A phase IIIb randomized, open, controlled study to assess the effect of prophylactic antipyretic treatment on the rate of febrile reactions following concomitant administration of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine with GSK Biologicals’ Infanrix hexa vaccine in children at 3, 4 and 5 months of age and GSK Biologicals’ Rotarix vaccine at 3 and 4 months of age. - 10PN-PD-DIT-010
- Conditions
- 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.
- Registration Number
- EUCTR2006-000559-16-CZ
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 459
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
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 < 4500 g at the time of enrolment.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Indication, other than specified in the protocol, for prophylactic antipyretic treatment.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines 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 since birth. (For corticosteroids, this will mean prednisone, or equivalent, > 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method