Trial NCT04368728
Publication Frenck R, N Engl J Med, 2021
Dates: 2020-10-15 to 2021-01-12
Funding: Private (BioNTech and Pfizer)
Conflict of interest: Yes
Methods | |
RCT | |
Location :
Multicenter / USA Follow-up duration (months): 4.7 | |
• 30 mcg BNT162b2 (n = 1134) • Placebo (n = 1130) |
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Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Intervention
2 IM doses of 3mcg, 21 days apart |
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Control
2 IM doses of placebo, 21 days apart | |
Participants | |
Randomized 2264 participants | |
Characteristics of participants Type of participants: Adolescents N=2264 1152 males Pregnant women: 0 Mean age: Age range: 12-15 | |
Description of participants Adolescents aged 12 to 15 years with no previous Covid-19 diagnosis or SARS-CoV-2 infection in 29 centers in the USA | |
Primary outcome | |
In the register Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination [ Time Frame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years ]; Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination [ Time Frame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years ]; Percentage of participants 12-15 years of age in Phase 3 reporting adverse events [ Time Frame: From dose 1 through 1 month after the last dose ], [ Time Frame: From dose 1 through 6 months after the last dose ]; In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting local reactions [ Time Frame: For 7 days after dose 1 and dose 2 ]; In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting systemic events [ Time Frame: For 7 days after dose 1 and dose 2 ] | |
In the report NR | |
Documents available |
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 |
Some concerns |
General comment | In addition to the published article, the prospective study registry and protocol were used in data extraction and risk of bias assessment. The report presented interim analyses for adolescents through the cutoff date of March 13, 2021; follow-up is ongoing. Target sample size was not calculated. There were no major differences between the registry and protocol and the published article in population, procedures, interventions, and outcomes. |