Introduction
Respiratory Syncytial Virus (RSV) is an infection that causes lung inflammation and pneumonia. The virus causes lung airwaves in infants, affecting infants with weak immune systems. The disease affects the lungs and causes breathing problems, and the effects can range from mild to life-threatening illnesses. Several clinical trials have been developed to find new treatments, drugs, or diets for RSV infection. This paper analyses the VAD00001: Respiratory Syncytial Virus (RSV) Study as a clinical trial for infants’ infection and other respiratory diseases.
Respiratory Syncytial Virus
VAD00001: Respiratory Syncytial Virus (RSV) Study is meant to determine the best nasal spray to prevent RSV in infants. Currently, the organization admits infants of age 6-18 months who receive 1 -2 nasal vaccine administrations or a placebo (Respiratory syncytial virus (RSV) vaccine study | Sanofi studies, 2022). This study aims at evaluating the safest antibody response of children by employing two different doses to combat the RSV. The study is meant to determine which vaccine is safe and robust to keep infants from RSV, and children are put in the study for 12 months, during which the child will be seeing the clinical research staff.
As a participant of this study, here is a listing of questions I would ask my physician about the clinical trial.
- What is the likely cause of the symptoms of RSV?
- What are the other causes of this infection?
- Are there any tests needed for this trial?
- Will my baby contact RSV infection during the test?
- What are the best treatments methods for RSV?
- Are the effects of these treatments dangerous to the life of my baby?
- How do I make my baby feel okay during the trial?
- Should I isolate my baby during this trial? And for how long should I do this?
- Are there any brochures or other printed material that I can take home?
- Is there a website to follow for more information?
The Food and Drug Administration (FDA) works to ensure the safety of participants in clinical trials. It ensures that the research team gives participants accurate and honest information about the test processes before joining the study. Below is a list of questions the FDA would ask on this study.
- What happens to the infants when on trial?
- What type of health care do infants receive?
- What are the costs, benefits, and risks of this trial?
- What are the terms and conditions of this study?
- Are there any compensations if any troubles occur?
The FDA ensures that participants receive accurate information about everything that happens during the test before joining the study. In addition, it ensures that participants are supplied with an informed consent document that describes their rights and details about the survey (Obando-Pacheco et al., 2018). Signing this document implies that one understands the terms of the trial.
Conclusion
In conclusion, RSV is a common infection among infants; nearly all children below two years have experienced this infection. It is essential to manage the effects of this infection at its early stages because the impact can lead to severe conditions and even death. The initial signs of this infection include; running nose, fever and sore throat. Other symptoms may include; loss of appetite, coughs and difficulties in breathing. Parents who realize these symptoms in their infants should seek medical attention before late. Developing a well-tolerated vaccine for this disease is still ongoing through major clinical trials in various health sectors.
References
Obando-Pacheco, P., Justicia-Grande, A. J., Rivero-Calle, I., Rodríguez-Tenreiro, C., Sly, P., Ramilo, O., Mejias, A., Baraldi, E., Papadopoulos, N. G., Nair H., Nunes M. C., Kragten-tabatabie L., Heikkinen T., Greenough A., Stein R. T., Manzoni P., Bonto L., & Martinón-Torres, F. (2018). Respiratory syncytial virus seasonality: a global overview. The journal of infectious diseases, 217(9), 1356-1364.
Respiratory syncytial virus (RSV) vaccine study | Sanofi studies. (2022). Clinical research and drug information |CenterWatch. Web.