Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being developed for the prevention of Respiratory Syncytial Virus (RSV) infections. It is currently in Phase 2 clinical development and has been studied in healthy women aged 18 years and older. The vaccine is designed to elicit an immune response against RSV.
RSV vaccine GSK3003895A is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's safety, reactogenicity, and immunogenicity in healthy adult women.
RSV vaccine GSK3003895A is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 2 trial has been completed, evaluating the vaccine in healthy women to assess its safety and immune response.
RSV vaccine GSK3003895A has been studied in one completed Phase 2 clinical trial, registered as NCT02360475. This randomized, double-blind, active-controlled study enrolled 507 healthy women aged 18 years and older across the United States, Australia, Czechia, and Germany to evaluate different formulations of the vaccine.
RSV vaccine GSK3003895A is related to GSK3003891A, which is the investigational vaccine formulation evaluated in the clinical trial NCT02360475. The trial title refers to GSK3003891A, while GSK3003895A is the drug name used in the development program. Both are investigational RSV vaccines from GSK.