Healthy volunteers (prevention of RSV-associated lower respiratory tract illnesses (LRTIs))
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Participants 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 participant prior to performance of any study specific procedure. • Healthy female participants; as established by medical history and clinical examination, aged 18 to 49 years at the time of the first study intervention administration. - Female participants of childbearing potential may be enrolled in the study, if the participant: - has practiced adequate contraception for 1 month prior to study intervention administration, and - has a negative pregnancy test on the day of study intervention administration, and - has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the study intervention administration. • No local condition precluding injection in both left and right deltoid muscles. 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 1541 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Medical conditions • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions; • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination; • Current autoimmune disorder, for which the participant has received immune-modifying therapy within 6 months, before study vaccination; • Hypersensitivity to latex; • Acute or chronic clinically significant abnormality or poorly controlled pre-existent co-morbidities or any other clinical conditions, as determined by physical examination or medical history that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study; • Significant or uncontrolled psychiatric illness; • Recurrent history or uncontrolled neurological disorders or seizures; • Documented HIV-positive participant; • Body mass index> 40 kg/m^2; • Any clinically significant* hematological parameter and/or biochemical laboratory abnormality. *The investigator should use his/her clinical judgment to decide which abnormalities are clinically significant. • Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. Prior/Concomitant therapy • Use of any investigational or non-registered product other than the study intervention(s) during the period starting 30 days before study intervention (Day -29 to Day 1), or planned use during the study period; • Administration of long-acting immune-modifying drugs at any time during the study period; • Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the study intervention or planned administration during the study period; • Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first study intervention 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 the vaccination dose; • Administration of a seasonal influenza vaccine during the 6 months preceding entry into the study; • Previous experimental vaccination against RSV. Prior/Concurrent clinical study experience Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product; Other exclusions • Pregnant or lactating female; • Female planning to become pregnant or planning to discontinue contraceptive precautions; • Alcoholism or substance use disorder within the past 24 months based on the presence of two or more of the following abuse criteria: hazardous use, social/interpersonal problems related to use, neglected major roles to use, withdrawal tolerance, use of larger amounts or longer, repeated attempts to quit or control use, much time spent using, physical or psychological problems related to use, activities given up to use, craving; • Any study personnel or their immediate dependents, family, or household members.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV vaccine up to Day 31 post administration. • To demonstrate the lot-to-lot consistency of 3 lots of the investigational RSV MAT vaccine based on Geometric mean concentration (GMC) of RSV MAT IgG ELISA at Day 31. • To demonstrate non-inferiority of Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone based on Geometric mean titer (GMT) of Flu D QIV antibody titers against 4 influenza strains at Day 31 post administration.;Secondary Objective: •Evaluate the safety of RSV MAT given alone and co-administered with Flu D-QIV from vaccination up to study end •Demonstrate the non-inferiority of: oRSV MAT vaccine co-administered with Flu D-QIV compared to given alone based on GMT of RSV A neutralizing antibody at Day 31 oFlu D-QIV vaccine co-administered with RSV MAT compared to given alone based on Seroconversion rate (SCR) of Flu D-QIV HI antibody titers against 4 influenza strains at Day 31 •Evaluate the humoral immune response of: oRSV MAT vaccine given alone and co-administered with Flu D-QIV in terms of RSV A, RSV B neutralizing antibody and RSV MAT IgG concentration at Days 1 and 31 oFlu D-QIV vaccine given alone and co-administered with RSV MAT vaccine in terms of antibody titers against 4 influenza strains at Days 1 and 31 •Evaluate seroprotection rate (SPR) and SCR of the Flu D-QIV vaccine given alone and co-administered with RSV MAT vaccine •Evaluate the humoral immune response in 3 individual lots of RSV MAT;Primary end point(s): 1. Percentage of participants reporting solicited administration site events in all study groups 2. Percentage of participants reporting solicited systemic events in all study groups 3. Percentage of participants reporting unsolicited adverse events (AEs) in all study groups 4. Percentage of participants reporting serious adverse events (SAEs) in | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Percentage of participants reporting SAEs from first vaccination up to study end in all study groups 2. RSV A neutralizing antibody titers for participants in RSV+Flu pooled group and RSV pooled group at Day 1 and Day 31 3. Seroconversion rate (SCR) to Flu D-QIV HI antibody titers against 4 influenza strains for participants in Flu+P group and RSV+Flu pooled group at Day 31 4. RSV B neutralizing antibody titers for participants in RSV+Flu pooled group and RSV pooled group at Day 1 and Day 31 5. RSV MAT IgG concentrations for participants in RSV+Flu pooled group and RSV pooled group at Day 1 and Day 31 6. Flu D-QIV HI antibody titers against 4 influenza strains for participants in Flu+P group and RSV+Flu pooled group at Day 1 and Day 31 7. Seroprotection rate (SPR) to Flu D-QIV HI antibody titers for participants in Flu+P group and RSV+Flu pooled group at Day 1 and Day 31 8. RSV A neutralizing antibody titers for participants in RSV1, RSV2 and RSV 3 groups at Day 1 and Day 31 9. RSV B neutralizing antibody titers for participants in RSV1, RSV2 and RSV 3 groups at Day 1 and Day 31 10. RSV MAT IgG concentrations for participants in RSV1, RSV2 and RSV3 groups at Day 1 and Day 31;Timepoint(s) of evaluation of this end point: 1. From first vaccination up to study end (Day 1 to Day 181) 2, 4, 5, 6, 7, 8, 9, 10. At Day 1 and Day 31 3. At Day 31 | — |
Countries
Canada, Finland, Korea, Republic of, Spain, United States
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed