NCT01106092 - Study to Evaluate the Immunogenicity and Reactogenicity of a Booster Dose of GSK2036874A Vaccine in Healthy Toddlers | Crick

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 24 MonthsHealthy volunteers:

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Inclusion Criteria: * A male or female subject, between and including 12 and 24 months of age at the time of booster vaccination. * Subjects who have received three doses of polio vaccine as primary vaccination along with the routine vaccinations indicated during the first year of life. * Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative (s) can and will comply with the requirements of the protocol. * Written informed consent obtained from the parent(s)/Legally Acceptable Representative (s) of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study. Exclusion Criteria: * Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose. * Administration of a vaccine not foreseen by the study protocol within 30 days prior to booster vaccination, or planned administration during the active study period (up to Visit 2). * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * History of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or Haemophilus influenza type b diseases. * Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or H. influenzae diseases. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * A family history of congenital or hereditary immunodeficiency. * Major congenital defects or serious chronic illness. * History of neurologic disorders or seizures. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. * Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period. * Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus. * Child in care. * Occurrence of any of the following adverse events after a previous administration of a diphtheria-tetanus-pertussis vaccine: * encephalopathy of unknown aetiology occurring within seven days following previous vaccination with pertussis-containing vaccine, * fever \>= 40 °C within 48 hours of vaccination not due to another identifiable cause, * collapse or shock-like state within 48 hours of vaccination, * convulsions with or without fever, occurring within 3 days of vaccination. * Acute disease and/or fever at the time of enrolment. * Fever is defined as temperature \>= 37.5°C on oral, axillary or tympanic setting, or \>= 38.0°C on rectal setting. * Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator. * Other conditions which, in the opinion of the investigator, may potentially interfere with interpretation of study results.

Outcomes

Primary Outcomes

Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3

Seroprotection was defined as anti-polio types 1, 2 and 3 antibody titres ≥ 8 effective dose (ED50), for 50% of vaccinated subjects.

Time frame: One month after booster vaccination (At Month 1)

Anti-polio Types 1, 2 and 3 Antibody Titers

Antibody titers were presented as geometric mean titers (GMTs).

Time frame: Prior to booster vaccination (At Month 0)

Anti-polio Types 1, 2 and 3 Antibody Titers

Antibody titers were presented as geometric mean titers (GMTs).

Time frame: One month after booster vaccination (At Month 1)

Secondary Outcomes

Number of Seroconverted Subjects for Anti-polio Types 1, 2 and 3

Seroconversion was defined as: For initially seronegative subjects, antibody titer ≥ 8 ED50 one month after the booster dose. For initially seropositive subjects: antibody titer one month after the booster dose ≥ 4 fold the pre-booster antibody titer. For subjects with pre-booster antibody titer below the highest dilution tested (reciprocal \< 8192 ED50): highest dilution tested one month after the booster dose (reciprocal \> 8192 ED50).

Time frame: One month after booster vaccination (At Month 1)

Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3

Seroprotection was defined as anti-polio types 1, 2 and 3 antibody titres ≥ 8 effective dose (ED50), for 50% of vaccinated subjects.

Time frame: Prior to booster vaccination (At Month 0)

Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)

Seroprotection was defined as anti-D and anti-T antibody concentration ≥ 0.1 international units per milliliter (IU/mL).

Time frame: Prior to (At Month 0) and one month after booster vaccination (At Month 1)

Anti-D and Anti-T Antibody Concentrations

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.

Time frame: Prior to (At Month 0) and one month after booster vaccination (At Month 1)

Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs)

Seropositivity was defined as anti-HBs antibody concentration ≥ 3.3 milli-international units per milliliter (mIU/mL). Seprotection was defined as anti-HBs antibody concentration ≥ 10 mIU/mL. Note that percentage of subjects with concentration ≥ 10 mIU/mL was over-estimated due to the use of in-house assay overestimating concentrations between 10-100 mIU/mL. Accordingly GMCs were also overestimated. A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Some of the available blood samples initially tested with ELISA were re-tested using the new assay, CLIA.

Time frame: Prior to (At Month 0) and one month after the booster vaccination (At Month 1)

Anti-HBs Antibody Concentrations

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.

Time frame: Prior to (At Month 0) and one month after the booster vaccination (At Month 1)

Number of Seroprotected Subjects Against Polyribosil-ribitol-phosphate (PRP)

Seprotection was defined as anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (μg/mL).

Time frame: Prior to (At Month 0) and one month after booster vaccination (At Month 1)

Anti-PRP Antibody Concentrations

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in μg/mL.

Time frame: Prior to (At Month 0) and one month after booster vaccination (At Month 1)

Number of Seropositive Subjects for Anti-Bordetella Pertussis (Anti-BPT)

Seropositivity was defined as anti-BPT antibody concentration ≥ 15 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Time frame: Prior to (At Month 0) and one month after the booster vaccination (At Month 1)

Anti-BPT Antibody Concentrations

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.

Time frame: Prior to (At Month 0) and one month after booster vaccination (At Month 1)

Number of Subjects With a Booster Response for Anti-BPT

Booster response was defined as: For initially seronegative subjects, antibody concentration ≥ 15 EL.U/mL one month after the booster dose. For initially seropositive subjects: antibody concentration one month after the booster dose ≥ 2 fold the pre-booster antibody concentration.

Time frame: One month after booster vaccination (At Month 1)

Number of Subjects With Any Solicited Local Symptoms

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

Time frame: During the 8-day (Days 0-7) post-vaccination period

Number of Subjects With Any Solicited General Symptoms

Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade.

Time frame: During the 8-day (Days 0-7) post-vaccination period

Number of Subjects With Any Unsolicited Adverse Events (AEs)

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Time frame: During the 31-day (Day 0-Day 30) post-vaccination period

Number of Subjects With Serious Adverse Events (SAEs)

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Time frame: During the entire study period (from Month 0 to Month 1)

Study to Evaluate the Immunogenicity and Reactogenicity of a Booster Dose of GSK2036874A Vaccine in Healthy Toddlers

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes