Active immunization against Haemophilus influenzae type b starting from 6 weeks of age as a 3-dose primary series with a single booster dose given at 15 to 18 months
Conditions
Interventions
Trade Name: Hiberix
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: -
Current Sponsor code: Hib
Other descriptive name: HAEMOPHILUS TYPE B CONJUGATE VACCINE (TE
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects for whom the investigator believes that their parent/Legally Acceptable Representative 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. Written informed consent obtained from the subject’s parent/LAR. Healthy subjects as established by medical history and clinical examination before entering into the study. Born after a gestation period of minimum 36 weeks. 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 enrollment. Are the trial subjects under 18? yes Number of subjects for this age range: 4009 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: Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Chronic administration of immunosuppressants or other immune-modifying drugs since birth. Planned administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine and until 30 days after the booster dose. Previous vaccination against Haemophilus influenzae type b, diphtheria, tetanus, pertussis, Pneumococcus, rotavirus and/or poliovirus; more than one previous dose of hepatitis B vaccine. History of Haemophilus influenzae type b, diphtheria, tetanus, pertussis, pneumococcal, rotavirus, poliovirus, and hepatitis B diseases. Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including dry natural latex rubber. Major congenital defects or serious chronic illness. History of any neurologic disorders or seizures. Acute disease at time of enrollment. A temperature greater than or equal to this cut-off warrants deferral of the vaccination pending recovery of the subject. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. Concurrent participation in another clinical study, up to 30 days prior to study entry or 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. Child in care. History of intussusception. History of uncorrected congenital malformation of the gastrointestinal tract that would predispose the infant to intussusception. History of Severe Combined Immunodeficiency Disease (SCID).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Consistency of the immune response post-dose 3 to PRP of 3 lots of Hiberix Non-inferiority of Hiberix to ActHIB in terms of post-dose 3 anti-PRP antibody conc. >= 1.0 & 0.15 µg/mL Non-inferiority of Pediarix co-ad with Hiberix to Pediarix co-ad with ActHIB in terms of post 3 primary vac. doses of immune response to diphtheria, tetanus, PT, FHA, PRN & polio-1, 2, 3 and acceptability of polio response Non-inferiority of a 3-dose primary vac. Prevnar 13 co-ad with Hiberix vs Prevnar 13 co-ad with ActHIB of S.pneumoniae GMC(s) To rule out a 10% decrease in seroresponse to PT, FHA & PRN in subjects receiving Pediarix co-ad with Hiberix, vs subjects receiving Pediarix co-ad with ActHIB Noninferiority of a booster dose of HIberix vs a booster dose of ActHIB in terms of anti-PRP conc. =1.0 µg/mL ;Secondary Objective: mmunogenicity to PRP (antibody conc =0.15, 1.0 µg/mL.and GMCs) of 3 lots of Hiberix post 3 primary vac. doses of Immunogenicity of a 3-dose primary vac. Hiberix, of ActHIB & of Pentacel for anti-PRP conc. =0.15 µg/mL, =1.0 µg/mL, & anti-PRP GMCs Immunogenicity of of Pediarix co-ad with Hiberix of Pedi-arix co-ad with ActHIB & of Pentacel co-ad with Engerix-B to diphtheria, tetanus, PT, FHA, PRN, hepatitis B & polio-1, 2, 3. Immunogenicity ofPrevnar 13 co-ad with Hiberix, of Prevnar 13 co-ad with ActHIB, & of Prevnar 13 co-ad with Pentacel to S.pneumoniae GMCs & antibody conc. ? 0.05, 0.2,1.0 µg/mL. Safety of all vaccination regimens Immunogenicity to all vaccines administered in the booster phase ;Primary end point(s): Immunogenicity (primary read-outs) with respect to com-ponents of the study vaccines and the studied co-administered vaccines (primary vaccination epoch): -anti-PRP GMCs and anti-PRP concentration =1.0 µg/mL and >= 0.15 µg/mL. -Anti-D antibody concentration >= 0.1 IU/mL. -Anti-T antibody concentration >= 0.1 IU/mL. -Anti-PT GMCs. -Anti-FHA GMCs. -Anti-PRN GMCs. -Anti-Poliovirus 1 antibody titers >= 8. -Anti-Poliovirus 2 antibody | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: For immunogenicity endpoints of primary vaccinatio epoch: One month after the last dose of primary vaccination (Visit 4), prior to booster vaccination (Visit 5) and one month after booster vaccination (Visit 6). . For solicited local and general AEs: During a 4-day follow-up period (Day 0 to Day 3) following each vaccination. For unsolicited AEs: Within 31 days following each vaccination. For SAEs and specific AEs: From Day 0 until 6 months following the last primary dose or until receipt of the booster vaccination, whichever comes first and from booster dose until 6 months following receipt of the booster dose. ;Secondary end point(s): Immunogenicity (other parameters) with respect to the components of the study vaccines and the studied co-administered vaccines (primary vaccination epoch) -anti-PRP GMCs, anti-PRP concentrations >= 0.15 µg/mL and >=1.0 µg/mL. -Anti-D concentrations and concentrations >= 0.1 IU/mL (seroprotection). -Anti-T concentrations and concentrations >= 0.1 IU/mL (seroprotection). -Anti-PT GMCs and concentrations >=5 EL.U/mL (seropositivity). -Anti-FHA GMCs and concentrations >=5 EL.U/mL (seropositivity). -Anti-PRN GMCs and concentrations>=5 EL.U/mL (seropositivity). -Anti-poliovirus types 1, 2, and 3 antibody titers and titers>= 8 (seroprotection). -Anti-HBs concentrations and concentrations >= 10.0 mIU/mL (seroprotection) and concentrations >=3.3 mIU/mL (seropositivity). -S. pneumoniae antibody concentrations >=0.05 microgram/mL (seropositivity),>=0.2 microgram/mL and >=1.0 microgram/mL for the 13 serotypes in Prevnar 13. -Anti-PT, anti-FHA and anti-PRN seroresponse de-fined as the percentage of subjects showing a concentra-tion above a threshold that leads to 90% seroresponse in the control group. Solicited local and general symptoms (primary and booster vaccination epoch ): -Occurrence of specifically solicited local symptoms (pain, redness, and swelling at the injection site). | — |
Countries
United States
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed