Explanation in informed consent forms
Aspiration benefit of the research
A vaccine is not yet available to prevent RSV infection but is under development. In order to know which group to target for vaccination in future when that vaccine becomes available, we need to know how the virus is spread within the community. We aim to closely monitor respiratory infections within members of the household in order to understand who transmits the RSV infection to young children.
Are there any advantages to me/my child if we participate? (immediate benefits to participants)
You/your child will benefit from close monitoring for any illness by a nurse during the home visits and will be referred to the health centre for further consultation and treatment where necessary. Medical expenses for outpatient treatment of acute illnesses will be paid for and where applicable transport costs and treatment at the Kilifi District Hospital will be met by KEMRI. These benefits will be applicable during the period of participation in this study only
Aspirational benefit of the research
Malaria is a common and serious disease in young children that results in many deaths. This study is a test of a new vaccine called (name of vaccine*) to see if it can prevent malaria. If the experimental vaccine works, then it might become part of the routine program of immunization in Africa. To date, there is no licensed vaccines to prevent malaria, the experimental malarial vaccine (name) is still being tested because it’s not known how well it will work in preventing malaria.
Even if your child takes part in the study, you must continue to follow the methods you normally use to prevent malaria in your family. Sleeping under an insecticide treated bed net with no holes in it can help protect against malaria. And if your child becomes ill, you should seek medical care as soon as possible.
Are there any benefits to me/my child for taking part? (immediate benefits to participants)
If your child takes part in the study, and receives the first vaccination, he/she will receive medical care from the day of the first dose of vaccine until the completion of the study. This care will include treatment of any symptoms caused by the vaccine or injuries related to the study procedures, as well as treatment for any acute illnesses during the study period and free of charge. Treatment of chronic (long-term) illnesses/injuries unrelated to the study or study procedure will not be paid for by the study. If your child is found to have such illnesses/injuries, he/she will be treated under the existing government services/programs. If your child has a medical problem that cannot be treated at the nearest health centre, we will refer him/her to colleagues at an appropriate clinic. If this were to happen, we will arrange transport for the first visit to see the doctor. All transport to and from the hospital will be provided by the study team so it should not cost you any money to let your child take part in the trial. You will not receive any direct payment just for participating in this study