CClinicalTrials.gg
CompletedNCT00694460Updated Jun 10, 2008

Evalution of Immunogenicity, Safety and Booster Response of a Rabies Vaccine Administered Concomitantly With Japanese Encephalitis Vaccine in Toddlers

A Phase 2 interventional study of Three 1 mL doses of Rabies vaccine and two JE vaccine and Three 0.5 mL doses of Rabies vaccine and two JE vaccine in Rabies, Japanese Encephalitis and Pre-Exposure Prophylaxis, sponsored by Novartis. Completed at 1 site in Thailand. Open to participants aged 12 Months to 18 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-06-10.

Sponsored by Novartis · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
12 Months to 18 Months
Sex
All
01

Study summary

This study evaluated the safety and immunogenicity of rabies vaccine and Japanese encephalitis vaccine in toddlers. All children developed adequate immune responses. Rabies vaccination with PCECV did not interfere with the antibody response to Japanese encephalitis vaccine. The rabies vaccine PCECV and Japanese encephalitis vaccine are safe and immunogenic when administered concomitantly to toddlers.

02

Conditions studied

  • Rabies
  • Japanese Encephalitis
  • Pre-Exposure Prophylaxis

Keywords

  • rabies vaccination
  • pre-exposure prophylaxis
  • rabies virus neutralizing antibody
03

In context

Rabies

118 studies on the registry are indexed under Rabies; 14 are open to participants now.

This study's enrollment of 200 is close to the median of 200 across 108 interventional studies indexed under Rabies.

Browse Rabies studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Months to 18 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male and female 12-18 months old toddlers if they
  • are in good health at time of entry into the study
  • are available for all the visits scheduled in the study
  • have been granted a written informed consent, signed by their parents

Exclusion criteria

Exclusion Criteria:

  • a history of rabies immunization
  • a history of Japanese encephalitis immunization or disease
  • a significant acute or chronic infectious disease at the time of enrollment
  • fever ≥ 38.0°C (axillary) or/and significant acute or chronic infection requiring antibiotic or antiviral therapy within the past 7 days before enrollment
  • being under treatment with corticosteroids, immunosuppressive drugs or other specific anti-inflammatory drugs or having taken chloroquine during the two months period before enrollment
  • administration of any vaccine within the past 14 days before enrollment
  • known immunodeficiency or an autoimmune disease
  • history of allergy to eggs, egg products
  • known hypersensitivity to neomycin, tetracycline, amphotericin-B
  • planned surgery during the study period
  • being enrolled in any other investigational trial contemporaneously
  • the family plans to leave the area of the study site before the end of study period
  • history of febrile convulsions
  • history of wheezing
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    1

    Biological: Three 1 mL doses of Rabies vaccine and two JE vaccine

  • Experimental
    2

    Biological: Three 0.5 mL doses of Rabies vaccine and two JE vaccine

  • Experimental
    3

    Biological: Three 0.1mL doses of Rabies Vaccine and two JE vaccine

  • Experimental
    4

    Biological: Two 0.1mL doses of Rabies vaccine and two JE vaccine

  • Active comparator
    5

    Biological: Two doses of JE vaccine

Interventions

  • BiologicalThree 1 mL doses of Rabies vaccine and two JE vaccine

    Vaccination with purified chick embryo cell rabies vaccine 1.0 mL intramuscularly on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses)

  • BiologicalThree 0.5 mL doses of Rabies vaccine and two JE vaccine

    Vaccination with purified chick embryo cell rabies vaccine 0.5 mL intramuscularly on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses)

  • BiologicalThree 0.1mL doses of Rabies Vaccine and two JE vaccine

    Vaccination with purified chick embryo cell rabies vaccine 0.1 mL intradermally at one site on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses)

  • BiologicalTwo 0.1mL doses of Rabies vaccine and two JE vaccine

    Vaccination with purified chick embryo cell rabies vaccine 0.1 mL intradermally at one site on Day 0 and Day 28 (a total of 2 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses)

  • BiologicalTwo doses of JE vaccine

    Vaccination with Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL only subcutaneously on Day 0 and Day 7 (a total of 2 doses)

06

What researchers measure

Primary outcomes

  1. Rabies virus neutralizing antibody concentrations

    Time frame: 2 years

Secondary outcomes

  1. Japanese encephalitis virus neutralizing antibody titers

    Time frame: 2 years

07

Study locations

1 site
  • Tropical Medicine, Mahidol University
    Bangkok, 10400, Thailand
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00694460
Lead sponsor
Novartis
Collaborators
Novartis Vaccines
First posted
Jun 10, 2008
Start date
Aug 2002
Primary completion
Aug 2004
Completion
Sep 2004
Last update
Jun 10, 2008

Study contacts

Novartis Vaccines
study chair · Novartis Vaccines
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion