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Immunogenicity and Safety Study of PriorixTetra™ When Co-administered With Conjugated MenC Vaccine in Healthy Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01506193
First received: January 5, 2012
Last updated: October 5, 2016
Last verified: September 2015
  Purpose
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.

Condition Intervention Phase
Rubella
Varicella
Measles
Mumps
Biological: PriorixTetra™
Biological: Meningitec
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of seroconverted subjects for measles, mumps, rubella, and varicella virus [ Time Frame: 42 days after vaccination ] [ Designated as safety issue: No ]
    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.

  • Number of seroprotected subjects for rSBA-MenC antibodies [ Time Frame: At 42 days after vaccination ] [ Designated as safety issue: No ]
    Seroprotection was defined as the appearance of rSBA-MenC antibody titer ≥ 1:8.


Secondary Outcome Measures:
  • Number of subjects reporting any and grade 3 solicited local symptoms [ Time Frame: During the 4-day (Days 0-3) post-vaccination period ] [ Designated as safety issue: No ]
    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.

  • Number of subjects reporting any, grade 3 and related solicited general symptoms [ Time Frame: During the 15-day (Days 0-14) post-vaccination period ] [ Designated as safety issue: No ]
    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.

  • Number of subjects reporting any, grade 3 and related solicited general symptoms [ Time Frame: During the 43-day (Days 0-42) post-vaccination period ] [ Designated as safety issue: No ]
    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.

  • Number of subjects reporting fever per half degree [ Time Frame: During the 43-day (Days 0-42) post-vaccination period ] [ Designated as safety issue: No ]
    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.

  • Number of subjects reporting any, localised and generalised rashes [ Time Frame: Within the 43-day (Days 0-42) post-vaccination period ] [ Designated as safety issue: No ]
    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.

  • Number of subjects with any unsolicited adverse events (AEs) [ Time Frame: Within 43 days (Days 0-42) after each vaccination ] [ Designated as safety issue: No ]
    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.

  • Number of subjects with serious adverse events (SAEs) [ Time Frame: Throughout study period (from Day 0 to approximately Month 4) ] [ Designated as safety issue: No ]
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  • Antibody titers against measles, mumps, rubella and varicella viruses [ Time Frame: At Day 42 after vaccination ] [ Designated as safety issue: No ]
    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.


Enrollment: 716
Study Start Date: February 2012
Study Completion Date: March 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Biological: PriorixTetra™
One dose administered subcutaneously
Other Name: MMRV vaccine (GSK208136)
Biological: Meningitec
One dose administered intramuscularly
Other Name: MenC vaccine
Experimental: Group B
Subjects will receive MMRV vaccine and MenC vaccine at Visit 1 (Day 0).
Biological: PriorixTetra™
One dose administered subcutaneously
Other Name: MMRV vaccine (GSK208136)
Biological: Meningitec
One dose administered intramuscularly
Other Name: MenC vaccine
Active Comparator: Group C
Subjects will receive Men C vaccine at Visit 1 (Day 0) and MMRV vaccine at Visit 2 (Day 35-49).
Biological: PriorixTetra™
One dose administered subcutaneously
Other Name: MMRV vaccine (GSK208136)
Biological: Meningitec
One dose administered intramuscularly
Other Name: MenC vaccine

  Eligibility

Ages Eligible for Study:   13 Months to 15 Months   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01506193

Locations
Italy
GSK Investigational Site
Roma, Lazio, Italy, 00165
GSK Investigational Site
Chiavari, Liguria, Italy, 16043
GSK Investigational Site
Genova, Liguria, Italy, 16132
GSK Investigational Site
Milano, Lombardia, Italy, 20122
GSK Investigational Site
Milano, Lombardia, Italy, 20142
GSK Investigational Site
Cuneo, Piemonte, Italy, 12100
GSK Investigational Site
Novara, Piemonte, Italy, 28100
GSK Investigational Site
Alghero (SS), Sardegna, Italy, 07041
GSK Investigational Site
Cagliari, Sardegna, Italy, 09127
GSK Investigational Site
Sassari, Sardegna, Italy, 07100
GSK Investigational Site
Catania, Sicilia, Italy, 95129
GSK Investigational Site
Modica (RG), Sicilia, Italy, 97100
GSK Investigational Site
Ragusa (RG), Sicilia, Italy, 97100
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01506193     History of Changes
Other Study ID Numbers: 115555  2011-001608-37 
Study First Received: January 5, 2012
Last Updated: October 5, 2016
Health Authority: Italy: AIFA - Agenzia Italiana del Farmaco

Keywords provided by GlaxoSmithKline:
safety
healthy
conjugated
immunogenicity
children
MenC vaccine
MMRV vaccine

Additional relevant MeSH terms:
Measles
Chickenpox
Herpes Zoster
Rubella
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Rubivirus Infections
Togaviridae Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016