Safety & Immunogenicity Study of Meningococcal Vaccine GSK134612 Given With Priorix-Tetra™ to 12-23 Month-Old Children - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00474266

Purpose

The purpose of this study is to demonstrate, in 12-23 month old children, the non-inferiority of the meningococcal vaccine 134612 given with Priorix-Tetra™. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Condition	Intervention	Phase
Meningococcal Serogroup A, C, W-135, Y Diseases Measles Mumps Rubella Varicella	Biological: Meningococcal vaccine GSK134612 Biological: Meningitec™ Biological: Priorix-Tetra™	Phase III

MedlinePlus related topics: Chickenpox Measles Mumps Rubella Shingles

Drug Information available for: Measles-Mumps-Rubella Vaccine Meningococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Immunogenicity & Safety Study of GSK Biologicals' Meningococcal Vaccine GSK134612 When co-Administered With GSK Biologicals' MMRV Vaccine (Priorix-Tetra™) in Healthy 12 to 23-Month-Old Children

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Meningococcal rSBA titres [ Time Frame: 42 days after the first vaccine dose ] [ Designated as safety issue: No ]
Anti-measles seroconversion [ Time Frame: 42 days after the first vaccine dose ] [ Designated as safety issue: No ]
Anti-mumps seroconversion [ Time Frame: 42 days after the first vaccine dose ] [ Designated as safety issue: No ]
Anti-rubella seroconversion [ Time Frame: 42 days after the first vaccine dose ] [ Designated as safety issue: No ]
Anti-varicella seroconversion [ Time Frame: 42 days after the first vaccine dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Meningococcal rSBA titres [ Time Frame: Prior to and 42 days after the first vaccine dose ] [ Designated as safety issue: No ]
Anti-meningococcal polysaccharide concentrations [ Time Frame: Prior to and 42 days after the first vaccine dose ] [ Designated as safety issue: No ]
Anti-measles concentrations [ Time Frame: 42 days after the first vaccine dose, in all groups, and 42 days after the second Priorix-Tetra™ vaccine dose, in a subset (30%) of Groups A and C only ] [ Designated as safety issue: No ]
Anti-mumps concentrations [ Time Frame: 42 days after the first vaccine dose, in all groups, and 42 days after the second Priorix-Tetra™ vaccine dose, in a subset (30%) of Groups A and C only ] [ Designated as safety issue: No ]
Anti-rubella concentrations [ Time Frame: 42 days after the first vaccine dose, in all groups, and 42 days after the second Priorix-Tetra™ vaccine dose, in a subset (30%) of Groups A and C only ] [ Designated as safety issue: No ]
Anti-varicella titres [ Time Frame: 42 days after the first vaccine dose, in all groups, and 42 days after the second Priorix-Tetra™ vaccine dose, in a subset (30%) of Groups A and C only ] [ Designated as safety issue: No ]
Occurrence of solicited local and general symptoms [ Time Frame: During the 4-day follow-up period after the first vaccine dose ] [ Designated as safety issue: Yes ]
Occurrence of general symptoms specific for MMR and varicella vaccination (Priorix-Tetra™) [ Time Frame: During the 43-day follow-up period after the first vaccine dose ] [ Designated as safety issue: Yes ]
Occurrence of unsolicited symptoms [ Time Frame: During the 43-day follow-up period after the first vaccine dose ] [ Designated as safety issue: Yes ]
Occurrence of serious adverse events [ Time Frame: Throughout the whole study duration ] [ Designated as safety issue: Yes ]
Occurrence of specific adverse events of rash, new onset of chronic illness(es) and conditions prompting emergency room visits and physician office visits not related to common illnesses [ Time Frame: Throughout the whole study duration ] [ Designated as safety issue: Yes ]

Enrollment:	1000
Study Start Date:	June 2007
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group C: Active Comparator Priorix-Tetra™, followed by Meningitec™ 42 days later and the second dose of Priorix-Tetra™ 84 days later	Biological: Meningitec™ Single dose intramuscular injection Biological: Priorix-Tetra™ 2-dose subcutaneous injection
Group D: Active Comparator Meningitec™, followed by 2 doses of Priorix-Tetra™, respectively 42 and 84 days later	Biological: Meningitec™ Single dose intramuscular injection Biological: Priorix-Tetra™ 2-dose subcutaneous injection
Group B: Experimental Meningococcal vaccine GSK134612, followed by 2 doses of Priorix-Tetra™, respectively 42 and 84 days later	Biological: Meningococcal vaccine GSK134612 Single dose intramuscular injection Biological: Priorix-Tetra™ 2-dose subcutaneous injection
Group A: Experimental Meningococcal vaccine GSK134612 + Priorix-Tetra™, followed by the second dose of Priorix-Tetra™ 84 days later	Biological: Meningococcal vaccine GSK134612 Single dose intramuscular injection Biological: Priorix-Tetra™ 2-dose subcutaneous injection

Detailed Description:

Open multicentre study with 4 treatment groups. Two groups will receive the 134612 vaccine with Priorix-Tetra™ either at the same or different visits followed by a second Priorix-Tetra™ vaccination at 84 days.

Two control groups will receive Priorix-Tetra™ and Meningitec™ at different visits followed by a second Priorix-Tetra™ vaccination at 84 days.

For all subjects, two blood samples will be taken: prior to and 42 days after the first vaccination. In a subset (30% of subjects in Groups A en C) from selected study centres: additional sample 42 days after second Priorix-Tetra™ dose.

Eligibility

Ages Eligible for Study:	12 Months to 23 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
A male or female between, and including, 12 and 23 months of age at the time of the vaccination.
Written informed consent obtained from the parent or guardian of the subject.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Previously completed routine childhood vaccinations to the best of parents' or legal guardians' knowledge.

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
Planned administration/ administration of a vaccine not foreseen by the study protocol within one month before and 42 days after the first dose of vaccine(s).
Previous vaccination with meningococcal vaccine of serogroup A, C W and/or Y.
History of meningococcal disease.
Previous vaccination against measles, mumps, rubella, and/or varicella.
History of measles, mumps, rubella and/or varicella.
Known exposure to measles, mumps, rubella, varicella or zoster within 30 days prior to vaccination.
Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including neomycin.
Major congenital defects or serious chronic illness.
Acute disease at the time of enrolment.
Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474266

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	109670
Study First Received:	May 15, 2007
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00474266 History of Changes
Health Authority:	Finland: Ministry of Social Affairs and Health

Keywords provided by GlaxoSmithKline:

meningococcal vaccine
MMRV vaccine
immunogenicity
conjugate vaccine
co-administration

Study placed in the following topic categories:

Virus Diseases
Herpes Zoster
Measles
Chickenpox
DNA Virus Infections

Healthy
Rubella
Mumps
Herpesviridae Infections

Additional relevant MeSH terms:

Virus Diseases
Chickenpox
DNA Virus Infections
Herpesviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009