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

NCT00751348 | Completed Phase 3 Results

• 1 other identifier: 110876
• Study Type: interventional
• Target: 475
• Locations: 1 country
• Sites: 13

Brief Summary

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

Conditions

Measles; Varicella; Mumps; Rubella

Keywords

second year of life; one-dose schedule; varicella; rubella; measles; mumps

Outcome Measures

Primary Outcomes (1)

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

  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.

  At 42 days post-vaccination

Secondary Outcomes (8)

• Antibody Concentrations Against Measles

  At 42-days post-vaccination

• Antibody Concentrations Against Mumps

  At 42-days post-vaccination

• Antibody Concentrations Against Rubella

  At 42-days post-vaccination

• Antibody Titers Against Varicela Viruses

  At 42-days post-vaccination

• Number of Subjects With Any and Grade 3 Solicited Local Symptoms

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

Study Arms (2)

PRIORIX-TETRA GROUP

EXPERIMENTAL

Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.

Biological: Priorix-Tetra®

PRIORIX + VARILRIX GROUP

ACTIVE COMPARATOR

Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.

Biological: PriorixTM; Biological: VarilrixTM

Interventions

PriorixTM BIOLOGICAL

Subcutaneous administration in left upper arm

PRIORIX + VARILRIX GROUP

VarilrixTM BIOLOGICAL

Subcutaneous administration in right upper arm

PRIORIX + VARILRIX GROUP

Priorix-Tetra® BIOLOGICAL

Subcutaneous injection in left upper arm

PRIORIX-TETRA GROUP

Eligibility Criteria

• Age: 11 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (13)

GSK Investigational Site

Bucheon-si, 420-767, South Korea

Location

GSK Investigational Site

Daejeon, 301-723, South Korea

Location

GSK Investigational Site

Gwangju, 501-717, South Korea

Location

GSK Investigational Site

GyeongSangNam-do, 641-560, South Korea

Location

GSK Investigational Site

Iksan, 570-711, South Korea

Location

GSK Investigational Site

Incheon, 400-711, South Korea

Location

GSK Investigational Site

Jeonju Jeonbuk, 561-712, South Korea

Location

GSK Investigational Site

Seongnam-si, Gyeonggi-do, 463-712, South Korea

Location

GSK Investigational Site

Seoul, 130-702, South Korea

Location

GSK Investigational Site

Seoul, 150-719, South Korea

Location

GSK Investigational Site

Seoul, 150-950, South Korea

Location

GSK Investigational Site

Uijeongbu, Kyonggi-do, 480-130, South Korea

Location

GSK Investigational Site

Wonju-si Kangwon-do, 220-701, South Korea

Location

Related Publications (1)

• Cha SH, Shin SH, Lee TJ, Kim CH, Povey M, Kim HM, Nicholson O. Immunogenicity and safety of a tetravalent measles-mumps-rubella-varicella vaccine: an open-labeled, randomized trial in healthy Korean children. Clin Exp Vaccine Res. 2014 Jan;3(1):91-9. doi: 10.7774/cevr.2014.3.1.91. Epub 2013 Dec 18.

  PMID: 24427766 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Measles; Chickenpox; Mumps; Rubella

Interventions

Priorix-Tetra vaccine

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2008
• First Posted: September 11, 2008
• Study Start: October 1, 2008
• Primary Completion: May 27, 2010
• Study Completion: May 27, 2010
• Last Updated: June 8, 2018
• Results First Posted: April 24, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

KR (13)