Vaccines, Bacterial and viral vaccines combined
Conditions
Interventions
Trade Name: Hexyon®
Product Name: Hexyon
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: Hexyon
Sponsors
Fundación Instituto Hispalense de Pediatría
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Preterm infants born between 24 (+0 days) – 36 (+6 days) weeks (42-90 days) (mean gestational age ± standard deviation, 31.05 ± 3.45 weeks) of gestation. • Subjects whose parents or legal guardians be able and wish to comply with all protocol requirements. - Male or female children 6 to 12 (42-90 days) weeks of age at first vaccine. - Written informed consent provided by the patient’s parents or legal guardians. - Healthy subjects according the investigator criteria prior to the enrolling in the trial. Are the trial subjects under 18? yes Number of subjects for this age range: 140 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: • Foster children (male or female) • Receipt of any investigational product (drug or vaccine) within 30 days before the first dose of study vaccine or planned during the trial period. • Prolonged administration (defined as a total period of over 14 days) of immunosuppressive or other immunomodulatory drugs since the birth. In case of corticoids, this implies = 0.5 mg/kg/day prednisone dose or equivalent. Inhaled or topic steroids will be allowed. • During the study period, simultaneous participation in another trial in which the subject have received or will be expected to receive investigational or non experimental product (pharmaceutical product or medical device). • Taking in account the clinical history and physical exam, any known or suspected status of immunosuppression or immunodeficiency. • Family history of congenital or inherited immunodeficiency. • History of reaction or hypersensibility probably exacerbated by any of the vaccine components. • Major congenital defects or serious chronic diseases, including Kawasaki syndrome. • History of severe neurologic damage or seizures, including both disorders and episodes of hypotension or hypo-responsiveness, encephalopathies or any type of convulsions (febrile and afebrile). • Episode of apnea (cessation of respiration > 20s) within 7 days before vaccination. • Acute disease and/or fever at recruitment in the study. ? Fever is defined as a temperature = 37.5ºC (oral or axial temperature) or = 38.0º C (rectal temperature). ? Subjects with mild diseases (such us mild diarrhea or mild upper respiratory tract infection) without fever could be recruited at physician discretion. • History of any immunoglobulin therapy and/or blood product since the birth or scheduled administration during the trial. • History of diphtheria, tetanus, pertussis, hepatitis B, polio and Hib vaccination or disease. • Any disease which in the opinion of the investigator would interfere with the evaluation of the objectives of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Immunologic response of DTaP-IPV-HB-Hib vaccine (licensed in Spain as Hexyon®) (Sanofi Pasteur) vaccine in preterm infants. All antibody determinations will be performed at the Sanofi Pasteur Global Clinical Immunology (GCI) platform using qualified assays. ;Secondary Objective: Reactogenicity and safety of Hexyon® vaccine in preterm infants.; Primary end point(s): Proportion of preterm infants who develop seroprotection/vaccine response (SP/VR) against all vaccine antigens 30 days after the second dose (month 5) and 30 days after the end of vaccination (month 12). Estimation of the confidence interval (95%) of the proportion of preterm infants who present immune response for the following antibodies 30 days after the second dose (month 5), the day of the third dose (month 11) and 30 days after the end of the vaccination (month 12) • Anti-diphteria- Diphteria toxoid antigen, D • Anti tetanus- Tetanus toxoid antigen, T • Anti-PT (target disease Pertussis)- pertussis toxoid antigen • Anti- FHA (target disease Pertussis)- filamentous hemagglutinin • Anti-polio virus o Type 1 (Mahoney) - D antigen of the poliovirus (PV) serotype 1 o Type 2 (MEF-1)- D antigen of the poliovirus (PV) serotype 1 o Type 3 (Saukett) - D antigen of the poliovirus (PV) serotype 1 • Anti hepatitis B- Hepatitis B surface antigen, HBsAg • Anti-PRP (target disease, Invasive H. influenza disease)- polyribosylribitol phosphate ;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Reactogenicity of Hexyon® vaccine will be evaluated by measuring the proportion of subjects with: o Solicited adverse events (AEs) during a follow-up period of 8 days (days 0 to 7) after each vaccination. • Safety of Hexyon® vaccine will be evaluated by measuring the proportion of subjects with: o AEs spontaneously reported by the vaccines during a follow-up period of 31 days (days 0 to 30) after each vaccination. o Serious adverse events (SAEs) during the total study period ;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Spain
Contacts
Public ContactDr. Ignacio Salamanca
Fundación Instituto Hispalense de Pediatría
Outcome results
None listed