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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00351923
Other study ID # 106670
Secondary ID
Status Completed
Phase Phase 3
First received July 12, 2006
Last updated October 9, 2008
Start date March 2006
Est. completion date December 2006

Study information

Verified date October 2008
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-Institut
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 330
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 11 Months to 22 Months
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
MeMuRu-OKA (study vaccine)


Locations

Country Name City State
Germany GSK Investigational Site Bad Kreuznach Rheinland-Pfalz
Germany GSK Investigational Site Boennigheim Baden-Wuerttemberg
Germany GSK Investigational Site Bretten Baden-Wuerttemberg
Germany GSK Investigational Site Eschwege Hessen
Germany GSK Investigational Site Ettenheim Baden-Wuerttemberg
Germany GSK Investigational Site Frankenthal Rheinland-Pfalz
Germany GSK Investigational Site Giessen Hessen
Germany GSK Investigational Site Karlsruhe Baden-Wuerttemberg
Germany GSK Investigational Site Kehl Baden-Wuerttemberg
Germany GSK Investigational Site Mainz Rheinland-Pfalz
Germany GSK Investigational Site Mainz Rheinland-Pfalz
Germany GSK Investigational Site Mannheim Baden-Wuerttemberg
Germany GSK Investigational Site Oberkirch Baden-Wuerttemberg
Germany GSK Investigational Site Offenburg Baden-Wuerttemberg
Germany GSK Investigational Site Schwaebisch-Hall Baden-Wuerttemberg
Germany GSK Investigational Site Stuttgart Baden-Wuerttemberg
Germany GSK Investigational Site Tauberbischofsheim Baden-Wuerttemberg
Germany GSK Investigational Site Trier Rheinland-Pfalz
Germany GSK Investigational Site Trier Rheinland-Pfalz
Germany GSK Investigational Site Worms Rheinland-Pfalz

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Seroconversion rates after vaccination
Secondary Antibody titres; safety: solicited local/ general, unsolicited AEs (42 days), SAEs (whole study)
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