A three-dose primary vaccination of healthy infants between 9-16 weeks (63-118 days) of age at the time of the first vaccination against Streptococcus pneumoniae.
Conditions
Interventions
Product Name: 10-valent streptococcus pneumoniae conjugate vaccine
Product Code: 10-Pn-PD-DiT
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: PS-PD for serotypes 1,4,5,6B,7F,9V,14,2
PS-DT for 19F
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: PS:32,PD:24
DT:9
Trade Name: Infanrix Hexa
Product Name: Infanrix Hexa
Product Code: DTPa-IPV-HBV/Hib
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Diphtheria Toxoid
C
2:16D-ml
3:64D/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
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects must satisfy the following criteria at study entry: Subjects who 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, 9-16 weeks (63-118 days) of age at the time of the first vaccination. 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. Born after a gestation period of minimum 36 weeks. 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: Body weight or = 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 first dose of vaccines (Visit 1) and up to Visit 4. Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception of vaccines where the first dose may be given within the first two weeks of life according to the national recommendations (for example, hepatitis B and BCG). History of , or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b disease. History of use of any experimental rotavirus vaccine(s). Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal (GI) tract, intussusception (IS) or other medical condition determined to be serious by the investigator. History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. History of seizures or neurological disease. Acute disease at the time of enrolment. (Acute disease is defined as the presence of a mild, moderate or severe illness with or without fever. 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 since birth or planned administration during the active phase of the study. Subject with any contraindication to treatment with paracetamol (e.g. known sensitivity to paracetamol or other components of the suppositories, functional impairment of the liver or kidney, Gilbert Syndrome, or current treatment with medication that interferes with paracetamol as described in the paracetamol summary of product characteristics [SPC]). The following conditions are temporary or self-limiting and a subject may be included in the study and/or vaccinated once the condition have resolved and no other exclusion criteria are met: Subject has received systemic antibiotic therapy for acute illness within 24 hours prior to the vaccination. Gastroenteritis within 7 days preceding the first study vaccine administration (warrants deferral of the vaccination). Subject is likely to receive antipyretic treatment as a result of a concomitant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the percentage reduction in febrile reactions (rectal temperature > or = 38.0°C) when prophylactic antipyretic treatment is administered compared to no prophylactic antipyretic treatment, after primary vaccination with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine and routine DTPa-HBV-IPV/Hib (Infanrix hexa) vaccination in children at 3, 4 and 5 months of age and oral live attenuated HRV (Rotarix) vaccination in children at 3 and 4 months of age.;Secondary Objective: To evaluate safety and reactogenicity after each dose of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine and DTPa-HBV-IPV/Hib vaccine when concomitantly administered, with or without prophylactic antipyretic treatment, at 3, 4 and 5 months of age and GSK Biologicals’ oral live attenuated HRV vaccine at 3 and 4 months of age. To evaluate one month post-dose three the immunogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine and the co-administered DTPa-HBV-IPV/Hib vaccine. To assess the immunogenicity of GSK Biologicals’ oral live attenuated HRV vaccine in terms of serum anti-rotavirus IgA antibody concentrations, 2 months after the second oral live attenuated HRV vaccine dose when given concomitantly with GSK Biologicals’ 10-valent pneumococcal conjugate and DTPa-HBV-IPV/Hib vaccines. Additional secondary objective included (refer protocol amendment 3) ;Primary end point(s): Occurrence of core fever > or = 38°C (rectal temperature) within 4 days (days 0 to 3) after the administration of at least one vaccination dose. | — |
Countries
Czech Republic
Outcome results
None listed