Safety and reactogenicity of GSK Biologicals’ DTPa-IPV/Hib (Infanrix-IPV/Hib) in infants.

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 50

Inclusion Criteria

•A male or female infant between, and including, 60 and 90 days of age at the time of the first study visit.
•Born after a gestation period of 36 to 42 weeks inclusive.
•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.
•Written informed consent obtained from the parent or guardian of the subject.
•Healthy subjects 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: 50
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

•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 study period.
•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, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
•Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
•Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of hepatitis B vaccine.
•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).
•Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis and/or Hib disease.
•Previous vaccination against diphtheria, tetanus, pertussis, poliovirus and/or Haemophilus influenzae type b diseases.
•History of seizures or progressive neurological disease.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
•Major congenital defects or serious chronic illness.
The following condition is temporary or self-limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:
•Current febrile illness or axillary temperature > 37.0 ºC or other moderate to severe illness within 24 hours of study vaccine administration.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the safety and reactogenicity of the study vaccine administered as a three-dose primary vaccination course.;Secondary Objective: Not applicable.;Primary end point(s): Safety and reactogenicity after each vaccine dose:<br>•Occurrence of solicited local and general symptoms.<br>•Occurrence of unsolicited symptoms.<br>•Occurrence of serious adverse events (SAEs).<br>;Timepoint(s) of evaluation of this end point: •Occurrence of solicited local and general symptoms-During the 4-day (Day 0-Day 3) follow-up period following each dose of the study vaccine.<br>•Occurrence of unsolicited symptoms-During the 31-day (Day 0-Day 30) follow-up period following each dose of the study vaccine.<br>•Occurrence of serious adverse events (SAEs)-during the whole study period<br>

Secondary Outcome Measures