Immunogenicity, Safety of Measles-mumps-rubella-varicella Vaccine (MeMuRu-OKA) Compared to Priorix™ Given With Varilrix™

Measles Clinical Trial

Official title:

Comparative Study Evaluating the Immunogenicity and Safety of MeMuRu-OKA Vaccine and Measles-mumps-rubella Vaccine (Priorix™) Co-administered With Varicella Vaccine (Varilrix™) in Children Primed With Measles-mumps-rubella Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00353288
• Other study ID #: 105908
• Status: Completed
• Phase: Phase 2
• First received: July 17, 2006
• Last updated: October 6, 2016
• Start date: March 2006
• Est. completion date: November 2006

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

As measles-mumps-rubella (MMR) vaccination is established as routine childhood practice in most industrialised countries and varicella vaccination is now being introduced in many countries during the second year of life, a combined measles-mumps-rubella-varicella vaccine was developed for administration convenience and improved compliance to vaccination. To account for situations where children have received a first dose of MMR vaccine without varicella, this study will evaluate the effect of the combined measles-mumps-rubella-varicella vaccine given in place of the second dose of MMR vaccine. A second dose of the monovalent varicella vaccine will be given to all children participating to this trial since there is a current debate on the need of a second dose to induce a full protection against varicella.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 446
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Months to 6 Years

Eligibility

Inclusion Criteria:

• Children must be healthy to participate

Exclusion Criteria:

• Immunosuppressive (including HIV) conditions, allergic diseases, neurological disorders, known anaphylactic reaction to MMR vaccine, and fever (axillary temperature ³ 37.5°C at the time of vaccination) are excluding factors.

• Children must have received one dose (but not more) of MMR 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, 30 days before until 56 days after vaccination.

• Children must not have been vaccinated against varicella.

• They must not have had measles, mumps, rubella or varicella, 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 vacc)

• MMR, Varicella vacc (control)

Locations

Country	Name	City	State
France	GSK Investigational Site	Ancenis
France	GSK Investigational Site	Boulogne
France	GSK Investigational Site	Dax
France	GSK Investigational Site	Draguignan
France	GSK Investigational Site	Essey les Nancy
France	GSK Investigational Site	Laon
France	GSK Investigational Site	Le Havre
France	GSK Investigational Site	Lingolsheim
France	GSK Investigational Site	Lyon
France	GSK Investigational Site	Nice
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Villeneuve les Avignons
Germany	GSK Investigational Site	Bad Oeynhausen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bad Saulgau	Baden-Wuerttemberg
Germany	GSK Investigational Site	Bindlach	Bayern
Germany	GSK Investigational Site	Boennigheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Cham	Bayern
Germany	GSK Investigational Site	Detmold	Nordrhein-Westfalen
Germany	GSK Investigational Site	Flensburg	Schleswig-Holstein
Germany	GSK Investigational Site	Flensburg	Schleswig-Holstein
Germany	GSK Investigational Site	Flensburg	Schleswig-Holstein
Germany	GSK Investigational Site	Herford	Nordrhein-Westfalen
Germany	GSK Investigational Site	Kehl	Baden-Wuerttemberg
Germany	GSK Investigational Site	Kempten	Bayern
Germany	GSK Investigational Site	Kirchzarten	Baden-Wuerttemberg
Germany	GSK Investigational Site	Krefeld	Nordrhein-Westfalen
Germany	GSK Investigational Site	Loehne	Nordrhein-Westfalen
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Neumuenster	Schleswig-Holstein
Germany	GSK Investigational Site	Olching	Bayern
Germany	GSK Investigational Site	Schwaebisch-Hall	Baden-Wuerttemberg
Germany	GSK Investigational Site	Schwieberdingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Stuttgart	Baden-Wuerttemberg
Germany	GSK Investigational Site	Tettnang	Baden-Wuerttemberg
Germany	GSK Investigational Site	Werneck	Bayern
Italy	GSK Investigational Site	Cagliari	Sardegna
Italy	GSK Investigational Site	Genova	Liguria
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Sassari	Sardegna

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

France,  Germany,  Italy, 

References & Publications (1)

Gillet Y, Steri GC, Behre U, Arsène JP, Lanse X, Helm K, Esposito S, Meister N, Desole MG, Douha M, Willems P. Immunogenicity and safety of measles-mumps-rubella-varicella (MMRV) vaccine followed by one dose of varicella vaccine in children aged 15 months-2 years or 2-6 years primed with measles-mumps-rubella (MMR) vaccine. Vaccine. 2009 Jan 14;27(3):446-53. doi: 10.1016/j.vaccine.2008.10.064. Epub 2008 Nov 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Varicella seroconversion and MMR titres at 42-56 days after first vaccination
Secondary	Safety: solicited local/general, unsolicited AEs (42 days), SAEs (whole study)

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