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Immunogenicity/Safety of Measles-Mumps-Rubella-Varicella Vaccine (MeMuRu-OKA): Using Two Different Administration Routes

Primary Purpose

Measles, Mumps, Rubella

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
MeMuRu-OKA (study vaccine)
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Measles

Eligibility Criteria

11 Months - 22 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Children must be healthy and have a birth weight > 2000 g to participate Exclusion Criteria: confirmed or suspected tuberculosis, immunosuppressive (including HIV) conditions, neurological disorders, history of allergic disease or reaction, major congenital defects, chronical administration of salicylates, and fever (axillary temperature ³ 37.5°C at the time of vaccination) are excluding factors. Children from pregnant mothers who have a negative history of chickenpox are also excluded from the study. Children must have received one dose (but not more) of MMR and of varicella at least 6 weeks before entering the study. They must not receive or have received other non-registered drug or vaccine within 30 days prior to study start, or immunosuppressants for more than 14 days. Immunoglobulins or any blood products are prohibited during the 6 months before and during the study, as well as vaccine other than that foreseen by the protocol within 30 days before vaccination. Children must not have had measles, mumps, rubella or varicella/zoster, or have been exposed to those diseases within 30 days prior to study start. New-born infants (< 5 weeks of age), pregnant women without previous exposure to chickenpox, and immunodeficient persons cannot live in the same household as the vaccinated child

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

Seroconversion rates after vaccination

Secondary Outcome Measures

Antibody titres; safety: solicited local/ general, unsolicited AEs (42 days), SAEs (whole study)

Full Information

First Posted
July 12, 2006
Last Updated
October 9, 2008
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00351923
Brief Title
Immunogenicity/Safety of Measles-Mumps-Rubella-Varicella Vaccine (MeMuRu-OKA): Using Two Different Administration Routes
Official Title
Open, Multicenter, Randomised, Controlled Phase IIIb Study Evaluating the Immunogenicity and Safety of Subcutaneous Versus Alternative Administration Route of Combined MeMuRu-OKA Vaccine to Healthy Children Aged 11 to 21 Months.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
This study will compare the immunogenicity and safety of the MeMuRu-OKA vaccine administered subcutaneously or using an alternative administration route.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Measles, Mumps, Rubella, Varicella

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
330 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
MeMuRu-OKA (study vaccine)
Primary Outcome Measure Information:
Title
Seroconversion rates after vaccination
Secondary Outcome Measure Information:
Title
Antibody titres; safety: solicited local/ general, unsolicited AEs (42 days), SAEs (whole study)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Months
Maximum Age & Unit of Time
22 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children must be healthy and have a birth weight > 2000 g to participate Exclusion Criteria: confirmed or suspected tuberculosis, immunosuppressive (including HIV) conditions, neurological disorders, history of allergic disease or reaction, major congenital defects, chronical administration of salicylates, and fever (axillary temperature ³ 37.5°C at the time of vaccination) are excluding factors. Children from pregnant mothers who have a negative history of chickenpox are also excluded from the study. Children must have received one dose (but not more) of MMR and of varicella at least 6 weeks before entering the study. They must not receive or have received other non-registered drug or vaccine within 30 days prior to study start, or immunosuppressants for more than 14 days. Immunoglobulins or any blood products are prohibited during the 6 months before and during the study, as well as vaccine other than that foreseen by the protocol within 30 days before vaccination. Children must not have had measles, mumps, rubella or varicella/zoster, or have been exposed to those diseases within 30 days prior to study start. New-born infants (< 5 weeks of age), pregnant women without previous exposure to chickenpox, and immunodeficient persons cannot live in the same household as the vaccinated child
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Boennigheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
74357
Country
Germany
Facility Name
GSK Investigational Site
City
Bretten
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
75015
Country
Germany
Facility Name
GSK Investigational Site
City
Ettenheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
77955
Country
Germany
Facility Name
GSK Investigational Site
City
Karlsruhe
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
76189
Country
Germany
Facility Name
GSK Investigational Site
City
Kehl
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
77694
Country
Germany
Facility Name
GSK Investigational Site
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
GSK Investigational Site
City
Oberkirch
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
77704
Country
Germany
Facility Name
GSK Investigational Site
City
Offenburg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
77654
Country
Germany
Facility Name
GSK Investigational Site
City
Schwaebisch-Hall
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
74523
Country
Germany
Facility Name
GSK Investigational Site
City
Stuttgart
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
70469
Country
Germany
Facility Name
GSK Investigational Site
City
Tauberbischofsheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
97941
Country
Germany
Facility Name
GSK Investigational Site
City
Eschwege
State/Province
Hessen
ZIP/Postal Code
37269
Country
Germany
Facility Name
GSK Investigational Site
City
Giessen
State/Province
Hessen
ZIP/Postal Code
35390
Country
Germany
Facility Name
GSK Investigational Site
City
Bad Kreuznach
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55543
Country
Germany
Facility Name
GSK Investigational Site
City
Frankenthal
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67227
Country
Germany
Facility Name
GSK Investigational Site
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55127
Country
Germany
Facility Name
GSK Investigational Site
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
GSK Investigational Site
City
Trier
State/Province
Rheinland-Pfalz
ZIP/Postal Code
54290
Country
Germany
Facility Name
GSK Investigational Site
City
Trier
State/Province
Rheinland-Pfalz
ZIP/Postal Code
54294
Country
Germany
Facility Name
GSK Investigational Site
City
Worms
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67547
Country
Germany

12. IPD Sharing Statement

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Immunogenicity/Safety of Measles-Mumps-Rubella-Varicella Vaccine (MeMuRu-OKA): Using Two Different Administration Routes

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