Study in Children to Evaluate the Immunogenicity and Safety of 4 Formulations of GSK Bio MenACWY-TT Conjugate Vaccine - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00126984

Purpose

The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy children aged 12 14 months and 3 5 years. The selection of the best formulation will be based on data obtained up to one month after the vaccine dose. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.

Condition	Intervention	Phase
Meningitis, Meningococcal	Biological: Conjugated meningococcal ACWY-TT (vaccine) Biological: DTPa/Hib containing vaccine Biological: Meningitec Biological: Mencevax ACWY	Phase II

MedlinePlus related topics: Meningitis

Drug Information available for: Meningococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Phase II, Dose-Range Study to Evaluate the Immunogenicity, Reactogenicity & Safety of 4 Formulations of GSK Biologicals' New MenACWY-TT Conjugate Vaccine vs MENINGITEC™ or MENCEVAX™ ACWY Given to Children (12 to 14 Mths & 3 to 5 Yrs Old)

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Percentage of meningococcal rSBA responders, in all subjects [ Time Frame: One month after the first vaccine dose ]

Secondary Outcome Measures:

Meningococcal rSBA titres [ Time Frame: Prior to & 1 month after the 1st dose in all subjects and 15 months after priming in all subjects of groups C and E and one month after administration of the Mencevax ACWY booster dose in all subjects who received the booster dose ]
Anti-meningococcal polysaccharide concentrations [ Time Frame: Prior to & 1 month after the 1st dose in all subjects and 15 months after priming in all subjects of groups C and E and one month after administration of the Mencevax ACWY booster dose in all subjects who received the booster dose ]
Anti-tetanus toxoid seropositivity and antibody concentrations [ Time Frame: Prior to and one month after administration of the first vaccine dose, in all subjects ]
Meningococcal hSBA titers [ Time Frame: Prior to & 1 month after the 1st dose and 15 months after priming in all subjects of groups C and E and one month after administration of the Mencevax ACWY booster dose in all subjects who received the booster dose ]
Occurrence of local and general solicited adverse events [ Time Frame: During the 8-day follow-up period following the administration of each vaccine dose. ]
Occurrence of unsolicited adverse events [ Time Frame: During the 31-day follow-up period following the administration of each vaccine dose. ]
Occurrence of any serious adverse events [ Time Frame: Throughout the study ]

Enrollment:	508
Study Start Date:	July 2005
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Experimental Subjects of 12-14 months of age or 3-5 years of age who will receive formulation A	Biological: Conjugated meningococcal ACWY-TT (vaccine) One intramuscular dose during the primary vaccination Biological: DTPa/Hib containing vaccine One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age
Group B: Experimental Subjects of 12-14 months of age or 3-5 years of age who will receive formulation B	Biological: Conjugated meningococcal ACWY-TT (vaccine) One intramuscular dose during the primary vaccination Biological: DTPa/Hib containing vaccine One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age
Group C: Experimental Subjects of 12-14 months of age or 3-5 years of age who will receive formulation C	Biological: Conjugated meningococcal ACWY-TT (vaccine) One intramuscular dose during the primary vaccination Biological: DTPa/Hib containing vaccine One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age Biological: Mencevax ACWY One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (group E) and subcutaneous administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (group C, group E)
Group D: Experimental Subjects of 12-14 months of age or 3-5 years of age who will receive formulation D	Biological: Conjugated meningococcal ACWY-TT (vaccine) One intramuscular dose during the primary vaccination Biological: DTPa/Hib containing vaccine One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age
Group E: Active Comparator Subjects of 12-14 months of age who will receive Meningitec and subjects of 3-5 years of age who will receive Mencevax ACWY.	Biological: DTPa/Hib containing vaccine One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age Biological: Meningitec One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age Biological: Mencevax ACWY One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (group E) and subcutaneous administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (group C, group E)

Detailed Description:

The study will enrol subjects of 12 to 14 months of age and subjects of 3 to 5 years of age. Meningitec™ or Mencevax™ ACWY vaccine will serve as active control. The study will be conducted in two stages: The primary vaccination phase (Study Stage 1) of the study will include all subjects; the second (booster/persistence) phase of the study (Study Stage 2) will include subjects in the active control groups and in the group which was primed with the selected MenACWY formulation.

Eligibility

Ages Eligible for Study:	12 Months to 14 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 14 months or 3 and 5 years of age at the time of the first 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. For pertussis vaccination, the children aged 12-14 months should have been vaccinated with an acellular pertussis vaccine.

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 first vaccine dose.
Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the first dose of vaccine and up to one month after administration of each study vaccine dose with the exception of oral polio vaccine.
Previous vaccination against meningococcal serogroup A, C, W-135 or Y disease.
Administration of a H. influenzae type b, diphtheria or tetanus vaccine within 3 months before the first dose of vaccine.
For subjects aged 12-14 months at enrolment, a DTPa/Hib containing booster vaccination, in the second year of life: these booster vaccines will be given at Visit 2.
History of meningococcal serogroup A, C, W-135 or Y disease.
Known exposure to meningococcal serogroup A, C, W-135 or Y disease within the previous year.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00126984

Locations

Austria

Wien, Austria
Germany

Berlin, Germany

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK Biologicals ( Isabelle Harpigny )
Study ID Numbers:	104703 (Primary study), 104704 (Booster study)
Study First Received:	August 4, 2005
Last Updated:	July 17, 2008
ClinicalTrials.gov Identifier:	NCT00126984
Health Authority:	Australia: Human Research Ethics Committee

Keywords provided by GlaxoSmithKline:

Meningococcal vaccine
Conjugate vaccine
Immunogenicity

Safety
Reactogenicity
Dose selection

Study placed in the following topic categories:

Bacterial Infections
Central Nervous System Infections
Meningococcal Infections
Meningitis, Bacterial
Meningitis, Meningococcal

Central Nervous System Diseases
Meningococcal infection
Gram-Negative Bacterial Infections
Neisseriaceae Infections
Meningitis

Additional relevant MeSH terms:

Nervous System Diseases
Central Nervous System Bacterial Infections

ClinicalTrials.gov processed this record on January 16, 2009