Immuno & Safety Study With 2 Formulations of DTPw-HBV/HIB When Given at Birth With Hepatitis B at 2, 4 and 6 Mths.Age.

Hepatitis B Clinical Trial

Official title:

Study to Assess Immunogenicity and Safety of GlaxoSmithKline Biologicals' Kft's DTPw-HBV/Hib vs DTPwCSL-HBV/Hib Kft and vs Concomitant Administration of CSL's Triple Antigen and GlaxoSmithKline Biologicals' Hiberix, to Infants at 2, 4, 6 Months of Age, After a Birth Dose of Hepatitis B

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00316680
• Other study ID #: 104489
• Status: Terminated
• Phase: Phase 3
• First received: April 20, 2006
• Last updated: October 6, 2016
• Start date: March 2006
• Est. completion date: November 2006

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Dominican Republic: Secretaría del Estado de Salud Pública y Asistencia Social (SESPAS)
• Study type: Interventional

Clinical Trial Summary

A trial to characterize the immunogenicity of 2 different formulations of a vaccine from GSK Biologicals, including the following five antigens: diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b. A vaccine from Commonwealth Serum Laboratories (diphtheria, tetanus, pertussis) which is co-administered with Haemophilus influenzae type b vaccine will also be used as a comparator. Reactogenicity and safety of all vaccines will be assessed as well.

Description:

"The study will be carried out in a partially double blind manner (i.e. double blind with respect to DTPwGöd-HBV/Hib Kft and DTPwCSL-HBV/Hib Kft groups and open with respect to CSL's Triple Antigen & Hib group). Subjects will be randomly allocated to one of the three following groups to receive:

• GSK Biologicals Kft's combined DTPwGöd-HBV/Hib Kft vaccine.

• GSK Biologicals Kft's combined DTPwCSL-HBV/Hib Kft vaccine.

• CSL's Triple Antigen + GSK Biologicals' Hib vaccines. There will be a specific follow-up of solicited local and general symptoms during 4 days after each vaccination and of unsolicited symptoms for 31 days after each vaccination. Serious adverse events reported during the study period will be recorded.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 288
• Est. completion date: November 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Weeks to 12 Weeks

Eligibility

Inclusion criteria

• Administration of one dose of hepatitis B vaccine at birth.

• A healthy male or female between, and including, 6 and 12 weeks of age at the time of the first DTPw vaccination.

Exclusion criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.

• Chronic administration of immunosuppressants or other immune-modifying drugs since birth.

• Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exception of oral polio vaccine hepatitis B vaccine for the Triple Antigen + Hib group.

• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required)

• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

• Bacille Calmette-Guérin (BCG) vaccine given after the first 2 weeks of life.

• Previous vaccination against diphtheria, tetanus, pertussis and/or Hib/History of diphteria, tetanus, pertussis, hepatitis B and/ or hib disease.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Haemophilus Influenzae Type b
• Hepatitis
• Hepatitis A
• Hepatitis B
• Tetanus
• Whole Cell Pertussis

Intervention

Biological:
• Diphtheria, tetanus, pertussis, hepatitis B, Hib vaccine

Locations

Country	Name	City	State
Dominican Republic	GSK Investigational Site	Santo Domingo

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Dominican Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GMC of anti-BPT Ab
Secondary	anti-HBs, anti-diphtheria, anti-tetanus, anti-BPT & anti-PRP conc. & GMCs; vaccine response to BPT
Secondary	Solicited & unsolicited symptoms, SAEs "

External Links

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