Safety & Immunogenicity of 1 Dose of GSK134612 in Children 12-14 Mths and 3-5 Yrs Old - Full Text View

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, Sep 2007.

Condition	Intervention	Phase
Meningococcal Serogroup Diseases	Biological: Conjugated meningococcal ACWY-TT (vaccine) Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib) Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) Biological: Meningitec™ Biological: Mencevax™ACWY	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Caregiver) Primary Purpose: Prevention
Official Title:	Evaluate the Immunogenicity, Reactogenicity, Safety of 4 Different Formulations of GSK Biologicals' Conjugate Vaccine (MenACWY) vs 1 Dose of MenC-CRM197 or Mencevax™ ACWY in Children Aged 12-14 m & 3-5 y

Resource links provided by NLM:

Drug Information available for: Boostrix Adacel

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Percentage of meningococcal SBA responders, in all subjects [ Time Frame: One month after the first vaccine dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Meningococcal SBA titres [ Time Frame: Prior to & 1 mth after the 1st dose, in all subjects; & 12 mths after priming, in all subjects of Group E & the group with the selected MenACWY-TT formulation; & 1 mth after the admin of the booster dose, in subjects who receive the booster dose ] [ Designated as safety issue: No ]
Anti-meningococcal polysaccharide concentrations [ Time Frame: Prior to & 1 mth after the 1st dose, in all subjects; & 12 mths after priming, in all subjects of Group E & the group with the selected MenACWY-TT formulation; & 1 mth after the admin of the booster dose, in subjects who receive the booster dose ] [ Designated as safety issue: No ]
Anti-tetanus toxoid seropositivity and antibody concentrations [ Time Frame: Prior to & one month after the first vaccine dose, in all subjects ] [ Designated as safety issue: No ]
Occurrence of local and general solicited adverse events [ Time Frame: During the 8-day follow-up period following administration of each vaccine dose ] [ Designated as safety issue: No ]
Occurrence of unsolicited adverse events [ Time Frame: During the 31-day follow-up period following administration of each vaccine dose ] [ Designated as safety issue: No ]
Occurrence of any serious adverse events [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Enrollment:	461
Study Start Date:	March 2005
Study Completion Date:	February 2007
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group A 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-IPV/Hib vaccine (Infanrix™-IPV/Hib) One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only Biological: Mencevax™ACWY One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (Group E) and intramuscular administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (Groups A and E)
Experimental: Group B 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-IPV/Hib vaccine (Infanrix™-IPV/Hib) One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only
Experimental: Group C 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-IPV/Hib vaccine (Infanrix™-IPV/Hib) One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only
Experimental: Group D 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-IPV/Hib vaccine (Infanrix™-IPV/Hib) One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only
Active Comparator: Group E Subjects of 12-14 months of age who will receive MenC-CRM197 and subjects of 3-5 years of age who will receive Mencevax™ ACWY	Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib) One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only Biological: Meningitec™ One intramuscular dose during the primary vaccination study in subjects of 12-24 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 intramuscular administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (Groups A and E)

Detailed Description:

The study will enrol subjects of 12 to 14 months of age and subjects of 3 to 5 years of age. 3 formulations of GSK's MenACWY conjugate vaccine will be administered in a double-blind manner, while the 4th one will be single-blinded. Administration of the candidate vaccine or the active controls (MenC-CRM197 or Mencevax™ ACWY) will be done in an open manner. 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.

The study will be conducted in a double-blind manner for groups receiving formulations A, B, C and in single blind manner with respect to the group receiving formulation D. The control vaccines will be administered in an open manner with respect to the investigational vaccination regimens.

Each group will have one blood sample prior to and one blood sample one month after the first vaccine dose.

Eligibility

Ages Eligible for Study:	12 Months to 60 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 (OPV).
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:
- For Austria: DTPa-HBV-IPV/Hib booster vaccination in the second year of life: these booster vaccines will be given at Visit 2.
- For Greece: DTPa-IPV/Hib 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: NCT00196976

Locations

Austria
GSK Investigational Site
Eferding, Austria, A-4070
GSK Investigational Site
Salzburg, Austria, A-5020
GSK Investigational Site
Vienna, Austria, A-1020
GSK Investigational Site
Villach, Austria, A-9500
GSK Investigational Site
Wels, Austria, A-4600
Greece
GSK Investigational Site
Athens, Greece, 11527
GSK Investigational Site
Ioannina, Greece, 452 21
GSK Investigational Site
Komotini, Greece, 69100
GSK Investigational Site
Koufalia, Greece, 571 00
GSK Investigational Site
Markopoulo, Greece, 19003
GSK Investigational Site
N. Efkarpia, Thessaloniki, Greece, 564 29
GSK Investigational Site
Nea Makri, Greece, 19005
GSK Investigational Site
Rio/Patras, Greece, 26500
GSK Investigational Site
Thessaloniki, Greece, 54636
GSK Investigational Site
Tripolis, Greece, 22100

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00196976 History of Changes
Other Study ID Numbers:	103533, 103534
Study First Received:	September 13, 2005
Last Updated:	November 3, 2011
Health Authority:	Austria: BMGF, Bundesministerium für Gesundheit und Frauen

Keywords provided by GlaxoSmithKline:

Safety
Meningococcal vaccine
Dose selection
Toddlers

Immunogenicity
Conjugate vaccine
Reactogenicity
Children

Additional relevant MeSH terms:

Pentetic Acid
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Antidotes
Protective Agents
Physiological Effects of Drugs
Iron Chelating Agents

ClinicalTrials.gov processed this record on May 23, 2013