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RSV vaccine GSK3003895A

Phase 2

Respiratory Syncytial Virus Infections | Monoclonal antibody | Respiratory |GSK plc|Last Updated: Jul 3, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment507
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02360475Safety, Reactogenicity and Immunogenicity Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals' Investigational RSV Vaccine (GSK3003891A), in Healthy WomenPHASE2 COMPLETED 507Mar 20, 2015Jun 21, 2016Jul 3, 201812 United States, Australia +2
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Study Endpoints
Primary Endpoints
Number of Subjects With Solicited Local Symptoms
During the 7-day (Days 0-6) post-vaccination period

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).

Number of Subjects With Solicited General Symptoms
During the 7-day (Days 0-6) post-vaccination period

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.

Number of Subjects With Unsolicited Adverse Events (AEs)
During the 30-Day (Days 0-29) post-vaccination period

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.

Number of Subjects With Serious Adverse Events (SAEs)
From vaccination at Day 0, up to Day 30 post-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.

Titres of RSV-A Neutralizing Antibodies
At Day 0 pre-vaccination

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).

Secondary Endpoints
Titres of RSV-A Neutralizing Antibodies
At Day 60 post-vaccination
Concentrations of Palivizumab Competing Antibodies (PCA)
At Day 0 pre-vaccination
Concentrations of PCA
At Day 30 post-vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
RSV vaccine formulation 1 GroupEXPERIMENTALSubjects in this group will receive a single dose of formulation 1 of the RSV vaccine
RSV vaccine formulation 2 GroupEXPERIMENTALSubjects in this group will receive a single dose of formulation 2 of RSV vaccine
RSV vaccine formulation 3 GroupEXPERIMENTALSubjects in this group will receive a single dose of formulation 3 of RSV vaccine
Boostrix GroupACTIVE_COMPARATORSubjects in this group will receive a single dose of Boostrix
Interventions
NameTypeDescription
RSV vaccine GSK3003895A (formulation 1)BIOLOGICALSingle dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
RSV vaccine GSK3003898A (formulation 2)BIOLOGICALSingle dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
RSV vaccine GSK3003899A (formulation 3)BIOLOGICALSingle dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
BoostrixBIOLOGICALSingle dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
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Eligibility Criteria
Age Range18 Years — 45 Years
SexFEMALE
Healthy VolunteersYes
Study Sites12

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 ...

Countries:United StatesAustraliaCzechiaGermany
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