Study in Children to Evaluate Non-Inferiority and Persistence up to 5 Years of GSK Bio Meningococcal Vaccine 134612 - Full Text View

Purpose

This study has 2 phases, a vaccination phase and a long-term follow-up phase. In the vaccination phase of this study, the new meningococcal vaccine 134612 will be evaluated in children using Mencevax™ ACWY (in children above 2 years) or Meningitec™ (in children below 2 years) as controls. In the long-term follow-up phase of the study, the long-term protection offered by the vaccines will be assessed up to 5 years after vaccination.

Subjects will be randomized in the primary vaccination phase of the study; no new subjects will be enrolled during the long-term follow-up phase of the study.

Condition	Intervention	Phase
Healthy	Biological: meningococcal vaccine 134612 Biological: Mencevax™ ACWY Biological: Meningitec™	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Evaluate Non-Inferiority and Persistence of the Immune Response of GSK Biologicals' Meningococcal Vaccine 134612 Versus Meningitec™ or Mencevax™ ACWY in Healthy Subjects (1-10 Years of Age)

Resource links provided by NLM:

Drug Information available for: Meningococcal Vaccines

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Vaccine response to meningococcal antigens for subjects of 2 years and above [ Time Frame: One month post vaccination ] [ Designated as safety issue: No ]
Meningococcal rSBA titres for subjects below two years of age [ Time Frame: Prior to and one month after vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Meningococcal rSBA titres in all evaluable subjects [ Time Frame: Prior to, one month and 1, 2, 3, 4, & 5 years after vaccination. ] [ Designated as safety issue: No ]
Anti-meningococcal polysaccharide concentrations in all evaluable subjects [ Time Frame: Prior to, one month and 1, 2, 3, 4, & 5 years after vaccination. ] [ Designated as safety issue: No ]
Anti-tetanus toxoid seroprotection and antibody concentrations [ Time Frame: Prior to and one month after vaccination ] [ Designated as safety issue: No ]
Meningococcal hSBA titres in subjects below two years of age [ Time Frame: Prior to and one month after vaccination and 1, 2, 3, 4, and 5 years after vaccination ] [ Designated as safety issue: No ]
Occurrence of solicited local and general symptoms [ Time Frame: During the 4-day follow-up period after vaccination ] [ Designated as safety issue: No ]
Occurrence of unsolicited symptoms [ Time Frame: Up to one month after vaccination ] [ Designated as safety issue: No ]
Occurrence of serious adverse events (including meningococcal diseases) [ Time Frame: Up to six months after vaccination ] [ Designated as safety issue: No ]
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 and any events related to lack of vaccine efficacy [ Time Frame: Up to six months after vaccination ] [ Designated as safety issue: No ]
Occurrence of serious adverse events related to vaccination and any event related to lack of vaccine efficacy (i.e. meningococcal disease) [ Time Frame: From 6 months up to five years after vaccination ] [ Designated as safety issue: No ]

Enrollment:	612
Study Start Date:	February 2007
Study Completion Date:	May 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group A All subjects received GSK Biolgicals' meningococcal vaccine 134612.	Biological: meningococcal vaccine 134612 One intramuscular dose.
Active Comparator: Group B Subjects including and above two years of age received Mencevax™ ACWY, subjects below two years of age received Meningitec™.	Biological: Mencevax™ ACWY One subcutaneous dose. Biological: Meningitec™ One intramuscular dose.

Detailed Description:

Subjects will be enrolled in 3 age strata. Subjects including and above two years of age will receive either GSK Biologicals meningococcal vaccine 134612 or Mencevax™ ACWY, subjects below two years of age will receive either GSK Biologicals meningococcal vaccine 134612 or Meningitec™. All subjects will have 7 blood samples taken: prior and one month after vaccination and one, two, three, four and five years after vaccination.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.

Eligibility

Ages Eligible for Study:	1 Year to 10 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects who the investigator believes that their parent or guardian can and will comply with the requirements of the protocol.
A male or female between, and including, 1 through 10 years of age at the time of 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 his/her parents/guardians' knowledge.

Exclusion Criteria:

For the primary phase:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the 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 of the dose of vaccine(s).
Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W, and/or Y (for subjects below 6 years) or within the last five previous years (for subjects 6 years old or above).
Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W, and/or Y.
Previous vaccination with tetanus toxoid containing vaccine within the last 28 days.
History of meningococcal disease due to serogroup A, C, W, or Y.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
A family history of congenital or hereditary immunodeficiency.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Major congenital defects or serious chronic illness.
History of any neurologic disorders or seizures.
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.

For the long term persistence phase:

History of meningococcal serogroup A, C, W, and/or Y disease.
Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine not planned in the protocol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00427908

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00427908 History of Changes
Other Study ID Numbers:	108658, 108660 (Y1), 108661 (Y2), 108663 (Y3), 108665 (Y4), 108668 (Y5)
Study First Received:	January 26, 2007
Last Updated:	March 28, 2013
Health Authority:	Finland: Ministry of Social Affairs and Health

Keywords provided by GlaxoSmithKline:

Meningococcal serogroups A, C, W-135 and/or Y diseases
Conjugate vaccine
Immunogenicity

Meningococcal vaccine
Persistence
Non-inferiority

ClinicalTrials.gov processed this record on June 13, 2013