Covid-19 Living Data

Trial ChiCTR2000032459
Publication Xia S , Lancet, 2021
Dates: 2020-08-14 to 2020-09-24
Funding: Private (Beijing Institute of Biological Products)
Conflict of interest: Yes

Methods
	RCT
	Location : Single center / China Follow-up duration (months): 2.9
	2 mcg BBIBP-CorV (n=252) 4 mcg BBIBP-CorV (n=252) 8 mcg BBIBP-CorV (n=252) Placebo adjuvant (n=252)
Inclusion criteria	Healthy individuals aged 3–17 years negative for serum-specific IgM or IgG antibodies against SARS-CoV-2 N and S proteins
Exclusion criteria	History of travelling to Hubei, regions outside of China, or regions within China with any reported COVID-19 cases since December, 2019 a history of infection with SARS-CoV fever (axillary temperature more than 37·3°C if aged older than 14 years, and axillary temperature of more than 37·5°C if aged 14 years or younger), respiratory syndromes, diarrhoea, dyspnoea, or tachypnoea within 14 days before vaccination abnormal results in laboratory tests (blood biochemistry tests [alanine aminotransferase, aspartate aminotransferase, total bilirubin, creatinine, urea nitrogen], routine blood tests [haemoglobin, white blood cell count], and routine urine tests [protein, urine sugar, blood cells—microscopic examination]) allergy to any ingredient included in the vaccine a history of seizures or mental illness (defined as a history of convulsion, epilepsy or psychosis) and being unable to comply with the study schedule
Interventions
	Intervention 3 IM doses of 2 mcg, 28 days apart 3 IM doses of 4 mcg, 28 days apart 3 IM doses of 8 mcg, 28 days apart
	Control 3 IM doses of adjuvant, 28 days apart
Participants
	Randomized 1008 participants
	Characteristics of participants Type of participants: Children and adolescents N=1008 525 males Children: 1008 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 3-18
	Description of participants Healthy children and adolescents aged 3 to 17 years free from SARS-CoV-2 infection and antibodies at a single centre in China
Primary outcome
	In the register Incidence of adverse reactions/events 0-7 days after each dose of vaccination
	In the report adverse reactions within 7 days after each vaccination
Documents available	Protocol NR Statistical plan * Data-sharing stated: Yes, IPD: beginning 3 months and ending 1 year after publication; Supporting clinical documents (study protocol, statistical analysis plan, informed consent form): immediately after publication for at least 1 year Data accessibility: Researchers who provide a scientifically sound proposal will be allowed access to the individual participant data. Proposals should be directed to wangyanxia99@163.com or nvsiclinicaltrials@163.com Correspondence to: Prof Wanshen Guo, Provincial Center for Disease Control and Prevention, Henan 450018, China, cdcgws@163.com; or to: Mr Xiaoming Yang, Institute of Biological Products Company Limited, Beijing 100176, China, yangxiaoming@sinopharm.com
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 supplementary materials and prospective trial registry were used in data extraction and risk of bias assessment. The protocol was not available at the time of data extraction. The study reported on 3 different concentrations using a schedule of 3 doses with 28 days interval in children and adolescents in phase 1 and 2 trials combined, but split by age group (3-5 years, 6-12 years, 13-17 years). Trialists indicated that a 2-dose schedule with 21 days interval between doses using 4 mcg will be used in a phase 3 immunobridging trial in children and adolescents. Immunogenicity results were extracted only for the group aged 13-17 years since overall results were not reported (aggregated). Serious adverse events were pre-specified in the registry but were not reported. There were no other important differences between registry and published report in population, procedures, or interventions. The target sample size specified in the registry was achieved.