Active immunization against diphtheria, tetanus, pertussis infection caused by all known subtypes of hepatitis B virus, poliomyelitis, and invasive disease caused by Haemophilus influenzae type B (Hib) in infants.
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects’ parents/ Legally Acceptable Representatives who, in the opinion of the investigator, can and will comply, with the requirements of the protocol A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination. Born full-term. Written informed consent obtained from parents/LARs of the subject. Healthy subjects as established by medical history and clinical examination before entering into the study. Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrolment. Are the trial subjects under 18? yes Number of subjects for this age range: 585 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Child in care Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the study period. Chronic administration of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed. Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting from 30 days before the first vaccination until 30 days after Dose 3 and from 30 days before the booster Dose 4 until 30 days after booster Dose 4. Inactivated influenza and hepatitis A vaccines are allowed throughout the study. Routine administrations of vaccines are allowed from 30 days after the last dose of primary vaccination until 30 days before the booster dose and after post-booster blood sampling. Routine administration of measles-mumps-rubella vaccine, varicella, pneumococcal vaccines are allowed from 30 days after last dose of primary vaccine until 30 days be-fore booster dose and from post-booster blood sampling, as well as according to the recommended immunization schedule in US. 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 Hib, diphtheria, tetanus, pertussis, pneumo-coccal, rotavirus, poliovirus and hepatitis B diseases. Previous vaccination against Hib, diphtheria, tetanus, pertussis, pneumococcus, rotavirus and/or poliovirus; more than one previous dose of hepatitis B vaccine. 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 vaccines. Hypersensitivity to latex. Major congenital defects or serious chronic illness. History of any neurological disorders including seizures. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. History of intussusception or of any uncorrected congenital malformation of the gastrointestinal tract that would predispose the infant to intussusception. History of Severe Combined Immunodeficiency Disease. Acute disease and/or fever at the time of enrolment. Fever is defined as temperature = 38.0°C /100.4°F by any route. The preferred route for recording tempera-ture in this study will be rectal for Epoch 001 and axillary for Epoch 002. Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the non-inferiority of Infanrix hexa to Pediarix co-administered with ActHIB, in terms of antibody geometric mean concentrations (GMCs) for pertussis antigens [pertussis toxoid (PT), filamentous hemagglutinin (FHA) and pertactin (PRN)] one month after the third dose of the primary vaccination.;Secondary Objective: -To assess the immune response to Infanrix hexa, Pediarix, ActHIB, Pentacel and Engerix-B, in terms of seroprotection status, seropositivity status and concentrations or titers of antibodies one month after the third dose of the primary vaccination. -To assess the safety and reactogenicity of a 3-dose course of Infanrix hexa, of Pentacel co-administered with Engerix-B, and that of Pediarix co-administered with ActHIB. -To assess the safety and reactogenicity of all study vaccines. -To assess the immunogenicity of Infanrix hexa, Pentacel, Engerix-B, Pediarix and ActHIB, before the booster dose. -To assess the immune response to Infanrix, Hiberix, ActHIB and Pentacel, in terms of seroprotection status, seropositivity status and antibody concentrations or titers in terms of booster response for pertussis antigens following Infanrix and Pentacel, one month after the booster dose. To assess the safety and reactogenicity of booster doses of Infanrix, Hiberix, ActHIB and Pentacel.;Primary end point(s): Immunogenicity with respect to pertussis components of the study vaccines Infanrix hexa and Pediarix. Anti-PT, anti-FHA, anti-PRN antibody concentrations. ;Timepoint(s) of evaluation of this end point: One month after the third dose of the primary vaccination (Visit 4) (Epoch 001). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Epoch 001: Immunogenicity (other parameters) with respect to the pertussis component of the study vaccines Infanrix hexa, Pentacel and Pediarix. Anti-PT, anti-FHA, anti-PRN seropositivity status. Anti-PT, anti-FHA, anti-PRN antibody concentrations. Immunogenicity with respect to the other components of the study vaccines Infanrix hexa, Pediarix, ActHIB, Pentacel and Engerix-B. Anti-D, anti-T, anti-HBs, anti-poliovirus types 1, 2 and 3 and anti-PRP seroprotection status, anti-PRP anti-body concentrations = 1.0 µg/mL and antibody concentrations/titres. Solicited local and general symptoms: Occurrence of each solicited local symptom (any, = Grade 2, Grade 3 and symptoms requiring medical attention). Occurrence of each solicited general symptom (any, = Grade 2, Grade 3, symptoms requiring medical attention, related and Grade 3 related). Occurrence of unsolicited AEs, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification. Occurrence of specific adverse events, i.e., new onset chronic diseases (e.g. autoimmune disorders, asthma, type I diabetes and allergies). Occurrence of serious adverse events. Epoch 002: Immunogenicity with respect to all study vaccines: Anti-D, anti-T, anti- PT, anti-FHA and anti-PRN, anti-HBs, anti-PRP and anti-poliovirus 1, 2, 3 seroprotection / seropositivity status, anti-PRP antibody concentrations = 1 µg/mL and antibody concentrations / titres. Immunogenicity with respect to the study vaccine Pentacel: Anti-D, anti-T, anti- PT, anti-FHA and anti-PRN, anti-PRP seroprotection / seropositivity status and antibody concentrations. Anti-PT, anti-FHA and anti-PRN booster response. Anti-PRP antibody concentrations = 1 µg/mL. Anti-D and anti-T antibody concentrations = 1 IU/mL. Immunogenicity with respect to the study vaccine Infanrix: Anti-D, anti-T, anti- PT, anti-FHA and anti-PRN seroprotection/ seropositivity status and antibody concentrations. Anti-PT, anti-FHA and anti- | — |
Countries
United States
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed