Healthy Volunteers (prevention of lower respiratory tract illness)
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Primary study •Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. •Written or witnessed/thumb printed informed consent obtained from the subject prior to performance of any study specific procedure. •Healthy female subjects; as established by medical history and clinical examination, aged 18 to 45 years at the time of the 1st vaccination; •Female subjects of childbearing potential may be enrolled in the study, if the subject: -has practiced adequate contraception for 30 days prior to primary vaccination, and -has a negative pregnancy test on the day of primary vaccination, and -has agreed to continue adequate contraception for 90 days after completion of the vaccination. •No local condition precluding injection in both left and right deltoid muscles. Extension study •Completed primary study and received 1st dose of a study vaccine. •Written or witnessed/thumb printed informed consent obtained from the subject prior to performance of any study specific procedure to the study extension. All subjects must satisfy ALL the following criteria: •Subjects who can and will comply with the requirements of the protocol. •Female subjects remain healthy; as established by medical history and clinical examination, aged 18 to 45 years at the time of the 1st vaccination; •Female subjects of childbearing potential are eligible for the extension, if the subject: - has practiced adequate contraception for 30 days prior to 2nd vaccination - has a negative pregnancy test with results available on the day of 2nd vaccination - has agreed to continue adequate contraception for 90 days after completion of the 2nd vaccination. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 500 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Primary study Medical conditions •History of any reaction/hypersensitivity likely to be exacerbated by any vaccines’ component •Any confirmed/suspected immunosuppressive/immunodeficient condition, based on medical history and physical examination •Hypersensitivity to latex •Major congenital defects •Acute/chronic clinically significant pulmonary,cardiovascular,hepatic/renal functional abnormality •Significant/uncontrolled psychiatric illness •Recurrent history/uncontrolled neurological disorders/seizures •Documented HIV-positive subject •History of/current autoimmune disease •Body mass index (BMI)>40 kg/m^2 •Any clinically significant hematological parameter and/or biochemical laboratory abnormality •Any other clinical condition that might pose additional risk to the subject due to participation in the study Prior/Concomitant therapy •Use of any investigational/non-registered product other than the study vaccines during the period starting 30 days before 1st vaccination,or planned use during the study •Administration of long-acting immune-modifying drugs at any time during the study •Administration of immunoglobulins and/or any blood products/plasma derivatives during the period starting 3 months before the 1st vaccination or planned administration during the study •Chronic administration of immunosuppressants/other immune-modifying drugs during the period starting 3 months prior to 1st vaccine dose(s).For corticosteroids,this will mean prednisone=5 mg/day,or equivalent.Inhaled and topical steroids are allowed •Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after study 1st vaccination,with the exception of any licensed influenza vaccine which may be administered=15 days before/after study vaccination •Administration of a vaccine containing diphtheria, tetanus/pertussis antigens/diphtheria and tetanus toxoids within the previous 5 years •Previous experimental vaccination against RSV Prior/Concurrent clinical study experience •Concurrently participating in another clinical study, at any time during the study, in which the subject has been/will be exposed to an investigational/a non-investigational vaccine/product Other exclusions •Pregnant/lactating female •Female planning to become pregnant/planning to discontinue contraceptive precautions •History of alcoholism, drug abuse and/or use disorder within the past 2 years •Any study personnel/their immediate dependents, family/household members Extension study Medical conditions •History of any reaction/hypersensitivity likely to be exacerbated by any component of the vaccines •Any confirmed/suspected immunosuppressive/immunodeficient condition, based on medical history and physical examination •Hypersensitivity to latex •Acute/chronic clinically significant pulmonary, cardiovascular, hepatic/renal functional abnormality •Significant/uncontrolled psychiatric illness •Recurrent history/uncontrolled neurological disorders/seizures •Documented HIV-positive subject •History of/current autoimmune disease •BMI>40 kg/m^2 •Participants who experienced any SAE judged to be possibly or probably related to 1st dose of RSVPreF3, including hypersensitivity reactions •Any other clinical condition that might pose additional risk to the subject due to participation in the study Prior/Concomitant therapy •Use of any investigational/non-registered product other than th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): 1. Percentage of subjects with at least one solicited local adverse event (AE) for each study group, after the 1st vaccination An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Solicited local AEs, at the site of injection in both limbs, are: pain, redness and swelling. 2. Percentage of subjects with at least one solicited general AE for each study group, after the 1st vaccination Solicited general AEs are: fatigue, fever, gastrointestinal symptoms including nausea, vomiting, diarrhea and/or abdominal pain, headache. 3. Percentage of subjects with any unsolicited AEs for each study group, after the 1st vaccination An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE. 4. Percentage of subjects with at least one serious adverse event (SAE) for each study group, after the 1st vaccination A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. 5. Percentage of subjects with at least one solicited local AE for each study group, after the 2nd vaccination An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Solicited local AEs, at the site of injection in both deltoids, are: pain, redness and swelling. 6. Percentage of subjects with at least one solicited general AE for each study group, after the 2nd vaccination Solicited general AEs are: fatigue, fever, gastrointestinal symptoms including nausea, | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Percentage of subjects with at least one solicited local AE for each group and formulation, after the 1st vaccination For description, please see primary (pri.) end point 1 2. Percentage of subjects with at least one solicited general AE for each group and formulation, after the 1st vaccination For description, please see pri. end point 2 3. Percentage of subjects with any unsolicited AE, for each group and formulation, after the 1st vaccination For description, please see pri. end point 3 4. Percentage of subjects with at least one SAE from 1st vaccination to Day 31, for each formulation For description, please see pri. end point 4 5. Percentage of subjects with at least one SAE from 1st vaccination to Day 181, for pooled formulations For description, please see pri. end point 4.This outcome measure evaluates the safety of 2 dose levels of RSVPreF3 when given alone and co-administered with dTpa compared to dTpa_Placebo groups. 6. Percentage of subjects with at least one report of SAE from 1st vaccination to Day 181, for each formulation For description, please see pri. end point 4.This outcome measure evaluates the safety of 2 dose levels of RSVPreF3 when given alone and co-administered. 7. Percentage of subjects with at least one SAE from 1st vaccination to Day 181, for pooled all groups receiving RSVPreF3 For description, please see pri. end point 4.This outcome measure evaluates the safety of all groups receiving RSVPreF3 vaccine. 8. Percentage of subjects with at least one SAE from 2nd vaccination to Day 181 post 2nd vaccination For description, please see secondary (sec.) end point 6 9. Humoral immune response in terms of RSV A neutralizing GMTs for each formulation, at Screening Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. 10. RSV A neutralizing GMTs for each formulation, at Day 8, after the 1st vaccination For description, please see sec. end point 9 | — |
Countries
Belgium, Canada, United States
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed