Virus DiseasesPhase 4NCT03192371
A Study to Evaluate the One Year Long-term Persistence of Immune Responses Following Two Different Rabies Vaccine Post-exposure Regimens in Chinese Children
A Phase 4 study testing Rabipur in people with Virus Diseases, run by GlaxoSmithKline.
Trial summary
The purpose of this study is to evaluate the 1 year immunogenicity persistence of Rabipur in children 6-17 years of age, and compare the Zagreb regimen with the Essen regimen. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Virus Diseases
- What is being tested?
- Rabipur
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2018to 12 May 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Individuals of 6 through 17 years of age on the day of informed consent/assent.
- Individuals who are in good health at the time of entry into the study as determined by medical history, physical examination and clinical judgment of the investigator.
- Individuals who or whose parent(s)/legal guardian(s) have voluntarily given written informed consent on behalf of their child, and adolescents who have provided written assent, after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
- Individuals who can comply with study procedures and are available for the duration of follow-up.
Who cannot join
- A body temperature ≥38°C (axillary) within 3 days of intended study vaccination.
- Known hypersensitivity to gentamycin, known allergies to excipients of Rabipur such as Polygeline, chicken protein, egg products or any other vaccine component.
- Previously received any rabies vaccine or rabies immune globulin.
- Subjects currently receiving or planning to receive antimalarial medications 4 days prior to V1/Day 1 vaccination and until the final vaccination.
- Progressive, unstable or uncontrolled clinical conditions.
- Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
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- Abnormal function of the immune system resulting from:
- Clinical conditions.
- Systemic administration of corticosteroids for more than 14 consecutive days within 90 days prior to informed consent.
- Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
- Received immunoglobulins or any blood products within 180 days prior to informed consent.
- Received an investigational or non-registered medicinal product within 30 days prior to informed consent.
- Study personnel as an immediate family or household member.
- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.
- Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.
- Children in care: A child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a child in care can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a child in care does not include a child who is adopted or has an appointed legal guardian.
- If female of childbearing potential and sexually active, refusal to use an "acceptable contraceptive method" for the duration of the study.
About this study
Official title: A Phase IV, Randomized, Open-label Study to Evaluate One Year Long-term Persistence of Immune Responses Following Two Different Rabies Vaccine Post-exposure Regimens (Zagreb 2-1-1 and Essen 1-1-1-1-1) in Chinese Children
The purpose of this study is to evaluate the 1 year immunogenicity persistence of Rabipur in children 6-17 years of age, and compare the Zagreb regimen with the Essen regimen.
Read the detailed description
The clinical basis for the last renewal of the Rabipur license in China was the results from study V49_24 (NCT01680016), an immunogenicity and safety trial conducted in Chinese children (6 to 17 years) and adults (≥51 years), which confirmed the non-inferior immunogenicity of the Zagreb versus the conventional Essen post exposure prophylaxis intramuscular (PEP IM) regimen at Day 15 for both age groups.
At the time of license renewal in 2015, the Chinese health authorities requested that GSK continue to conduct immunogenicity persistence follow-ups for at least 1 year to compare the Zagreb regimen with the Essen regimen in populations under 17 years old.
V49_24E1 is an extension study to meet this request, in which subjects aged 17 years or younger who were immunized in the parent trial V49_24 will be recalled for a blood immunogenicity analysis approximately 4-5 years after the original vaccination.
- Conditions
- Virus Diseases
- Being tested
- Rabipur
- Keywords
- Zagreb regimen, Encephalitis, Antibody persistence, Essen regimen, Post-Exposure Prophylaxis (PEP), Rabies
- Medical subject headings
- Virus Diseases, Encephalitis, Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RabipurBiological
Also called Rabies Vaccine (Chicken Embryo Cell) for Human use
Rabies vaccine administered as an intramuscular injection according to Zagreb or Essen regimen to subjects aged ≥6 to ≤17 years.
| Study group | Role | What they receive |
|---|---|---|
| Zagreb 2-1-1 Group | Experimental | 4 doses of Rabipur vaccine, administered intramuscularly according to the Zagreb (2-1-1) regimen (i.e., 2 doses of vaccine administered on Day 1 and 1 dose of vaccine administered on Days 8 and 22). Receives: Biological: Rabipur |
| Essen 1-1-1-1-1 Group | Experimental | 5 doses of Rabipur vaccine, administered intramuscularly according to the Essen (1-1-1-1-1) regimen (i.e., 1 dose of vaccine administered on Days 1, 4, 8, 15, and 29). Receives: Biological: Rabipur |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of immunogenicity in terms of antibody concentrations.
Immunogenicity is assessed in terms of Geometric Mean Concentration (GMC) of Rabies Virus Neutralizing Antibody (RVNA) concentrations.
Comparison between Zagreb and Essen groups will be reported in terms of difference between GMCs.
Measured: Study days 1, 15, 43, 197 and 393.
Percentage of subjects with RVNA concentrations ≥ 0.5 IU/mL
Comparison between Zagreb and Essen groups will be reported in terms of difference between percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL.
Measured: Study days 1, 15, 43, 197 and 393.
All Serious Adverse Events (SAEs) and Adverse Events (AEs) leading to subject withdrawal.
Only SAEs and unsolicited AEs leading to study withdrawal will be collected. SAEs to be assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity, result in congenital anomaly/or birth defect or significant medical event that may not be immediately life threatening or resulting in death or hospitalization but may jeopardize the subject or require intervention to prevent one of the other outcomes listed.
An unsolicited AE is an AE that was not solicited using a Subject Diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent. Potential unsolicited AEs may be medically attended (defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider), or were of concern to the subject and/or parent(s)/legal guardian(s).
Measured: From Day1/Visit 1 through Day 393/Visit 11 (study termination).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start15 Feb 2018 (estimated)
- Primary completion12 May 2019 (estimated)
- Study completion12 May 2019 (estimated)
Why it stopped: Due to supply constraints \& prioritization according to medical need (availability of alternative rabies vaccines), Rabipur will no longer be supplied to China.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virus DiseasesStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be stratified into age subsets of equal numbers within each age cohort (children: 6 to11 years of age and 12 to 17 years of age). Within each age subset, subjects will be assigned randomly in a 1:1 ratio, to one of the two regimens: Zagreb (2-1-1) Group and Essen (1-1-1-1-1) Group.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192371
- Sponsor's protocol ID
- 205854
- Status last verified
- Feb 2018
- First submitted
- 16 Jun 2017
- Last updated
- 26 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Randomized, Open-label Study to Evaluate One Year Long-term Persistence of Immune Responses Following Two Different Rabies Vaccine Post-exposure Regimens (Zagreb 2-1-1 and Essen 1-1-1-1-1) in Chinese Children
- ClinicalTrials.gov ID
- NCT03192371
- Acronym / sponsor ID
- 205854
- Conditions
- Virus Diseases
- Keywords
- Zagreb regimen, Encephalitis, Antibody persistence, Essen regimen, Post-Exposure Prophylaxis (PEP), Rabies
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to supply constraints \& prioritization according to medical need (availability of alternative rabies vaccines), Rabipur will no longer be supplied to China.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2018 (estimated)
- Primary completion
- 12 May 2019 (estimated)
- Study completion
- 12 May 2019 (estimated)
- First posted
- 20 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the 1 year immunogenicity persistence of Rabipur in children 6-17 years of age, and compare the Zagreb regimen with the Essen regimen.
Detailed description
The clinical basis for the last renewal of the Rabipur license in China was the results from study V49_24 (NCT01680016), an immunogenicity and safety trial conducted in Chinese children (6 to 17 years) and adults (≥51 years), which confirmed the non-inferior immunogenicity of the Zagreb versus the conventional Essen post exposure prophylaxis intramuscular (PEP IM) regimen at Day 15 for both age groups.
At the time of license renewal in 2015, the Chinese health authorities requested that GSK continue to conduct immunogenicity persistence follow-ups for at least 1 year to compare the Zagreb regimen with the Essen regimen in populations under 17 years old.
V49_24E1 is an extension study to meet this request, in which subjects aged 17 years or younger who were immunized in the parent trial V49_24 will be recalled for a blood immunogenicity analysis approximately 4-5 years after the original vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be stratified into age subsets of equal numbers within each age cohort (children: 6 to11 years of age and 12 to 17 years of age). Within each age subset, subjects will be assigned randomly in a 1:1 ratio, to one of the two regimens: Zagreb (2-1-1) Group and Essen (1-1-1-1-1) Group.
| Arm | Type | Receives |
|---|---|---|
| Zagreb 2-1-1 Group | Experimental | Biological: Rabipur4 doses of Rabipur vaccine, administered intramuscularly according to the Zagreb (2-1-1) regimen (i.e., 2 doses of vaccine administered on Day 1 and 1 dose of vaccine administered on Days 8 and 22). |
| Essen 1-1-1-1-1 Group | Experimental | Biological: Rabipur5 doses of Rabipur vaccine, administered intramuscularly according to the Essen (1-1-1-1-1) regimen (i.e., 1 dose of vaccine administered on Days 1, 4, 8, 15, and 29). |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Individuals of 6 through 17 years of age on the day of informed consent/assent.
- Individuals who are in good health at the time of entry into the study as determined by medical history, physical examination and clinical judgment of the investigator.
- Individuals who or whose parent(s)/legal guardian(s) have voluntarily given written informed consent on behalf of their child, and adolescents who have provided written assent, after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
- Individuals who can comply with study procedures and are available for the duration of follow-up.
Key exclusion criteria (17 listed)
- A body temperature ≥38°C (axillary) within 3 days of intended study vaccination.
- Known hypersensitivity to gentamycin, known allergies to excipients of Rabipur such as Polygeline, chicken protein, egg products or any other vaccine component.
- Previously received any rabies vaccine or rabies immune globulin.
- Subjects currently receiving or planning to receive antimalarial medications 4 days prior to V1/Day 1 vaccination and until the final vaccination.
- Progressive, unstable or uncontrolled clinical conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RabipurAlso: Rabies Vaccine (Chicken Embryo Cell) for Human useRabies vaccine administered as an intramuscular injection according to Zagreb or Essen regimen to subjects aged ≥6 to ≤17 years. | Biological | Essen 1-1-1-1-1 Group, Zagreb 2-1-1 Group |
Primary outcome
Evaluation of immunogenicity in terms of antibody concentrations.
Time frame: Study days 1, 15, 43, 197 and 393.
Immunogenicity is assessed in terms of Geometric Mean Concentration (GMC) of Rabies Virus Neutralizing Antibody (RVNA) concentrations. Comparison between Zagreb and Essen groups will be reported in terms of difference between GMCs.
Percentage of subjects with RVNA concentrations ≥ 0.5 IU/mL
Time frame: Study days 1, 15, 43, 197 and 393.
Comparison between Zagreb and Essen groups will be reported in terms of difference between percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL.
All Serious Adverse Events (SAEs) and Adverse Events (AEs) leading to subject withdrawal.
Time frame: From Day1/Visit 1 through Day 393/Visit 11 (study termination).
Only SAEs and unsolicited AEs leading to study withdrawal will be collected. SAEs to be assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity, result in congenital anomaly/or birth defect or significant medical event that may not be immediately life threatening or resulting in death or hospitalization but may jeopardize the subject or require intervention to prevent one of the other outcomes listed. An unsolicited AE is an AE that was not solicited using a Subject Diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent. Potential unsolicited AEs may be medically attended (defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider), or were of concern to the subject and/or parent(s)/legal guardian(s).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rabipur in people with Virus Diseases, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of immunogenicity in terms of antibody concentrations. (time frame: Study days 1, 15, 43, 197 and 393.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2018.