Booster vaccination against Streptococcus pneumoniae in children 12 to 18 months old.
Conditions
Interventions
Product Name: 10 valent streptococcus pneumoniae conjugate vaccine
Product Code: 10Pn-PD-DiT
Pharmaceutical Form: Suspension for injection
Concentration unit: µg/ml microgram(s)/millilitre
Concentrati
-DT:9
TT:14
Trade Name: Infanrix Hexa
Product Name: DTPa-IPV-HBV/Hib
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Diphtheria Toxoid
Concentration unit: IU/ml in
3:64DU/ml
INN or Proposed INN: Haemophilus type B conjugated to tetanus toxoid (TT)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: Hib:20-TT:40-80
T
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects must satisfy the following criteria at study entry: • Male or female between, and including, 12-18 months of age at the time of vaccination. • Subjects who previously participated in the study 10PN-PD-DIT-001 and received at least one dose of pneumococcal conjugate vaccine during the primary study. • 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 visit). • Written informed consent obtained from the parent or guardian of the subject. • Free of obvious health problems as established by medical history and clinical examination before entering into the study. Specific for France: A subject will be eligible for inclusion in this study if he /her is either affiliated to or beneficiary of a social security category. It is the investigator’s responsibility to ensure and to document (in source document - patient notes) that the patient is either affiliated to or beneficiary of a social security category. 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: The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study: • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the entire study period (active phase and extended safety follow-up). • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the dose of vaccine(s). (For corticosteroids, this will mean prednisone, or equivalent, = 0.5 mg/kg/day. Inhaled and topical steroids are allowed.) • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before the dose of vaccine(s) up to Visit 2. • Administration of any additional pneumococcal vaccine or DTPa-combined vaccine since end of 10PN-PD-DIT-001 study. • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required). • A family history of congenital or hereditary immunodeficiency. • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. • Major congenital defects or serious chronic illness. • History of seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included) or progressive neurological disease. • Administration of immunoglobulins and/or any blood products since birth or planned administration during the active phase of the study. • Anaphylactic reaction following the administration of vaccine(s). • 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 or mild upper respiratory infections with or without low-grade fever, i.e oral/axillary/tympanic temperature <37.5°C / rectal temperature <38.0°C). • Febrile illness defined as oral, axillary or tympanic temperature =37.5°C, rectal temperature =38.0°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject. Prevenar Absolute contraindications: • Hypersensitivity to any component of the vaccine, including diphtheria toxoid. Precautions: Precautions include ‘moderate to severe illness, with or without fever is a reason to defer routine immunization with most vaccines’. The decision to delay vaccination depends on the severity and aetiology of the underlying disease. DTPa-HBV-IPV/Hib vaccine The following adverse events constitute absolute contraindications to administration of DTPa-HBV-IPV/Hib; if any of these adverse events occur during the study, the investigator must decide which vaccine to give to the subject for these antigens: • DTPa-HBV-IPV/Hib should not be administered to subjects with known hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B, polio and Hib vaccines or to any component of the vaccines. • DTPa-HBV-IPV/Hib are contra-indicated if the infant has experienced an encephalopathy, defined as an acute, severe central nervous system disorder occurring within 7 days following pertussis vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To demonstrate that a booster dose of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine is non-inferior to Prevenar, both co-administered with DTPa-HBV-IPV/Hib vaccine, in terms of post-immunization febrile reactions with rectal fever > 39.0°C. Criteria for safety: Non-inferiority will be demonstrated if the upper limit of the 95% CI of the difference (10Pn-10Pn group minus 7Pn-7Pn group), in terms of percentage of subjects with rectal fever >39.0°C, is lower than 10%. ;Secondary Objective: • To assess the safety, reactogenicity and immunogenicity of a booster dose of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine, when co-administered with DTPa-HBV-IPV/Hib vaccine at 12-18 months of age. • To assess the immunogenicity of a booster dose of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine following a 3-dose primary vaccination with Prevenar co-administered with DTPa-HBV-IPV/Hib vaccine. • To assess the antibody persistence induced by GSK Biologicals’ 10-valent pneumococcal conjugate vaccine or Prevenar, 8-14 months after completion of the 3-dose immunization course in study 10PN-PD-DIT-001. • To assess the immunogenicity, safety and reactogenicity of a booster dose of DTPa-HBV-IPV/Hib vaccine when co-administered with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine or Prevenar at 12-18 months of age. ;Primary end point(s): Safety • Occurrence of rectal fever >39.0°C within 4 days (day 0-day 3) after the booster vaccination. | — |
Countries
Finland, France
Outcome results
None listed