Immunogenicity and Safety of GlaxoSmithKline Biologicals' Infanrix™-IPV+Hib Vaccine

GlaxoSmithKline454 enrolled

Overview

This study is designed to evaluate the safety and immunogenicity of Infanrix™-IPV+Hib vaccine when administered as a primary vaccination course to healthy Korean infants at 2, 4 and 6 months of age.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

454

Conditions

Poliomyelitis Tetanus Acellular Pertussis Diphtheria Haemophilus Influenzae Type b

Interventions

Infanrix™-IPV+HibBIOLOGICAL

Intramuscular, 3 doses

Infanrix™ IPVBIOLOGICAL

Intramuscular, 3 doses

Hiberix™BIOLOGICAL

Intramuscular, 3 doses

Synflorix™

Eligibility

Sex: ALLMin age: 42 DaysMax age: 69 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * A male or female between, and including, 42 and 69 days of age at the time of the first vaccination. * Born after a gestation period of 37 to 42 weeks inclusive. * Subjects who the investigator believes that 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: * Child in care. * Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs since birth. * Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, with the exception of hepatitis B and Bacillus Calmette-Guérin vaccination; or planned administration during the study period, with the exception of hepatitis B and influenza vaccines, which will be allowed at least 7 days before or 30 days after the administration of the DTPa vaccine. * 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. * Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis and Hib vaccination or disease. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * Family history of congenital or hereditary immunodeficiency. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). * Major congenital defects or serious chronic illness. * History of any neurological disorders or seizures. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * Acute disease and/or fever at the time of enrolment.

Locations (11)

GSK Investigational Site

Daegu, South Korea

GSK Investigational Site

Goyang, South Korea

GSK Investigational Site

GyeongSangNam-do, South Korea

Outcomes

Primary Outcomes

Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.

A seroprotected subject was defined as a vaccinated subject who had an anti-D and anti-T antibody concentration equal to or above (≥) 0.1 international units per milliliter (IU/mL).

Time frame: At Month 5

Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3.

A seroprotected subject was defined as a vaccinated subject who had an anti-polio types 1, 2 and 3 antibody titres equal to or above (≥) 8, cut off corresponding to the effective dose for 50% of the vaccinated subjects.

Time frame: At Month 5

Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.

A seroprotected subject was defined as a vaccinated subject who had an anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).

Time frame: At Month 5

Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations.

Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 5 ELISA units per milliliter (EL.U/mL).

Time frame: At Month 5

Secondary Outcomes

Number of Seropositive Subjects for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN).

A seropositive subjects was defined as a vaccinated subjects who had an anti-PRN, anti-PT and anti-FHA antibody concentration ≥ 5 ELISA units per milliliter (EL.U/mL).

Time frame: At Month 0 and Month 5

Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations

Data from ClinicalTrials.gov

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Intramuscular, 3 doses

Rotarix™BIOLOGICAL

Oral, 2 doses

GSK Investigational Site

Jeonju Jeonbuk, South Korea

GSK Investigational Site

Seongnam-si, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Suwon City, Gyeonggi-do, South Korea

GSK Investigational Site

Uijeongbu, Gyeonggi-do, South Korea

...and 1 more locations

Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 5 EL.U/mL.

Time frame: At Month 0

Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.

A seroprotected subject was defined as a vaccinated subject who had an anti-D and anti-T antibody concentration equal to or above (≥) 0.1 international units per milliliter (IU/mL).

Time frame: At Month 0

Concentrations for Anti-D and Anti-T Antibodies.

Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.

Time frame: At Month 0 and Month 5

Number of Seroprotected Subjects Anti-poliovirus (Anti-polio) Types 1, 2 and 3.

Time frame: At Month 0

Titres for Anti-polio Types 1, 2 and 3.

Titres were expressed as geometric mean titres (GMTs). The seroprotection cut-off of the assay was 8.

Time frame: At Month 0 and Month 5

Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.

A seroprotected subject was defined as a vaccinated subject who had an anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).

Time frame: At Month 0

Concentrations of Anti-PRP Antibodies.

Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg/mL.

Time frame: At Month 0 and Month 5

Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN.

Vaccine response was defined as antibody concentration ≥ 5 EL.U/mL at post vaccination, for initially seronegative subjects, and at least maintenance of antibody concentration from pre to post-vaccination (i.e. antibody concentration at post vaccination ≥ 1 fold the pre-vaccination antibody concentration), for initially seropositive subjects.

Time frame: At Month 5

Number of Subjects With Any Solicited Local Symptoms.

Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade.

Time frame: During the 4-day (Days 0-3) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™

Number of Subjects With Any Solicited General Symptoms.

Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite and fever \[defined as tympanic temperature ≥ 37.5 degrees Celsius (°C)\]. Any = incidence of a particular symptom regardless of intensity grade.

Time frame: During the 4-day (Days 0-3) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™

Number of Subjects With Any Unsolicited Adverse Events (AEs).

Unsolicited AE covers any AE 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 = any unsolicited AE regardless of intensity or relationship to vaccination.

Time frame: During the 31-day (Days 0-30) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™

Number of Subjects With Any 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 7)