Single Center, Open Label, Follow up Study in Subjects Who Previously Received Rabies Vaccine as Simulated Post-Exposure Regimen

A Phase III, Single Center, Open Label, Follow-up Immunogenicity Study in Subjects Who Previously Received Post-exposure Rabies Vaccine According to the Essen or 2:1:1 (Zagreb) Schedule

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01067079

Enrollment

200

Registered

2010-02-11

Start date

2010-01-31

Completion date

2010-01-31

Last updated

2011-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rabies

Keywords

Rabies vaccine, Long-term Immunogenicity

Brief summary

This study will evaluate the immunogenicity of rabies vaccine at 13 months, 3 year and 5 years after initial vaccination, administered in two different post-exposure vaccination schedules

Interventions

OTHERNo vaccine administered; subjects only have blood sampling for immunogenicity

No vaccine administered; subjects only have blood sampling for

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

* Male and Female subjects who received complete vaccine series in accordance to the designated vaccination schedule in the previous M49P8 study

Exclusion criteria

* Any disease condition, that in the opinion of investigator may interfere with subjects ability to participate in the study. * Receipt of additional doses of rabies vaccine after completion of initial vaccine series. * For additional entry criteria please refer to protocol.

Design outcomes

Primary

Measure	Time frame
Rabies virus neutralizing antibody(RVNA) responses 13months, 3 years and 5 years after completion of initial vaccination series as evaluated by percentage of subjects with RVNA greater than or equal to 0.5 IU/mL	13 months, 3 years and 5 years after initial vaccination

Secondary

Measure	Time frame
Rabies virus neutralizing antibody(RVNA) responses 13months, 3 years and 5 years after completion of initial vaccination series as evaluated by geometric mean concentration	13months, 3 years and 5years after initial vaccination

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026