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

Measles Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00351923
• Other study ID #: 106670
• 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
• 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

• Chickenpox
• Herpes Zoster
• Measles
• Mumps
• Rubella
• Varicella

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)