Last updated: 11/03/2018 19:51:22

Study to evaluate the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ investigational Respiratory Syncytial Virus (RSV) vaccines

GSK study ID

116969

See study documents

Clinicaltrials.gov ID

NCT01905215

EudraCT ID

Not applicable

EU CT Number

Not applicable

Trial status

Study complete

Overview

Eligibility

Locations

Study documents

Results summary

Plain language summaries

Additional information

Trial overview

Official title: An observer-blind study to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals’ Respiratory Syncytial Virus (RSV) investigational vaccine (GSK3003891A) in healthy men

Trial description: The purpose of this first time in human (FTiH) study is to evaluate the safety, reactogenicity and immunogenicity of several formulations of Respiratory Syncytial Virus (RSV) investigational vaccines in healthy men.

Primary purpose:

Prevention

Trial design:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Allocation:

Randomized

Primary outcomes:

Occurrence of each solicited local and general adverse event (AE)

Timeframe: During the 7 days (Days 0-6) follow-up period after vaccination

Occurrence of any hematological (hemoglobin level, white blood cells [WBC], lymphocyte, neutrophil, eosinophil and platelet count) and biochemical (alanine amino-transferase [ALT], aspartate amino-transferase [AST] and creatinine) laboratory abnormality

Timeframe: At Day 0

Occurrence of any hematological (hemoglobin level, white blood cells [WBC], lymphocyte, neutrophil, eosinophil and platelet count) and biochemical (alanine amino-transferase [ALT], aspartate amino-transferase [AST] and creatinine) laboratory abnormality

Timeframe: At Day 7

Occurrence of any hematological (hemoglobin level, white blood cells [WBC], lymphocyte, neutrophil, eosinophil and platelet count) and biochemical (alanine amino-transferase [ALT], aspartate amino-transferase [AST] and creatinine) laboratory abnormality

Timeframe: At Day 30

Occurrence of any hematological (hemoglobin level, WBC, lymphocyte, neutrophil, eosinophil and platelet count) and biochemical (alanine amino-transferase [ALT], aspartate amino-transferase [AST] and creatinine) laboratory abnormality

Timeframe: At Day 60

Occurrence of any unsolicited AE

Timeframe: During a 30-day (Days 0-29) follow-up period after vaccination

Occurrence of any Serious Adverse Events (SAEs)

Timeframe: From Day 0 to Day 60

Secondary outcomes:

Humoral immune response in terms of neutralizing antibody titers to the investigational RSV vaccines, in all subjects, in all groups

Timeframe: At pre-vaccination (Day 0) and post-vaccination (Day 7, Day 30 and Day 60)

Persistence of the humoral immune response in terms of neutralizing antibody titers to the investigational RSV vaccines, in all subjects, in all groups

Timeframe: At Day 180 and Day 360

Occurrence of any hematological (hemoglobin level, WBC, lymphocyte, neutrophil, eosinophil and platelet count) and biochemical (ALT, AST and creatinine) laboratory abnormality

Timeframe: At Day 180 and Day 360

Occurrence of any SAE

Timeframe: From Day 60 to the study conclusion (i.e. Day 360)

Interventions:

Biological/vaccine: RSV vaccine GSK3003892A (formulation 1)

Biological/vaccine: RSV vaccine GSK3003893A (formulation 2)

Biological/vaccine: RSV vaccine GSK3003895A (formulation 3)

Biological/vaccine: RSV vaccine GSK3003896A (formulation 4)

Biological/vaccine: RSV vaccine GSK3003898A (formulation 5)

Biological/vaccine: RSV vaccine GSK3003899A (formulation 6)

Drug: Placebo comparator

Enrollment:

128

Primary completion date:

2014-09-04

Observational study model:

Not applicable

Time perspective:

Not applicable

Clinical publications:

Not applicable

Medical condition

Infections, Respiratory Syncytial Virus

Product

GSK3003891A, GSK3003892A, GSK3003893A, GSK3003895A, GSK3003896A, GSK3003898A, GSK3003899A

Collaborators

Not applicable

Study date(s)

July 2013 to March 2015

Type

Interventional

Phase

Participation criteria

Sex

Male

Age

18 - 44 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.

Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the dose of study vaccine, or planned use during the study period.
Concurrently participating in 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.

Inclusion and exclusion criteria

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.
A male between, and including, 18 and 44 years of age at the time of vaccination.
Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion criteria:

Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the dose of study vaccine, or planned use during the study period.

Concurrently participating in 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.
Planned administration/ administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after vaccination, with the exception of any licensed influenza vaccine which may be administered ≥ 15 days before or after vaccination.
Previous vaccination against RSV.
Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the vaccine dose. Inhaled and topical steroids are allowed.
Administration of long-acting immune-modifying drugs at any time during the study period.
Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study vaccine or planned administration during the study period.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Family history of congenital or hereditary immunodeficiency.
History of or current autoimmune disease.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
Hypersensitivity to latex.
Any clinically significant hematological (hemoglobin level, white blood cell [WBC], lymphocyte, neutrophil, eosinophil and platelet count) and biochemical (alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine) abnormality as per the opinion of the investigator, based on the local laboratory normal ranges.

Subjects with hematological/ biochemical values out of normal range which are expected to be temporary may be re-screened at a later date.

Any acute or chronic, clinically significant disease, as determined by physical examination or laboratory screening tests.
Malignancies within previous 5 years (excluding non-melanoma skin cancer) and lymphoproliferative disorders.
Current alcoholism and/or drug abuse.
Acute disease and/or fever at the time of Screening.

Fever is defined as temperature ≥ 37.5°C /99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C /100.4°F on rectal route. The preferred route for recording temperature in this study will be oral.
Subjects with a minor illness (such as mild diarrhea) without fever may be enrolled at the discretion of the investigator.

Subjects with acute disease and/ or fever at the time of Screening may be re screened at a later date.

Planned move to a location that will prohibit participating in the trial until study end.
Any other condition that the investigator judges may interfere with study procedures (e.g. drawing blood) or findings (e.g. immune response).

Trial location(s)

Location

Status

Location

GSK Investigational Site

Toronto, Ontario, Canada, M9W 4L6

Status

Study Complete

Location

GSK Investigational Site

Brampton, Ontario, Canada, L6T 0G1

Status

Study Complete

Location

GSK Investigational Site

Halifax, Nova Scotia, Canada, B3K 6R8

Status

Study Complete

Study documents

Scientific result summary

Available language(s): English

Download document(s)

Protocol

Available language(s): English

Download document(s)

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

Results overview

Refer to study documents

Recruitment status

Study complete

Actual primary completion date

2014-09-04

Actual study completion date

2015-16-03

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

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Additional information

Results for study 116969 can be found on the GSK Clinical Study Register

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Access to clinical trial data by researchers

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