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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03636906
Ethics application status
Date submitted
16/08/2018
Date registered
17/08/2018
Date last updated
27/07/2022

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:
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 - RSV (GSK3389245A) lower dose formulation vaccine
Other interventions - RSV (GSK3389245A) higher dose formulation vaccine
Other interventions - GSK's multicomponent meningococcal B vaccine
Other interventions - Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine
Other interventions - GSK's pneumococcal polysaccharide conjugate vaccine
Other interventions - GSK's meningococcal group A, C, W-135 and Y conjugate vaccine
Treatment: Drugs - Placebo

Experimental: RSV1D Pooled Group - Subjects received the interventions as follows:
Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1).
Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.

Experimental: RSV2D Pooled Group - Subjects received the interventions as follows:
Either 2 doses of experimental RSV (GSK3389245A) higher dose formulation (administered at Day 1 and Day 31) and followed by any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1).
Or 2 doses of experimental RSV (GSK3389245A) higher dose formulation administered at Day 1 and Day 31.

Active Comparator: Comparator_Placebo Pooled Group - Subjects received either one of interventions schedules as follows:
3 doses of GSK's multicomponent meningococcal B vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121).
3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121).
3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121).
2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61) .
2 doses of Placebo alone (administered at Days 1 and 31).


Other interventions: RSV (GSK3389245A) lower dose formulation vaccine
1 dose of RSV (GSK3389245A) lower dose formulation vaccine administered intramuscularly at Day 1.

Other interventions: RSV (GSK3389245A) higher dose formulation vaccine
2 doses of RSV (GSK3389245A) higher dose formulation vaccine administered intramuscularly, at Day 1 and Day 31.

Other interventions: GSK's multicomponent meningococcal B vaccine
3 doses of GSK's multicomponent meningococcal B vaccine administered intramuscularly, at Day 61, Day 121 and at the end of RSV season 1, or at Day 1, Day 61 and end of RSV season 1, depending on the vaccination schedule.

Other interventions: Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine
3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine administered intramuscularly, at Day 61, Day 121 and at the end of RSV season 1, or at Day 1, Day 61 and end of RSV season 1, depending on the vaccination schedule.

Other interventions: GSK's pneumococcal polysaccharide conjugate vaccine
3 doses of GSK's pneumococcal polysaccharide conjugate vaccine administered intramuscularly, at Day 61, Day 121 and at the end of RSV season 1, or at Day 31, Day 61 and end of RSV season 1, depending on the vaccination schedule.

Other interventions: GSK's meningococcal group A, C, W-135 and Y conjugate vaccine
2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine administered intramuscularly, at Day 61 and at the end of RSV season 1, or at Day 31 and end of RSV season 1, depending on the vaccination schedule.

Treatment: Drugs: Placebo
1 dose or 2 doses of Placebo administered intramuscularly at Day 31, or at Day 1 and Day 31, or at Day 1 and Day 61, or at Day 31 and Day 121, depending on the vaccination schedule.
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 (AEs) During a 7-day Follow-up Period After the First Vaccination (Administered at Day 1)
Timepoint [1] 0 0
During a 7-day follow-up period after the first vaccination (administered at Day 1)
Primary outcome [2] 0 0
Number of Subjects With Any Solicited Local Adverse Events (AEs) During a 7-day Follow-up Period After the Second Vaccination (Administered at Day 31)
Timepoint [2] 0 0
During a 7-day follow-up period after the second vaccination (administered at Day 31)
Primary outcome [3] 0 0
Number of Subjects With Any Solicited General AEs During a 7-day Follow-up Period After the First Vaccination (Administered at Day 1)
Timepoint [3] 0 0
During a 7-day follow-up period after the first vaccination (administered at Day 1)
Primary outcome [4] 0 0
Number of Subjects With Any Solicited General AEs During a 7-day Follow-up Period After the Second Vaccination (Administered at Day 31)
Timepoint [4] 0 0
During a 7-day follow-up period after the second vaccination (administered at Day 31)
Primary outcome [5] 0 0
Number of Subjects With Any Unsolicited AEs
Timepoint [5] 0 0
During a 30-day follow-up period across the 2 vaccinations administered at Day 1 and Day 31
Primary outcome [6] 0 0
Number of Subjects With Any Serious Adverse Events (SAEs) From Day 1 up to Day 61
Timepoint [6] 0 0
From Day 1 up to Day 61
Primary outcome [7] 0 0
Number of Subjects With Episode of Spontaneous or Excessive Bleeding (AE of Special Interest)
Timepoint [7] 0 0
During a 30-day follow-up period across the 2 vaccinations administered at Day 1 and Day 31
Secondary outcome [1] 0 0
Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), Lower Respiratory Tract Infection Associated With RSV Infection (RSV-LRTI), Severe RSV-LRTI and Very Severe RSV-LRTI (According to Standardized Case Definitions)
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 RSV-RTI, RSV-LRTI, Severe RSV-LRTI and Very Severe RSV-LRTI (According to Standardized Case Definitions)
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 SAEs From First Vaccination (Day 1) up to the End of the Second RSV Transmission Season (up to 2 Years)
Timepoint [3] 0 0
From first vaccination (Day 1) up to the end of the second RSV transmission season (up to 2 years)
Secondary outcome [4] 0 0
Number of Subjects With RSV-LRTI (AE of Special Interest) From First Vaccination (Day 1) up to the End of the First RSV Transmission Season (up to 1 Year)
Timepoint [4] 0 0
From first vaccination (Day 1) up to the end of the first RSV transmission season (up to 1 year)
Secondary outcome [5] 0 0
Number of Subjects With RSV-LRTI (AE of Special Interest) From First Vaccination (Day 1) up to the End of the Second RSV Transmission Season (up to 2 Years)
Timepoint [5] 0 0
From first vaccination (Day 1) up to the end of the second RSV transmission season (up to 2 years)
Secondary outcome [6] 0 0
Number of RSV Infected Subjects With a Negative RSV Exposure Status (at Screening Based on In-stream Baseline Serological Testing) With Very Severe RSV-LRTI (According to Standardized Case Definition)
Timepoint [6] 0 0
From first vaccination (Day 1) up to the end of the first RSV transmission season (up to 1 year)
Secondary outcome [7] 0 0
Anti-RSV-A Neutralizing Antibody Titers
Timepoint [7] 0 0
At pre-vaccination (Screening), Day 31, Day 61 and at the end of the first RSV transmission season (EOS1) (up to 1 year)
Secondary outcome [8] 0 0
Anti-RSV-F Antibody Concentrations
Timepoint [8] 0 0
At pre-vaccination (Screening), Day 31, Day 61 and at the end of the first RSV transmission season (EOS1) (up to 1 year)

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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/04/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/07/2021
Sample size
Target
Accrual to date
Final
201
Recruitment in Australia
Recruitment state(s)
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
Brazil
State/province [5] 0 0
Minas Gerais
Country [6] 0 0
Brazil
State/province [6] 0 0
São Paulo
Country [7] 0 0
Canada
State/province [7] 0 0
Nova Scotia
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
Canada
State/province [9] 0 0
Québec
Country [10] 0 0
Colombia
State/province [10] 0 0
Cali
Country [11] 0 0
Finland
State/province [11] 0 0
Jarvenpaa
Country [12] 0 0
Finland
State/province [12] 0 0
Tampere
Country [13] 0 0
Finland
State/province [13] 0 0
Turku
Country [14] 0 0
Italy
State/province [14] 0 0
Lazio
Country [15] 0 0
Mexico
State/province [15] 0 0
Mexico
Country [16] 0 0
Panama
State/province [16] 0 0
Chiriquí
Country [17] 0 0
Panama
State/province [17] 0 0
Panama
Country [18] 0 0
Poland
State/province [18] 0 0
Debica
Country [19] 0 0
Poland
State/province [19] 0 0
Gdansk
Country [20] 0 0
Poland
State/province [20] 0 0
Trzebnica
Country [21] 0 0
Poland
State/province [21] 0 0
Warszawa
Country [22] 0 0
Poland
State/province [22] 0 0
Wroclaw
Country [23] 0 0
Spain
State/province [23] 0 0
Burgos
Country [24] 0 0
Spain
State/province [24] 0 0
Madrid
Country [25] 0 0
Spain
State/province [25] 0 0
Majadahonda (Madrid)
Country [26] 0 0
Spain
State/province [26] 0 0
Santiago de Compostela
Country [27] 0 0
Spain
State/province [27] 0 0
Sevilla
Country [28] 0 0
Spain
State/province [28] 0 0
Valencia
Country [29] 0 0
Thailand
State/province [29] 0 0
Bangkok
Country [30] 0 0
Turkey
State/province [30] 0 0
Eskisehir
Country [31] 0 0
Turkey
State/province [31] 0 0
Izmir
Country [32] 0 0
Turkey
State/province [32] 0 0
Kayseri
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Manchester
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Southampton

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03636906