Safety & Immunogenicity of 1 Dose of GSK134612 in Children 12-14 Months and 3-5 Years Old

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Infections, Meningococcal

Treatments: Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib); Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™); Biological: Meningitec™; Biological: Conjugated meningococcal ACWY-TT (vaccine); Biological: Mencevax™ACWY

Study type: Interventional

Funder types: Industry

Identifiers

NCT00196976

103534 (Other Identifier)

103533

Details and patient eligibility

About

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.

Full 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.

Enrollment: 461 patients

Sex: All

Ages: 12 to 60 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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461 participants in 14 patient groups

GSK134612A Form1 (T), Primary Group

Experimental group

Description:

Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.

Treatment:

Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib)

Biological: Mencevax™ACWY

Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)

Biological: Conjugated meningococcal ACWY-TT (vaccine)

GSK134612A Form2 (T), Primary Group

Experimental group

Description:

Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.

Treatment:

Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib)

Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)

Biological: Conjugated meningococcal ACWY-TT (vaccine)

GSK134612A Form3 (T), Primary Group

Experimental group

Description:

Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.

Treatment:

Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib)

Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)

Biological: Conjugated meningococcal ACWY-TT (vaccine)

GSK134612A Form4 (T), Primary Group

Experimental group

Description:

Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.

Treatment:

Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib)

Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)

Biological: Conjugated meningococcal ACWY-TT (vaccine)

Control (T), Primary Group

Active Comparator group

Description:

Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.

Treatment:

Biological: Meningitec™

Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib)

Biological: Mencevax™ACWY

Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)

GSK134612A Form1 (C), Primary Group

Experimental group

Description:

Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).

Treatment:

Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib)

Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)

Biological: Conjugated meningococcal ACWY-TT (vaccine)

GSK134612A Form2 (C), Primary Group

Experimental group

Description:

Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).

Treatment:

Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib)

Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)

Biological: Conjugated meningococcal ACWY-TT (vaccine)

GSK134612A Form3 (C), Primary Group

Experimental group

Description:

Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).

Treatment:

Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib)

Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)

Biological: Conjugated meningococcal ACWY-TT (vaccine)

GSK134612A Form4 (C), Primary Group

Experimental group

Description:

Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).

Treatment:

Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib)

Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)

Biological: Conjugated meningococcal ACWY-TT (vaccine)

Control (C), Primary Group

Active Comparator group

Description:

Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).

Treatment:

Biological: Mencevax™ACWY

GSK134612A Form1 (T), Booster Group

Experimental group

Description:

Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).

Treatment:

Biological: Mencevax™ACWY

Biological: Conjugated meningococcal ACWY-TT (vaccine)

Control (T), Booster Group

Active Comparator group

Description:

Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).

Treatment:

Biological: Meningitec™

Biological: Mencevax™ACWY

GSK134612A Form1 (C), Booster Group

Experimental group

Description:

Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.

Treatment:

Biological: Conjugated meningococcal ACWY-TT (vaccine)

Control (C), Booster Group

Active Comparator group

Description:

Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, did not receive any booster vaccination.

Treatment:

Biological: Meningitec™