoq@sinovac.com (Qiang Gao, MSc) or liqicdc226@163.com (Qi Li, PhD)
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 and the prospective trial registry was used in data extraction and risk of bias assessment. The protocol and appendix referred to in the report were not available at the time of data extraction. The follow-up of participants will continue up to one year. A target sample size was not calculated. There is no change from the trial registration in the population, outcomes, or interventions.
This trial was updated on September 19, 2022 after publication of the study report.