A Study to Assess the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologic… (NCT02491463) | Clinical Trial Compass
CompletedPhase 1
A Study to Assess the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' RSV Investigational Vaccine (ChAd155-RSV) (GSK3389245A) in Healthy Adults
United Kingdom73 participantsStarted 2015-07-23
Plain-language summary
The purpose of this first time in human (FTiH) study is to assess the safety, reactogenicity and immunogenicity of 2 doses of the RSV investigational vaccine, when administered intramuscularly according to a 0, 1 month schedule, in healthy adults aged 18 to 45 years.
Who can participate
Age range18 Years – 45 Years
SexALL
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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 prior to performing any study specific procedure
* A male or female between, and including, 18 and 45 years of age at the time of first vaccination
* Healthy subjects as established by medical history and clinical examination before entering into the study
* Female subjects of non-childbearing potential may be enrolled in the study
* Female subjects of childbearing potential may be enrolled in the study, if the subject:
* has practiced adequate contraception for 30 days prior to vaccination, and
* has a negative pregnancy test on the day of vaccina-tion, and
* has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series
Exclusion Criteria:
* 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
* Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines, or planned use during the study period
* Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to study vaccination, or planned administration during the study period
*…
What they're measuring
1
Number of Subjects With Solicited Local Symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
2
Number of Subjects With Solicited General Symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
3
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Timeframe: At Day 1
4
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Timeframe: At Day 3
5
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Timeframe: At Day 7
6
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Timeframe: At Day 30
7
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities