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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00352898
Other study ID # 105909
Secondary ID
Status Completed
Phase Phase 2
First received July 14, 2006
Last updated October 6, 2016
Start date April 2006
Est. completion date November 2006

Study information

Verified date October 2016
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical Trial Summary

Since measles-mumps-rubella (MMR) and varicella vaccinations are established as routine childhood practice and often co-administered during the second year of life, a combined measles-mumps-rubella-varicella (MeMuRu-OKA) vaccine is fully justified. Such a combined vaccine was developed and extensively studied in susceptible children. In countries where varicella mass-vaccination is already implemented, a transition period is necessary as children who started with separate first-dose vaccinations of MMR and varicella will receive a single shot of the combined vaccine as the second dose. To account for those situations, this study will evaluate the effect of the combined measles-mumps-rubella-varicella vaccine given in place of separate MMR and varicella vaccines as a second dose.


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date November 2006
Est. primary completion date
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 and of varicella vaccine 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. 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 vac)

MMR, Varicella vacc (control)


Locations

Country Name City State
Canada GSK Investigational Site Edmonton Alberta
Canada GSK Investigational Site Halifax Nova Scotia
Canada GSK Investigational Site Vancouver British Columbia
Italy GSK Investigational Site Enna Sicilia
Italy GSK Investigational Site Ragusa Sicilia
Italy GSK Investigational Site San Gregorio di Catania (CT) Sicilia

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Canada,  Italy, 

Outcome

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