Clinical trial NCT00964028: Safety Study of GSK Biologicals' DTPa-IPV/Hib (Infanrix™-IPV/Hib)
Official title: Safety and Reactogenicity of GSK Biologicals' DTPa-IPV/Hib (Infanrix™-IPV/Hib) in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Haemophilus Influenzae Type b
Acellular Pertussis
Diphtheria
Tetanus
Poliomyelitis
Keywords: Combined vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-08-24
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the safety and reactogenicity of Infanrix-IPV/Hib given as a three-dose primary vaccination course to healthy infants at 2-3-4 or 3-4-5 months of age.


Eligibility criteria: 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 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.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
* 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.
* 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.
* 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.

Primary outcomes:
measure: Number of Subjects With Any Solicited Local Symptoms
timeFrame: During the 4-day (Days 0-3) follow-up period after each dose and across doses
measure: Number of Subjects With Any Solicited General Symptoms
timeFrame: During the 4-day (Days 0-3) follow-up period after each dose and across doses
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: During the 31-day (Days 0-30) follow-up period after each vaccination
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the whole study period (from Day 0 until Month 3 or Month 4)
Secondary outcomes:
Other outcomes:
Locations:
city: Wuzhou
country: China
facility: GSK Investigational Site
state: Guangxi
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: