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Immunogenicity and Safety of GlaxoSmithKline Biologicals' MMRV Vaccine vs. ProQuad® in Children 12-14 Months of Age

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00578175
Recruitment Status : Completed
First Posted : December 21, 2007
Results First Posted : August 26, 2010
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
The purpose of this observer blinded study is to provide information on vaccine immunogenicity and reactogenicity in comparison with the US standard of care (ProQuad®) when administered with Hepatitis A vaccine and Pneumococcal vaccine.

Condition or disease Intervention/treatment Phase
Varicella Rubella Mumps Measles Biological: Priorix-Tetra™ (MMRV vaccine 208136) Biological: ProQuad® Biological: Havrix® Biological: Prevnar® Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1851 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity of GlaxoSmithKline Biologicals' MMRV Vaccine (208136) vs. ProQuad®, When Coadministered With Hepatitis A and Pneumococcal Conjugate Vaccines to Children 12-14 Months of Age.
Study Start Date : November 20, 2007
Actual Primary Completion Date : February 24, 2009
Actual Study Completion Date : March 17, 2009

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Shingles
MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A
Subjects received refrigerator-stored Priorix-Tetra™ (MMRV vaccine 208136 formulation A) co-administered with Havrix® and Prevnar® at Day 0 and a second dose of Havrix® at Day 180
 Biological: Priorix-Tetra™ (MMRV vaccine 208136)
One subcutaneous injection.

Biological: Havrix®
Two intramuscular injections.

Biological: Prevnar®
One intramuscular injection.
Experimental: Group B
Subjects received freezer-stored Priorix-Tetra™ (MMRV vaccine 208136 formulation B) co-administered with Havrix® and Prevnar® at Day 0 and a second dose of Havrix® at Day 180
 Biological: Priorix-Tetra™ (MMRV vaccine 208136)
One subcutaneous injection.

Biological: Havrix®
Two intramuscular injections.

Biological: Prevnar®
One intramuscular injection.
Active Comparator: Group C
Subjects received ProQuad® co-administered with Havrix® and Prevnar® at Day 0 and a second dose of Havrix® at Day 180
 Biological: ProQuad®
One subcutaneous injection.

Biological: Havrix®
Two intramuscular injections.

Biological: Prevnar®
One intramuscular injection.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Subjects With Seroresponse for Antibodies to Varicella Virus (VZV) [ Time Frame: At Day 42 after vaccination ]
    Seroresponse for antibodies to VZV is defined as the appearance post-vaccination of anti-VZV antibodies [concentration greater than or equal to the threshold of 75 milli-international units per milliliter (mIU/mL)] in the serum of subjects below the assay cut-off value of 25 mIU/mL before vaccination.

  2. Concentration of Antibodies to Varicella Virus (VZV) [ Time Frame: At Day 42 after vaccination ]
    Concentrations are given as Geometric Mean Concentrations (GMCs).

  3. Number of Subjects With Seroresponse for Antibodies to Mumps Virus [ Time Frame: At Day 42 after vaccination ]
    Seroresponse for antibodies to mumps virus is defined as the appearance post-vaccination of anti-mumps virus antibodies [titer greater than or equal to the threshold of 51 Effective Doses (ED50)] in the serum of subjects below the assay cut-off value of 24 ED50 before vaccination.

  4. Number of Subjects With Seroresponse for Antibodies to Measles Virus [ Time Frame: At Day 42 after vaccination ]
    Seroresponse for antibodies to measles virus is defined as the appearance post-vaccination of anti-measles virus antibodies [concentration greater than or equal to the threshold of 200 milli-international units per milliliter (mIU/mL)] in the serum of subjects below the assay cut-off value of 150 mIU/mL before vaccination.

  5. Number of Subjects With Seroresponse for Antibodies to Rubella Virus [ Time Frame: At Day 42 after vaccination ]
    Seroresponse for antibodies to rubella virus is defined as the appearance post-vaccination of anti-rubella virus antibodies [concentration greater than or equal to the threshold of 10 international units per milliliter (IU/mL)] in the serum of subjects below the assay cut-off value of 4 IU/mL before vaccination.

  6. Concentration of Antibodies to Hepatitis A Virus (HAV) [ Time Frame: At Day 42 after vaccination ]
    Concentrations are given as Geometric Mean Concentrations (GMCs).

  7. Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F [ Time Frame: At Day 42 after vaccination ]
    Concentrations are given as Geometric Mean Concentrations (GMCs).


Secondary Outcome Measures :
  1. Antibody Titers to Mumps Virus [ Time Frame: At Day 42 after vaccination ]
    Data are expressed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum.

  2. Concentration of Antibodies to Measles Virus [ Time Frame: At Day 42 after vaccination ]
    Concentrations are given as Geometric Mean Concentrations (GMCs).

  3. Concentration of Antibodies to Rubella Virus [ Time Frame: At Day 42 after vaccination ]
    Concentrations are given as Geometric Mean Concentrations (GMCs).

  4. Number of Subjects With Vaccine Response to Havrix [ Time Frame: At Day 42 after vaccination ]
    Vaccine response to Havrix is defined as the appearance post-vaccination of anti-hepatitis A virus (anti-HAV) antibodies [concentration greater than or equal to 15 milli-international units per milliliter (mIU/mL)] in the serum of subjects seronegative before vaccination (concentration below the assay cut-off value of 15 mIU/mL) or having a 2-fold increase above the pre-vaccination concentration in subjects who were seropositive before vaccination.

  5. Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value [ Time Frame: At Day 42 after vaccination ]
    Cut-off value assessed include 0.05 micrograms per milliliter (µg/mL).

  6. Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value [ Time Frame: At Day 42 after vaccination ]
    Cut-off value assessed include 0.2 micrograms per milliliter (µg/mL).

  7. Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value [ Time Frame: At Day 42 after vaccination ]
    Cut-off value assessed include 0.5 micrograms per milliliter (µg/mL).

  8. Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value [ Time Frame: At Day 42 after vaccination ]
    Cut-off value assessed include 1.0 micrograms per milliliter (µg/mL).

  9. Number of Subjects Reporting Solicited Local Symptoms [ Time Frame: During the 4 day follow up period following vaccination ]
    Solicited local symptoms assessed include pain, redness and swelling.

  10. Number of Subjects Reporting Fever ≥ 38.0°C/100.4°F and > 39.5°C/103.1°F During the 15-day Follow up Period After Vaccination [ Time Frame: During the 15-day follow-up period following vaccination ]
    Fever was measured rectally.

  11. Number of Subjects Reporting Fever ≥ 38.0°C/100.4°F and > 39.5°C/103.1°F During the 43-day Follow-up Period After Vaccination [ Time Frame: During the 43-day follow-up period following vaccination ]
    Fever was measured rectally.

  12. Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash [ Time Frame: During the 43-day follow-up period after vaccination ]
  13. Number of Subjects Reporting Investigator-confirmed Varicella-like Rash [ Time Frame: During the 43-day follow-up period after vaccination ]
  14. Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling [ Time Frame: During the 43-day follow-up period after vaccination ]
  15. Number of Subjects Reporting Unsolicited Adverse Events and Medically-attended Adverse Events (Excluding Rash and Parotid/Salivary Gland Swelling) [ Time Frame: During the 43-day follow-up period after vaccination ]

    Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

    Medically-attended adverse event covers any adverse event which received medical attention. Medical attention is defined as hospitalization, an emergency room visit or a visit to or from medical personnel.


  16. Number of Subjects Reporting New Onset Chronic Illnesses and Conditions Prompting Emergency Room Visits [ Time Frame: For approximately 6 months (Day 0-180) ]
    New onset chronic illnesses include autoimmune disorders, asthma, type I diabetes and allergies.

  17. Number of Subjects Reporting Serious Adverse Events [ Time Frame: For approximately 6 months (Day 0-180) ]
    Serious adverse events assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.


Eligibility Criteria
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Ages Eligible for Study:   12 Months to 14 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects for whom the investigator believes their parents/guardians can and will comply with the requirements of the protocol.
  • Male or female between 12 and 14 months of age at the time of first vaccination.
  • Written informed consent obtained from the parent/guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Have previously received 3 doses of 7-valent pneumococcal conjugate vaccine within the first year of life.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol from 30 days prior to vaccination until 42 days after vaccination, except for influenza vaccine.
  • Previous vaccination against measles, mumps, rubella and/or varicella.
  • Previous vaccination against hepatitis A or receipt of a fourth dose of pneumococcal conjugate vaccine.
  • History of measles, mumps, rubella and/or varicella/zoster diseases.
  • Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the study.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination, including human immunodeficiency virus infection.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures. Uncomplicated febrile convulsions are not an exclusion criterion.

  • Residence in the same household as the following persons:

    • New-born infants (0-4 weeks of age).
    • Pregnant mother/women with a negative history of chickenpox disease and without recorded vaccination against chickenpox.
    • Pregnant women at or beyond 28 weeks gestation regardless of varicella vaccination status or varicella disease history.
    • Persons with known immunodeficiency.
  • Acute disease at the time of enrolment. All vaccines can be administered to persons with a minor illness.
  • Administration of polyclonal immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
  • Contra-indications to commercially available vaccines used in this study (Havrix®, Prevnar®, ProQuad®).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00578175


Locations
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Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Additional Information:

Study Data/Documents: Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 110058
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 110058
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 110058
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 110058
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 110058
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 110058
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 110058
For additional information about this study please refer to the GSK Clinical Study Register

Publications:

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00578175    
Other Study ID Numbers: 110058
First Posted: December 21, 2007    Key Record Dates
Results First Posted: August 26, 2010
Last Update Posted: October 9, 2018
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Keywords provided by GlaxoSmithKline:
Vaccines
Rubella
Varicella Vaccine
Children
Humans
 Mumps
Immunogenicity
Safety
Measles
Combined Vaccine
Additional relevant MeSH terms:
Layout table for MeSH terms
Measles
Chickenpox
Herpes Zoster
Rubella
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
 Infections
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Rubivirus Infections
Togaviridae Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs