RabiesPhase 3NCT01662440

Safety and Immunogenicity of 2 Different Vaccination Schedules of Rabies and Japanese Encephalitis Vaccines in Healthy Adult Subjects

A Phase 3 study testing Rabies and Japanese Encephalitis in people with Rabies and Japanese Encephalitis, run by Novartis Vaccines at 3 sites in 3 countries.

Completed

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

Official record

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Trial summary

Establish non-inferiority of the immune response and evaluate the safety and tolerability of Rabies and Japanese Encephalitis (JE) vaccines given concomitantly or alone and according to either of 2 schedules for preexposure prophylaxis. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Rabies, Japanese Encephalitis
What is being tested?: Rabies and Japanese Encephalitis
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 661 participants
Where: 3 sitesin 3 countries
Study dates: Aug 2012to Oct 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 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Males and females between 18 and 65 years of age (inclusive).
Subjects who have given written consent.
Individuals in good health as per investigator judgement.

Who cannot join

If female, pregnancy or unwillingness to practice acceptable contraception.
If female, pregnant or breast-feeding or any positive/indeterminate pregnancy test.
Contraindication or precaution against Rabies and Japanese Encephalitis vaccination.
Unable to comprehend and to follow all required study procedures for the whole period of the study.
Participating in any other clinical trial 30 days prior to first study visit.
History of previous rabies/rabies immunoglobulin and/or Japanese Encephalitis immunization.

Show all 12Show fewer

Receiving or planning to receive anti-malarial medications (e.g. Mefloquine) 14 days prior to Day 1 vaccination through Day 43.
Received any other vaccines within 2 weeks prior to enrollment in this study or plan to receive any vaccine within 4 weeks from the study vaccines.
Ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks.
Individuals who are part of study personnel or close family members conducting this study.
Body temperature ≥38 degrees Celsius (≥ 100.4° F) within 3 days of intended study vaccination.
Plans to travel within the next year to areas where Rabies and/or Japanese Encephalitis vaccine may be considered or offered. This includes but is not limited to India, Asia, Pacific-Rim, African countries.

Trial locations and contacts

3 sites in 3 countries.

Country

City, postcode or hospital

3 sites in 3 countries

Austria1 site

Institute of Specific Prophylaxis and Tropical Medicine Center for Pathophysiology, Infectious Diseases and Immunology Medical University of Vienna
Kinderspitalgasse 15, State of Vienna, A-1090

Other trials in Austria

Germany1 site

Bernhard Nocht Institute for Tropical Medicine
Bernhard-Nocht-Strasse 74, Free and Hanseatic City of Hamburg, D-20359

Other trials in Germany

Switzerland1 site

The University of Zurich
Rämistrasse 71, Canton of Zurich, CH-8006

Other trials in Switzerland

About this study

Official title: A Phase III, Multicenter, Observer-blind, Safety and Immunogenicity Study of Rabies Vaccine and Japanese Encephalitis Vaccine Administered Concomitantly and/or Separately According to 1 of 2 Different Preexposure Prophylaxis Schedules to Healthy Adult Subjects.

Conditions: Rabies, Japanese Encephalitis
Being tested: Rabies, Japanese Encephalitis, Placebo
Keywords: Rabies, JE, accelerated schedule
Medical subject headings: Rabies, Encephalitis, Japanese

What participants receive

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

RabiesBiological
Subjects received three doses of Rabies, whole virus vaccine (inactivated, Germany).
Japanese EncephalitisBiological
Subjects received two doses of Japanese Encephalitis vaccine.
PlaceboOther
Subjects received either two, three, four or five doses of normal saline, 0.9% w/v sodium chloride depending on the vaccine group.

Study groups in NCT01662440
Study group	Role	What they receive
R/JE - Conv	Active comparator	Subjects received Rabies and Japanese Encephalitis (JE) vaccines following the conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm. Receives: Biological: Rabies; Biological: Japanese Encephalitis; Other: Placebo
R/JE - Acc	Experimental	Subjects received Rabies and JE vaccines following the accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm. Receives: Biological: Rabies; Biological: Japanese Encephalitis; Other: Placebo
R - Conv	Active comparator	Subjects received Rabies vaccine following the conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm. Receives: Biological: Rabies; Other: Placebo
JE - Conv	Active comparator	Subjects received JE vaccine following the conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm. Receives: Biological: Japanese Encephalitis; Other: Placebo

What is being measured

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

Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 7 Days After Last Active Vaccination
Immune response was measured as the percentage of subjects with rabies virus neutralizing antibody (RVNA) concentrations ≥0.5 IU/mL, evaluated using the rapid fluorescent focus inhibition test at day 7 after last active vaccination, i.e. the third out of four vaccinations given in the accelerated Rabies vaccine schedule and the fourth out of four vaccinations given in the conventional Rabies vaccine schedule.
As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs R - Conv.
Measured: Day 7 after last active vaccination (day 15 - group that received accelerated schedule, day 36 - group that received conventional schedule)
Percentages of Subjects With PRNT50 Titer ≥1:10 At 28 Days After Last Active Vaccination
Immune response was measured as the percentages of subjects with a titer of ≥1:10 in a 50% plaque reduction neutralization test (PRNT50) 28 days after last active vaccination, ie, the second out of three vaccinations given in the accelerated JE vaccine schedule and the third out of three vaccinations given in the conventional JE vaccine schedule.
As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs JE - Conv.
Measured: Day 28 after last active vaccination (day 36 - group that received accelerated schedule, day 57 - group that received conventional schedule)

Secondary outcomes (13)

RVNA Geometric Mean Concentrations (GMCs) At 28 Days After Last Active Vaccination
Immune response was measured as the RVNA GMCs 28 days after last active vaccination, ie, day 57 for all groups that received the conventional schedule.
Data were adjusted using ANOVA model, as per protocol specification.
Measured: Day 57 (28 days after last active vaccination)
PRNT50 Geometric Mean Titers (GMTs) At 28 Days After Last Active Vaccination
Immune response was measured as the PRNT50 GMTs 28 days after last active vaccination, ie, day 57 for all groups that received the conventional schedule.
Data were adjusted using ANOVA model, as per protocol specifications.
Measured: Day 57 (28 days after last active vaccination)
Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 28 Days After Last Active Vaccination
Immune response was measured as the percentages of subjects with RVNA concentration ≥0.5 IU/mL 28 days after last active vaccination, ie, day 36 for the group that received the accelerated schedule and day 57 for the group that received the conventional schedule.
As per study design, this secondary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs R - Conv.
Measured: Day 36 and day 57 (28 days after last active vaccination)
Percentage of Subjects With PRNT50 Titer ≥1:10 At 7 Days After Last Active Vaccination
Immune response was measured as the percentage of subjects with PRNT50 titer of ≥1:10 7 days after last active vaccination, ie, day 15 for the group that received the accelerated schedule and day 36 for the group that received the conventional schedule.
As per study design, this secondary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs JE - Conv.
Measured: Day 15 and day 36 (28 after last active vaccination)
Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL
To evaluate the kinetics of antibody response to Rabies vaccine, the immunogenicity was measured as the percentage of subjects with RVNA concentrations ≥0.5 IU/mL on days 1, 8, 15, 36, 57, 91, 181, and 366.
Measured: Day 1, 8, 15, 36, 57, 91, 181 and Day 366
Kinetics of Rabies Immune Response Measured as the RVNA GMCs
To evaluate the kinetics of antibody response to Rabies vaccine, the immunogenicity was measured as the RVNA GMCs on days 1, 8, 15, 36, 57, 91, 181, and 366.
Measured: Day 1, 8, 15, 36, 57, 91, 181, and 366
Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10
To evaluate the kinetics of antibody response to JE vaccine, the immunogenicity was measured as the percentage of subjects with PRNT50 titer ≥1:10 on days 1, 15, 22, 36, 57, 91, 181, and 366 (group that received JE vaccine as an accelerated schedule) and days 1, 36, 57, 181, and 366 (group that received JE vaccine as a conventional schedule).
Measured: Days 1, 15, 22, 36, 57, 91, 181 and 366
Kinetics of JE Immune Response Measured as PRNT50 GMTs
To evaluate the kinetics of antibody response to JE vaccine, the immunogenicity was measured as the PRNT50 GMTs on days 1, 15, 22, 36, 57, 91, 181, and 366 (group that received JE vaccine as an accelerated schedule) and days 1, 36, 57, 181, and 366 (group that received JE vaccine as a conventional schedule).
Measured: Day 1, 15, 22, 36, 57, 91, 181, and 366 (accelerated schedule) and day 1, 36, 57, 181, and 366 (conventional schedule)
Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination
Safety was assessed as the number of subjects who reported solicited local adverse events (AEs) after each rabies vaccination given according to accelerated or conventional schedule as follows: from day 1 through day 7 (vaccination on day 1; all Rabies groups), day 4 through day 10 (vaccination on day 4; in R/JE - Acc group only), day 8 through day 14 (vaccination on day 8; all Rabies groups), or day 29 through day 35 (vaccination on day 29; R/JE - Conv and R - Conv groups).
Measured: Day 1 through day 7 after each vaccination (on day 1, 4, 8 and 29)
Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination
Safety was assessed as the number of subjects who reported solicited local AEs after each JE vaccination given according to accelerated or conventional schedule as follow: from day 1 through day 7 (vaccination on day 1; all JE groups), day 8 through day 14 (vaccination on day 8; R/JE - Acc group only), or day 29 through day 35 (vaccination on day 29; R/JE - Con and JE - Conv groups).
Measured: Day 1 through day 7 after each vaccination (on day 1, 8 and 29)
Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection
Safety was assessed as the number of subjects who reported solicited local AEs after each placebo injection given according to accelerated and conventional schedule as follow: from day 1 through day 7 (injection on day 1; R - Conv and JE - Conv groups), day 4 through day 10 (injection on day 4; in R/JE - Conv, R - Conv and JE - Conv groups), day 8 through day 14 (injection on day 8; in R/JE - Conv, R - Conv and JE - Conv groups), and day 29 through day 35 (injection on day 29; R/JE - Acc, R - Con and JE - Conv groups).
Measured: Day 1 through day 7 after each injection (day 1, 4, 8 and 29)
Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination
Safety was assessed as the number of subjects who reported solicited systemic AEs and other indicators of reactogenicity after each vaccination given according to accelerated and conventional schedule.
Measured: Day 1 through day 7 after each vaccination (day 1, 4, 8 and 29)
Numbers of Subjects Reporting Unsolicited AEs After Any Vaccination From Day 1 Through Day 57
Safety was assessed as the number of subjects who reported unsolicited AEs after any vaccination given according to accelerated and conventional schedule.
Measured: Day 1 through Day 57

Timeline

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

Aug 2012Oct 2013

First posted10 Aug 2012 (estimated)
Study startAug 2012
Primary completionDec 2012
Study completionOct 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 (2)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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 661 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01662440
Sponsor's protocol ID: V49_23
Other IDs: 2011-005173-23
Status last verified: Dec 2014
First submitted: 2 Aug 2012
Last updated: 8 Dec 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Cramer JP, Jelinek T, Paulke-Korinek M, Reisinger EC, Dieckmann S, Alberer M, Buhler S, Bosse D, Meyer S, Fragapane E, Costantini M, Pellegrini M, Lattanzi M, Dovali C. One-year immunogenicity kinetics and safety of a purified chick embryo cell rabies vaccine and an inactivated Vero cell-derived Japanese encephalitis vaccine administered concomitantly according to a new, 1-week, accelerated primary series. J Travel Med. 2016 Mar 19;23(3):taw011. doi: 10.1093/jtm/taw011. Print 2016 Mar.
PubMed 26994987
Jelinek T, Cramer JP, Dieckmann S, Hatz C, Paulke-Korinek M, Alberer M, Reisinger EC, Costantini M, Gniel D, Bosse D, Lattanzi M. Evaluation of rabies immunogenicity and tolerability following a purified chick embryo cell rabies vaccine administered concomitantly with a Japanese encephalitis vaccine. Travel Med Infect Dis. 2015 May-Jun;13(3):241-50. doi: 10.1016/j.tmaid.2015.05.008. Epub 2015 May 18.
PubMed 26005163

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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All Rabies trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Multicenter, Observer-blind, Safety and Immunogenicity Study of Rabies Vaccine and Japanese Encephalitis Vaccine Administered Concomitantly and/or Separately According to 1 of 2 Different Preexposure Prophylaxis Schedules to Healthy Adult Subjects.
ClinicalTrials.gov ID: NCT01662440
Acronym / sponsor ID: V49_23
Conditions: Rabies, Japanese Encephalitis
Keywords: Rabies, JE, accelerated schedule
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 661 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Aug 2012
Primary completion: Dec 2012 (actual)
Study completion: Oct 2013 (actual)
First posted: 10 Aug 2012 (estimated)
Results: Posted 8 Dec 2014

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
R/JE - Conv	Active comparator	Biological: Rabies, Biological: Japanese Encephalitis, Other: PlaceboSubjects received Rabies and Japanese Encephalitis (JE) vaccines following the conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
R/JE - Acc	Experimental	Biological: Rabies, Biological: Japanese Encephalitis, Other: PlaceboSubjects received Rabies and JE vaccines following the accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
R - Conv	Active comparator	Biological: Rabies, Other: PlaceboSubjects received Rabies vaccine following the conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm.
JE - Conv	Active comparator	Biological: Japanese Encephalitis, Other: PlaceboSubjects received JE vaccine following the conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Males and females between 18 and 65 years of age (inclusive).
Subjects who have given written consent.
Individuals in good health as per investigator judgement.

Key exclusion criteria (12 listed)

If female, pregnancy or unwillingness to practice acceptable contraception.
If female, pregnant or breast-feeding or any positive/indeterminate pregnancy test.
Contraindication or precaution against Rabies and Japanese Encephalitis vaccination.
Unable to comprehend and to follow all required study procedures for the whole period of the study.
Participating in any other clinical trial 30 days prior to first study visit.

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
RabiesSubjects received three doses of Rabies, whole virus vaccine (inactivated, Germany).	Biological	R - Conv, R/JE - Acc, R/JE - Conv
Japanese EncephalitisSubjects received two doses of Japanese Encephalitis vaccine.	Biological	JE - Conv, R/JE - Acc, R/JE - Conv
PlaceboSubjects received either two, three, four or five doses of normal saline, 0.9% w/v sodium chloride depending on the vaccine group.	Other	JE - Conv, R - Conv, R/JE - Acc, R/JE - Conv

Primary outcome

Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 7 Days After Last Active Vaccination
Time frame: Day 7 after last active vaccination (day 15 - group that received accelerated schedule, day 36 - group that received conventional schedule)
Immune response was measured as the percentage of subjects with rabies virus neutralizing antibody (RVNA) concentrations ≥0.5 IU/mL, evaluated using the rapid fluorescent focus inhibition test at day 7 after last active vaccination, i.e. the third out of four vaccinations given in the accelerated Rabies vaccine schedule and the fourth out of four vaccinations given in the conventional Rabies vaccine schedule. As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs R - Conv.
Percentages of Subjects With PRNT50 Titer ≥1:10 At 28 Days After Last Active Vaccination
Time frame: Day 28 after last active vaccination (day 36 - group that received accelerated schedule, day 57 - group that received conventional schedule)
Immune response was measured as the percentages of subjects with a titer of ≥1:10 in a 50% plaque reduction neutralization test (PRNT50) 28 days after last active vaccination, ie, the second out of three vaccinations given in the accelerated JE vaccine schedule and the third out of three vaccinations given in the conventional JE vaccine schedule. As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs JE - Conv.

13 secondary outcomes

RVNA Geometric Mean Concentrations (GMCs) At 28 Days After Last Active Vaccination
Time frame: Day 57 (28 days after last active vaccination)
PRNT50 Geometric Mean Titers (GMTs) At 28 Days After Last Active Vaccination
Time frame: Day 57 (28 days after last active vaccination)
Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 28 Days After Last Active Vaccination
Time frame: Day 36 and day 57 (28 days after last active vaccination)
Percentage of Subjects With PRNT50 Titer ≥1:10 At 7 Days After Last Active Vaccination
Time frame: Day 15 and day 36 (28 after last active vaccination)
Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL
Time frame: Day 1, 8, 15, 36, 57, 91, 181 and Day 366
Kinetics of Rabies Immune Response Measured as the RVNA GMCs
Time frame: Day 1, 8, 15, 36, 57, 91, 181, and 366
Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10
Time frame: Days 1, 15, 22, 36, 57, 91, 181 and 366
Kinetics of JE Immune Response Measured as PRNT50 GMTs
Time frame: Day 1, 15, 22, 36, 57, 91, 181, and 366 (accelerated schedule) and day 1, 36, 57, 181, and 366 (conventional schedule)
Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination
Time frame: Day 1 through day 7 after each vaccination (on day 1, 4, 8 and 29)
Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination
Time frame: Day 1 through day 7 after each vaccination (on day 1, 8 and 29)
Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection
Time frame: Day 1 through day 7 after each injection (day 1, 4, 8 and 29)
Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination
Time frame: Day 1 through day 7 after each vaccination (day 1, 4, 8 and 29)
Numbers of Subjects Reporting Unsolicited AEs After Any Vaccination From Day 1 Through Day 57
Time frame: Day 1 through Day 57

Results and safety

Results posted to the registry on 8 Dec 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
R/JE - Conv	167	158
R/JE - Acc	217	211
R - Conv	221	215
JE - Conv	56	52

Primary outcome: Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 7 Days After Last Active Vaccination

Time frame: Day 7 after last active vaccination (day 15 - group that received accelerated schedule, day 36 - group that received conventional schedule). Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	R/JE - Acc n = 209	R - Conv n = 207
Value	100 (97 to 100)	100 (97 to 100)

R/JE - Acc vs R - Conv: Difference in percentages of subjects: 0 (97.5% CI -2.8 to 2.8)

Population analysed: Analysis was done on the per-protocol (PP) dataset, ie, 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 unblinding.

Primary outcome: Percentages of Subjects With PRNT50 Titer ≥1:10 At 28 Days After Last Active Vaccination

Time frame: Day 28 after last active vaccination (day 36 - group that received accelerated schedule, day 57 - group that received conventional schedule). Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	R/JE - Acc n = 209	JE - Conv n = 49
Value	99 (96 to 100)	100 (93 to 100)

R/JE - Acc vs JE - Conv: Difference in percentages of subjects: -1 (97.5% CI -4.8 to 7.9)

Population analysed: Analysis was done on the PP dataset.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
R/JE - Conv	2 of 166 (1.2%)	138 of 166 (83.1%)	Not reported
R/JE - Acc	3 of 217 (1.4%)	186 of 217 (85.7%)	Not reported
R - Conv	2 of 220 (0.9%)	185 of 220 (84.1%)	Not reported
JE - Conv	3 of 56 (5.4%)	45 of 56 (80.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26994987Cramer JP, Jelinek T, Paulke-Korinek M, Reisinger EC, Dieckmann S, Alberer M, Buhler S, Bosse D, Meyer S, Fragapane E, Costantini M, Pellegrini M, Lattanzi M, Dovali C. One-year immunogenicity kinetics and safety of a purified chick embryo cell rabies vaccine and an inactivated Vero cell-derived Japanese encephalitis vaccine administered concomitantly according to a new, 1-week, accelerated primary series. J Travel Med. 2016 Mar 19;23(3):taw011. doi: 10.1093/jtm/taw011. Print 2016 Mar.
Derived from this study: PubMed 26005163Jelinek T, Cramer JP, Dieckmann S, Hatz C, Paulke-Korinek M, Alberer M, Reisinger EC, Costantini M, Gniel D, Bosse D, Lattanzi M. Evaluation of rabies immunogenicity and tolerability following a purified chick embryo cell rabies vaccine administered concomitantly with a Japanese encephalitis vaccine. Travel Med Infect Dis. 2015 May-Jun;13(3):241-50. doi: 10.1016/j.tmaid.2015.05.008. Epub 2015 May 18.

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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 and Diagnostics study chair

Novartis Vaccines

3 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rabies and Japanese Encephalitis in people with Rabies and Japanese Encephalitis, run by Novartis Vaccines at 3 sites in 3 countries.

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 12 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 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Austria, Germany, Switzerland. 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 8 Dec 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?

Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 7 Days After Last Active Vaccination (time frame: Day 7 after last active vaccination (day 15 - group that received accelerated schedule, day 36 - group that received conventional schedule)). The study lists 2 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 NCT01662440, which also lists 2 linked publications.

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 8 Dec 2014.