Hata 2016.

Methods	Study design: double‐blind, randomised, placebo controlled Duration: 3 months postvaccination
Participants	Inclusion criteria Setting: outpatient Country: Japan, single‐centre, Kitano Hospital, a general hospital in Osaka Number: 54 participants; treatment (N = 27), control (N = 27) Participants' health status: participants with diabetes mellitus had glycated haemoglobin levels within the range 6% to 9.5% (Japan Diabetes Society) or 6.4% to 9.9% (National Glycohemoglobion Standardization Program) and were without moderate or severe acute illness Age: mean 66.2 years Sex: 44.4% female Other relevant information: aged 60 to 70 years 100% Asians Exclusion criteria "Smokers, immunocompromised patients with any potential malignant disease, autoimmune disease, renal failure, users of steroids or other immunosuppressive drugs, those with heart disease treated by antiplatelet drugs, patients with dermatological disorders that might hinder judgement of a skin test reaction, and HZ patients were not included in the study."
Interventions	Treatment group 1 dose of LZV (˜ 50,000 pfu per dose) on day 0 SC (N = 27) Control group Placebo SC on day 0 (N = 27) Observation: 1 dose of PPSV23 was given subcutaneously on the other arm of each participant in both groups.
Outcomes	Zoster events over a 1–year observational period Local and systemic adverse experiences on days 0 to 42 after vaccination Severe adverse experiences over a 1–year observational period
Purpose of the study	"To evaluate the immunogenicity and safety of a live Oka varicella zoster vaccine generally recommended for concurrent vaccination with PPSV23 in 60–70‐year‐old people with diabetes mellitus"
Funding sources	"This work was supported by a grant from the Ministry of Health, Labour and Welfare of Japan, no. C2250068 during 2010–2015"
Conflicts of interest	"YM has received a grant from the Research Foundation for Microbial Diseases of Osaka University (BIKEN). This grant is unrelated to the conduct and results of this study. TO has received a payment for lectures on the speaker’s bureau from Mitsubishi Tanabe Pharma Corp. related to cardiovascular diseases. All other authors affirm that no financial arrangement or other factor might present a potential conflict of interest related to this study.”
Notes	"A live, attenuated Oka varicella vaccine (Lot No. VZ059, 068‐073,079) manufactured by the Research Foundation for Microbial Diseases of Osaka University (BIKEN) was used. The estimated potency was approximately 50 000 plaque forming units per dose." PPSV23 SC was administered in the other arm for all participants on day 0: "Each participant received one dose of the ZV or placebo and one dose of PPSV23 on day 0" We asked Dr Hata: "We would like to be clear whether the subcutaneous injection contained both vaccine (VZV and PPSV23) or those vaccine were administered in different arms. Also, was the same procedure done in the placebo group?" Dr Hata's answer: "We administered different vaccines in separate arms to confirm adverse reactions" "During follow up, one participant was unable to visit the hospital (we consider lost of follow up) and another died of acute cardiac insufficiency (heart failure) that was wholly unrelated to the vaccination". Both losses were in the intervention group (LZV group) "No zosteriform rash was reported during the observation period" "The secondary outcomes of safety were local and systemic adverse experiences on days 0–42 after vaccination, and severe adverse experiences and zoster events over a 1–year observational period" "VZ/Oka is a live, attenuated Oka varicella vaccine (Lot No. VZ059, 068‐073,079) manufactured by the Research Foundation for Microbial Diseases of Osaka University (BIKEN)" ITT analysis was used.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"After receiving the consent of participants, the study staff determined treatment allocation using a randomization system. An independent epidemiologist generated a series of randomization codes for varicella zoster vaccine solution or distilled water based on a random number table. Independent research staff at the hospital pharmacy were then informed of the codes"
Allocation concealment (selection bias)	Low risk	"A member of the medical staff was informed of the allocated participant code according to the order in the code table, but was blinded to the contents of the codes."
Blinding (performance bias and detection bias) All outcomes	Low risk	"Pharmacists produced a vaccine solution or purified distilled water that were identical in appearance"
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"The medical staff member than administered the assigned vaccine solution or distilled water to the participants."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"The contents of the code were concealed by the independent research staff until the study was completed."
Incomplete outcome data (attrition bias) All outcomes	Low risk	Clear patient flow
Selective reporting (reporting bias)	Low risk	All data on effectiveness and adverse events proposed by the authors in the methodology were described in the results for both groups.
Other bias	Unclear risk	Insufficient information