RabiesPhase 3NCT01680016

A Randomized, Open-label Study Comparing Two Different Rabies Vaccine Schedules in Chinese Children and Older Adults

A Phase 3 study testing Zagreb and Essen in people with Rabies, run by Novartis Vaccines at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study was designed to evaluate the safety and immunogenicity of two simulated postexposure rabies vaccination schedules (Zagreb 2-1-1 and Essen 1-1-1-1-1) in Chinese children and older adults. Read more about this study

Who is it for?: Ages 6 years and olderHealthy volunteers can take part
Conditions the study is for: Rabies
What is being tested?: Zagreb and Essen
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 644 participants
Where: 1 siteChina
Study dates: Sep 2012to Jan 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Individuals between 6-17 years of age and 51 years of age or older
Individuals who were in good health
Provided consent, complied with study procedures and duration of follow-up

Who cannot join

Contraindications to vaccination with rabies vaccine
Body temperature ≥37.5◦C (axillary) within 3 days of intended study vaccination
Known hypersensitivity to the components of the vaccine
Previously received any rabies vaccine or immune globulin
Previous or planned treatment with antimalarial medications
History of psychiatric disease, immune disorder, bleeding disorder, drug/alcohol abuse within the past 2 years, malignancy
Female subjects who were pregnant or unwilling to practice acceptable birth control methods
Individuals enrolled or plans to enroll in another investigational trial

Trial locations and contacts

1 site in 1 country.

China1 site

Mengshan Center for Disease Prevention and Control (CDC)
Mengshan, Guangxi, 530028

Other trials in China

About this study

Official title: A Phase IIIb, Randomized, Open-label Study Comparing Two Different Rabies Vaccine Post-exposure Schedules (Zagreb 2-1-1 and Rabipur® Essen 1-1-1-1-1) in Chinese Children and Older Adults

This study was designed to evaluate the safety and immunogenicity of two simulated postexposure rabies vaccination schedules (Zagreb 2-1-1 and Essen 1-1-1-1-1) in Chinese children and older adults.

Read the detailed description

This study was designed to evaluate the safety and immunogenicity of Rabipur Zagreb (2-1-1) and Rabipur Essen (1-1-1-1-1) simulated post exposure vaccination schedules in Chinese children and older adults. Subjects randomized to Group 1 (Zagreb) will receive 4 doses of rabies vaccine Day 1 (2 doses), and on Day 8 and Day 22. Subjects randomized to Group 2 (Essen) will receive 5 doses of rabies vaccine on Days 1, 4, 8, 15, and 29. First vaccine will be administered on study Day 1.

240 children and 400 older adults, a total of 640, is planned to be enrolled into the study. Subjects will be divided further into age subsets of equal numbers within each age cohort (children: 6 to 11 years of age and 12 to 17 years of age; older adults: 51 to 60 years of age and 61 years of age and older. Within each age subset, subjects will be assigned randomly in a 1:1 ratio.

The primary objective is to establish the non-inferiority of the Rabipur Zagreb (2-1-1) schedule relative to the conventional Rabipur Essen (1-1-1-1-1) schedule based on geometric mean titers (GMC), and the secondary objective is to assess the percent of subjects with rabies virus neutralizing titer ≥ 0.5 IU/mL 14 days after the first vaccinations (study Day 15) for each schedule and age cohort

Conditions: Rabies
Being tested: Zagreb, Essen
Keywords: Rabies virus, postexposure, vaccine schedule, children, older adults
Medical subject headings: Rabies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ZagrebBiological
Subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
EssenBiological
Subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29

Study groups in NCT01680016
Study group	Role	What they receive
Zagreb(≥6 to ≤17 Years)	Experimental	Not described Receives: Biological: Zagreb
Zagreb(≥51 Years)	Experimental	Not described Receives: Biological: Zagreb
Essen(≥6 to ≤17 Years)	Active comparator	Not described Receives: Biological: Essen
Essen(≥51 Years)	Active comparator	Not described Receives: Biological: Essen

What is being measured

The primary outcome is the main question the study is designed to answer.

Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After First Vaccination in Children Aged ≥6 to ≤17 Years.
Immunogenicity was measured as the geometric mean concentrations (GMCs) of rabies virus neutralizing antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
Measured: Before vaccination (day 1) and 14 days after first vaccination (day 15)
Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After the First Vaccination in Older Adults Aged ≥51 Years
Immunogenicity was measured as the GMCs of Rabies Virus Neutralizing Antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
Measured: Before vaccination (day 1) and 14 days after first vaccination (day 15).
Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
Safety was assessed as the number of children who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
Measured: Days 1 to 7 postvaccination
Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
Measured: Days 1 to 7 postvaccination
Number of Children Who Reported Unsolicited Adverse Events (AEs)
The safety of Rabipur was assessed in terms of subjects(Children) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events [SAE]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43.
Measured: From V1/day 1 (postvaccination) through V7/study termination day 43
Number of Older Adults Who Reported Unsolicited Adverse Events (AEs)
The safety of Rabipur was assessed in terms of subjects(Older Adults) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events [SAE]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43.
Measured: from V1/day 1 (postvaccination) through V7/study termination day 43

Secondary outcomes (6)

Percentages of Children With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur
Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
Measured: Before vaccination (day 1) and 14 days after first vaccination (day 15).
Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur
Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
Measured: Before vaccination (day 1) and 14 days after first vaccination (day 15).
Percentages of Children With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur
Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
Measured: Before vaccination (day 1) and 42 days after first vaccination (day 43).
Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur
Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
Measured: Before vaccination (day 1) and 42 days after first vaccination (day 43).
GMCs of RVNA Titer 42 Days After First Vaccination in Children.
Immunogenicity was measured as the GMCs of RVNA titers, evaluated using the rapid fluorescent focus inhibition test, before vaccination and 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
Measured: Before vaccination (day 1) and 42 days after first vaccination (day 43)
GMCs of RVNA Titer 42 Days After the First Vaccination in Older Adults.
Immunogenicity was measured as the GMCs of RVNA titers, evaluated using the rapid fluorescent focus inhibition test, before vaccination and 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
Measured: Before vaccination (day 1) and 42 days after first vaccination (day 43)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2012Jan 2013

First posted6 Sep 2012 (estimated)
Study startSep 2012
Primary completionJan 2013
Study completionJan 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for RabiesStudies of the same condition, open and under way.
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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 644 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01680016
Sponsor's protocol ID: V49_24
Status last verified: Apr 2014
First submitted: 3 Sep 2012
Last updated: 20 May 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Li R, Li Y, Wen S, Wen H, Nong Y, Mo Z, Xie F, Pellegrini M. Immunogenicity and safety of purified chick-embryo cell rabies vaccine under Zagreb 2-1-1 or 5-dose Essen regimen in Chinese children 6 to 17 years old and adults over 50 years: a randomized open-label study. Hum Vaccin Immunother. 2015;11(2):435-42. doi: 10.4161/21645515.2014.994460.
PubMed 25692350

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingPhase 3
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Rabies
Enrolling by invitationPhase 3
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Rabies Prevention
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Rabies (Healthy Volunteers)

All Rabies trials

Study at a glance

From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIIb, Randomized, Open-label Study Comparing Two Different Rabies Vaccine Post-exposure Schedules (Zagreb 2-1-1 and Rabipur® Essen 1-1-1-1-1) in Chinese Children and Older Adults
ClinicalTrials.gov ID: NCT01680016
Acronym / sponsor ID: V49_24
Conditions: Rabies
Keywords: Rabies virus, postexposure, vaccine schedule, children, older adults
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 644 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Sep 2012
Primary completion: Jan 2013 (actual)
Study completion: Jan 2013 (actual)
First posted: 6 Sep 2012 (estimated)
Results: Posted 20 May 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study was designed to evaluate the safety and immunogenicity of two simulated postexposure rabies vaccination schedules (Zagreb 2-1-1 and Essen 1-1-1-1-1) in Chinese children and older adults.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Zagreb(≥6 to ≤17 Years)	Experimental	Biological: Zagreb
Zagreb(≥51 Years)	Experimental	Biological: Zagreb
Essen(≥6 to ≤17 Years)	Active comparator	Biological: Essen
Essen(≥51 Years)	Active comparator	Biological: Essen

Who may qualify

Ages: 6 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Individuals between 6-17 years of age and 51 years of age or older
Individuals who were in good health
Provided consent, complied with study procedures and duration of follow-up

Key exclusion criteria (8 listed)

Contraindications to vaccination with rabies vaccine
Body temperature ≥37.5◦C (axillary) within 3 days of intended study vaccination
Known hypersensitivity to the components of the vaccine
Previously received any rabies vaccine or immune globulin
Previous or planned treatment with antimalarial medications

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
ZagrebSubjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22	Biological	Zagreb(≥51 Years), Zagreb(≥6 to ≤17 Years)
EssenSubjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29	Biological	Essen(≥51 Years), Essen(≥6 to ≤17 Years)

Primary outcome

Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After First Vaccination in Children Aged ≥6 to ≤17 Years.
Time frame: Before vaccination (day 1) and 14 days after first vaccination (day 15)
Immunogenicity was measured as the geometric mean concentrations (GMCs) of rabies virus neutralizing antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After the First Vaccination in Older Adults Aged ≥51 Years
Time frame: Before vaccination (day 1) and 14 days after first vaccination (day 15).
Immunogenicity was measured as the GMCs of Rabies Virus Neutralizing Antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
Time frame: Days 1 to 7 postvaccination
Safety was assessed as the number of children who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
Time frame: Days 1 to 7 postvaccination
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
Number of Children Who Reported Unsolicited Adverse Events (AEs)
Time frame: From V1/day 1 (postvaccination) through V7/study termination day 43
The safety of Rabipur was assessed in terms of subjects(Children) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events [SAE]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43.
Number of Older Adults Who Reported Unsolicited Adverse Events (AEs)
Time frame: from V1/day 1 (postvaccination) through V7/study termination day 43
The safety of Rabipur was assessed in terms of subjects(Older Adults) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events [SAE]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43.

6 secondary outcomes

Percentages of Children With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur
Time frame: Before vaccination (day 1) and 14 days after first vaccination (day 15).
Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur
Time frame: Before vaccination (day 1) and 14 days after first vaccination (day 15).
Percentages of Children With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur
Time frame: Before vaccination (day 1) and 42 days after first vaccination (day 43).
Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur
Time frame: Before vaccination (day 1) and 42 days after first vaccination (day 43).
GMCs of RVNA Titer 42 Days After First Vaccination in Children.
Time frame: Before vaccination (day 1) and 42 days after first vaccination (day 43)
GMCs of RVNA Titer 42 Days After the First Vaccination in Older Adults.
Time frame: Before vaccination (day 1) and 42 days after first vaccination (day 43)

Results and safety

Results posted to the registry on 20 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Zagreb(≥6 to ≤17 Years)	121	115
Essen(≥6 to ≤17 Years)	122	114
Zagreb(≥51 Years)	201	196
Essen(≥51 Years)	200	195

Primary outcome: Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After First Vaccination in Children Aged ≥6 to ≤17 Years.

Time frame: Before vaccination (day 1) and 14 days after first vaccination (day 15). Geometric mean (95% Confidence Interval). Unit: IU/mL

Measure	Zagreb(≥6 to ≤17 Years) n = 114	Essen(≥6 to ≤17 Years) n = 110
Day 1	0.052 (0.048 to 0.056)	0.054 (0.05 to 0.058)
Day 15	12 (10 to 14)	14 (12 to 16)

Zagreb(≥6 to ≤17 Years) vs Essen(≥6 to ≤17 Years): Ratio of GMCs between two groups(Day 15): 0.84 (95% CI 0.69 to 1.02), ANOVA

Population analysed: Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.

Primary outcome: Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After the First Vaccination in Older Adults Aged ≥51 Years

Time frame: Before vaccination (day 1) and 14 days after first vaccination (day 15).. Geometric mean (95% Confidence Interval). Unit: IU/mL

Measure	Zagreb(≥51 Years) n = 190	Essen(≥51 Years) n = 188
Day 1	0.057 (0.052 to 0.063)	0.06 (0.055 to 0.066)
Day 15	8.57 (7.34 to 10)	7.89 (6.75 to 9.21)

Zagreb(≥51 Years) vs Essen(≥51 Years): Ratio of GMCs between two groups(Day 15): 1.09 (95% CI 0.87 to 1.35), ANOVA

Population analysed: Analysis was done on the PP set.

Primary outcome: Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur

Time frame: Days 1 to 7 postvaccination. Number. Unit: Subjects

Measure	Zagreb(≥6 to ≤11 Years) n = 60	Essen(≥6 to ≤11 Years) n = 59	Zagreb(≥12 to ≤17 Years) n = 61	Essen(≥12 to ≤17 Years) n = 60	Zagreb( ≥6 to ≤17 Years) n = 121	Essen(≥6 to ≤17 Years) n = 119
Injection Site Erythema(N=59,58,60,60,119,118)	2	1	0	0	2	1
Injection Site Induration(N=59,58,60,60,119,118)	1	0	1	0	2	0
Injection Site Pain(N=59,58,60,60,119,118)	21	18	24	29	45	47
Nausea(N=59,58,60,60,119,118)	2	4	5	6	7	10
Myalgia(N=59,58,60,60,119,118)	4	4	7	9	11	13
Arthralgia(N=59,58,60,60,119,118)	1	0	2	1	3	1
Headache(N=59,58,60,60,119,118)	4	4	7	6	11	10
Fatigue(N=59,58,60,60,119,118)	8	4	10	11	18	15

Population analysed: Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.

Primary outcome: Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur

Time frame: Days 1 to 7 postvaccination. Number. Unit: Subjects

Measure	Zagreb(≥51 to ≤60 Years) n = 100	Essen(≥51 to ≤60 Years) n = 100	Zagreb(≥61 Years) n = 100	Essen(≥61 Years) n = 100	Zagreb(≥51 Years) n = 200	Essen(≥51 Years) n = 200
Injection Site Erythema(N=98,100,99,100,197,200)	1	1	0	2	1	3
Injection Site Induration(N=98,100,99,100,197,200)	1	1	0	0	1	1
Injection Site Pain(N=98,100,99,100,197,200)	9	12	9	10	18	22
Nausea(N=98,100,99,100,197,200)	1	0	1	2	2	2
Myalgia(N=98,100,99,100,197,200)	0	0	0	2	0	2
Arthralgia(N=98,100,99,100,197,200)	0	2	3	1	3	3
Headache(N=98,100,99,100,197,200)	4	2	3	6	7	8
Fatigue(N=98,100,99,100,197,200)	3	4	6	3	9	7

Population analysed: Analysis was done on the safety set

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Whole study period (From day 1 to day 43). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Zagreb(≥6 to ≤17 Years)	0 of 121 (0%)	64 of 121 (52.9%)	Not reported
Essen(≥6 to ≤17 Years)	0 of 119 (0%)	63 of 119 (52.9%)	Not reported
Zagreb(≥51 Years)	1 of 200 (0.5%)	19 of 200 (9.5%)	Not reported
Essen(≥51 Years)	0 of 200 (0%)	24 of 200 (12%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25692350Li R, Li Y, Wen S, Wen H, Nong Y, Mo Z, Xie F, Pellegrini M. Immunogenicity and safety of purified chick-embryo cell rabies vaccine under Zagreb 2-1-1 or 5-dose Essen regimen in Chinese children 6 to 17 years old and adults over 50 years: a randomized open-label study. Hum Vaccin Immunother. 2015;11(2):435-42. doi: 10.4161/21645515.2014.994460.

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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.

Novartis Vaccines study chair

Novartis Vaccines

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zagreb and Essen in people with Rabies, run by Novartis Vaccines at 1 site in China.

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 3 inclusion and 8 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: finished, as of the sponsor's last update on 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After First Vaccination in Children Aged ≥6 to ≤17 Years. (time frame: Before vaccination (day 1) and 14 days after first vaccination (day 15)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01680016, which also lists 1 linked publication.

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 20 May 2014.