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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

461 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-24

Study Completion Date

2006-03-03

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infections, Meningococcal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

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GSK134612A Form1 (T), Primary Group

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.

Group Type EXPERIMENTAL

Conjugated meningococcal ACWY-TT (vaccine)

Intervention Type BIOLOGICAL

One intramuscular dose during the primary vaccination

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

Intervention Type BIOLOGICAL

One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only

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

Intervention Type BIOLOGICAL

One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only

Mencevax™ACWY

Intervention Type BIOLOGICAL

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)

GSK134612A Form2 (T), Primary Group

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.

Group Type EXPERIMENTAL

Conjugated meningococcal ACWY-TT (vaccine)

Intervention Type BIOLOGICAL

One intramuscular dose during the primary vaccination

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

Intervention Type BIOLOGICAL

One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only

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

Intervention Type BIOLOGICAL

One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only

GSK134612A Form3 (T), Primary Group

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.

Group Type EXPERIMENTAL

Conjugated meningococcal ACWY-TT (vaccine)

Intervention Type BIOLOGICAL

One intramuscular dose during the primary vaccination

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

Intervention Type BIOLOGICAL

One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only

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

Intervention Type BIOLOGICAL

One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only

GSK134612A Form4 (T), Primary Group

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.

Group Type EXPERIMENTAL

Conjugated meningococcal ACWY-TT (vaccine)

Intervention Type BIOLOGICAL

One intramuscular dose during the primary vaccination

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

Intervention Type BIOLOGICAL

One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only

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

Intervention Type BIOLOGICAL

One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only

Control (T), Primary Group

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type BIOLOGICAL

One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only

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

Intervention Type BIOLOGICAL

One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only

Meningitec™

Intervention Type BIOLOGICAL

One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age

Mencevax™ACWY

Intervention Type BIOLOGICAL

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)

GSK134612A Form1 (C), Primary Group

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).

Group Type EXPERIMENTAL

Conjugated meningococcal ACWY-TT (vaccine)

Intervention Type BIOLOGICAL

One intramuscular dose during the primary vaccination

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

Intervention Type BIOLOGICAL

One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only

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

Intervention Type BIOLOGICAL

One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only

GSK134612A Form2 (C), Primary Group

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).

Group Type EXPERIMENTAL

Conjugated meningococcal ACWY-TT (vaccine)

Intervention Type BIOLOGICAL

One intramuscular dose during the primary vaccination

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

Intervention Type BIOLOGICAL

One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only

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

Intervention Type BIOLOGICAL

One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only

GSK134612A Form3 (C), Primary Group

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).

Group Type EXPERIMENTAL

Conjugated meningococcal ACWY-TT (vaccine)

Intervention Type BIOLOGICAL

One intramuscular dose during the primary vaccination

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

Intervention Type BIOLOGICAL

One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only

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

Intervention Type BIOLOGICAL

One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only

GSK134612A Form4 (C), Primary Group

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).

Group Type EXPERIMENTAL

Conjugated meningococcal ACWY-TT (vaccine)

Intervention Type BIOLOGICAL

One intramuscular dose during the primary vaccination

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

Intervention Type BIOLOGICAL

One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only

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

Intervention Type BIOLOGICAL

One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only

Control (C), Primary Group

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).

Group Type ACTIVE_COMPARATOR

Mencevax™ACWY

Intervention Type BIOLOGICAL

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)

GSK134612A Form1 (T), Booster Group

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).

Group Type EXPERIMENTAL

Conjugated meningococcal ACWY-TT (vaccine)

Intervention Type BIOLOGICAL

One intramuscular dose during the primary vaccination

Mencevax™ACWY

Intervention Type BIOLOGICAL

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)

Control (T), Booster Group

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).

Group Type ACTIVE_COMPARATOR

Meningitec™

Intervention Type BIOLOGICAL

One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age

Mencevax™ACWY

Intervention Type BIOLOGICAL

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)

GSK134612A Form1 (C), Booster Group

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.

Group Type EXPERIMENTAL

Conjugated meningococcal ACWY-TT (vaccine)

Intervention Type BIOLOGICAL

One intramuscular dose during the primary vaccination

Control (C), Booster Group

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.

Group Type ACTIVE_COMPARATOR

Meningitec™

Intervention Type BIOLOGICAL

One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age

Interventions

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Conjugated meningococcal ACWY-TT (vaccine)

One intramuscular dose during the primary vaccination

Intervention Type 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

Intervention Type 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

Intervention Type BIOLOGICAL

Meningitec™

One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age

Intervention Type 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)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

12 Months

Maximum Eligible Age

60 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Eferding, , Austria

Site Status

GSK Investigational Site

Graz, , Austria

Site Status

GSK Investigational Site

Salzburg, , Austria

Site Status

GSK Investigational Site

Vienna, , Austria

Site Status

GSK Investigational Site

Villach, , Austria

Site Status

GSK Investigational Site

Wels, , Austria

Site Status

GSK Investigational Site

Athens, , Greece

Site Status

GSK Investigational Site

Heraklion, Crete, , Greece

Site Status

GSK Investigational Site

Ioannina, , Greece

Site Status

GSK Investigational Site

Komotini, , Greece

Site Status

GSK Investigational Site

Koufalia, , Greece

Site Status

GSK Investigational Site

Markopoulo Mesogaias, , Greece

Site Status

GSK Investigational Site

N. Efkarpia, Thessaloniki, , Greece

Site Status

GSK Investigational Site

Nea Makri, , Greece

Site Status

GSK Investigational Site

Rio/Patras, , Greece

Site Status

GSK Investigational Site

Thessaloniki, , Greece

Site Status

GSK Investigational Site

Tripoli, , Greece

Site Status

Countries

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Austria Greece

Study Documents

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Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 103533 are summarised with study 103534 on the GSK Clinical Study Register.

View Document