1. Study report to assess quality of non‐randomised, non‐controlled studies.

Item	Question	Evaluation
1. a. b. c.	Sample definition and selection Are inclusion and exclusion criteria clearly defined? Is the study population a representative selection of the true population? Are baseline characteristics adequately described?	Yes No ? Yes No ? Yes No ?
2 a. b.	Interventions Are the interventions clearly defined (type of vaccine, antigen, adjuvant, route of vaccination, and vaccination schedule)? Did patients receive concurrent/concomitant treatment with immunomodulatory effects?	Yes No ? Yes No ?
3 a. b. c.	Outcomes Are the selected outcome measures clearly specified? Are the outcome measures relevant? Are the outcome measures clearly reported?	Yes No ? Yes No ? Yes No ?
4. a. b. c.	Statistical analysis Is there an adequate rationale for the number of participants included? Is there an adequate description of withdrawal/exclusion of participants during the study? Is presentation of the results adequate?	Yes No ? Yes No ? Yes No ?