Booster immunisation of healthy toddlers in the second year of life against diphtheria, tetanus, pertussis, hepatitis B, polio and Haemophilus influenzae type b.
Conditions
Interventions
Trade Name: Infanrix Hexa
Product Name: Infanrix hexa
Product Code: DTPa-HBV-IPV/Hib
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: diphtheria toxoid
Current Sponsor code: D
Other
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study. Subjects must have completed the full three-dose primary vaccination course with one of the formulations of the DTPa-HBV-IPV/Hib vaccine in primary study DTPa-HBV-IPV-116 (106786). A male or female between, and including, 16 and 20 months of age at the time of booster vaccination. Written informed consent obtained from the parent or guardian of the subject Healthy subjects as established by medical history and clinical examination before entering into the study. Are the trial subjects under 18? yes Number of subjects for this age range: 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 (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, ? 0.5 mg/kg/day. Inhaled and topical steroids are allowed). Participation in another clinical study, between the primary study DTPa-HBV-IPV-116 (106786) and the present booster study, or at any time during the study, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). Planned administration / administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the booster dose and ending 30 days after the booster dose. Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib booster vaccination or disease since the conclusion visit of study DTPa-HBV-IPV-116. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination (no laboratory testing required). History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. axillary temperature < 37.5°C. Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period. Absolute contraindications One of the following adverse events having occurred after previous administration of DTP vaccine ? Hypersensitivity reaction due to the vaccine. ? Encephalopathy defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalised or focal seizures that persist more than a few hours, with failure to recover within 24 hours. Warnings and precautions ? Fever = 40.5°C rectal temperature within 48 hours of vaccination. ? Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination. ? Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting = 3 hours Convulsions with or without fever, occurring within 3 days of vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the immunogenicty of the DSSITGDPa-HBV-IPV/Hib vaccine (preservative-free or preservative-containing), in terms of persistence of the antibodies to all vaccine antigens at the time of the booster vaccination. To assess the immunogenicity of a booster dose of DTPa-HBV-IPV/Hib vaccine given after primary vaccination with the DSSITGDPa-HBV-IPV/Hib vaccine (preservative-free or preservative-containing), in terms of response to all vaccine antigens. ;Secondary Objective: To assess the immunogenicity of the DTPa-HBV-IPV/Hib vaccine in terms of persistence of the antibodies to all vaccine antigens at the time of the booster vaccination. To assess the immunogenicity of a booster dose of DTPa-HBV-IPV/Hib vaccine given after primary vaccination with DTPa-HBV-IPV/Hib vaccine, in terms of response to all vaccine antigens. To assess the reactogenicity and safety of the DTPa-HBV-IPV/Hib vaccine given as a booster after primary vaccination with either DSSITGDPa-HBV-IPV/Hib vaccine (preservative-free or preservative-containing) or with DTPa-HBV-IPV/Hib vaccine for the primary vaccination course. ;Primary end point(s): For the DSSITGDPa-HBV-IPV/Hib groups (preservative-free or preservative containing): Immunogenicity before and one month after the booster vaccination • Seroprotection status: ? Anti-diphtheria* and anti-tetanus toxoid antibody concentrations greater than or equal to 0.1 IU/ml ? Anti-HBs antibody concentrations greater than or equal to 10 mIU/ml and greater than or equal to100 mIU/ml ? Anti-poliovirus type 1, type 2 & type 3 antibody titres greater than or equal to8 ? Anti-PRP antibody concentrations greater than or equal to 0.15µg/ml and greater than or equal to 1.0 µg/ml * Sera negative for anti-diphtheria antibodies by ELISA will be retested with the more sensitive in vitro Vero-cell assay. • Seropositivity status: ? Anti-PT, anti-FHA and anti-PRN concentrations greater than or equal to 5 El.U/ml • Anti-diphtheria and anti-tetanus toxoids | — |
Countries
Finland
Outcome results
None listed