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Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00751348
First received: September 10, 2008
Last updated: January 12, 2012
Last verified: August 2011
  Purpose

This Phase 3b study is being conducted for the purpose of registration of the GSK208136 vaccine in Korea.


Condition Intervention Phase
Rubella
Varicella
Mumps
Measles
Measles-Mumps-Rubella-Varicella Vaccine
Biological: PriorixTM
Biological: VarilrixTM
Biological: GSK Biologicals' vaccine 208136
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Seroconversion rates for measles, mumps, rubella and varicella [ Time Frame: approximately 42-56 days after vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measles, mumps, rubella and varicella antibody titres [ Time Frame: 42-56 days after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of solicited local symptoms (injection site redness, pain and swelling) [ Time Frame: within four days after vaccination (Day 0-3) ] [ Designated as safety issue: No ]
  • Occurrence of solicited general symptoms in terms of fever, rash, any sign of meningitis including febrile convulsion and parotitis [ Time Frame: within 43 days after each vaccination (Day 0-42) ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited symptoms [ Time Frame: within 43 days after vaccination (Day 0-42) ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: from the study vaccine dose up to study end ] [ Designated as safety issue: No ]

Enrollment: 475
Study Start Date: October 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: GSK Biologicals' vaccine 208136
Subcutaneous injection in left upper arm
Active Comparator: Group B Biological: PriorixTM
Subcutaneous administration in left upper arm
Biological: VarilrixTM
Subcutaneous administration in right upper arm

  Eligibility

Ages Eligible for Study:   11 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female between, and including 11 and 24 months of age, at the time of the vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
  • Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days prior to until 42 days after the study vaccine dose with the exception of inactivated vaccines such as pneumococcal, Haemophilus influenzae type b conjugate vaccines, inactivated influenza, hepatitis A or B vaccine or diphtheria/tetanus-containing vaccines which can be administered up to eight days before the study vaccine dose.
  • Previous vaccination against measles, mumps, rubella and/or varicella.
  • History of measles, mumps, rubella and/or varicella/zoster diseases.
  • Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to study start.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic hypersensitivity to neomycin.
  • Major congenital defects or serious chronic illness.
  • Acute disease at the time of enrolment.
  • Rectal temperature ≥ 38°C or axillary temperature ≥ 37.5°C at the time of vaccination.
  • Residence in the same household as a high risk person e.g.:

    • New-born infants (0-4 weeks of age)
    • Pregnant women who have a negative history of chickenpox
    • Persons with known immunodeficiency
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751348

Locations
Korea, Republic of
GSK Investigational Site
Bucheon-si,, Korea, Republic of, 420-767
GSK Investigational Site
Daejeon, Korea, Republic of, 301-723
GSK Investigational Site
Gwangju, Korea, Republic of, 501-717
GSK Investigational Site
GyeongSangNam-do, Korea, Republic of, 641-560
GSK Investigational Site
Iksan, Korea, Republic of, 570-711
GSK Investigational Site
Incheon, Korea, Republic of, 400-711
GSK Investigational Site
Jeonju Jeonbuk, Korea, Republic of, 561-712
GSK Investigational Site
Seoul, Korea, Republic of, 130-702
GSK Investigational Site
Seoul, Korea, Republic of, 150-950
GSK Investigational Site
Seoul, Korea, Republic of, 150-719
GSK Investigational Site
Uijeongbu, Kyonggi-do, Korea, Republic of, 480-130
GSK Investigational Site
Wonju-si Kangwon-do, Korea, Republic of, 220-701
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00751348     History of Changes
Other Study ID Numbers: 110876
Study First Received: September 10, 2008
Last Updated: January 12, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by GlaxoSmithKline:
second year of life
one-dose schedule
varicella
rubella
measles
mumps

Additional relevant MeSH terms:
Rubella
Chickenpox
Herpes Zoster
Measles
Mumps
Parotitis
DNA Virus Infections
Herpesviridae Infections
Mononegavirales Infections
Morbillivirus Infections
Mouth Diseases
Paramyxoviridae Infections
Parotid Diseases
RNA Virus Infections
Rubivirus Infections
Rubulavirus Infections
Salivary Gland Diseases
Sialadenitis
Stomatognathic Diseases
Togaviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014