Last updated: 07/17/2024 17:20:14

A study to rank different dosages of antigen of GlaxoSmithKline (GSK) Biologicals’ investigational Respiratory Syncytial Virus (RSV) vaccine (GSK3003891A), based on their immune response and safety, when administered to healthy adult women

GSK study ID
204812
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An observer-blind study to rank different formulations of GSK Biologicals’ investigational RSV vaccine (GSK3003891A) administered to healthy women
Trial description: The purpose of this study is to rank different RSV vaccine dosages of antigen (or formulations) based on safety/reactogenicity and immune response data. The formulations eliciting strong immune responses while maintaining an acceptable safety profile will be considered for further evaluation, including in studies vaccinating pregnant women.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Number of subjects with any Grade 2 and Grade 3 general Adverse Events (AEs) - solicited and unsolicited

Timeframe: During the 7-day (Days 0-6) post-vaccination period

Number of subjects with Grade 2 and Grade 3 fever

Timeframe: During the 7-day (Days 0-6) post-vaccination period

Number of subjects with related serious adverse events (SAEs)

Timeframe: During the 7-day (Days 0-6) post-vaccination period

Neutralizing antibody titers against RSV-A subtype

Timeframe: At Day 0

Neutralizing antibody titers against RSV-A subtype

Timeframe: At Day 30

Palivizumab competing antibody (PCA) concentrations

Timeframe: At Day 0

Pavilizumab competing antibody (PCA) concentrations

Timeframe: At Day 30

Secondary outcomes:

Number of subjects with any, Grade 2, Grade 3 and medically attended solicited local AEs

Timeframe: During the 7-day (Days 0-6) post-vaccination period

Number of subjects with any, Grade 2, Grade 3, related and medically attended solicited general AEs

Timeframe: During the 7-day (Days 0-6) post-vaccination period

Number of subjects with any unsolicited AEs

Timeframe: During the 30-day (Days 0-29) post-vaccination period

Number of subjects with any SAEs

Timeframe: From Day 0 up to study end, at Day 360

Number of subjects with any biochemical and hematological laboratory abnormalities

Timeframe: At Day 7

Number of subjects with any biochemical and hematological laboratory abnormalities

Timeframe: At Day 30

Number of subjects with any biochemical and hematological laboratory abnormalities

Timeframe: At Day 60

Number of subjects with any biochemical and hematological laboratory abnormalities

Timeframe: At Day 90

Number of subjects with any biochemical and hematological laboratory abnormalities, by maximum grading

Timeframe: From Day 7 up to Day 90

Neutralizing antibody titers against RSV-A subtype

Timeframe: At Day 60 and Day 90

Neutralizing antibody titers against RSV-B subtype

Timeframe: At Day 0, Day 30, Day 60 and Day 90

Palivizumab competing antibody (PCA) concentrations

Timeframe: At Day 60 and Day 90

Antibody concentrations against neogenin (NEO) residual host cell protein

Timeframe: At Day 0 and Day 30

Number of subjects with any medically attended (MA) respiratory tract infections (RTIs) associated with RSV

Timeframe: From Day 0 up to study end, at Day 360

Interventions:
Biological/vaccine: RSV Vaccine (GSK3003891A) formulation 1
Biological/vaccine: RSV Vaccine (GSK3003891A) formulation 2
Biological/vaccine: RSV Vaccine (GSK3003891A) formulation 3
Drug: Placebo (Formulation buffer S9b)
Enrollment:
406
Observational study model:
Not applicable
Primary completion date:
2017-30-08
Time perspective:
Not applicable
Clinical publications:
Schwarz TF et al. (2019) Immunogenicity and safety of 3 formulations of a respiratory syncytial virus candidate vaccine in non-pregnant women: a phase II, randomized trial. J Infect Dis. pii: jiz395. doi: 10.1093/infdis/jiz395.
Medical condition
Respiratory Syncytial Virus Infections
Product
GSK3003891A
Collaborators
Not applicable
Study date(s)
November 2016 to February 2018
Type
Interventional
Phase
2

Participation criteria

Sex
Female
Age
18 - 45 years
Accepts healthy volunteers
Yes
  • 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 performance of any study specific procedure.
  • Use of any investigational or non-registered product other than the study vaccines within 30 days prior to study vaccination, or planned use during the study period.
  • Concurrently participating in the active phase of another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Clermont-Ferrand, France, 63003
Status
Study Complete
Location
GSK Investigational Site
Gent, Belgium, 9000
Status
Study Complete
Location
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30159
Status
Study Complete
Location
GSK Investigational Site
Paris, France, 75679
Status
Study Complete
Location
GSK Investigational Site
Tallinn, Estonia, 10117
Status
Study Complete
Location
GSK Investigational Site
Tartu, Estonia, 50106
Status
Study Complete
Location
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
Status
Study Complete

Study documents

Statistical analysis plan
Available language(s): English
Protocol
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2017-30-08
Actual study completion date
2018-05-02

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website