ClinicalTrials.gg
CompletedNCT04062669Updated Mar 1, 2024

A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Experimental Rabies Vaccine in Healthy Adults

A Phase 1 interventional study of Low dose formulation of RG SAM (CNE) vaccine (GSK3903133A) and Medium dose formulation of RG SAM (CNE) vaccine (GSK3903133A) in Virus Diseases, sponsored by GlaxoSmithKline. Completed at 4 sites in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-01.

Primary conditionRabiesRegistry: Virus DiseasesReclassifiedWhy we changed it
Registry
Virus Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Rabies
Why
  1. The study's title name Rabies, a narrower term within Virus Diseases.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Prevention

From the registry’s dates

  • Primary completion was Jul 2021, 5 years 3 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

The purpose of this first time-in-human (FTiH) study is to evaluate the safety, reactogenicity and immunogenicity of different dose levels of an experimental rabies glycoprotein G (RG) vaccine (RG-SAM [CNE] vaccine), made using a new technology, when administered intramuscularly (IM) on a 0, 2, 6 *-month schedule to healthy adults.

* There will be no vaccinations with the third dose of any of the study treatments.

02

Conditions studied

  • Virus Diseases

Browse trials for

Keywords

  • First Time in Human
  • Vaccine
  • Healthy subjects
  • Rabies
03

In context

Rabies Reclassified

114 studies on the registry are indexed under Rabies; 15 are open to participants now.

This study's enrollment of 160 is below the median of 201 across 104 interventional studies indexed under Rabies.

Browse Rabies studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.

Compared within Rabies, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Virus Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. participation in genetics research, completion of the electronic diary cards, return for follow-up visits).
  • Written obtained from the participant prior to performance of any study specific procedure.
  • Healthy participants as established by medical history and clinical examination before entering into the study.
  • A male or female participant between, and including, 18 and 40 years of age at the time of the first vaccination.
  • >18 Kg/m\^2 and \<35 Kg/m\^2.
  • Participants with following hematological/biochemical parameters:

    • White Blood Cells and differential, within the study designated laboratory normal range. Participants with FDA toxicity grade 1 differential cell counts and considered not may be enrolled at the discretion of the investigator, and with the review and approval of the medical monitor.
    • = 125,000 - 500,000 cells/mm\^3
    • within normal range of the study designated laboratory
    • within the study designated laboratory normal range
    • Aspartate aminotransferase within the study designated laboratory normal range
    • Total within the study designated laboratory normal range
    • Alkaline phosphatase within the study designated laboratory normal range
    • Serum creatinine less than or equal to 1.1 times study designated laboratory's upper normal limit .
    • Seronegative for surface antigen, virus antibodies, or antibodies
  • Female participants of non- may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or .
  • Female participants of childbearing potential may be enrolled in the study, if the participant

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

Exclusion criteria

Exclusion Criteria:

  • History of diagnosis with rabies exposure, infection or disease.
  • Any confirmed or suspected or immunodeficient condition based on medical history and physical examination.
  • Family history of congenital or hereditary immunodeficiency.
  • History of or current disease.
  • History of any reaction or likely to be exacerbated by any components of RabAvert including polygeline, bovine gelatin, neomycin, chlortetracycline and amphotericin B, chicken protein, egg products or any other vaccine component.
  • Lymphoproliferative disorder or within previous 5 years (excluding effectively treated non-melanotic skin cancer).
  • Hypersensitivity to latex.
  • History of Type I hypersensitivity reactions to any beta-lactam antibiotics (penicillin, aminopenicillins, cephalosporins and carbapenems).
  • Any acute or chronic, disease, as determined by physical examination, laboratory screening tests, subject personal report and/or General Physician (GP) information.
  • Use of any or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines, or planned use during the study period.
  • Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the vaccination and ending 30 days after (Influenza vaccine excluded).
  • Previous vaccination with any licensed or investigational rabies vaccine.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study vaccine or planned administration during the study period.
  • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period within 6 months prior to the vaccine dose.
  • Current allergy treatment with allergen immunotherapy with antigen injections, unless on maintenance schedule.
  • Concomitant or planned administration of antimalarial drugs, to include hydroxychloroquine within 30 days of vaccination.
  • Current anti-tuberculosis prophylaxis or therapy.
  • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been/will be exposed to an investigational or a non-investigational vaccine/product.
  • Pregnant or lactating female participant.
  • Female participant planning to become pregnant or planning to discontinue precautions.
  • Participants at a higher risk than the average US resident with regard to exposure to rabies, per the RabAvert package insert and rabies vaccination recommendations from the Centers for Disease Control (CDC).
  • Participants with extensive tattoos covering deltoid region on both the arms that would preclude the assessment of local reactogenicity.
  • Planned move to a location that will prohibit participating in the trial until study end.
  • Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a to protocol participation.
Terms in these criteria, in plain language(19)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
160 participants (actual)

Study arms

  • Experimental
    Low dose (Ld-) RG SAM (CNE) group

    In Part 1 of the study, healthy adults, 18 to 40 years of age, will receive one intramuscular injection of RG SAM (CNE) low dose formulation vaccine in one arm and one intramuscular injection of saline solution in the opposite arm at Days 1 and 61). In Part 2 of the study, healthy adults, 18 to 40 years of age, will receive one intramuscular injection of RG SAM (CNE) low dose formulation vaccine in one arm according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61)

    Biological: Low dose formulation of RG SAM (CNE) vaccine (GSK3903133A)

  • Experimental
    Medium dose (Md-) RG SAM (CNE) group

    Healthy adults,18 to 40 years of age, will receive one intramuscular injection of RG SAM (CNE) medium dose formulation vaccine in one arm and one intramuscular injection of saline solution in the opposite arm at Day 1.

    Biological: Medium dose formulation of RG SAM (CNE) vaccine (GSK3903133A)

  • Experimental
    Lower dose (Lrd-) RG SAM (CNE) group

    Healthy adults, 18 to 40 years of age, will receive one intramuscular injection of RG SAM (CNE) lower dose formulation vaccine in one arm according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61)

    Biological: Lower dose formulation of RG SAM (CNE) vaccine (GSK3903133A)

  • Experimental
    Lowest dose (Ltd-) RG SAM (CNE) group

    Healthy adults, 18 to 40 years of age, will receive one intramuscular injection of RG SAM (CNE) lowest dose formulation vaccine in one arm according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61)

    Biological: Lowest dose formulation of RG SAM (CNE) vaccine (GSK3903133A)

  • Placebo comparator
    Saline Placebo group

    In Part 1 of the study, healthy adults, 18 to 40 years of age, will receive two intramuscular injections of saline placebo, one in each arm, according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61). In Part 2 of the study, healthy adults, 18 to 40 years of age will receive one intramuscular injections of saline placebo in one arm according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61).

    Drug: Saline Placebo

  • Active comparator
    RabAvert group

    In Part 1 of the study, healthy adults, 18 to 40 years of age, will receive one intramuscular injection of RabAvert in one arm and one intramuscular injection of saline solution in the other arm, according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61). In Part 2 of the study, healthy adults, 18 to 40 years of age, will receive one intramuscular injection of RabAvert in one arm according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61).

    Biological: RabAvert

Interventions

  • BiologicalLow dose formulation of RG SAM (CNE) vaccine (GSK3903133A)

    Subjects in the low dose (Ld-) RG SAM (CNE) group will receive 2 doses of RG SAM (CNE) low dose formulation, administered intramuscularlyat Days 1 and 61.

  • BiologicalMedium dose formulation of RG SAM (CNE) vaccine (GSK3903133A)

    Subjects in the medium dose (Md-) RG SAM (CNE) group will receive 1 doses of RG SAM (CNE) medium dose formulation, administered intramuscularly at Day 1.

  • BiologicalLower dose formulation of RG SAM (CNE) vaccine (GSK3903133A)

    Subjects in the Lower dose (Lrd-) RG SAM (CNE) group will receive 2 doses of RG SAM (CNE) lower dose formulation, administered intramuscularly, according to a 0, 2-month schedule (i.e. at Days 1 and 61)

  • BiologicalLowest dose formulation of RG SAM (CNE) vaccine (GSK3903133A)

    Subjects in the Lowest dose (Ltd-) RG SAM (CNE) group will receive 2 doses of RG SAM (CNE) lowest dose formulation, administered intramuscularly, according to a 0, 2-month schedule (i.e. at Days 1 and 61)

  • DrugSaline Placebo

    Subjects in the Saline Placebo group will receive 2 doses of saline Placebo, administered intramuscularly Day 1 and 61.

  • BiologicalRabAvert

    Subjects in the RabAvert Group will receive 2 doses of RabAvert vaccine, administered intramuscularly, at Days 1 and 61.

06

What researchers measure

Primary outcomes

  1. Number of participants reporting solicited local adverse events (AEs) during the 7-day follow-up period after the first dose received in the Primary vaccination phase

    The following local AEs are solicited: pain, redness and swelling at injection site.

    Time frame: During the 7-day follow-up period after the first dose (administered at Day 1)

  2. Number of participants reporting solicited local adverse events (AEs) during the 7-day follow-up period after the second dose received in the Primary vaccination phase

    The following local AEs are solicited: pain, redness and swelling at injection site.

    Time frame: During the 7-day follow-up period after the second dose (administered at Day 61)

  3. Number of participants reporting solicited general AEs during the 7-day follow-up period after the first dose received in the Primary vaccination phase

    The following general AEs are solicited: fatigue, fever, nausea, vomiting, diarrhea, abdominal pain and headache. Fever is defined as temperature ≥ 38.0°C / 100.4°F. The preferred location for measuring temperature in this study is the oral cavity.

    Time frame: During the 7-day follow-up period after the first dose (administered at Day 1)

  4. Number of participants reporting solicited general AEs during the 7-day follow-up period after the second dose received in the Primary vaccination phase

    The following general AEs are solicited: fatigue, fever, nausea, vomiting, diarrhea, abdominal pain and headache. Fever is defined as temperature ≥ 38.0°C / 100.4°F. The preferred location for measuring temperature in this study is the oral cavity.

    Time frame: During the 7-day follow-up period after the second dose (administered at Day 61)

  5. Number of participants reporting unsolicited AEs during a 30-day follow-up period follow-up after the first dose received in the Primary vaccination phase

    Unsolicited AE is defined as an AE reported in addition to those solicited during the clinical study and as any solicited AE with onset outside the specified period of follow-up for solicited symptoms.

    Time frame: During the 30-day follow-up period after the first dose (administered at Day 1).

  6. Number of participants reporting unsolicited AEs during a 30-day follow-up period follow-up after the second dose received in the Primary vaccination phase

    Unsolicited AE is defined as an AE reported in addition to those solicited during the clinical study and as any solicited AE with onset outside the specified period of follow-up for solicited symptoms.

    Time frame: During the 30-day follow-up period after the second dose (administered at Day 61).

  7. Number of participants with hematological and biochemical laboratory abnormalities at Day 1.

    Clinically significant abnormal laboratory findings (e.g. clinical chemistry and hematology) are reported. The investigator exercises his or her medical and scientific judgement in deciding whether an abnormal laboratory finding or other abnormal assessment is clinically significant.

    Time frame: At Day 1

  8. Number of participants with hematological and biochemical laboratory abnormalities at Day 4.

    Clinically significant abnormal laboratory findings (e.g. clinical chemistry and hematology) are reported. The investigator exercises his or her medical and scientific judgement in deciding whether an abnormal laboratory finding or other abnormal assessment is clinically significant.

    Time frame: At Day 4.

  9. Number of participants with hematological and biochemical laboratory abnormalities at Day 8.

    Clinically significant abnormal laboratory findings (e.g. clinical chemistry and hematology) are reported. The investigator exercises his or her medical and scientific judgement in deciding whether an abnormal laboratory finding or other abnormal assessment is clinically significant.

    Time frame: At Day 8.

  10. Number of participants with hematological and biochemical laboratory abnormalities at Day 61.

    Clinically significant abnormal laboratory findings (e.g. clinical chemistry and hematology) are reported. The investigator exercises his or her medical and scientific judgement in deciding whether an abnormal laboratory finding or other abnormal assessment is clinically significant.

    Time frame: At Day 61.

  11. Number of participants with hematological and biochemical laboratory abnormalities at Day 64.

    Clinically significant abnormal laboratory findings (e.g. clinical chemistry and hematology) are reported. The investigator exercises his or her medical and scientific judgement in deciding whether an abnormal laboratory finding or other abnormal assessment is clinically significant.

    Time frame: At Day 64.

  12. Number of participants with hematological and biochemical laboratory abnormalities at Day 68.

    Clinically significant abnormal laboratory findings (e.g. clinical chemistry and hematology) are reported. The investigator exercises his or her medical and scientific judgement in deciding whether an abnormal laboratory finding or other abnormal assessment is clinically significant.

    Time frame: At Day 68.

  13. Number of participants reporting medically attended AE (MAEs)

    A medically attended adverse event is an AE for which the participants received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (i.e., nurse practitioner or physician assistant or medical doctor) for any reason.

    Time frame: During 90 days (from Day 1 to Day 91)

  14. Number of participants reporting serious adverse events (SAEs)

    SAEs assessed include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study patient.

    Time frame: During 90 days (from Day 1 to Day 91)

  15. Number of participants reporting potential immune-mediated diseases (pIMDs)

    pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

    Time frame: During 90 days (from Day 1 to Day 91)

Secondary outcomes

  1. Number of participants reporting solicited local adverse events (AEs) during the 7-day follow-up period after each vaccination received from Day 1 up to study conclusion at Month 18

    The following local AEs are solicited: pain, redness and swelling at injection site.

    Time frame: During the 7-day follow-up period after the third dose (administered at Day 181)

  2. Number of participants reporting solicited general AEs during the 7-day follow-up period after each vaccination received from Day 1 up to study conclusion at Month 18

    The following general AEs are solicited: fatigue, fever, nausea, vomiting, diarrhea, abdominal pain and headache. Fever is defined as temperature ≥ 38.0°C / 100.4°F. The preferred location for measuring temperature in this study is the oral cavity.

    Time frame: During the 7-day follow-up period after the third dose (administered at Day 181)

  3. Number of participants reporting unsolicited AEs during a 30-day follow-up period after each vaccination from Day 1 up to study conclusion at Month 18

    Unsolicited AE is defined as an AE reported in addition to those solicited during the clinical study and as any solicited AE with onset outside the specified period of follow-up for solicited symptoms.

    Time frame: During the 30-day follow-up period after the third dose (administered at Day 181)

  4. Number of participants with hematological and biochemical laboratory abnormalities at Day 1, Day 4, Day 8, Day 61, Day 64, Day 68, Day 181, Day 184 and Day 188

    Clinically significant abnormal laboratory findings (e.g. clinical chemistry and hematology) are reported. The investigator exercises his or her medical and scientific judgement in deciding whether an abnormal laboratory finding or other abnormal assessment is clinically significant.

    Time frame: At Day 1, Day 4, Day 8, Day 61, Day 64, Day 68, Day 181, Day 184 and Day 188

  5. Number of participants reporting MAEs from Day 1 up to study conclusion at Month 14

    A medically attended adverse event is an AE for which the participants received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (i.e., nurse practitioner or physician assistant or medical doctor) for any reason.

    Time frame: From Day 1 up to study conclusion at Month 14

  6. Number of participants reporting SAEs from Day 1 up to study conclusion at Month 14

    SAEs assessed include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study patient.

    Time frame: From Day 1 to up to study end at Month 14

  7. Number of participants reporting pIMDs from Day 1 up to study conclusion at Month 14

    pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

    Time frame: From Day 1 up to study conclusion at Month 14

  8. Evaluation of immunogenicity in terms of Rabies Virus Neutralizing Antibody (RVNA) concentrations

    RVNA concentrations determined by Rapid Fluorescence Foci Inhibition Test (RFFIT) are presented as geometric mean concentrations (GMCs), expressed in International Unit per milliliter (IU/mL).

    Time frame: At Day 1 and Day 91

  9. Evaluation of immunogenicity in terms of Anti-rabies G IgG antibody concentrations

    Anti-rabies G IgG antibody concentrations determined by Enzyme Linked Immunosorbent Assay (ELISA) are presented as GMCs, expressed in ELISA unit per milliliter (EU/mL).

    Time frame: At Day 1 and Day 91

  10. Evaluation of persistence of immunogenicity in terms of anti-rabies G IgG antibody concentrations at 5 months after last vaccination

    Anti-rabies G IgG antibody concentrations determined by ELISA are presented as GMCs, expressed in EU/mL.

    Time frame: At Month 7 (i.e. 5 months after the last vaccination)

  11. Evaluation of persistence of immunogenicity in terms of anti-rabies G IgG antibody concentrations at 10 months after last vaccination

    Anti-rabies G IgG antibody concentrations determined by ELISA are presented as GMCs, expressed in EU/mL.

    Time frame: At Month 12 (i.e. 10 months after the last vaccination)

07

Study locations

4 sites
  • GSK Investigational Site
    South Miami, Florida 33143, United States
  • GSK Investigational Site
    Lenexa, Kansas 66219, United States
  • GSK Investigational Site
    Baltimore, Maryland 21201, United States
  • GSK Investigational Site
    Rochester, New York 14609, United States
08

References and documents

Individual participant data

Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

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 exemption can be granted, when justified, for up to another 12 months.

Data sharing details ↗ · www.clinicalstudydatarequest.com

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04062669
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Aug 20, 2019
Start date
Aug 13, 2019
Primary completion
Jul 28, 2021
Completion
Jul 1, 2022
Last update
Mar 1, 2024

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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