Trials / Withdrawn
WithdrawnNCT03192371
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 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
- Status
- Withdrawn
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 6 Years – 17 Years
- Healthy volunteers
- Accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Rabipur | Rabies vaccine administered as an intramuscular injection according to Zagreb or Essen regimen to subjects aged ≥6 to ≤17 years. |
Timeline
- Start date
- 2018-02-15
- Primary completion
- 2019-05-12
- Completion
- 2019-05-12
- First posted
- 2017-06-20
- Last updated
- 2018-02-26
Source: ClinicalTrials.gov record NCT03192371. Inclusion in this directory is not an endorsement.