ab Caplan 1977.
Methods | Randomised controlled trial to assess the reactogenicity and safety of monovalent whole‐virus and split‐virus vaccines prepared with strain A/Victoria/3/75 from different US manufacturers. | |
Participants | 208 healthy adult volunteers aged between 18 and 64 years, recruited from the University of Maryland, USA. | |
Interventions | Monovalent whole‐virus vaccine (Merck Sharp & Dohme, Merrell‐National Laboratories) or monovalent split‐virus vaccine (Parke‐Davis and Company; Wyeth Laboratories) administered in different antigen concentrations (200, 400, or 800 CCA units) versus placebo. All from A/Victoria75. 1 dose intramuscularly. | |
Outcomes | Temperature >= 100 °F (37.8 °C), feverishness, pain or burning, tenderness, malaise or myalgia, nausea or vomiting, headache, other. 21‐day follow‐up. Safety outcomes are also given as cumulative % for each category: local, systemic, bothersome; febrile; or scores for systemic reactions. | |
Notes | Safety data only were extracted. Government funded |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Unclear |
Allocation concealment (selection bias) | Unclear risk | Unclear |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Unclear |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear |
Summary assessment | Unclear risk | Unclear |