Covid-19 Living Data

Trial NCT04588480
Publication Haranaka M, Nat. Commun., 2021
Dates: 2020-10-21 to 2020-11-10
Funding: Private (Pfizer Inc.)
Conflict of interest: Yes

Methods
	RCT
	Location : Multicenter / Japan Follow-up duration (months): 1
	BNT162b2 (n = 119) Placebo (n = 41)
Inclusion criteria	Healthy adults 20–85 years of age, including those with stable preexisting disease
Exclusion criteria	Known infection with hepatitis B virus or hepatitis C virus, or HIV a history of severe allergic reactions associated with vaccination previous confirmed COVID-19 diagnosis of an immunocompromising or immunodeficiency disorder pregnant or breastfeeding receipt of medicines intended to prevent COVID-19 previous vaccination with any coronavirus vaccine treatment with immunosuppressive therapy
Interventions
	Intervention 2 IM doses of 30 mcg BNT162b2, 21 days apart
	Control 2 IM doses of saline placebo, 21 days apart
Participants
	Randomized 160 participants
	Characteristics of participants Type of participants: Adults N=160 81 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 20-74
	Description of participants Adults including elderly and co-morbidities with no history of COVID-19 at 2 centres in Japan
Primary outcome
	In the register 1) Percentage of participants reporting local reactions [ Time Frame: For 7 days after dose 1 and dose 2 ] Pain at the injection site, redness, and swelling as self-reported on electronic diaries; 2) Percentage of participants reporting systemic events [ Time Frame: For 7 days after dose 1 and dose 2 ] Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries; 3) Percentage of participants reporting adverse events [ Time Frame: From dose 1 through 1 month after the last dose ] As elicited by investigational site staff; 4) Percentage of participants reporting serious adverse events [ Time Frame: From dose 1 through 12 months after the last dose ] As elicited by investigational site staff; 5) Percentage of subset participants with abnormal hematology and chemistry laboratory values [ Time Frame: 1 day after dose 1 ] As measured at the local laboratory; 6) Percentage of subset participants with abnormal hematology and chemistry laboratory values [ Time Frame: 7 days after dose 1 ] As measured at the local laboratory; 7) Percentage of subset participants with abnormal hematology and chemistry laboratory values [ Time Frame: 7 days after dose 2 ] As measured at the local laboratory; 8) Percentage of subset participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between baseline and 1 day after dose 1 ] As measured at the local laboratory; 9) Percentage of subset participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between baseline and 7 days after dose 1 ] As measured at the local laboratory; 10) Percentage of subset participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between before dose 2 and 7 days after dose 2 ] As measured at the local laboratory; 11) SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs [ Time Frame: 1 month after dose 2 ] As measured at the central laboratory; 12) GMFR in SARS-CoV-2 serum neutralizing titers [ Time Frame: From before vaccination to 1 month after dose 2 ] As measured at the central laboratory; 13) SARS-CoV-2 S1-binding IgG levels, expressed as GMCs [ Time Frame: 1 month after dose 2 ] as measured at the central laboratory; 14) GMFR in SARS-CoV-2 S1-binding IgG levels [ Time Frame: From before vaccination to 1 month after dose 2 ] as measured at the central laboratory
	In the report 1) local reactions or 2) systemic events for 7 days after each dose; 3) adverse events from dose 1 through 1 month after dose 2; 4) serious AEs (SAEs) collected from dose 1 through 12 months after dose 2 (reported to 1 month after dose 2 in this report); 5) hematology and clinical chemistry laboratory parameters up to 7 days after dose 2; 6) geometric mean titers (GMTs) of SARS-CoV-2 neutralization 1 month after dose 2; 7) geometric mean fold rises (GMFRs) of neutralizing titers from baseline to 1 month after dose 2.
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing stated: Yes, Data may be requested from Pfizer trials 24 months after study completion Data accessibility: upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests. Corresponding author: James Barber, james.baber@pfizer.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, prospective study registry, and protocol were used in data extraction and risk of bias assessment. The primary outcomes in the article reflect those in the registry and protocol. The study size was not based on any formal hypothesis test.