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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2019-16-04
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
Location
GSK Investigational Site
Rochester, New York, United States, 14609
Status
Study Complete
Location
GSK Investigational Site
Tampere, Finland, FI-33100
Status
Study Complete
Location
GSK Investigational Site
Turku, Finland, 20100
Status
Study Complete
Location
GSK Investigational Site
Turku, Finland, 20540
Status
Study Complete
Location
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
Status
Study Complete

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
Completed
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
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