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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 RSV-seropositive Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02927873
Recruitment Status : Completed
First Posted : October 7, 2016
Results First Posted : October 28, 2021
Last Update Posted : October 28, 2021
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of the respiratory syncytial virus (RSV) candidate vaccine when first administered via intramuscular (IM) injection according to a 0, 1-month schedule to RSV-seropositive infants aged 12 to 23 months.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infections Biological: RSV (GSK3389245A) low dose formulation vaccine Biological: RSV (GSK3389245A) middle dose formulation vaccine Biological: RSV (GSK3389245A) high dose formulation vaccine Drug: Placebo Phase 1 Phase 2

Detailed Description:
The RSV PED-002 study, designed to evaluate the safety, reactogenicity and immunogenicity of the RSV candidate vaccine when administered in 3 sequential doses to seropositive infants aged 12 to 23 months, will be conducted in an observer-blind manner in Epoch 1 and single-blinded in Epoch 2.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Observer blind
Primary Purpose: Prevention
Official Title: A Phase 1/2, Randomized, Observer-blind, Controlled, Multi-center, Dose-escalation Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Respiratory Syncytial Virus (RSV) Investigational Vaccine Based on the RSV Viral Proteins F, N and M2-1 Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A), When Administered Intramuscularly According to a 0, 1-month Schedule to RSV-seropositive Infants Aged 12 to 23 Months
Actual Study Start Date : January 11, 2017
Actual Primary Completion Date : February 19, 2019
Actual Study Completion Date : November 26, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RSV LD Group
RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.
Biological: RSV (GSK3389245A) low dose formulation vaccine
2 doses of 0.5 ml each of RSV (GSK3389245A) low dose formulation vaccine administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.

Experimental: RSV MD Group
RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.
Biological: RSV (GSK3389245A) middle dose formulation vaccine
2 doses of 0.15 ml each of RSV (GSK3389245A) middle dose formulation vaccine administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.

Experimental: RSV HD Group
RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.
Biological: RSV (GSK3389245A) high dose formulation vaccine
2 doses of 0.5 ml each of RSV (GSK3389245A) high dose formulation vaccine administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.

Placebo Comparator: Placebo LD group
RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Drug: Placebo
2 doses (0.5 mL each for Placebo LD and Placebo HD groups and 0.15 mL each for Placebo MD group) of Placebo administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.

Placebo Comparator: Placebo MD group
RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Drug: Placebo
2 doses (0.5 mL each for Placebo LD and Placebo HD groups and 0.15 mL each for Placebo MD group) of Placebo administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.

Placebo Comparator: Placebo HD group
RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Drug: Placebo
2 doses (0.5 mL each for Placebo LD and Placebo HD groups and 0.15 mL each for Placebo MD group) of Placebo administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.




Primary Outcome Measures :
  1. Number of Subjects With Any Solicited Local Adverse Events (AEs) [ Time Frame: During a 7-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31) ]
    Assessed solicited local symptoms are pain, redness and swelling at injection site. Any = occurrence of the symptom regardless of intensity grade. Any redness and swelling symptom = symptom reported with a surface diameter greater than 0 millimeters.

  2. Number of Subjects With Any Solicited General AEs [ Time Frame: During a 7-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31) ]
    Assessed solicited general symptoms are drowsiness, fever [defined as temperature equal to or above (≥) 37.5 degrees Celsius (°C)/99.5 degrees Fahrenheit (°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 being axillary], irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade or relation to study vaccination.

  3. Number of Subjects With Any Unsolicited AEs [ Time Frame: During a 30-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31) ]
    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. Unsolicited AEs are 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 is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to study vaccination.

  4. Number of Subjects With Any Serious Adverse Events (SAEs) From Day 1 up to Day 61 [ Time Frame: From Day 1 up to Day 61 ]
    Assessed SAEs include any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any = occurrence of SAE regardless of intensity grade or relation to study vaccination.

  5. Number of Subjects With Episode of Spontaneous or Excessive Bleeding (AE of Specific Interest) [ Time Frame: During a 30-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31) ]
    Any episode of spontaneous or excessive bleeding if occurring after vaccination was to be fully investigated with a full range of hematological tests to identify the underlying cause and reported as an AE of specific interest.

  6. Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 [ Time Frame: At Day 2 ]
    Assessed hematological laboratory parameters include hemoglobin level [HgL] white blood cells [WBC] and platelet count [PLC]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Unknown, Below, Within or Above. [e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 2].

  7. Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 [ Time Frame: At Day 8 ]
    Assessed hematological laboratory parameters include hemoglobin level [HgL] white blood cells [WBC] and platelet count [PLC]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Below, Within or Above. [e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 8].

  8. Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 [ Time Frame: At Day 31 ]
    Assessed hematological laboratory parameters include hemoglobin level [HgL] white blood cells [WBC] and platelet count [PLC]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Unknown, Below, Within or Above. [e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 31].

  9. Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 [ Time Frame: At Day 32 ]
    Assessed hematological laboratory parameters include hemoglobin level [HgL] white blood cells [WBC] and platelet count [PLC]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Unknown, Below, Within or Above. [e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 32].

  10. Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 [ Time Frame: At Day 38 ]
    Assessed hematological laboratory parameters include hemoglobin level [HgL] white blood cells [WBC] and platelet count [PLC]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Below, Within or Above. [e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 38].

  11. Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 [ Time Frame: At Day 61 ]
    Assessed hematological laboratory parameters include hemoglobin level [HgL] white blood cells [WBC] and platelet count [PLC]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Unknown, Below, Within or Above. [e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 61].

  12. Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 [ Time Frame: At Day 31 ]
    Assessed biochemical laboratory parameters include alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CREA]. Biochemical abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Unknown, Below, Within or Above. [e.g. ALT, Below, Below = ALT below normal ranges at baseline versus below normal ranges at Day 31].

  13. Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 [ Time Frame: At Day 61 ]
    Assessed biochemical laboratory parameters include alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CREA]. Biochemical abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Below, Within or Above. [e.g. ALT, Below, Below = ALT below normal ranges at baseline versus below normal ranges at Day 61].


Secondary Outcome Measures :
  1. Number of Subjects With Any SAEs From Day 1 up to Day 366 [ Time Frame: From Day 1 up to Day 366 ]
    Assessed SAEs include any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any = occurrence of SAE regardless of intensity grade or relation to study vaccination.

  2. Number of Subjects With Lower Respiratory Tract Infection Associated With RSV Infection (RSV-LRTI) (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Day 366 [ Time Frame: From Dose 1 administration (Day 1) up to Day 366 ]
    Subjects experiencing an LRTI associated with RSV infection were reported as AE of specific interest. To identify RSV-LRTI for the purpose of AE of specific interest, the diagnosis was based on the investigators' clinical judgment taking into account the clinical history, the examination, relevant medical investigations and locally-available diagnostic test for RSV.

  3. Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Day 366 [ Time Frame: From Dose 1 administration (Day 1) up to Day 366 ]
    RSV-RTI refers to subject having runny nose OR blocked nose OR cough AND confirmed RSV infection [RSV infection confirmed on nasal swab positive for RSV A or B by quantitative Reverse Transcription Polymerase Chain Reaction (qRT-PCR) performed at sponsor level]. RSV-LRTI refers to subject with history of cough OR difficulty breathing [based on history reported by parents/legally acceptable representatives (LARs) and includes difficulty breathing (e.g. showing signs of wheezing or stridor, tachypnoea, flaring of nostrils, chest in-drawing, apnoea) associated with nasal obstruction] AND Blood Oxygen Saturation (SpO2) lower than (<) 95 percent (%), OR respiratory rate (RR) increase [defined as ≥ 40/minute (12 months of age or above)] AND confirmed RSV infection. RSV-severe LRTI are cases meeting the case definition of RSV-LRTI AND SpO2 < 93%, OR lower chest wall in-drawing.

  4. Number of Subjects With Any SAEs From Day 1 up to Study Conclusion at Day 731 [ Time Frame: From Day 1 up to study conclusion at Day 731 ]
    Assessed SAEs include any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any = occurrence of SAE regardless of intensity grade or relation to study vaccination.

  5. Number of Subjects With RSV-LRTI (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731 [ Time Frame: From Dose 1 administration (Day 1) up to study conclusion at Day 731 ]
    Subjects experiencing an LRTI associated with RSV infection were reported as AE of specific interest. To identify RSV-LRTI for the purpose of AE of specific interest, the diagnosis was based on the investigators' clinical judgment taking into account the clinical history, the examination, relevant medical investigations and locally-available diagnostic test for RSV.

  6. Number of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731 [ Time Frame: From Dose 1 administration (Day 1) up to study conclusion at Day 731 ]
    RSV-RTI refers to subject having runny nose OR blocked nose OR cough AND confirmed RSV infection (RSV infection confirmed on nasal swab positive for RSV A or B by qRT-PCR performed at sponsor level). RSV-LRTI refers to subject with history of cough OR difficulty breathing [based on history reported by parents/LARs and includes difficulty breathing (e.g. showing signs of wheezing or stridor, tachypnoea, flaring of nostrils, chest in-drawing, apnoea) associated with nasal obstruction] AND Sp02 < 95% OR respiratory rate (RR) increase [defined as ≥ 40/minute (12 months of age or above)] AND confirmed RSV infection. RSV-severe LRTI are cases meeting the case definition of RSV-LRTI AND SpO2 < 93%, OR lower chest wall in-drawing.

  7. Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools [ Time Frame: At Pre-vaccination (Screening), Day 31, Day 61 and Day 366 ]

    Magnitude of cell mediated immunity (CMI) response to the investigational RSV vaccine was measured in terms of frequency of RSV-specific CD4+ T-cells expressing at least two markers upon stimulation with F, N and M2-1 peptide pools and expressed in RSV-specific CD4+ T-cells/million cells.

    Assessed markers were CD40-L, IL-2, TNF-α and IFN-ɣ.


  8. Anti-RSV-A Neutralizing Antibody Titers [ Time Frame: At Pre-vaccination (Screening), Day 31, Day 61 and Day 366 ]
    Humoral response to the investigational RSV vaccine was measured in terms of anti-RSV-A neutralizing antibody titers and expressed as geometric mean titers (GMTs) in Estimated Dilution 60 (ED60) titers.

  9. Anti-RSV-F Antibody Concentrations [ Time Frame: At Pre-vaccination (Screening), Day 31, Day 61 and Day 366 ]
    Humoral response to the investigational RSV vaccine was measured as anti-RSV F antibody concentrations and expressed as geometric mean concentrations (GMCs) in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL).

  10. Palivizumab-competing Antibody Concentrations [ Time Frame: At Pre-vaccination (Screening), Day 31 and Day 61 ]
    Humoral response to the investigational RSV vaccine was measured as Palivizumab-competing antibody concentrations and expressed as geometric mean concentrations (GMCs) in microgram/milliliter (µg/mL).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 performance of any study specific procedure.
  • A male or female between, and including, 12 and 23 months at the time of the first vaccination.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Seropositive for RSV as determined by IBL International kit.
  • 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)
  • Subjects' parent(s)/LAR(s) need to have access to a consistent mean of telephone contact or computer.

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 0), or planned use during the study period.
  • Any medical condition that in the judgment of the investigator would make IM injection unsafe.
  • 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.
  • 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 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.
  • Serious chronic illness.
  • Major congenital defects.
  • History of any neurological disorders or seizures.
  • History of or current autoimmune disease.
  • History of recurrent wheezing.
  • History of chronic cough.
  • Previous hospitalization for respiratory illnesses.
  • History of thrombocytopenia.
  • History of anemia.
  • Previous, current or planned administration of Synagis.
  • Neurological complications following any prior vaccination.
  • Born to a mother known or suspected to be 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 likely to be exacerbated by any component of the vaccine.
  • Hypersensitivity to latex.
  • Current severe eczema.
  • 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.
  • Any clinically significant Grade 1 or any ≥ Grade 2 hematological or biochemical laboratory abnormality detected at the last screening blood sampling.
  • Any other conditions that the investigator judges may interfere with study procedures or 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.
  • 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.
  • Planned move to a location that will prohibit participating in the trial until study end.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927873


Locations
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United States, California
GSK Investigational Site
Anaheim, California, United States, 92804
United States, Colorado
GSK Investigational Site
Aurora, Colorado, United States, 80045
United States, Kansas
GSK Investigational Site
Topeka, Kansas, United States, 66604
United States, Maryland
GSK Investigational Site
Frederick, Maryland, United States, 21702
United States, New York
GSK Investigational Site
Syracuse, New York, United States, 13210
United States, South Dakota
GSK Investigational Site
Sioux Falls, South Dakota, United States, 57105
Canada, Nova Scotia
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3K 6R8
Italy
GSK Investigational Site
Milano, Lombardia, Italy, 20122
GSK Investigational Site
Perugia, Umbria, Italy, 06132
Mexico
GSK Investigational Site
Mexico, Mexico, 04530
Panama
GSK Investigational Site
David, Chiriquí, Panama, 0401
GSK Investigational Site
Panama, Panama, 0801
Poland
GSK Investigational Site
Debica, Poland, 39-200
Spain
GSK Investigational Site
Burgos, Spain, 09006
GSK Investigational Site
Madrid, Spain, 28040
GSK Investigational Site
Madrid, Spain, 28041
GSK Investigational Site
Madrid, Spain, 28046
GSK Investigational Site
Majadahonda (Madrid), Spain, 28222
GSK Investigational Site
Santiago de Compostela, Spain, 15706
GSK Investigational Site
Valencia, Spain, 46020
Taiwan
GSK Investigational Site
Hsinchu, Taiwan, 300
GSK Investigational Site
Taipei, Taiwan, 100
GSK Investigational Site
Taipei, Taiwan, 104
GSK Investigational Site
Taoyuan, Taiwan, 333
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
  Study Documents (Full-Text)

Documents provided by GlaxoSmithKline:
Study Protocol  [PDF] December 10, 2017
Statistical Analysis Plan  [PDF] March 28, 2018

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02927873    
Other Study ID Numbers: 204838
2016-000117-76 ( EudraCT Number )
First Posted: October 7, 2016    Key Record Dates
Results First Posted: October 28, 2021
Last Update Posted: October 28, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: https://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Safety
Respiratory syncytial virus (RSV)
Immunogenicity
Reactogenicity
Infants
Vaccine
Additional relevant MeSH terms:
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Respiratory Syncytial Virus Infections
Virus Diseases
Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs