- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01506193
Immunogenicity and Safety Study of PriorixTetra™ When Co-administered With Conjugated MenC Vaccine in Healthy Children
July 11, 2018 updated by: GlaxoSmithKline
Immunogenicity and Safety Study of GlaxoSmithKline Biological's Live Attenuated Measles Mumps Rubella Varicella Vaccine (PriorixTetra™) When Co-administered With Conjugated Meningococcal C Vaccine (Meningitec®, Nuron Biotechs' Vaccine) in Healthy Children
The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' investigational measles, mumps, rubella and varicella (MMRV) vaccine (GSK208136, PriorixTetra™) when co-administered along with conjugated Meningococcal C (MenC) vaccine (Meningitec®, Nuron Biotechs' Vaccine) in healthy children.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
716
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Lazio
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Roma, Lazio, Italy, 00165
- GSK Investigational Site
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Liguria
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Chiavari, Liguria, Italy, 16043
- GSK Investigational Site
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Genova, Liguria, Italy, 16132
- GSK Investigational Site
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Lombardia
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Milano, Lombardia, Italy, 20122
- GSK Investigational Site
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Milano, Lombardia, Italy, 20142
- GSK Investigational Site
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Piemonte
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Cuneo, Piemonte, Italy, 12100
- GSK Investigational Site
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Novara, Piemonte, Italy, 28100
- GSK Investigational Site
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Sardegna
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Alghero (SS), Sardegna, Italy, 07041
- GSK Investigational Site
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Cagliari, Sardegna, Italy, 09127
- GSK Investigational Site
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Sassari, Sardegna, Italy, 07100
- GSK Investigational Site
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Sicilia
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Catania, Sicilia, Italy, 95129
- GSK Investigational Site
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Modica (RG), Sicilia, Italy, 97100
- GSK Investigational Site
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Ragusa (RG), Sicilia, Italy, 97100
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects who the investigator believes that parent(s)/Legally Acceptable Representatives (LAR) can and will comply with the requirements of the protocol.
- A male or female between, and including, 13 and 15 months of age at the time of the first vaccination.
- Written informed consent obtained from the parent(s)/ LAR of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
- Child in care.
- Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the dose of study vaccine, or planned use during the study period.
- 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 starting 30 days prior to the study vaccination/s and ending 42 days after the vaccination/s (at Visit 2), with the exception of inactivated influenza (flu) vaccine, which may be given at any time during the study, including the day of study vaccination/s.
- 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.
- Previous vaccination against measles, mumps, rubella, varicella/ herpes zoster and/or N. meningitidis serogroup C.
- History of measles, mumps, rubella, varicella and/or N. meningitidis serogroup C diseases.
- Known exposure to measles, mumps, rubella and or varicella starting 30 days prior to enrolment.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Family history of congenital or hereditary immunodeficiency.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- Major congenital defects or serious chronic illness.
- Acute disease and/or fever at the time of enrollment.
- Documented human immunodeficiency virus (HIV) positive subject.
- Any contraindications as stated in the Summary of Product Characteristics.
- Administration of immunoglobulins and/or any blood products within three months prior to the first vaccine dose or planned administration during the study period.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group A
Subjects in this arm will receive MMRV vaccine at Visit 1 (Day 0) and MenC vaccine at Visit 2 (Days 35-49).
|
One dose administered subcutaneously
Other Names:
One dose administered intramuscularly
Other Names:
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Experimental: Group B
Subjects will receive MMRV vaccine and MenC vaccine at Visit 1 (Day 0).
|
One dose administered subcutaneously
Other Names:
One dose administered intramuscularly
Other Names:
|
Active Comparator: Group C
Subjects will receive Men C vaccine at Visit 1 (Day 0) and MMRV vaccine at Visit 2 (Day 35-49).
|
One dose administered subcutaneously
Other Names:
One dose administered intramuscularly
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus
Time Frame: At 42 days after vaccination
|
Seroconversion was defined as the appearance of antibodies (i.e.
concentration/titer ≥ the cut-off value) in the serum of subjects seronegative before vaccination.
The cut-off values for serocoversion were 150 mIU/mL, 231 U/mL, 4 IU/mL and 25 mIU/mL for measles, mumps, rubella and varicella, respectively.
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At 42 days after vaccination
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Number of Seroprotected Subjects for rSBA-MenC Antibodies
Time Frame: At 42 days after vaccination
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Seroprotection was defined as the appearance of rSBA-MenC antibody titer ≥ 1:8.
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At 42 days after vaccination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Time Frame: During the 4-day (Days 0-3) post-vaccination period
|
Assessed solicited local symptoms were pain, redness and swelling.
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 pain = Cried when limb is moved/spontaneously painful.
Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
This outcome measure concerns subjects in Priorix-Tetra + Meningitec Group and Priorix-Tetra Group only.
Subjects in Priorix-Tetra Group did not receive Meningitec® vaccine.
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During the 4-day (Days 0-3) post-vaccination period
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Time Frame: During the 15-day (Days 0-14) post-vaccination period
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Assessed solicited general symptoms were drowsiness, irritability/fussiness and loss of appetite.
Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
Grade 3 symptom = symptom that prevented normal activity.
Related = symptom assessed by the investigator as related to the vaccination.
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During the 15-day (Days 0-14) post-vaccination period
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Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Time Frame: During the 43-day (Days 0-42) post-vaccination period
|
Assessed solicited general symptoms were Parotid / salivary gland swelling and suspected signs of meningism / febrile convulsions.
Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
Grade 3 parotid / salivary gland swelling = swelling with accompanying general symptoms and Related = symptom assessed by the investigator as related to the vaccination.
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During the 43-day (Days 0-42) post-vaccination period
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Number of Subjects Reporting Fever Per Half Degree
Time Frame: During the 43-day (Days 0-42) post-vaccination period
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Any fever = fever ≥ 38.0°C on rectal setting, grade 3 fever = fever > 39.5 °C and related = fever assessed by the investigator as causally related to study vaccination.
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During the 43-day (Days 0-42) post-vaccination period
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Number of Subjects Reporting Any, Localised and Generalised Rashes
Time Frame: Within the 43-day (Days 0-42) post-vaccination period
|
Rash/exanthem was defined as: 1) measles/ rubella rashes (macular or maculo-papular rashes): presence of macules, discolored small patches or spots of the skin, neither elevated nor depressed below the skin's surface.
2) varicella rash (maculo-papulo-vesicular): simultaneous presence of macules, papules and vesicles raised above the skin's surface or other types of rash (heat rash, diaper rash etc.).
Any rash = no lesions and grade 3 = > 150 lesions.
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Within the 43-day (Days 0-42) post-vaccination period
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Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time Frame: Within 43 days (Days 0-42) after each vaccination
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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 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.
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Within 43 days (Days 0-42) after each vaccination
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Number of Subjects With Serious Adverse Events (SAEs)
Time Frame: Throughout study period (from Day 0 to approximately Month 4)
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SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
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Throughout study period (from Day 0 to approximately Month 4)
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Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses
Time Frame: At Day 42 after vaccination
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Antibody titers were summarized by geometric mean concentrations (GMCs) with their 95% confidence intervals (CIs) for the following cut-offs: ≥ 150 mIU/mL, ≥ 231 U/mL, ≥ 4 IU/mL and ≥ 25 mIU/mL for anti-measles, anti-mumps, anti-rubella and anti-varicella, respectively.
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At Day 42 after vaccination
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 6, 2012
Primary Completion (Actual)
February 17, 2014
Study Completion (Actual)
March 31, 2014
Study Registration Dates
First Submitted
January 5, 2012
First Submitted That Met QC Criteria
January 5, 2012
First Posted (Estimate)
January 9, 2012
Study Record Updates
Last Update Posted (Actual)
August 17, 2018
Last Update Submitted That Met QC Criteria
July 11, 2018
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- DNA Virus Infections
- Morbillivirus Infections
- Paramyxoviridae Infections
- Mononegavirales Infections
- Herpesviridae Infections
- Varicella Zoster Virus Infection
- Togaviridae Infections
- Rubivirus Infections
- Measles
- Herpes Zoster
- Chickenpox
- Rubella
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- 115555
- 2011-001608-37 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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