A phase IIIb, open, controlled study to assess the effect of prophylactic antipyretic treatment on the rate of febrile reactions following concomitant booster administration of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine with GSK Biologicals’ Infanrix hexa vaccine in children at 12-15 months of age following a 3-dose primary vaccination in study 10PN-PD-DIT-010 (107017) and to evaluate the impact of pneumococcal vaccination on nasopharyngeal carriage compared to a pneumococcal vaccine unprimed control group receiving GSK iologicals' meningococcal serogroup ACWY conjugate vaccine. - 10PN-PD-DIT-014 BST:010
- Conditions
- A single dose booster vaccination against Streptococcus pneumoniae of healthy children between 12-15 months of age who were previously primed with three doses of GSK Biologicals’10-valent conjugate pneumococcal vaccine in the primary vaccination study 10PN-PD-DIT-010 and a first single dose vaccination against meningococcal disease due to serogroups A, C, W-135, or Y, of pneumococcal vaccine unprimed healthy children of 12-15 months of age.
- Registration Number
- EUCTR2006-001481-17-CZ
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 860
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, 12-15 months of age at the time of the booster 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.
Subjects in the primed antipyretic and primed non-antipyretic group:
•A male or female who previously participated in study 10PN-PD-DIT-010 and received three doses of pneumococcal conjugate vaccine.
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
For all subjects:
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 one month (30 days) preceding the dose of study vaccines, or planned use during the entire study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the 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 dose of study vaccines (Visit 1) and up to one month after the dose of study vaccines (Visit 2).
History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b disease.
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, 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 within three months preceding dose of study vaccines or planned administration during the study period.
Subjects of which both parents have a history of atopia (polinosis, asthma, atopic eczema).
The following conditions are temporary or self-limiting and a subject may be included in the study and/or vaccinated once the condition has resolved and no other exclusion criteria are met:
Subject has received systemic antibiotic therapy for acute illness within 24 hours prior to the vaccination.
Subject is likely to receive antipyretic treatment as a result of a concomitant illness or has been treated with paracetamol within the past 24 hours.
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.
Known hypersensitivity after previous administration of diphtheria, tetanus, pertussis, polio, hepatitis B and Hib vaccines or to any component of the vaccines.
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 than a few hours, with failure to recover within 24 hours.
As with other vaccines, administration of DTPa-HBV-IPV/Hib should be postponed in subjects suffering from acute mild, moderate or severe illness.
N.B. Contraindication to the administratio
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