Pharmaceutical Industry Information Portal

GSK halts phase III vaccine trial of respiratory virus in pregnant women

GlaxoSmithKline, a science-led global healthcare company, on Monday announced that the Company has decided to stop enrolment and vaccination in trials evaluating its potential respiratory syncytial virus (RSV) maternal vaccine candidate in pregnant women.

Further analysis to better understand safety data from these trials is ongoing, and the relevant regulatory authorities have been informed.

This decision does not impact the ongoing AReSVi 006 phase III trial for RSV older adults (60 years and above). This trial remains on track with an anticipated data readout in the first half of 2022.

Respiratory syncytial virus

RSV causes infections of the lungs and respiratory tract. It’s so common that most children have been infected with the virus by age 2. Respiratory syncytial (sin-SISH-ul) virus can also infect adults.

In adults and older, healthy children, RSV symptoms are mild and typically mimic the common cold. Self-care measures are usually all that’s needed to relieve any discomfort.

RSV can cause severe infection in some people, including babies 12 months and younger (infants), especially premature infants, older adults, people with heart and lung disease, or anyone with a weak immune system (immunocompromised).

RSV is one of the leading causes of pneumonia in children and the elderly, but due to failures, vaccine development has been hampered for decades. However, numerous pharmaceutical companies are now trying to bring a vaccine to market in the coming years.


Expert Articles