Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00879827
• Other study ID #: 217744/049
• 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

Related Conditions & MeSH terms

• Acellular Pertussis
• Diphtheria
• Hepatitis B
• Poliomyelitis
• Tetanus

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

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.