Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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: February 10, 2017
Last verified: February 2017

January 5, 2012
February 10, 2017
February 2012
February 2014   (Final data collection date for primary outcome measure)
  • 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.
  • Number of Seroprotected Subjects for rSBA-MenC Antibodies [ Time Frame: At 42 days after vaccination ]
    Seroprotection was defined as the appearance of rSBA-MenC antibody titer ≥ 1:8.
  • Immunogenicity with respect to the components of MMRV when administered concomitantly with MenC as compared to MMRV alone. [ Time Frame: 42 days after vaccination ]
  • Immunogenicity with respect to the MenC conjugate vaccine when administered concomitantly with MMRV as compared to MenC conjugate vaccine alone. [ Time Frame: 42 days after vaccination ]
Complete list of historical versions of study NCT01506193 on ClinicalTrials.gov Archive Site
  • 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.
  • Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 15-day (Days 0-14) post-vaccination period ]
    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 ]
    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 ]
    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 ]
    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 ]
    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) ]
    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 ]
    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.
  • Immunogenicity with respect to the components of MMRV when administered concomitantly with MenC as compared to MMRV alone [ Time Frame: 42 days after vaccination ]
  • Occurrence of solicited local symptoms [ Time Frame: Within 4 days after each vaccination (Day 0-3) ]
  • Occurrence of solicited general symptoms [ Time Frame: Within 43 days after vaccination (Day 0 - 42) ]
  • Occurrence of unsolicited symptoms [ Time Frame: Within 43 days after each vaccination (Day 0-42) ]
  • Occurrence of Serious Adverse Events (SAEs) [ Time Frame: Throughout the study (from Day 0 to approximately Month 4) ]
Not Provided
Not Provided
 
Immunogenicity and Safety Study of PriorixTetra™ When Co-administered With Conjugated MenC Vaccine in Healthy Children
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Prevention
  • Rubella
  • Varicella
  • Measles
  • Mumps
  • Biological: PriorixTetra™
    One dose administered subcutaneously
    Other Name: MMRV vaccine (GSK208136)
  • Biological: Meningitec
    One dose administered intramuscularly
    Other Name: MenC vaccine
  • 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).
    Interventions:
    • Biological: PriorixTetra™
    • Biological: Meningitec
  • Experimental: Group B
    Subjects will receive MMRV vaccine and MenC vaccine at Visit 1 (Day 0).
    Interventions:
    • Biological: PriorixTetra™
    • Biological: Meningitec
  • Active Comparator: Group C
    Subjects will receive Men C vaccine at Visit 1 (Day 0) and MMRV vaccine at Visit 2 (Day 35-49).
    Interventions:
    • Biological: PriorixTetra™
    • Biological: Meningitec
Durando P, Esposito S, Bona G, Cuccia M, Desole MG, Ferrera G, Gabutti G, Pellegrino A, Salvini F, Henry O, Povey M, Marchetti F. The immunogenicity and safety of a tetravalent measles-mumps-rubella-varicella vaccine when co-administered with conjugated meningococcal C vaccine to healthy children: A phase IIIb, randomized, multi-center study in Italy. Vaccine. 2016 Aug 5;34(36):4278-84. doi: 10.1016/j.vaccine.2016.07.009. Epub 2016 Jul 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
716
March 2014
February 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
13 Months to 15 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01506193
115555
2011-001608-37 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP