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Safety, Immunogenicity and Efficacy of GSK S. Aureus Candidate Vaccine (GSK3878858A) When Administered to Healthy Adults (Dose-escalation) and to Adults 18 to 50 Years of Age With a Recent S. Aureus Skin and Soft Tissue Infection (SSTI)

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ClinicalTrials.gov Identifier: NCT04420221
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : November 22, 2021
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE June 4, 2020
First Posted Date  ICMJE June 9, 2020
Last Update Posted Date November 22, 2021
Actual Study Start Date  ICMJE June 29, 2020
Estimated Primary Completion Date May 8, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2021)
  • Number of participants with solicited local adverse events (AEs) (any, grade 3) [ Time Frame: During 7 days after the first dose (Days 1 to 8) ]
    The solicited local AE(s) assessed are pain, redness and swelling. Any = any solicited local AE, regardless of intensity; Grade 3 pain = Significant pain at rest, that prevents normal every day activities; Grade 3 redness/swelling = greater than or equal to (≥)100 mm diameter (greatest surface diameter in millimetres [mm]).
  • Number of participants with solicited local adverse events (AEs) (any, grade 3) [ Time Frame: During 7 days after the second dose (Days 61 to 68) ]
    The solicited local AE(s) assessed are pain, redness and swelling. Any = any solicited local AE, regardless of intensity; Grade 3 pain = Significant pain at rest, that prevents normal every day activities; Grade 3 redness/swelling = greater than or equal to (≥)100 mm diameter (greatest surface diameter in millimeters [mm]).
  • Number of participants with solicited general AEs (any, grade 3) [ Time Frame: During 7 days after the first dose (Days 1 to 8) ]
    The solicited general AE(s) assessed are headache, fatigue, nausea, vomiting, diarrhea, abdominal pain, myalgia, shivering and fever (temperature ≥ 38.0 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F). Any = any solicited general AE regardless of intensity; Grade 3 headache/fatigue/nausea/abdominal pain/myalgia/shivering = Severe: Prevents daily activity. Grade 3 vomiting = Severe: 6 or more times in 24 hours or requires intravenous hydration. Grade 3 diarrhea = Severe: 6 or more loose stools in 24 hours or requires intravenous hydration. Grade 3 fever = body temperature greater than (>) 40.0°C/104°F.
  • Number of participants with solicited general AEs (any, grade 3) [ Time Frame: During 7 days after the second dose (Days 61 to 68) ]
    The solicited general AE(s) assessed are headache, fatigue, nausea, vomiting, diarrhea, abdominal pain, myalgia, shivering and fever (temperature ≥ 38.0 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F). Any = any solicited general AE regardless of intensity; Grade 3 headache/fatigue/nausea/abdominal pain/myalgia/shivering = Severe: Prevents daily activity. Grade 3 vomiting = Severe: 6 or more times in 24 hours or requires intravenous hydration. Grade 3 diarrhea = Severe: 6 or more loose stools in 24 hours or requires intravenous hydration. Grade 3 fever = body temperature greater than (>) 40.0°C/104°F.
  • Number of participants with unsolicited AEs (any, grade 3, related, related grade 3) [ Time Frame: During 30 days after the first dose (Days 1 to 31) ]
    Any (independent from causality) unsolicited AEs regardless of intensity; Grade 3 unsolicited AEs = An AE which prevents normal, everyday activities. Such an AE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related unsolicited AEs = AEs assessed by the investigator to be causally related to vaccination. Grade 3 related unsolicited AEs = An AE which prevents normal, everyday activities. Such an AE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.
  • Number of participants with unsolicited AEs (any, grade 3, related, related grade 3) [ Time Frame: During 30 days after the second dose (Days 61 to 91) ]
    Any (independent from causality) unsolicited AEs regardless of intensity; Grade 3 unsolicited AEs = An AE which prevents normal, everyday activities. Such an AE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related unsolicited AEs = AEs assessed by the investigator to be causally related to vaccination. Grade 3 related unsolicited AEs = An AE which prevents normal, everyday activities. Such an AE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.
  • Number of participants with serious AEs (SAEs) (any, grade 3, related, related grade 3) [ Time Frame: Throughout the study period [from Day 1 (day of vaccination) until Day 366 ]
    Any (independent from causality) SAEs regardless of intensity; Grade 3 SAEs = SAE which prevents normal, everyday activities. Such an SAE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related SAEs = SAEs assessed by the investigator to be causally related to vaccination. Grade 3 related SAEs = SAE which prevents normal, everyday activities. Such an SAE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.
  • Number of participants with serious AEs (SAEs) (any, grade 3, related, related grade 3) [ Time Frame: Throughout the study period [from Day 1 (day of vaccination) until Day 426 ]
    Any (independent from causality) SAEs regardless of intensity; Grade 3 SAEs = SAE which prevents normal, everyday activities. Such an SAE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related SAEs = SAEs assessed by the investigator to be causally related to vaccination. Grade 3 related SAEs = SAE which prevents normal, everyday activities. Such an SAE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.
  • Number of participants with potential immune-mediated diseases (PIMDs) (any, grade 3, related, related grade 3) [ Time Frame: Throughout the study period [from Day 1 (day of vaccination) until Day 366 ]
    Any (independent from causality) PIMDs regardless of intensity; Grade 3 PIMDs = PIMD which prevents normal, everyday activities. Such an PIMD would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related PIMDs = PIMDs assessed by the investigator to be causally related to vaccination. Grade 3 related PIMDs = PIMD which prevents normal, everyday activities. Such an PIMD would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.
  • Number of participants with potential immune-mediated diseases (PIMDs) (any, grade 3, related, related grade 3) [ Time Frame: Throughout the study period [from Day 1 (day of vaccination) until Day 426 ]
    Any (independent from causality) PIMDs regardless of intensity; Grade 3 PIMDs = PIMD which prevents normal, everyday activities. Such an PIMD would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related PIMDs = PIMDs assessed by the investigator to be causally related to vaccination. Grade 3 related PIMDs = PIMD which prevents normal, everyday activities. Such an PIMD would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.
  • Number of participants with haematological and biochemical laboratory abnormalities and changes from the baseline values [ Time Frame: At Day 8 (7 days after the first dose) ]
    The number of participants having hematology and biochemistry results below, within or above the normal laboratory ranges, compared to baseline range indicator.
  • Number of participants with haematological and biochemical laboratory abnormalities and changes from the baseline values [ Time Frame: At Day 68 (7 days after the second dose) ]
    The number of participants having hematology and biochemistry results below, within or above the normal laboratory ranges, compared to baseline range indicator.
Original Primary Outcome Measures  ICMJE
 (submitted: June 4, 2020)
  • Number of participants with solicited local adverse events (AEs) (any, grade 3) [ Time Frame: During 7 days after the first dose (Days 1 to 8) ]
    The solicited local AE(s) assessed are pain, redness and swelling. Any = any solicited local AE, regardless of intensity; Grade 3 pain = Significant pain at rest, that prevents normal every day activities; Grade 3 redness/swelling = greater than or equal to (≥)100 mm diameter (greatest surface diameter in millimetres [mm]).
  • Number of participants with solicited local adverse events (AEs) (any, grade 3) [ Time Frame: During 7 days after the second dose (Days 61 to 68) ]
    The solicited local AE(s) assessed are pain, redness and swelling. Any = any solicited local AE, regardless of intensity; Grade 3 pain = Significant pain at rest, that prevents normal every day activities; Grade 3 redness/swelling = greater than or equal to (≥)100 mm diameter (greatest surface diameter in millimetres [mm]).
  • Number of participants with solicited general AEs (any, grade 3) [ Time Frame: During 7 days after the first dose (Days 1 to 8) ]
    The solicited general AE(s) assessed are headache, fatigue, nausea, vomiting, diarrhea, abdominal pain and fever (temperature ≥ 38.0 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F). Any = any solicited general AE regardless of intensity; Grade 3 headache/fatigue/nausea/abdominal pain = Severe: Prevents daily activity. Grade 3 vomiting = Severe: 6 or more times in 24 hours or requires intravenous hydration. Grade 3 diarrhea = Severe: 6 or more loose stools in 24 hours or requires intravenous hydration. Grade 3 fever = body temperature greater than (>) 40.0°C/104°F.
  • Number of participants with solicited general AEs (any, grade 3) [ Time Frame: During 7 days after the second dose (Days 61 to 68) ]
    The solicited general AE(s) assessed are headache, fatigue, nausea, vomiting, diarrhea, abdominal pain and fever (temperature ≥ 38.0 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F). Any = any solicited general AE regardless of intensity; Grade 3 headache/fatigue/nausea/abdominal pain = Severe: Prevents daily activity. Grade 3 vomiting = Severe: 6 or more times in 24 hours or requires intravenous hydration. Grade 3 diarrhea = Severe: 6 or more loose stools in 24 hours or requires intravenous hydration. Grade 3 fever = body temperature greater than (>) 40.0°C/104°F.
  • Number of participants with unsolicited AEs (any, grade 3, related, related grade 3) [ Time Frame: During 30 days after the first dose (Days 1 to 31) ]
    Any (independent from causality) unsolicited AEs regardless of intensity; Grade 3 unsolicited AEs = An AE which prevents normal, everyday activities. Such an AE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related unsolicited AEs = AEs assessed by the investigator to be causally related to vaccination. Grade 3 related unsolicited AEs = An AE which prevents normal, everyday activities. Such an AE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.
  • Number of participants with unsolicited AEs (any, grade 3, related, related grade 3) [ Time Frame: During 30 days after the second dose (Days 61 to 91) ]
    Any (independent from causality) unsolicited AEs regardless of intensity; Grade 3 unsolicited AEs = An AE which prevents normal, everyday activities. Such an AE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related unsolicited AEs = AEs assessed by the investigator to be causally related to vaccination. Grade 3 related unsolicited AEs = An AE which prevents normal, everyday activities. Such an AE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.
  • Number of participants with serious AEs (SAEs) (any, grade 3, related, related grade 3) [ Time Frame: Throughout the study period [from Day 1 (day of vaccination) until Day 366 ]
    Any (independent from causality) SAEs regardless of intensity; Grade 3 SAEs = SAE which prevents normal, everyday activities. Such an SAE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related SAEs = SAEs assessed by the investigator to be causally related to vaccination. Grade 3 related SAEs = SAE which prevents normal, everyday activities. Such an SAE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.
  • Number of participants with serious AEs (SAEs) (any, grade 3, related, related grade 3) [ Time Frame: Throughout the study period [from Day 1 (day of vaccination) until Day 426 ]
    Any (independent from causality) SAEs regardless of intensity; Grade 3 SAEs = SAE which prevents normal, everyday activities. Such an SAE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related SAEs = SAEs assessed by the investigator to be causally related to vaccination. Grade 3 related SAEs = SAE which prevents normal, everyday activities. Such an SAE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.
  • Number of participants with potential immune-mediated diseases (PIMDs) (any, grade 3, related, related grade 3) [ Time Frame: Throughout the study period [from Day 1 (day of vaccination) until Day 366 ]
    Any (independent from causality) PIMDs regardless of intensity; Grade 3 PIMDs = PIMD which prevents normal, everyday activities. Such an PIMD would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related PIMDs = PIMDs assessed by the investigator to be causally related to vaccination. Grade 3 related PIMDs = PIMD which prevents normal, everyday activities. Such an PIMD would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.
  • Number of participants with potential immune-mediated diseases (PIMDs) (any, grade 3, related, related grade 3) [ Time Frame: Throughout the study period [from Day 1 (day of vaccination) until Day 426 ]
    Any (independent from causality) PIMDs regardless of intensity; Grade 3 PIMDs = PIMD which prevents normal, everyday activities. Such an PIMD would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related PIMDs = PIMDs assessed by the investigator to be causally related to vaccination. Grade 3 related PIMDs = PIMD which prevents normal, everyday activities. Such an PIMD would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.
  • Number of participants with haematological and biochemical laboratory abnormalities [ Time Frame: At Day 8. ]
    The number of participants having hematology and biochemistry results below or above the normal laboratory ranges.
  • Number of participants with haematological and biochemical laboratory abnormalities [ Time Frame: At Day 68. ]
    The number of participants having hematology and biochemistry results below or above the normal laboratory ranges.
  • Number of participants with changes from the haematological and biochemical laboratory baseline values to values after vaccination [ Time Frame: At Day 8. ]
    Changes of haematological and biochemical laboratory values from the baseline values to values 7 days after the first dose.
  • Number of participants with changes from the haematological and biochemical laboratory baseline values to values after vaccination [ Time Frame: At Day 68. ]
    Changes of haematological and biochemical laboratory values from the baseline values to values 7 days after the second dose.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2020)
  • Number of participants with at least one culture confirmed case of recurrent S. aureus SSTI [ Time Frame: Starting from Day 75 (i.e.14 days after the second dose) up to Day 426 (12 months after the second dose). ]
    This key secondary outcome measure is to evaluate efficacy in terms of number of participants with at least one culture confirmed case of recurrent S. aureus SSTI starting 14 days after the second dose.
  • Number of participants with at least one culture confirmed case of recurrent S. aureus SSTI [ Time Frame: Starting from Day 15 (i.e. 14 days after the first dose) up to Day 426 (12 months after the second dose). ]
    This co-secondary outcome measure is to evaluate efficacy in terms of number of participants with at least one culture confirmed case of recurrent S. aureus SSTI starting 14 days after the first dose.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Immunogenicity and Efficacy of GSK S. Aureus Candidate Vaccine (GSK3878858A) When Administered to Healthy Adults (Dose-escalation) and to Adults 18 to 50 Years of Age With a Recent S. Aureus Skin and Soft Tissue Infection (SSTI)
Official Title  ICMJE A Phase I/II, Observer-blind, Randomised, Placebo-controlled Study to Assess Safety, Immunogenicity and Efficacy of GSK S. Aureus Candidate Vaccine When Administered to Healthy Adults (Dose-escalation) and to Adults 18 to 50 Years of Age With a Recent S. Aureus Skin and Soft Tissue Infection (SSTI)
Brief Summary Safety, immunogenicity and efficacy of GSK S. aureus candidate vaccine (GSK3878858A) when administered to healthy adults (dose-escalation) and to adults 18 to 50 years of age with a recent S. aureus skin and soft tissue infection (SSTI). In the dose-escalation safety lead-in phase in healthy adults safety and immunogenicity of 4 different compositions is assessed. After safety has been shown in this phase, in the second phase, proof of principle (PoP) phase of the study in adults with a recent SSTI safety, immunogenicity and efficacy of the final composition of the vaccine is assessed.
Detailed Description The main reasons for Protocol Amendment 2, dated 09-04-2021, have been to simplify the study procedures for the PoP phase, including those related to the screening of subjects and to outline specific measures related to an emergency mass vaccination for an unforeseen public health threat (e.g.: a pandemic) that may be applicable during the subjects' participation in the study. Additionally, some minor corrections have been made as well.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Infections, Soft Tissue
Intervention  ICMJE
  • Biological: Sa-5Ag half dose non-adjuvanted
    1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, non-adjuvanted at Day 1, administered intramuscularly.
  • Biological: Sa-5Ag full dose non-adjuvanted
    1 dose of Sa-5Ag (5 antigens of S. aureus) full dose, non-adjuvanted at Day 1, administered intramuscularly.
  • Biological: Sa-5Ag half dose adjuvanted
    1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, adjuvanted at Day 1, administered intramuscularly.
  • Biological: Sa-5Ag full dose adjuvanted
    A series of 2 doses of S. aureus candidate vaccine (Sa-5Ag full dose adjuvanted) given approximately 2 months apart (Days 1 and 61), administered intramuscularly.
  • Drug: Placebo
    One dose of placebo (saline) at Day 1 for placebo groups 1 to 3 and a series of 2 doses of placebo (saline) given approximately 2 months apart (Days 1 and 61) for placebo groups 4 and 5, administered intramuscularly.
Study Arms  ICMJE
  • Experimental: Half dose non-adj Group 1a
    Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, non-adjuvanted at Day 1.
    Intervention: Biological: Sa-5Ag half dose non-adjuvanted
  • Placebo Comparator: Placebo Group 1b
    Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of placebo (saline) at Day 1.
    Intervention: Drug: Placebo
  • Experimental: Full dose non-adj Group 2a
    Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of Sa-5Ag (5 antigens of S. aureus) full dose, non-adjuvanted at Day 1
    Intervention: Biological: Sa-5Ag full dose non-adjuvanted
  • Placebo Comparator: Placebo Group 2b
    Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of placebo (saline) at Day 1.
    Intervention: Drug: Placebo
  • Experimental: Half dose adj Group 3a
    Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, adjuvanted at Day 1.
    Intervention: Biological: Sa-5Ag half dose adjuvanted
  • Placebo Comparator: Placebo Group 3b
    Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of placebo (saline) at Day 1.
    Intervention: Drug: Placebo
  • Experimental: Full dose adj Group 4a
    Subjects aged 18 to 50 at the time of first vaccination who receive a series of 2 doses of S. aureus candidate vaccine (Sa-5Ag full dose adjuvanted) given approximately 2 months apart (Days 1 and 61)
    Intervention: Biological: Sa-5Ag full dose adjuvanted
  • Placebo Comparator: Placebo Group 4b
    Subjects aged 18 to 50 at the time of first vaccination who receive a series of 2 doses of placebo (saline) given approximately 2 months apart (Days 1 and 61).
    Intervention: Drug: Placebo
  • Experimental: Vaccine Group 5a
    Subjects aged 18 to 50 at the time of first vaccination who receive a series of 2 doses of S. aureus candidate vaccine (Sa-5Ag full dose adjuvanted) given approximately 2 months apart (Days 1 and 61).
    Intervention: Biological: Sa-5Ag full dose adjuvanted
  • Placebo Comparator: Placebo Group 5b
    Subjects aged 18 to 50 at the time of first vaccination who receive a series of 2 doses of placebo (saline) given approximately 2 months apart (Days 1 and 61).
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 4, 2020)
632
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 8, 2023
Estimated Primary Completion Date May 8, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

All subjects must satisfy all the following criteria at study entry:

  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
  • Written or witnessed informed consent obtained from the subject prior to performance of any study specific procedure.
  • Subject satisfying screening requirements.
  • Subjects who, after the nature of the study has been explained to them, have shown adequate comprehension of the study procedures and knowledge of study.
  • A male or female between 18 and 50 years of age, inclusive, at the time of first vaccination.
  • Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:

    • has practiced adequate contraception for 30 days prior to vaccination,
    • has a negative pregnancy test on the day of enrolment, and
    • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Additional inclusion criteria only for subjects to be enrolled in the dose-escalation safety lead-in screening epoch:

- Healthy subjects as established by medical history, clinical examination and laboratory assessment.

Additional inclusion criteria only for subjects to be enrolled in the PoP screening epoch:

- Healthy subjects as established by medical history and clinical examination before entering into the study with an ongoing SSTI suspected to be caused by S. aureus, as diagnosed by investigator (before randomization subjects have to be treated until clinical resolution of culture confirmed SSTI caused by S. aureus). SSTI must be amenable to microbiological culturing per standard clinical practice (i.e. recovery of drainage sample from abscess or suppurative cellulitis).

OR - Healthy subjects as established by medical history and clinical examination before entering into the study with an ongoing S. aureus SSTI (i.e. S. aureus is the most likely cause), as confirmed by a S. aureus positive culture performed outside the study procedures and not earlier than 14 days prior to Informed Consent Form signature. Before randomisation subjects have to be treated until clinical resolution of the culture confirmed SSTI caused by S. aureus. These subjects will be enrolled whether they have or have not already started specific treatment of the infection. In case they have not started the treatment, this will be then given in compliance with the standard medical practice for the management of S. aureus SSTIs and the choice and judgment of the most appropriate treatment will be applied by the investigator, outside the study procedures.

Exclusion Criteria:

All subjects at study entry

  • BMI >40 kg/m2
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
  • Hypersensitivity to latex
  • Recurrent history of uncontrolled neurological disorders or seizures
  • History of potential immune-mediated disease (pIMD)
  • Clinical conditions that in the investigator's opinion represent a contraindication to intramuscular vaccination and blood draws
  • Known bleeding diathesis or any condition that may be associated with a prolonged bleeding time
  • Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccine(s) within 30 days before the first dose of study vaccine(s)/placebo (Day -29 to Day 1), or during the study period
  • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine/placebo dose
  • Cytotoxic therapy (e.g., medications used during cancer chemotherapy)
  • Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab)
  • Administration of immunoglobulins and/or any blood products or plasma derivatives within 3 months before the first dose of study vaccine or during the study period
  • Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 15 days before the first dose and ending 15 days after the last dose of vaccine(s) administration with the exception of any non-adjuvanted influenza vaccine which may be administered ≥7 days before or after each study vaccination

    *In case an emergency mass vaccination for an unforeseen public health threat (e.g.: a pandemic) is organised by the public health authorities, outside the routine immunisation program, the time period described above can be reduced if necessary for that vaccine provided it is licensed and used according to its Product Information.

  • Concurrently participating in another clinical study, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (drug or medical device)
  • Received a vaccine against S. aureus
  • Pregnant or lactating female
  • Female planning to become pregnant or planning to discontinue contraceptive precautions before 2 months after completion of the vaccination series
  • Female planning to become pregnant or planning to discontinue contraceptive precautions before 2 months after completion of the vaccination series
  • History of chronic alcohol consumption and/or drug abuse
  • Any study personnel or immediate dependents, family, or household member

All subjects at the time of vaccination - Any clinically significant hematological (hemoglobin level, white blood cell, lymphocyte, neutrophil, eosinophil, platelet count and red blood cell count) and/or biochemical (alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine) laboratory abnormality

Additional exclusion criteria applied only for dose-escalation safety lead-in

  • Any active or ongoing illness at screening or time of injection
  • History of any serious chronic or progressive disease according to the judgment of the investigator

Additional exclusion criteria applied only for PoP at study entry

  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
  • Major congenital defects, as assessed by the investigator
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, neoplasm, diabetes type 1 and 2, as determined by physical examination or laboratory screening tests
  • Any behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study
  • Individuals at risk for severe or life-threatening SSTIs (e.g., lymphatic or venous insufficiency, liver and kidney disease, IV drug use, etc.)
  • Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study

Additional exclusion criteria applied only for PoP at vaccination

- Microbiological test results of drainage suggest that the SSTI etiology could be other than infection with S. aureus

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com
Listed Location Countries  ICMJE Australia,   New Zealand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04420221
Other Study ID Numbers  ICMJE 208833
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: 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
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKlline
PRS Account GlaxoSmithKline
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP