Clinical trial NCT00879827: Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants
Official title: Immunogenicity and Reactogenicity of GSK Biologicals' DTPa-HBV-IPV and Hib Vaccines When Administered Concomitantly to Healthy Infants Administered as a Three-dose Primary Vaccination Course at the Age of 1.5, 3.5 and 6 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diphtheria
Poliomyelitis
Hepatitis B
Tetanus
Acellular Pertussis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-04-13
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the immune response and reactogenicity of GSK Biologicals' DTPa-HBV-IPV combined pentavalent vaccine and Hib tetanus conjugate vaccine, administered concomitantly as a three-dose primary vaccination course.


Eligibility criteria: Inclusion Criteria:

* A male or female infant between 6 and 8 weeks of age at the time of the first vaccination.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Written informed consent obtained from the parents or guardians of the subject.
* Born after a normal gestation period (between 36 and 42 weeks).

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
* Administration of chronic immunosuppressants or other immune-modifying drugs since birth or planned administration during the study.
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after.
* Previous vaccination against diphtheria, tetanus, pertussis, polio or Haemophilus influenzae type b.
* History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, polio and/or Haemophilus influenzae type b.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
* Major congenital defects
* Serious chronic illness
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Acute disease at the time of enrollment.

Primary outcomes:
measure: Anti-PT, anti-FHA and anti-PRN antibody titers.
timeFrame: One month after the 3rd dose of the primary vaccination course
measure: Anti-diphtheria toxoid and anti-tetanus toxoid antibody titers
timeFrame: One month after the 3rd dose of the primary vaccination course
measure: Anti-HBs antibody titers
timeFrame: One month after the 3rd dose of the primary vaccination course
measure: Anti-polio virus types 1, 2 and 3 antibody titers
timeFrame: One month after the 3rd dose of the primary vaccination course
measure: Anti-PRP antibody titers
timeFrame: One month after the 3rd dose of the primary vaccination course
Secondary outcomes:
measure: Occurrence of solicited adverse events
timeFrame: During the 4-day follow-up period after each dose
measure: Occurrence of unsolicited adverse events
timeFrame: During the 30-day follow-up period after each dose
measure: Occurrence of Serious Adverse Events
timeFrame: Over the course of the study
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Shao PL, Lu CY, Hsieh YC; Taiwan Infanrix-049 Study Group; Bock HL, Huang LM. Immunogenicity and reactogenicity of diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus and Haemophilus influenzae type B. J Formos Med Assoc. 2011 May;110(5):336-41. doi: 10.1016/S0929-6646(11)60050-8.