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
Study complete
Study complete
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
    Primary completion date:
    2017-30-08
    Observational study model:
    Not applicable
    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
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    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
    Study complete
    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
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