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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03636906




Registration number
NCT03636906
Ethics application status
Date submitted
16/08/2018
Date registered
16/08/2018
Date last updated
18/04/2019

Titles & IDs
Public title
Respiratory Syncytial Virus (RSV) Investigational Vaccine in Infants Aged 6 and 7 Months Likely to be Unexposed to RSV
Scientific title
A Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' RSV Investigational Vaccine Based on Viral Proteins Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A) in Infants
Secondary ID [1] 0 0
2018-000431-27
Secondary ID [2] 0 0
204894
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections 0 0
Respiratory Syncytial Virus Infections 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Respiratory syncytial virus (RSV) vaccine GSK3389245A
Other interventions - Bexsero
Other interventions - Nimenrix
Other interventions - Menveo
Other interventions - Synflorix
Treatment: Drugs - Placebo
Other interventions - Respiratory syncytial virus (RSV) vaccine GSK3389245A
Other interventions - Bexsero
Other interventions - Nimenrix
Other interventions - Menveo
Other interventions - Synflorix
Treatment: Drugs - Placebo

Experimental: 1 Dose GSK3389245A + Bexsero Group - Subjects, males or females between and including 6 and 7 months of age will receive 1 dose of the experimental GSK3389245A vaccine followed by placebo and Bexsero vaccine

Experimental: 2 Dose GSK3389245A + Bexsero Group - Subjects, males or females between and including 6 and 7 months of age will receive 2 doses of the experimental GSK3389245A vaccine followed by Bexsero vaccine

Active Comparator: Bexsero Group - Subjects, males or females between and including 6 and 7 months of age will receive the Bexsero vaccine comparator and placebo

Experimental: 1 Dose GSK3389245A + Nimenrix Group - Subjects, males or females between and including 6 and 7 months of age will receive 1 dose of the experimental GSK3389245A vaccine followed by placebo and Nimenrix vaccine

Experimental: 2 Dose GSK3389245A + Nimenrix Group - Subjects, males or females between and including 6 and 7 months of age will receive 2 doses of the experimental GSK3389245A vaccine followed by Nimenrix vaccine

Active Comparator: Nimenrix Group - Subjects, males or females between and including 6 and 7 months of age will receive the Nimenrix comparator vaccine and placebo.

Experimental: 1 Dose GSK3389245A + Menveo Group - Subjects, males or females between and including 6 and 7 months of age will receive 1 dose of the experimental GSK3389245A vaccine followed by placebo and Menveo vaccine

Experimental: 2 Dose GSK3389245A + Menveo Group - Subjects, males or females between and including 6 and 7 months of age will receive 2 doses of the experimental GSK3389245A vaccine followed by Menveo vaccine

Active Comparator: Menveo Group - Subjects, males or females between and including 6 and 7 months of age will receive the Menveo comparator vaccine and placebo.

Experimental: 1 dose GSK3389245A + Synflorix Group - Subjects, males or females between and including 6 and 7 months of age will receive1 dose of the experimental GSK3389245A vaccine followed by placebo and Synflorix vaccine

Experimental: 2 dose GSK3389245A + Synflorix Group - Subjects, males or females between and including 6 and 7 months of age will receive2 doses of the experimental GSK3389245A vaccine followed by Synflorix vaccine

Active Comparator: Synflorix Group - Subjects, males or females between and including 6 and 7 months of age will receive the Synflorix comparator vaccine and placebo

Experimental: 1 dose GSK3389245A + Placebo - Subjects, males or females between and including 6 and 7 months of age will receive the 1 dose of the GSK3389245A experimental vaccine followed by placebo.

Experimental: 2 dose GSK3389245A + Placebo - Subjects, males or females between and including 6 and 7 months of age will receive the 2 doses of the GSK3389245A experimental vaccine followed by placebo.

Placebo Comparator: Placebo Group - Subjects, males or females between and including 6 and 7 months of age will receive the Placebo vaccine

Experimental: 1 Dose GSK3389245A + Bexsero Group - Subjects, males or females between and including 6 and 7 months of age will receive 1 dose of the experimental GSK3389245A vaccine followed by placebo and Bexsero vaccine

Experimental: 2 Dose GSK3389245A + Bexsero Group - Subjects, males or females between and including 6 and 7 months of age will receive 2 doses of the experimental GSK3389245A vaccine followed by Bexsero vaccine

Active Comparator: Bexsero Group - Subjects, males or females between and including 6 and 7 months of age will receive the Bexsero vaccine comparator and placebo

Experimental: 1 Dose GSK3389245A + Nimenrix Group - Subjects, males or females between and including 6 and 7 months of age will receive 1 dose of the experimental GSK3389245A vaccine followed by placebo and Nimenrix vaccine

Experimental: 2 Dose GSK3389245A + Nimenrix Group - Subjects, males or females between and including 6 and 7 months of age will receive 2 doses of the experimental GSK3389245A vaccine followed by Nimenrix vaccine

Active Comparator: Nimenrix Group - Subjects, males or females between and including 6 and 7 months of age will receive the Nimenrix comparator vaccine and placebo.

Experimental: 1 Dose GSK3389245A + Menveo Group - Subjects, males or females between and including 6 and 7 months of age will receive 1 dose of the experimental GSK3389245A vaccine followed by placebo and Menveo vaccine

Experimental: 2 Dose GSK3389245A + Menveo Group - Subjects, males or females between and including 6 and 7 months of age will receive 2 doses of the experimental GSK3389245A vaccine followed by Menveo vaccine

Active Comparator: Menveo Group - Subjects, males or females between and including 6 and 7 months of age will receive the Menveo comparator vaccine and placebo.

Experimental: 1 dose GSK3389245A + Synflorix Group - Subjects, males or females between and including 6 and 7 months of age will receive1 dose of the experimental GSK3389245A vaccine followed by placebo and Synflorix vaccine

Experimental: 2 dose GSK3389245A + Synflorix Group - Subjects, males or females between and including 6 and 7 months of age will receive2 doses of the experimental GSK3389245A vaccine followed by Synflorix vaccine

Active Comparator: Synflorix Group - Subjects, males or females between and including 6 and 7 months of age will receive the Synflorix comparator vaccine and placebo

Experimental: 1 dose GSK3389245A + Placebo - Subjects, males or females between and including 6 and 7 months of age will receive the 1 dose of the GSK3389245A experimental vaccine followed by placebo.

Experimental: 2 dose GSK3389245A + Placebo - Subjects, males or females between and including 6 and 7 months of age will receive the 2 doses of the GSK3389245A experimental vaccine followed by placebo.

Placebo Comparator: Placebo Group - Subjects, males or females between and including 6 and 7 months of age will receive the Placebo vaccine


Other interventions: Respiratory syncytial virus (RSV) vaccine GSK3389245A
2 doses of study vaccine administered intramuscularly in the left anterolateral thigh side, at Day 1 and Day 31

Other interventions: Bexsero
3 doses of active comparator administered intramuscularly in the left anterolateral thigh side, at Day 61, Day 121 and at the end of RSV season, or at Day 1, Day 61 and end of RSV season.

Other interventions: Nimenrix
3 doses of active comparator administered intramuscularly in the left anterolateral thigh side, at Day 61, Day 121 and at the end of RSV season, or at Day 1, Day 61 and end of RSV season.

Other interventions: Menveo
2 doses of active comparator administered intramuscularly in the left anterolateral thigh side, at Day 61 and at the end of RSV season, or at Day 31 and end of RSV season.

Other interventions: Synflorix
3 doses of active comparator administered intramuscularly in the left anterolateral thigh side, at Day 61, Day 121 and at the end of RSV season, or at Day 1, Day 61 and end of RSV season.

Treatment: Drugs: Placebo
2 doses of placebo administered intramuscularly in the left anterolateral thigh side at Day 1 and Day 61, or at Day 31 and Day 121

Other interventions: Respiratory syncytial virus (RSV) vaccine GSK3389245A
2 doses of study vaccine administered intramuscularly in the left anterolateral thigh side, at Day 1 and Day 31

Other interventions: Bexsero
3 doses of active comparator administered intramuscularly in the left anterolateral thigh side, at Day 61, Day 121 and at the end of RSV season, or at Day 1, Day 61 and end of RSV season.

Other interventions: Nimenrix
3 doses of active comparator administered intramuscularly in the left anterolateral thigh side, at Day 61, Day 121 and at the end of RSV season, or at Day 1, Day 61 and end of RSV season.

Other interventions: Menveo
2 doses of active comparator administered intramuscularly in the left anterolateral thigh side, at Day 61 and at the end of RSV season, or at Day 31 and end of RSV season.

Other interventions: Synflorix
3 doses of active comparator administered intramuscularly in the left anterolateral thigh side, at Day 61, Day 121 and at the end of RSV season, or at Day 1, Day 61 and end of RSV season.

Treatment: Drugs: Placebo
2 doses of placebo administered intramuscularly in the left anterolateral thigh side at Day 1 and Day 61, or at Day 31 and Day 121

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of subjects with any solicited local adverse events. - Assessed solicited local adverse events are pain, redness and swelling. Any = occurrence of the adverse event regardless of intensity grade. Grade 3 pain = pain that prevents normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Timepoint [1] 0 0
During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)
Primary outcome [2] 0 0
Number of subjects with any solicited general adverse events - Assessed solicited general adverse events are drowsiness, fever [defined as axillary temperature equal to or above 38.degrees Celsius (°C)], irritability/fussiness and loss of appetite. Any = occurrence of the adverse events regardless of intensity grade. Grade 3 irritability/fussiness/drowsiness = adverse event that prevented normal activity. Grade 3 fever = fever > 40.0 °C. Grade 3 loss of appetite = not eating at all. Related = adverse event assessed by the investigator as related to the vaccination.
Timepoint [2] 0 0
During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)
Primary outcome [3] 0 0
Number of subjects with any unsolicited adverse events (AEs). - An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Timepoint [3] 0 0
During a 30-day follow-up period after each vaccination (i.e. the day of vaccination and 29 subsequent days).
Primary outcome [4] 0 0
Number of subjects with any serious adverse events (SAEs). - Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Timepoint [4] 0 0
From Day 1 up to Day 61
Primary outcome [5] 0 0
Number of subjects with any AEs of specific interest. - AEs of specific interest include episodes of spontaneous or excessive bleeding.
Timepoint [5] 0 0
During a 30-day follow-up period after each vaccination (i.e. the day of vaccination and 29 subsequent days).
Primary outcome [6] 0 0
Number of subjects with any solicited local adverse events. - Assessed solicited local adverse events are pain, redness and swelling. Any = occurrence of the adverse event regardless of intensity grade. Grade 3 pain = pain that prevents normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Timepoint [6] 0 0
During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)
Primary outcome [7] 0 0
Number of subjects with any solicited general adverse events - Assessed solicited general adverse events are drowsiness, fever [defined as axillary temperature equal to or above 38.degrees Celsius (°C)], irritability/fussiness and loss of appetite. Any = occurrence of the adverse events regardless of intensity grade. Grade 3 irritability/fussiness/drowsiness = adverse event that prevented normal activity. Grade 3 fever = fever > 40.0 °C. Grade 3 loss of appetite = not eating at all. Related = adverse event assessed by the investigator as related to the vaccination.
Timepoint [7] 0 0
During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)
Primary outcome [8] 0 0
Number of subjects with any unsolicited adverse events (AEs). - An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Timepoint [8] 0 0
During a 30-day follow-up period after each vaccination (i.e. the day of vaccination and 29 subsequent days).
Primary outcome [9] 0 0
Number of subjects with any serious adverse events (SAEs). - Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Timepoint [9] 0 0
From Day 1 up to Day 61
Primary outcome [10] 0 0
Number of subjects with any AEs of specific interest. - AEs of specific interest include episodes of spontaneous or excessive bleeding.
Timepoint [10] 0 0
During a 30-day follow-up period after each vaccination (i.e. the day of vaccination and 29 subsequent days).
Secondary outcome [1] 0 0
Number of subjects with respiratory tract infection (RTI), lower respiratory tract infection (LRTI), severe LRTI and very severe LRTI associated with RSV infection - RSV-RTI case definition includes runny nose, or blocked nose, or cough and confirmed RSV infection.
RSV-LRTI case definition includes a history of cough or difficulty breathing and blood oxygen saturation (SpO2) lower than (<) 95 percent (%), or respiratory rate increased defined as respiratory rate higher than or equal to (=) 50 per (/) minute (for 2-11 months of age) and =40/min (for 12 months of age or above) and confirmed RSV infection.
RSV severe LRTI includes the RSV LRTI case definition and a SpO2 < 93%, or lower chest wall in-drawing.
RSV very severe LRTI case definition meets the case definition of RSV-LRTI and a SpO2 <90%, or inability to feed, or failure to respond/unconscious.
Timepoint [1] 0 0
From first vaccination (Day 1) up to the end of the first RSV transmission season (up to 1 year).
Secondary outcome [2] 0 0
Number of subjects with SAEs - Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Timepoint [2] 0 0
From first vaccination (Day 1) up to the end of the second RSV transmission season (up to 2 years).
Secondary outcome [3] 0 0
Number of subjects with RSV LRTI AE of special interest - RSV-LRTI case definition includes a history of cough or difficulty breathing and blood oxygen saturation (SpO2) lower than (<) 95 percent (%), or respiratory rate increased defined as respiratory rate higher than or equal to (=) 50 per (/) minute (for 2-11 months of age) and =40/min (for 12 months of age or above) and confirmed RSV infection.
Timepoint [3] 0 0
From first vaccination (Day 1) up to the end of the first RSV transmission season (up to 1 year), and up to the end of the second RSV transmission season (up to 2 years).
Secondary outcome [4] 0 0
Titers of neutralizing antibodies against RSV type A - Titers are expressed as geometric mean titers (GMTs).
Timepoint [4] 0 0
At pre-vaccination (Screening), post-Dose 1 (Day 31) and post-Dose 2 (Day 61) and at the end of the first RSV transmission season (up to 1 year).
Secondary outcome [5] 0 0
Concentrations of RSV type F antibodies - RSV F antibody concentrations are expressed as geometric mean concentrations (GMCs).
Timepoint [5] 0 0
At pre-vaccination (Screening), post-Dose 1 (Day 31) and post-Dose 2 (Day 61) and at the end of the first RSV transmission season (up to 1 year).
Secondary outcome [6] 0 0
Palivizumab-competing antibody concentrations. - Concentrations of Palivizumab-competing antibodies are expressed as Geometric Mean Concentrations (GMCs).
Timepoint [6] 0 0
At pre-vaccination (Screening), post-Dose 1 (Day 31) and post-Dose 2 (Day 61)
Secondary outcome [7] 0 0
Number of subjects with respiratory tract infection (RTI), lower respiratory tract infection (LRTI), severe LRTI and very severe LRTI associated with RSV infection - RSV-RTI case definition includes runny nose, or blocked nose, or cough and confirmed RSV infection.
RSV-LRTI case definition includes a history of cough or difficulty breathing and blood oxygen saturation (SpO2) lower than (<) 95 percent (%), or respiratory rate increased defined as respiratory rate higher than or equal to (=) 50 per (/) minute (for 2-11 months of age) and =40/min (for 12 months of age or above) and confirmed RSV infection.
RSV severe LRTI includes the RSV LRTI case definition and a SpO2 < 93%, or lower chest wall in-drawing.
RSV very severe LRTI case definition meets the case definition of RSV-LRTI and a SpO2 <90%, or inability to feed, or failure to respond/unconscious.
Timepoint [7] 0 0
From first vaccination (Day 1) up to the end of the first RSV transmission season (up to 1 year).
Secondary outcome [8] 0 0
Number of subjects with SAEs - Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Timepoint [8] 0 0
From first vaccination (Day 1) up to the end of the second RSV transmission season (up to 2 years).
Secondary outcome [9] 0 0
Number of subjects with RSV LRTI AE of special interest - RSV-LRTI case definition includes a history of cough or difficulty breathing and blood oxygen saturation (SpO2) lower than (<) 95 percent (%), or respiratory rate increased defined as respiratory rate higher than or equal to (=) 50 per (/) minute (for 2-11 months of age) and =40/min (for 12 months of age or above) and confirmed RSV infection.
Timepoint [9] 0 0
From first vaccination (Day 1) up to the end of the first RSV transmission season (up to 1 year), and up to the end of the second RSV transmission season (up to 2 years).
Secondary outcome [10] 0 0
Titers of neutralizing antibodies against RSV type A - Titers are expressed as geometric mean titers (GMTs).
Timepoint [10] 0 0
At pre-vaccination (Screening), post-Dose 1 (Day 31) and post-Dose 2 (Day 61) and at the end of the first RSV transmission season (up to 1 year).
Secondary outcome [11] 0 0
Concentrations of RSV type F antibodies - RSV F antibody concentrations are expressed as geometric mean concentrations (GMCs).
Timepoint [11] 0 0
At pre-vaccination (Screening), post-Dose 1 (Day 31) and post-Dose 2 (Day 61) and at the end of the first RSV transmission season (up to 1 year).
Secondary outcome [12] 0 0
Palivizumab-competing antibody concentrations. - Concentrations of Palivizumab-competing antibodies are expressed as Geometric Mean Concentrations (GMCs).
Timepoint [12] 0 0
At pre-vaccination (Screening), post-Dose 1 (Day 31) and post-Dose 2 (Day 61)

Eligibility
Key inclusion criteria
- 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

- Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to
performing any study specific procedure.

- A male or female between and including 6 and 7 months of age (from the day the infant
becomes 6 months of age until the day before the infant achieves 8 months of age) at
the time of the first vaccination.

- Healthy subjects as established by medical history and clinical examination before
entering into the study.

- Born full-term with a minimum birth weight of 2.5 kilograms (kg).

- Subjects' parent(s)/LAR(s) need to have access to a consistent mean of telephone
contact or computer.
Minimum age
6 Months
Maximum age
7 Months
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Child in care

- 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 1), or planned use during the study period.

- 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 = 0.5 milligrams (mg)/kg/day (for pediatric subjects), or
equivalent. Topical steroids are allowed.

- Administration of long-acting immune-modifying drugs or planned administration at any
time during the study period.

- 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.

- 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. Scheduled routine pediatric vaccines may be administered = 7 days before a
dose of study vaccine or = 7 days following a dose of study vaccine, with the
exception of live viral vaccines which may be administered = 14 days before a dose or
= 7 days after a dose.

- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
functional abnormality, as determined by physical examination or laboratory screening
tests.

- A history of, or on-going confirmed RSV disease or highly compatible clinical picture.

- Serious chronic illness.

- Major congenital defects.

- History of any neurological disorders or seizures.

- History of or current autoimmune disease.

- History of recurrent wheezing in the subject's lifetime.

- History of chronic cough.

- Previous hospitalization for lower respiratory illnesses.

- Previous, current or planned administration of Synagis (palivizumab).

- Neurological complications following any prior vaccination.

- Born to a mother known or suspected to be Human Immunodeficiency Virus (HIV)-positive
.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination .

- Family history of congenital or hereditary immunodeficiency.

- Previous vaccination with a recombinant simian or human adenoviral vaccine.

- History of any reaction or hypersensitivity to any component of the vaccines
(investigational or control) or placebo used in this study or any contraindication to
them.

- Hypersensitivity to latex.

- Current severe eczema.

- Acute disease and/or fever at the time of enrolment (Visit 1).

- Any clinically significant Grade 1 or any = Grade 2 hematological or biochemical
laboratory abnormality detected at the last screening blood sampling.

- Any medical condition that in the judgment of the investigator would make
intramuscular (IM) injection unsafe.

- Any other conditions that the investigator judges may interfere with study procedures,
findings.

- Any conditions that could constitute a risk for the subjects while participating to
this study.

- Weight below the fifth percentile of the local weight-for-age curve according to the
World Health Organization (WHO) weight- for- age tables. Participating in another
clinical study, at any time during the study period, in which the subject or mother
(if breastfeeding) has been or will be exposed to an investigational or a
non-investigational vaccine/product.

- Planned move to a location that will prohibit participating in the trial until study
end.

- For Thailand only, subjects who have received Synflorix prior to enrolment.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Parkville
Recruitment hospital [2] 0 0
GSK Investigational Site - Subiaco
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment postcode(s) [2] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Idaho
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Rhode Island
Country [9] 0 0
United States of America
State/province [9] 0 0
South Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Utah
Country [12] 0 0
United States of America
State/province [12] 0 0
Virginia
Country [13] 0 0
Argentina
State/province [13] 0 0
Mendoza
Country [14] 0 0
Argentina
State/province [14] 0 0
Buenos Aires
Country [15] 0 0
Argentina
State/province [15] 0 0
Ciudad Autónoma de Buenos Aires
Country [16] 0 0
Belgium
State/province [16] 0 0
Edegem
Country [17] 0 0
Belgium
State/province [17] 0 0
Leuven
Country [18] 0 0
Brazil
State/province [18] 0 0
Minas Gerais
Country [19] 0 0
Brazil
State/province [19] 0 0
São Paulo
Country [20] 0 0
Canada
State/province [20] 0 0
British Columbia
Country [21] 0 0
Canada
State/province [21] 0 0
Nova Scotia
Country [22] 0 0
Colombia
State/province [22] 0 0
Cali
Country [23] 0 0
Colombia
State/province [23] 0 0
Floridablanca-Santander
Country [24] 0 0
Finland
State/province [24] 0 0
Jarvenpaa
Country [25] 0 0
Finland
State/province [25] 0 0
Tampere
Country [26] 0 0
Finland
State/province [26] 0 0
Turku
Country [27] 0 0
Hong Kong
State/province [27] 0 0
Shatin
Country [28] 0 0
Italy
State/province [28] 0 0
Lazio
Country [29] 0 0
Italy
State/province [29] 0 0
Lombardia
Country [30] 0 0
Italy
State/province [30] 0 0
Umbria
Country [31] 0 0
Italy
State/province [31] 0 0
Firenze
Country [32] 0 0
Mexico
State/province [32] 0 0
Nuevo León
Country [33] 0 0
Mexico
State/province [33] 0 0
Mexico
Country [34] 0 0
Panama
State/province [34] 0 0
Chiriquí
Country [35] 0 0
Panama
State/province [35] 0 0
Panama
Country [36] 0 0
Panama
State/province [36] 0 0
Panamá
Country [37] 0 0
Poland
State/province [37] 0 0
Debica
Country [38] 0 0
Poland
State/province [38] 0 0
Leczna
Country [39] 0 0
Poland
State/province [39] 0 0
Lodz
Country [40] 0 0
Poland
State/province [40] 0 0
Siemianowice Slaskie
Country [41] 0 0
Poland
State/province [41] 0 0
Trzebnica
Country [42] 0 0
Poland
State/province [42] 0 0
Warszawa
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Murmansk
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Tomsk
Country [45] 0 0
Spain
State/province [45] 0 0
Boadilla Del Monte (Madrid)
Country [46] 0 0
Spain
State/province [46] 0 0
Burgos
Country [47] 0 0
Spain
State/province [47] 0 0
Madrid
Country [48] 0 0
Spain
State/province [48] 0 0
Majadahonda (Madrid)
Country [49] 0 0
Spain
State/province [49] 0 0
Móstoles
Country [50] 0 0
Spain
State/province [50] 0 0
Santiago de Compostela
Country [51] 0 0
Spain
State/province [51] 0 0
Sevilla
Country [52] 0 0
Spain
State/province [52] 0 0
Valencia
Country [53] 0 0
Thailand
State/province [53] 0 0
Bangkok
Country [54] 0 0
Turkey
State/province [54] 0 0
Eskisehir
Country [55] 0 0
Turkey
State/province [55] 0 0
Izmir
Country [56] 0 0
Turkey
State/province [56] 0 0
Kayseri
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Edinburgh
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Liverpool
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Manchester
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to provide critical information on the safety, reactogenicity
and immunogenicity profile of the investigational recombinant chimpanzee adenovirus Type
155-vectored RSV (ChAd155-RSV) vaccine in infants likely to be unexposed to RSV, and will
assess a single lower dose and a higher two dose regimen, before moving to future studies.
This study will also assess if there is a risk of 'vaccine-induced enhanced RSV disease'
after vaccination of these infants with the ChAd155-RSV vaccine.
Trial website
https://clinicaltrials.gov/show/NCT03636906
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US GSK Clinical Trials Call Center
Address 0 0
Country 0 0
Phone 0 0
877-379-3718
Fax 0 0
Email 0 0
GSKClinicalSupportHD@gsk.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03636906