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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00353288
Other study ID # 105908
Secondary ID
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


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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