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Also known as RSV vaccine GSK3003895A (formulation 3), RSV vaccine GSK3003895A (formulation 1)
RSV vaccine GSK3003895A · 1 trial · 1 indication
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 100 millimeters (mm).
Assessed solicited general symptoms (symp.) were headache, fever \[defined as oral temperature (temp.) equal to or above 37.5 degrees Celsius (°C)\], fatigue, gastrointestinal (Gastro.) symptoms \[nausea, vomiting, diarrhoea and/or abdominal pain\]. Any = occurrence of the symptom regardless of intensity grade and relationship. Grade 3 (G3) symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. "Any" was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs). Seropositive subjects were defined as subjects whose antibody titre was greater than or equal to (≥) the cut-off 8 serum dilution that induced 60 % inhibition in plaque forming units (ED60).
| Arm | Type | Description |
|---|---|---|
| RSV vaccine formulation 1 Group | EXPERIMENTAL | Subjects in this group will receive a single dose of formulation 1 of the RSV vaccine |
| RSV vaccine formulation 2 Group | EXPERIMENTAL | Subjects in this group will receive a single dose of formulation 2 of RSV vaccine |
| RSV vaccine formulation 3 Group | EXPERIMENTAL | Subjects in this group will receive a single dose of formulation 3 of RSV vaccine |
| Boostrix Group | ACTIVE_COMPARATOR | Subjects in this group will receive a single dose of Boostrix |
| Name | Type | Description |
|---|---|---|
| RSV vaccine GSK3003895A (formulation 1) | BIOLOGICAL | Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm |
| RSV vaccine GSK3003898A (formulation 2) | BIOLOGICAL | Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm |
| RSV vaccine GSK3003899A (formulation 3) | BIOLOGICAL | Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm |
| Boostrix | BIOLOGICAL | Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm |
Inclusion Criteria: * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject prior to performing any study specific procedure. * Non-pregnant female between, and including, 18 and 45 years of ...
RSV vaccine GSK3003895A is an investigational vaccine developed by GSK plc for the prevention of respiratory syncytial virus infections. It is a Phase 2 candidate that has been studied in healthy adult women. The vaccine is designed to protect against RSV, a common cause of respiratory illness.
RSV vaccine GSK3003895A is being developed for the prevention of respiratory syncytial virus infections. RSV is a viral pathogen that causes respiratory illness. The candidate is intended for use in healthy adult women, based on the population enrolled in its clinical study.
RSV vaccine GSK3003895A is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating this investigational RSV vaccine candidate.
RSV vaccine GSK3003895A is in Phase 2 development. It is an investigational vaccine and has not been approved by the FDA. The Phase 2 trial evaluating the candidate has been completed, and no active trials are currently listed for this asset.
RSV vaccine GSK3003895A has been evaluated in one completed Phase 2 trial, NCT02360475. The study was titled a safety, reactogenicity and immunogenicity study of different formulations of GSK's investigational RSV vaccine in healthy women. It enrolled 507 participants across the United States, Australia, Czechia, and Germany.
Yes. RSV vaccine GSK3003895A is also referred to as RSV vaccine GSK3003895A (formulation 3) and RSV vaccine GSK3003895A (formulation 1). These names refer to different formulations of the same investigational GSK RSV vaccine candidate studied in the Phase 2 program.