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: June 12, 2014
Last verified: June 2014

January 5, 2012
June 12, 2014
February 2012
March 2014   (final data collection date for primary outcome measure)
  • Immunogenicity with respect to the components of MMRV when administered concomitantly with MenC as compared to MMRV alone [ Time Frame: 42 days after vaccination ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of MMRV when administered concomitantly with MenC as compared to MMRV alone. [ Time Frame: 42 days after vaccination ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01506193 on ClinicalTrials.gov Archive Site
  • Immunogenicity with respect to the components of MMRV when administered concomitantly with MenC as compared to MMRV alone [ Time Frame: 42 days after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of solicited local symptoms [ Time Frame: Within 4 days after each vaccination (Day 0-3) ] [ Designated as safety issue: No ]
  • Occurrence of solicited general symptoms [ Time Frame: Within 43 days after vaccination (Day 0 - 42) ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited symptoms [ Time Frame: Within 43 days after each vaccination (Day 0-42) ] [ Designated as safety issue: No ]
  • Occurrence of Serious Adverse Events (SAEs) [ Time Frame: Throughout the study (from Day 0 to approximately Month 4) ] [ Designated as safety issue: No ]
Same as current
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 Biologicals Live Attenuated Measles Mumps Rubella Varicella Vaccine (PriorixTetra™) When Co-administered With Conjugated MenC Vaccine (Meningitec, Wyeth Vaccines) 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, Wyeth Vaccines) in healthy children.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
716
March 2014
March 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.
Both
13 Months to 15 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01506193
115555, 2011-001608-37
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2014

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