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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00226499 |
An observer-blind study to evaluate GlaxoSmithKline Biologicals' live attenuated varicella vaccine and GlaxoSmithKline Biologicals' combined measles-mumps-rubella-varicella vaccine in the prevention of varicella disease in children. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Condition | Intervention | Phase |
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Measles Mumps Rubella Chickenpox |
Biological: Priorix-tetra™ Biological: Priorix™ Biological: Varilrix™ |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Study in Healthy Children (<2 Years) to Evaluate the Safety & Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) & of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine |
Estimated Enrollment: | 5784 |
Study Start Date: | September 2005 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Group A: Experimental |
Biological: Priorix-tetra™
2 IM doses
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Group B: Experimental |
Biological: Priorix™
2 IM doses in Group C, 1 IM dose in Group B
Biological: Varilrix™
1 IM dose in Group B
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Group C: Active Comparator |
Biological: Priorix™
2 IM doses in Group C, 1 IM dose in Group B
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According to treatment group allocation, participants will receive study vaccines and be followed for antibody titres and occurrence of varicella disease.
This study is conducted in 2 phases. Phase A includes the vaccination period and an observation period for efficacy. The efficacy endpoints will be evaluated over at least two years after vaccination. During this period, the immunogenicity endpoints will be evaluated with respect to the immune response 43 days after vaccination and the persistence of antibodies over two years to varicella (for all subjects) and to measles, mumps and rubella (for a subset of subjects). Regarding the safety endpoints, SAEs (including any complicated varicella cases if observed) will be assessed for all subjects during the whole Phase A duration, whereas, solicited (local and general) and unsolicited adverse events will be assessed in a subset of subjects within a 43-day period after vaccination.
Phase B is an extension of Phase A. It is a long-term follow-up until Year 10 to examine the long-term efficacy of the study vaccines against clinical varicella disease as well as the long-term persistence of antibodies to varicella (for all subjects) and to measles, mumps and rubella (in a subset of subjects) after vaccination.
Ages Eligible for Study: | 11 Months to 22 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Subjects:
Exclusion criteria:
Additional exclusion criteria for subjects included in the subset:
- Administration of a licensed vaccine within 14 days prior to vaccination and planned use until approximately 42 days after the last study vaccine dose (Day 84) with the exception of oral polio vaccine (OPV).
Czech Republic | |
GSK Clinical Trials Call Center | |
Praha, Czech Republic | |
Greece | |
GSK Clinical Trials Call Center | |
Athens, Greece | |
Italy | |
GSK Clinical Trials Call Center | |
Rome, Italy | |
Lithuania | |
GSK Clinical Trials Call Center | |
Vilnius, Lithuania | |
Norway | |
GSK Clinical Trials Call Center | |
Oslo, Norway | |
Poland | |
GSK Clinical Trials Call Center | |
Krakow, Poland | |
Romania | |
GSK Clinical Trials Call Center | |
Bucharest, Romania | |
Russian Federation | |
GSK Clinical Trials Call Center | |
Moscow, Russian Federation | |
Slovakia | |
GSK Clinical Trials Call Center | |
Bratislava, Slovakia | |
Sweden | |
GSK Clinical Trials Call Center | |
Malmo, Sweden |
Study Director: | Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Isabelle Harpigny ) |
Study ID Numbers: | 100388, 103494 (EXT FU Y1), 104105 (EXT FU Y2), 104106 (EXT FU Y4-Y6-Y8-Y10) |
Study First Received: | September 23, 2005 |
Last Updated: | September 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00226499 |
Health Authority: | Czech Republic: State Institute for Drug Control |
Herpes Zoster Mouth Diseases Paramyxoviridae Infections Measles Chickenpox Healthy Rubella Togaviridae Infections |
Herpesviridae Infections Virus Diseases DNA Virus Infections Chicken pox Stomatognathic Diseases Salivary Gland Diseases Mumps |
Rubivirus Infections Parotid Diseases RNA Virus Infections Morbillivirus Infections |
Rubulavirus Infections Parotitis Mononegavirales Infections |