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
  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, Wyeth Vaccines) 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 Biologicals Live Attenuated Measles Mumps Rubella Varicella Vaccine (PriorixTetra™) When Co-administered With Conjugated MenC Vaccine (Meningitec, Wyeth Vaccines) in Healthy Children

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 716
Study Start Date: February 2012
Study Completion Date: March 2014
Primary Completion Date: March 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
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

No publications provided

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: June 12, 2014
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
Herpes Zoster
Chickenpox
Rubella
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Rubivirus Infections
Togaviridae Infections

ClinicalTrials.gov processed this record on October 01, 2014