Clinical trial NCT00196976: Safety & Immunogenicity of 1 Dose of GSK134612 in Children 12-14 Months and 3-5 Years Old
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 Months & 3-5 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infections, Meningococcal
Keywords: Safety
Meningococcal vaccine
Dose selection
Toddlers
Immunogenicity
Conjugate vaccine
Reactogenicity
Children
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 461
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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.

Primary outcomes:
measure: Number of Subjects With an Immune Response to Different Meningococcal Serogroups
timeFrame: One month after the first vaccine dose (Month 1)
Secondary outcomes:
measure: Number of Seroprotected Subjects Against Different Meningococcal Serogroups
timeFrame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
measure: Number of Seropositive Subjects for Different Anti-meningococcal Serogroups
timeFrame: Prior to (Month 0) and one month after (Month 1) after the first vaccine dose
measure: Antibody Titers Against Different Meningococcal Serogroups
timeFrame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
measure: Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides
timeFrame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
measure: Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides
timeFrame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
measure: Antibody Concentrations Against Different Meningococcal Polysaccharides
timeFrame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
measure: Number of Seropositive Subjects for Anti-tetanus (Anti-T)
timeFrame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
measure: Antibody Concentrations Against Tetanus (Anti-T)
timeFrame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
measure: Number of Toddlers With Any Solicited Local Symptoms
timeFrame: During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
measure: Number of Children With Any Solicited Local Symptoms
timeFrame: During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
measure: Number of Toddlers With Any Solicited General Symptoms
timeFrame: During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
measure: Number of Children With Any Solicited General Symptoms
timeFrame: During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
measure: Number of Seroprotected Subjects Against Different Meningococcal Serogroups
timeFrame: At one month (M1) and 12 months (M12) post-primary vaccination
measure: Number of Seropositive Subjects for Different Anti-meningococcal Serogroups
timeFrame: At one month (M1) and 12 months (M12) post-primary vaccination
measure: Antibody Titers Against Different Meningococcal Serogroups
timeFrame: At one month (M1) and 12 months (M12) post-primary vaccination
measure: Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides
timeFrame: At one month (M1) and 12 months (M12) post-primary vaccination
measure: Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides
timeFrame: At one month (M1) and 12 months (M12) post primary vaccination
measure: Antibody Concentrations Against Different Meningococcal Polysaccharides
timeFrame: At one month (M1) and 12 months (M12) post-primary vaccination
measure: Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups
timeFrame: Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
measure: Antibody Titers Against Different Meningococcal Serogroups
timeFrame: Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
measure: Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides
timeFrame: Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
measure: Antibody Concentrations Against Different Meningococcal Polysaccharides
timeFrame: Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
measure: Number of Subjects With Any Solicited Local Symptoms
timeFrame: During the 8-day (Days 0-7) post-vaccination period following booster dose
measure: Number of Subjects With Any Solicited General Symptoms
timeFrame: During the 8-day (Days 0-7) post-vaccination period following booster dose
measure: Number of Subjects With Any Unsolicited Adverse Events (AEs) After the Primary Vaccination
timeFrame: Within 31 days (Days 0-30) after the primary meningococcal vaccination
measure: Number of Subjects With Any Unsolicited AEs During the Primary Vaccination
timeFrame: Within 31 days (Days 0-30) post-vaccination with diphteria, tetanus and acellular pertusis-containing vaccine, during the primary vaccination
measure: Number of Subjects With Any Unsolicited AEs
timeFrame: Within 31 days (Days 0-30) after the booster vaccination
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the primary vaccination study (from Month 0 up to Month 2)
measure: Number of Subjects With SAEs
timeFrame: Since the last study contact in the primary study up to the end of the booster study (from Month 2 up to Month 13)
Other outcomes:
Locations:
city: Eferding
country: Austria
facility: GSK Investigational Site
city: Graz
country: Austria
facility: GSK Investigational Site
city: Salzburg
country: Austria
facility: GSK Investigational Site
city: Vienna
country: Austria
facility: GSK Investigational Site
city: Villach
country: Austria
facility: GSK Investigational Site
city: Wels
country: Austria
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Heraklion, Crete
country: Greece
facility: GSK Investigational Site
city: Ioannina
country: Greece
facility: GSK Investigational Site
city: Komotini
country: Greece
facility: GSK Investigational Site
city: Koufalia
country: Greece
facility: GSK Investigational Site
city: Markopoulo
country: Greece
facility: GSK Investigational Site
city: N. Efkarpia, Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Nea Makri
country: Greece
facility: GSK Investigational Site
city: Rio/Patras
country: Greece
facility: GSK Investigational Site
city: Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Tripolis
country: Greece
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: