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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00879827
Other study ID # 217744/049
Secondary ID
Status Completed
Phase Phase 3
First received April 9, 2009
Last updated September 6, 2016
Start date September 2000
Est. completion date May 2001

Study information

Verified date September 2016
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 2001
Est. primary completion date May 2001
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Weeks to 8 Weeks
Eligibility 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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Biological:
Pediarix TM, Infanrix penta TM
The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.
Hiberix TM
The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Anti-PT, anti-FHA and anti-PRN antibody titers. One month after the 3rd dose of the primary vaccination course No
Primary Anti-diphtheria toxoid and anti-tetanus toxoid antibody titers One month after the 3rd dose of the primary vaccination course No
Primary Anti-HBs antibody titers One month after the 3rd dose of the primary vaccination course No
Primary Anti-polio virus types 1, 2 and 3 antibody titers One month after the 3rd dose of the primary vaccination course No
Primary Anti-PRP antibody titers One month after the 3rd dose of the primary vaccination course No
Secondary Occurrence of solicited adverse events During the 4-day follow-up period after each dose No
Secondary Occurrence of unsolicited adverse events During the 30-day follow-up period after each dose No
Secondary Occurrence of Serious Adverse Events Over the course of the study No
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