Active immunization of infants for the prevention of any lower respiratory tract infections (LRTI
Conditions
Interventions
Product Name: ChAd155-RSV (high dose)
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: ChAd155-RSV
Current Sponsor code: ChAd155-RSV
Concentration unit: Other
Concentration type: equ
Sponsors
GlaxoSmithKline S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects’ parent(s)/ Legally acceptable representative (LAR[s]) who, in the opinion of the investigator, can and will comply with the requirements of the protocol. 2. Written informed consent obtained from the par-ent(s)/LAR(s) of the subject prior to performance of any study specific procedure. 3. A male or female between, and including, 12 and 23 months at the time of the first vaccination. 4. Healthy subjects as established by medical history and clinical examination before entering into the study. 5. Seropositive for RSV as determined by IBL International kit. 6. Born full-term (i.e. after a gestation period of 37 to less than 42 completed weeks) with a minimum birth weight of 2.5 kg. (Required for Spain) 7. Subjects’ parent(s)/LAR(s) need to have access to a consistent mean of telephone contact or computer. Are the trial subjects under 18? yes Number of subjects for this age range: 96 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Child in care 2. Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine (Day -29 to Day 0), or planned use during the study period. 3. Any medical condition that in the judgment of the investigator would make IM injection unsafe. 4. Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine. For corticosteroids, this will mean prednisone, or equivalent. Inhaled and topical steroids are allowed. 5. Administration of long-acting immune-modifying drugs or planned administration at any time during the study period. 6. Administration of immunoglobulins and/or any blood products during the period starting three months before the first dose of study vaccine or planned administration during the study period. 7. Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine administration, with the exception of scheduled routine pediatric vaccines which may be administered >= 14 days before a dose or >= 7 days after a dose. 8. Acute or chronic, clinically significant pulmonary, cardio-vascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. 9. Serious chronic illness. 10. Major congenital defects. 11. History of any neurological disorders or seizures. 12. History of or current autoimmune disease. 13. History of recurrent wheezing. 14. History of chronic cough. 15. Previous hospitalization for respiratory illnesses. 16. History of thrombocytopenia. 17. History of anemia. 18. Previous, current or planned administration of Synagis. 19. Neurological complications following any prior vaccination. 20. Born to a mother known or suspected to be HIV-positive. 21. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. 22. Family history of congenital or hereditary immunodeficiency. 23. Previous vaccination with a recombinant simian or human adenoviral vaccine. 24. History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. 25. Hypersensitivity to latex. 26. Current severe eczema. 27. Acute disease and/or fever at the time of enrolment. - Fever is defined as temperature = 37.5°C/99.5°F for oral, axillary or tympanic route, or = 38.0°C/100.4°F for rectal route. The preferred route for recording temperature in this study will be axillary. - Clinically significant upper respiratory tract infection - Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator. 28. Any clinically significant Grade 1 or any = Grade 2 hema-tological or biochemical laboratory abnormality detected at the last screening blood sampling. 29. Any other conditions that the investigator judges may interfere with study procedures or findings. 30. Any conditions that could constitute a risk for the subjects while participating to this study. 31. Weight below the fifth percentile of the local weight-for-age curve. 32. 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. 33. Planned move to a location that will prohibit pa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and reactogenicity of three dose levels of the RSV investigational vaccine when administered as two IM doses according to a 0, 1-month schedule, up to 30 days after Dose 2 (i.e. Day 60) in RSV-seropositive infants aged 12 to 23 months.;Secondary Objective: 1. To evaluate the safety of two IM doses of three dose levels of the RSV investigational vaccine when administered according to a 0, 1-month schedule from study start (Day 0) up to study conclusion (Day 730) in RSV-seropositive infants aged 12 to 23 months. 2. To evaluate the occurrence of RSV respiratory tract infections in RSV-seropositive infants from Visit 1 (Day 0, after Dose 1) up to study conclusion (Day 730). 3. To evaluate the magnitude of the cell-mediated immunity (CMI) induced by two IM doses of three dose levels of the RSV investigational vaccine when administered according to a 0, 1-month schedule, up to Day 365 in RSV-seropositive infants aged 12 to 23 months. 4. To evaluate the humoral immunogenicity induced by two IM doses of three dose levels of the RSV investigational vaccine when administered according to a 0, 1-month schedule, up to Day 365 in RSV-seropositive infants aged 12 to 23 months.;Primary end point(s): 1. Number of subjects with any solicited local adverse events (AEs):Assessed solicited local symptoms were pain, redness and swelling. Any occurrence of the symptom regardless of intensity grade. Grade 3 pain=pain that prevented normal activity. Grade 3 redness/swelling=redness/swelling spreading beyond 20 millimeters (mm) of injection site. Relationship analysis was not performed 2. Number of subjects with any solicited general AEs: Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability/fussiness and loss of appetite. Any occurrence of the symptom regardless of intensity grade. Grade 3 symptom=symptom that prevented normal activity. Grade 3 fever=fev | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Number of subjects with any SAEs: SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. 2. Number of subjects with any lower respiratory tract infection associated with RSV infection (RSV-LRTI): Occurrence of RSV-LRTI AE of specific interest. 3. Number of subjects with any respiratory tract infection associated with RSV infection (RSV-RTI), RSV-LRTI, severe RSV-LRTI (according to standardized case definitions): Occurrence of RSV-RTI, RSV-LRTI, severe RSV-LRTI. 4. Frequency of CD3+/CD4+ T-cells expressing at least one marker among cluster of differentiation 40-ligand (CD40-L), Interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-alpha) and interferon-gamma (IFNgamma) upon stimulation with F, N and M2-1 peptide pools. 5. Neutralizing antibody titers against RSV-A: Titers were expressed as geometric mean titers (GMTs) for the seroprotection cut-off. 6. RSV F antibody concentrations: Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off. 7. Palivizumab-competing antibody concentrations: Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off.;Timepoint(s) of evaluation of this end point: 1. From study start (Day 0) up to study conclusion (Day 730). 2. From Dose 1 administration (Day 0) up to study conclusion (Day730). 3. From Dose 1 administration (Day 0) up to study conclusion (Day 730). 4. Pre-vaccination (Screening), post-Dose 1 (Day 30) and post-Dose 2 (Day 60 and Day 365). 5. Pre-vaccination (Screening), post-Dose 1 (Day 30) and post-Dose 2 (Day 60 and Day 365). 6. Pre-vaccination (Screening), post-Dose 1 (Day 30) and post-Dose 2 (Day 60 and Day 365). 7. Pre-vaccination (Screening), post-Dose 1 (Day 30) and post-Dose 2 (Day 60). | — |
Countries
Australia, Canada, Hong Kong, Italy, Mexico, Panama, Poland, Russian Federation, Spain, Taiwan, Thailand, United States
Contacts
Public ContactCentro de Información
GlaxoSmithKline S.A.
Outcome results
None listed