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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Poliovirus; Haemophilus Influenzae Type b Disease

Intervention: Hiberix TM (Biological); Pediarix TM, Infanrix penta TM (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

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

Primary outcome:

Anti-PT, anti-FHA and anti-PRN antibody titers.

Anti-diphtheria toxoid and anti-tetanus toxoid antibody titers

Anti-HBs antibody titers

Anti-polio virus types 1, 2 and 3 antibody titers

Anti-PRP antibody titers

Secondary outcome:

Occurrence of solicited adverse events

Occurrence of unsolicited adverse events

Occurrence of Serious Adverse Events

Eligibility

Minimum age: 6 Weeks. Maximum age: 8 Weeks. Gender(s): Both.

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.

Locations and Contacts

Additional Information

Starting date: September 2000
Last updated: April 9, 2009

Page last updated: August 20, 2015

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