Clinical trial NCT01086423: Immunogenicity and Safety Study of GSK Biologicals' Infanrix-IPV+Hib™ Vaccine
Official title: Immunogenicity and Safety of GlaxoSmithKline Biologicals' DTPa-IPV/Hib (Infanrix-IPV+Hib™) in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tetanus
Poliomyelitis
Acellular Pertussis
Diphtheria
Haemophilus Influenzae Type b
Keywords: Infanrix-IPV+Hib
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-03-15
Enrollment: 985
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: The purpose of the study is to evaluate the immunogenicity and reactogenicity of Infanrix-IPV/Hib™ vaccine when administered to healthy Chinese infants at 2, 3 and 4 or 3, 4 and 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 parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
* Written informed consent obtained from the parent(s) or LAR(s) 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(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Child in care.
* 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 Haemophilus influenzae type b (Hib) disease or vaccination.
* History of seizures or progressive neurological disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
* 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°C or other moderate to severe illness within 24 hours of study vaccine administration.

Primary outcomes:
measure: Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens
timeFrame: One month after the third vaccine dose (Month 3 or Month 4)
measure: Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigen
timeFrame: One month after the third vaccine dose (Month 3 or Month 4)
measure: Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens
timeFrame: One month after the third vaccine dose (Month 3 or Month 4)
measure: Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens
timeFrame: One month after the third vaccine dose (Month 3 or Month 4)
Secondary outcomes:
measure: Anti-D and Anti-T Antibody Concentrations
timeFrame: Before the first dose (Month 0) and one month after the third dose of vaccination (Month 3 or Month 4)
measure: Anti-PRP Antibody Concentrations
timeFrame: Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)
measure: Anti-polio Types 1, 2 and 3 Antibody Titers
timeFrame: Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)
measure: Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
timeFrame: Before (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)
measure: Number of Subjects With Any Solicited Local Symptoms
timeFrame: During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses
measure: Number of Subjects With Any Solicited General Symptoms
timeFrame: During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: During the 31-day (Days 0-30) post-vaccination period after any dose
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the entire study period (from Month 0 to Month 4/5)
Other outcomes:
Locations:
city: Wuzhou
country: China
facility: GSK Investigational Site
state: Guangxi
city: Wuzhou
country: China
facility: GSK Investigational Site
state: Guangxi
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: