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This study investigates the safety and immunogenicity (non-inferiority) of a Purified Chick Embryo Cell Vaccine (PCECV) administered in two different schedules (conventional versus abbreviated schedule) in healthy adults 18 to 50 years of age in China
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zagreb (2-1-1) | Experimental | Rabies PCEC vaccine was applied according Zagreb schedule with 2 vaccinations on day 0, 1 vaccination on day 7 and day 21, respectively |
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| Essen (1-1-1-1-1) | Active Comparator | Rabies PCEC vaccine was applied according Essen schedule, i.e. 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abbreviated Zagreb 2-1-1 schedule | Biological | Subjects received the abbreviated Zagreb 2-1-1 schedule in a safety-lead-in phase. |
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| Measure | Description | Time Frame |
|---|---|---|
| Rabies Virus Neutralizing Antibody Concentrations on Day 14. | Rabies virus neutralizing antibody concentrations of the abbreviated Zagreb regimen compared with the conventional Essen regimen. Results are presented on log2 scale. For results on original geometric (multiplicative) scale please raise numbers to the basis of 2. | 14 days |
| Number of Participants Who Reported a Local or Systemic Reaction After Any Vaccination | Specified local and systemic reactions were solicited for 7 days after each vaccination. Number of participants were calculated who reported a local or systemic reaction after any of the vaccinations. | 7 days after each vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Rabies Virus Neutralizing Antibody Concentrations on Day 7 and Day 42. | Rabies virus neutralizing antibody concentrations the abbreviated Zagreb regimen compared with the conventional Essen regimen. Results are presented on log2 scale. For results on original geometric (multiplicative) scale please raise numbers to the basis of 2. | 7 days and 42 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines | Novartis Vaccines | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jizhou | Hebei | 053200 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25483635 | Derived | Ma J, Wang H, Li J, Chang L, Xie Y, Liu Z, Zhao Y, Malerczyk C. A randomized open-labeled study to demonstrate the non-inferiority of purified chick-embryo cell rabies vaccine administered in the Zagreb regimen (2-1-1) compared with the Essen regimen in Chinese adults. Hum Vaccin Immunother. 2014;10(10):2805-12. doi: 10.4161/21645515.2014.972773. |
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All enrolled subjects were randomized, but one subject in the Zagreb (2-1-1) group was not vaccinated.
Study participants were enrolled in November 2008 at 1 center in China.
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| ID | Title | Description |
|---|---|---|
| FG000 | Abbreviated Zagreb (2-1-1) | Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21. |
| FG001 | Conventional Essen(1-1-1-1-1) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Standard Essen 1-1-1-1-1 schedule | Biological | Subjects received the standard Essen regimen. |
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| Percentages of Participants With Seroconversion (Rabies Virus Neutralizing Antibody Concentrations Equal and Above 0.5 IU/ml) on Days 7, 14 and 42. | Percentages of participants with seroconversion (defined as rabies virus neutralizing antibody concentrations equal and above 0.5 IU/ml) on days 7, 14 and 42. | 7 days, 14 days and 42 days |
Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
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| ID | Title | Description |
|---|---|---|
| BG000 | Abbreviated Zagreb (2-1-1) | Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21. |
| BG001 | Conventional Essen(1-1-1-1-1) | Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age Continuous | Baseline measures are presented for safety population. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Baseline measures are presented for safety population. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Rabies Virus Neutralizing Antibody Concentrations on Day 14. | Rabies virus neutralizing antibody concentrations of the abbreviated Zagreb regimen compared with the conventional Essen regimen. Results are presented on log2 scale. For results on original geometric (multiplicative) scale please raise numbers to the basis of 2. | Due to the Chinese registration requirements, only a subset of subjects bloodsamples were drawn and immunogenicity was evaluated. The per protocol population of this subset was analyzed. | Posted | Log Mean | 95% Confidence Interval | IU/mL | 14 days |
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| Secondary | Rabies Virus Neutralizing Antibody Concentrations on Day 7 and Day 42. | Rabies virus neutralizing antibody concentrations the abbreviated Zagreb regimen compared with the conventional Essen regimen. Results are presented on log2 scale. For results on original geometric (multiplicative) scale please raise numbers to the basis of 2. | Due to the Chinese registration requirements, only a subset of subjects bloodsamples were drawn and immunogenicity was evaluated. The per protocol population of this subset was analyzed. | Posted | Log Mean | 95% Confidence Interval | IU/ml | 7 days and 42 days |
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| Primary | Number of Participants Who Reported a Local or Systemic Reaction After Any Vaccination | Specified local and systemic reactions were solicited for 7 days after each vaccination. Number of participants were calculated who reported a local or systemic reaction after any of the vaccinations. | Safety was analyzed for the safety set. One enrolled subject was not vaccinated and not included in the safety set because of inappropriate inclusion. | Posted | Number | participants | 7 days after each vaccination |
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| Secondary | Percentages of Participants With Seroconversion (Rabies Virus Neutralizing Antibody Concentrations Equal and Above 0.5 IU/ml) on Days 7, 14 and 42. | Percentages of participants with seroconversion (defined as rabies virus neutralizing antibody concentrations equal and above 0.5 IU/ml) on days 7, 14 and 42. | Due to the Chinese registration requirements, only a subset of subjects bloodsamples were drawn and immunogenicity was evaluated. The per protocol population of this subset was analyzed. | Posted | Mean | 95% Confidence Interval | percentages of participants | 7 days, 14 days and 42 days |
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Any unsolicited adverse events were collected for 7 days after each vaccination, all serious adverse events were collected throughout the whole study period (beyond individual study participation, from 12 Nov 2008 to 12 Jan 2009).
Subjects were instructed to report on a daily basis any adverse events and record them on a diary card.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Abbreviated Zagreb (2-1-1) | Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21. | 0 | 549 | 52 | 549 | ||
| EG001 | Conventional Essen(1-1-1-1-1) | Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively. | 1 | 275 | 26 | 275 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injury of soft tissue in the leg and shoulder | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment | Safety was analyzed for the safety set. One enrolled subject in the abbreviated Zaghreb group was not vaccinated and not included in the safety set, because of inappropriate inclusion. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment | Safety was analyzed for the safety set. One enrolled subject in the abbreviated Zaghreb group was not vaccinated and not included in the safety set, because of inappropriate inclusion. |
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| Title | Organization | Phone | Extension | |
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| Posting Director | Novartis Vaccines and Diagnostics | RegContactVacUS.nvdit@Novartis.com |
| ID | Term |
|---|---|
| D011818 | Rabies |
| ID | Term |
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| D018353 | Rhabdoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| Male |
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