Booster vaccination against Streptococcus pneumoniae or Haemophilus influenzae in healthy infants 12 to 18 months of age who were previously primed with three doses of pneumococcal conjugate vaccine in the primary vaccination study 10PN-PD-DIT-012 (107007).
Conditions
Interventions
TT:14-DT:19
Trade Name: Prevenar
Product Name: Prevenar
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Mixture of 7 pnemococcal CRM 197 conjugate serotypes 4, 6B, 9V, 14, 18C, 19F
4:6B
Trade Name: Tritanrix HepB
Product Name: Tritanrix Hep B
Product Code: DTPw-HBV
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Diphtheria toxoid
Concentration unit: IU/ml int
-TT:~60
Trade Name: Poliorix
Product Name: Poliorix
Product Code: IPV
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Poliovirus inactivated 3 types
Concentration unit: IU/ml interna
3:64DU/ml
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects must satisfy the following criteria at study entry: • 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. • A male or female between, and including, 12-18 months of age at the time of the booster vaccination. • A male or female who previously participated in study 10PN-PD-DIT-012 (107007) and received three doses of pneumococcal conjugate vaccine. • 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. 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: • Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within one month (30 days) preceding the booster dose of study vaccines, 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 6 months prior to the booster dose of study vaccines. (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 (30 days) before the booster dose of study vaccines (Visit 1) and up to the follow-up visit (Visit 2). • Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b vaccine other than the study vaccines from study 10PN-PD-DIT-012 (107007). • History of, or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b diseases. • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. • History of seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included) or progressive neurological disease. • 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 diarrhea or mild upper respiratory infections with or without low-grade febrile illness, i.e. oral/axillary/tympanic temperature <37.5°C / rectal temperature <38.0°C). • 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. • Major congenital defects or serious chronic illness. • Administration of immunoglobulins and/or any blood products within three months preceding the booster dose of study vaccines or planned administration during the active phase of the study.
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 when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines, in terms of post-immunization booster reactions with rectal fever > 39.0°C in children at 12 to 18 months of age. Criteria for safety: Non-inferiority will be demonstrated if one can rule out an increase, in terms of percentage of subjects with rectal fever >39.0°C (10Pn-PD-DiT group as compared to Prevenar group), above 5% + half the incidence in the control group (= the null hypothesis) as shown by an one-sided P-value 39°C within 4 days (days 0 to 3) after the booster vaccination. | — |
Countries
Poland
Outcome results
None listed