Last updated: 11/03/2018 23:36:13
A study to evaluate the one year long-term persistence of immune responses following two different rabies vaccine post-exposure regimens in Chinese Children
GSK study ID
205854
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Evaluation of immunogenicity in terms of antibody concentrations.
Timeframe: Study days 1, 15, 43, 197 and 393.
Percentage of subjects with RVNA concentrations ≥ 0.5 IU/mL
Timeframe: Study days 1, 15, 43, 197 and 393.
All Serious Adverse Events (SAEs) and Adverse Events (AEs) leading to subject withdrawal.
Timeframe: From Day1/Visit 1 through Day 393/Visit 11 (study termination).
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
0
Primary completion date:
2019-12-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Virus Diseases
Product
GSK3536851A
Collaborators
Not applicable
Study date(s)
February 2018 to May 2019
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
6 - 17 years
Accepts healthy volunteers
Yes
- 1. Individuals of 6 through 17 years of age on the day of informed consent/assent.
- 2. 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.
- 1. A body temperature ≥38°C (axillary) within 3 days of intended study vaccination.
- 2. Known hypersensitivity to gentamycin, known allergies to excipients of Rabipur such as Polygeline, chicken protein, egg products or any other vaccine component.
Inclusion and exclusion criteria
Inclusion criteria:
- 1. Individuals of 6 through 17 years of age on the day of informed consent/assent. 2. 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. 3. 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. 4. Individuals who can comply with study procedures and are available for the duration of follow-up.
Exclusion criteria:
- 1. A body temperature ≥38°C (axillary) within 3 days of intended study vaccination. 2. Known hypersensitivity to gentamycin, known allergies to excipients of Rabipur such as Polygeline, chicken protein, egg products or any other vaccine component. 3. Previously received any rabies vaccine or rabies immune globulin. 4. Subjects currently receiving or planning to receive antimalarial medications 4 days prior to V1/Day 1 vaccination and until the final vaccination. 5. Progressive, unstable or uncontrolled clinical conditions. 6. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. 7. Abnormal function of the immune system resulting from: a. Clinical conditions. b. Systemic administration of corticosteroids for more than 14 consecutive days within 90 days prior to informed consent. c. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent. 8. Received immunoglobulins or any blood products within 180 days prior to informed consent. 9. Received an investigational or non-registered medicinal product within 30 days prior to informed consent. 10. Study personnel as an immediate family or household member. 11. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study. 12. 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. 13. 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. 14. If female of childbearing potential and sexually active, refusal to use an “acceptable contraceptive method” for the duration of the study.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Other
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website