Immunogenicity & Safety Study of GSK Biologicals' 208136 Vaccine Formulated With New Measles and Rubella Working Seeds

NCT00892775 | Completed Phase 2 Results

• 2 other identifiers: 1087602011-005881-38
• Study Type: interventional
• Target: 501
• Locations: 2 countries
• Sites: 6

Brief Summary

This study is undertaken to generate clinical data on GSK Biologicals' combined measles-mumps-rubella-varicella vaccine manufactured with measles and rubella obtained from newly established working seed viruses which are one passage further than the current working seed viruses. The measles-mumps-rubella-varicella vaccine manufactured with the current working seed viruses will serve as comparator. A seed lot system is a system according to which successive batches of a vaccine are derived from the same master seed virus. For routine production, a working seed lot is prepared from the master seed virus.

Conditions

Measles; Varicella; Mumps; Rubella

Keywords

Working seed virus; Rubella; Mumps; Varicella; Combined measles-mumps-rubella-varicella vaccine; Pediatric immunization; Measles

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies Greater Than or Equal to (≥) the Cut-off Value.

  Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 milli international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and 1:4 dilution for measles, mumps, rubella and varicella, respectively.

  At 42-56 days after the first dose of study vaccine (Week 6)

Secondary Outcomes (9)

• Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies ≥ the Cut-off Value.

  At 42-56 days after the second dose of study vaccine (Week 18)

• Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses

  At 42-56 days after the first and second dose of study vaccine(s).

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

  Within 4 days after each vaccination (Days 0-3)

• Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms

  Within 43 days (Days 0-42) after each vaccination

• Number of Subjects Reporting Any, Grade 3 and Related Fever

  Within 43 days (Days 0-42) after each vaccination

Study Arms (2)

Priorix-Tetra new WS Group

EXPERIMENTAL

Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.

Biological: GSK Biologicals' 208136, new formulation

Priorix-Tetra current WS Group

EXPERIMENTAL

Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12.

Biological: Priorix-Tetra (combined measles-mumps-rubella-varicella vaccine)

Interventions

Priorix-Tetra (combined measles-mumps-rubella-varicella vaccine) BIOLOGICAL

Vaccine will be administered subcutaneously in the left upper arm (deltoid region)

Priorix-Tetra current WS Group

GSK Biologicals' 208136, new formulation BIOLOGICAL

Vaccine will be administered subcutaneously in the left upper arm (deltoid region)

Priorix-Tetra new WS Group

Eligibility Criteria

• Age: 11 Months - 21 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 (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
• A male or female between, and including, 11 and 21 months of age (e.g. from age 11months until the day before age 22 months) at the time of the first vaccination.
• Written informed consent obtained from the parent or guardian of the subject after they have been advised on the risks and benefits of the study in a language they clearly understand, and before performance of any study procedure.
• Free of obvious healthy problems 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 first 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 first 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 each study vaccine dose with the exception of oral polio vaccine (OPV) which can be given at any time and routine inactivated vaccines such as pneumococcal, meningococcal or Haemophilus influenzae type b conjugate vaccines, inactivated influenza or diphtheria/tetanus containing vaccines which can be administered up to eight days before each 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.
• History of any neurologic disorders or seizures.
• 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.:

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (6)

GSK Investigational Site

Singapore, 119074, Singapore

Location

GSK Investigational Site

Singapore, 228510, Singapore

Location

GSK Investigational Site

Singapore, 229899, Singapore

Location

GSK Investigational Site

Taipei, 100, Taiwan

Location

GSK Investigational Site

Taipei, 104, Taiwan

Location

GSK Investigational Site

Taipei, Taiwan

Location

Related Publications (1)

• Huang LM, Lee BW, Chan PC, Povey M, Henry O. Immunogenicity and safety of combined measles-mumps-rubella-varicella vaccine using new measles and rubella working seeds in healthy children in Taiwan and Singapore: a phase II, randomized, double-blind trial. Hum Vaccin Immunother. 2013 Jun;9(6):1308-15. doi: 10.4161/hv.24035. Epub 2013 Feb 20.

  PMID: 23425607 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

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 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2009
• First Posted: May 5, 2009
• Study Start: June 3, 2009
• Primary Completion: September 17, 2010
• Study Completion: December 13, 2010
• Last Updated: November 15, 2019
• Results First Posted: October 9, 2017

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

SG (3); TW (3)