Last updated: 07/17/2024 17:35:48

A study to evaluate different dose levels of GlaxoSmithKline (GSK) Biologicals’ investigational Respiratory Syncytial Virus (RSV) vaccine (GSK3888550A), based on the vaccine safety and the antibodies (body defences) produced following vaccine administration, when given to healthy non-pregnant women

GSK study ID
208068
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: A study to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals’ investigational unadjuvanted RSV maternal vaccine compared to placebo when administered to healthy non-pregnant women.
Trial description: The purpose of this study is to evaluate different dose levels of the investigational RSV maternal vaccine (GSK3888550A) based on safety/reactogenicity and immune response data.
As this is the first time the investigational RSV maternal vaccine (GSK3888550A) is being been used in humans, this study will be performed in healthy non-pregnant women 18-45 years of age before testing in pregnant women.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Number of Subjects With Any and Grade 3 Solicited Local Adverse events (AE) during a 7-day follow-up period

Timeframe: During a 7-day follow-up period (i.e., on the day of vaccination and 6 subsequent days)

Number of Subjects With Any, Grade 3 and related Solicited general Adverse events (AE) during a 7-day follow-up period

Timeframe: During a 7-day follow-up period (i.e., on the day of vaccination and 6 subsequent days)

Number of subjects with any unsolicited AEs during a 30-day follow-up period

Timeframe: During a 30-day follow-up period after vaccination (i.e., on the day of vaccination and 29 subsequent days)

Number of subjects with serious adverse events (SAEs) during a 30-day follow-up period

Timeframe: From Day 1 (vaccination) up to Day 30 (i.e., on the day of vaccination and 29 subsequent days)

Number of subjects with hematological laboratory results change with respect to normal laboratory ranges and versus baseline, at Day 8

Timeframe: At Day 8

Number of subjects with hematological laboratory results change with respect to normal laboratory ranges and versus baseline, at Day 31

Timeframe: At Day 31

Number of subjects with biochemical laboratory results change with respect to normal laboratory ranges and versus baseline, at Day 8

Timeframe: At Day 8

Number of subjects with biochemical laboratory results change with respect to normal laboratory ranges and versus baseline, at Day 31

Timeframe: At Day 31

Number of subjects with hematological laboratory results versus baseline, by maximum grading, at Day 8

Timeframe: At Day 8

Number of subjects with hematological laboratory results versus baseline, by maximum grading, at Day 31

Timeframe: At Day 31

Number of subjects with biochemical laboratory results versus baseline, by maximum grading, at Day 8

Timeframe: At Day 8

Number of subjects with biochemical laboratory results versus baseline, by maximum grading, at Day 31

Timeframe: At Day 31

Secondary outcomes:

Number of subjects with SAEs

Timeframe: From Day 1 (vaccination) up to Day 91 and up to Day 181

Neutralizing antibody (Nab) titers against RSV serotype A

Timeframe: At pre-vaccination at screening (PRE), 7 days post vaccination (Day 8), 30 days post vaccination (Day 31), 60 days post vaccination (Day 61) and 90 days post vaccination (Day 91)

Anti-RSVPreF3 Immunoglobulin G (IgG) antibody concentrations

Timeframe: At pre-vaccination at screening (PRE), 7 days post vaccination (Day 8), 30 days post vaccination (Day 31), 60 days post vaccination (Day 61) and 90 days post vaccination (Day 91)

Interventions:
  • Biological/vaccine: GSK3888550A RSV Maternal vaccine formulation 1
  • Biological/vaccine: GSK3888550A RSV Maternal vaccine formulation 2
  • Biological/vaccine: GSK3888550A RSV Maternal vaccine formulation 3
  • Drug: Placebo (Normal Saline)
  • Enrollment:
    502
    Primary completion date:
    2019-16-04
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Tino Schwarz, Casey Johnson, Christine Grigat, Dan Apter, Peter Csonka, Niklas Lindblad, Thi Lien-Anh Nguyen, Feng F Gao, Hui Qian, Antonella Tullio, Ilse Dieussaert, Marta Picciolato, Ouzama Henry. Three dose levels of a maternal respiratory syncytial virus vaccine candidate are well tolerated and immunogenic in a randomized trial in non-pregnant women. J Infect Dis. doi: 10.1093/infdis/jiab317.
    Medical condition
    Respiratory Syncytial Virus Infections
    Product
    GSK3888550A
    Collaborators
    Not applicable
    Study date(s)
    October 2018 to September 2019
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female
    Age
    18 - 45 years
    Accepts healthy volunteers
    Yes
    • Subjects who the investigator believes will comply with the requirements of the protocol (e.g. completion of the diary cards/questionnaires, return for follow-up visits, have regular contact to allow evaluation during the study);
    • Written informed consent obtained from the subject;
    • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding vaccination or any 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
    Goch, Nordrhein-Westfalen, Germany, 47574
    Status
    Study Complete
    Location
    GSK Investigational Site
    Hamburg, Hamburg, Germany, 22143
    Status
    Study Complete
    Location
    GSK Investigational Site
    Hannover, Niedersachsen, Germany, 30159
    Status
    Study Complete
    Location
    GSK Investigational Site
    Helsinki, Finland, 00260
    Status
    Study Complete
    Location
    GSK Investigational Site
    Lenexa, Kansas, United States, 66219
    Status
    Study Complete
    Location
    GSK Investigational Site
    Mainz, Rheinland-Pfalz, Germany, 55116
    Status
    Study Complete
    Showing 1 - 6 of 11 Results

    Study documents

    Study report synopsis
    Available language(s): English
    Protocol
    Available language(s): English
    Statistical analysis plan
    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
    2019-16-04
    Actual study completion date
    2019-02-09

    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