Skip to main content
OpenTrials
Completed

NCT Number: NCT00751348

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Measles Chickenpox DNA Virus Infections Herpesviridae Infections Infections Mononegavirales Infections Morbillivirus Infections Mouth Diseases Mumps Paramyxoviridae Infections Parotid Diseases Parotitis RNA Virus Infections Rubella Rubivirus Infections Rubulavirus Infections Salivary Gland Diseases Stomatognathic Diseases Togaviridae Infections Varicella Varicella Zoster Virus Infection Virus Diseases

Age range

11 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Bucheon-si, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PriorixTM

Biological

Subcutaneous administration in left upper arm

VarilrixTM

Biological

Subcutaneous administration in right upper arm

Priorix-Tetra®

Biological

Subcutaneous injection in left upper arm

Primary outcomes

  1. Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Zoster Virus (VZV) Antibodies Above the Cut-off Values

    Time frame: At 42 days post-vaccination

    Seroconversion was defined as the appearance of antibodies [i.e. titer greater than or equal to (≥) the cut-off value] in the sera of subjects seronegative [i.e. titer below (<) cut-off value] before vaccination. Cut-off values were the following: Anti-measles concentration ≥ 150 milli-international units per milliliter (mIU/mL); Anti-mumps concentration ≥ 231 units per milliliter (U/mL); Anti-rubella concentration ≥ 4 international units per milliliter (IU/mL); Anti-VZV titer ≥ 1:4 dilution.

Secondary outcomes

  1. Antibody Concentrations Against Measles

    Time frame: At 42-days post-vaccination

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).

  2. Antibody Concentrations Against Mumps

    Time frame: At 42-days post-vaccination

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL).

  3. Antibody Concentrations Against Rubella

    Time frame: At 42-days post-vaccination

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).

  4. Antibody Titers Against Varicela Viruses

    Time frame: At 42-days post-vaccination

    Antibody titers were presented as geometric mean titers (GMTs).

  5. Number of Subjects With Any and Grade 3 Solicited Local Symptoms

    Time frame: During the 4-day (Days 0-3) post-vaccination period

    Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cry when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.

  6. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

    Time frame: During the 43-day (Days 0-42) post-vaccination period

    Solicited general symptoms assessed were fever [defined as rectal temperature ≥38.0 degrees Celsius (°C)], rash, meningism and parotid gland swelling. Any= incidence of the specified symptoms regardless of intensity grade or relationship to study vaccine. Grade 3 fever= rectal temperature above (>) 39.5°C. Grade 3 rash= more than 150 lesions. Grade 3 meningism and parotid gland swelling= meningism/parotid gland swelling symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the vaccination.

  7. Number of Subjects With Any Unsolicited Adverse Events (AEs)

    Time frame: Within the 43-day (Days 0-42) post-vaccination period

    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.

  8. Number of Subjects With Serious Adverse Events (SAEs)

    Time frame: During the entire study period (from Day 0 up to Day 43 or Day 57)

    Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 11, 2008
Registry last updated
Jun 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.