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TerminatedNCT00316680Updated Oct 7, 2016

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

A Phase 3 interventional study of Diphtheria, tetanus, pertussis, hepatitis B, Hib vaccine in Haemophilus Influenzae Type b, Diphtheria and Tetanus, sponsored by GlaxoSmithKline. Terminated at 1 site in Dominican Republic. Open to participants aged 6 Weeks to 12 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-07.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
288
Allocation
Randomized
Ages
6 Weeks to 12 Weeks
Sex
All
01

Study 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.

Read the detailed 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.

"

02

Conditions studied

  • Haemophilus Influenzae Type b
  • Diphtheria
  • Tetanus
  • Hepatitis B
  • Whole Cell Pertussis
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 288 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Weeks to 12 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
288 participants

Interventions

  • BiologicalDiphtheria, tetanus, pertussis, hepatitis B, Hib vaccine

    Also known as: Diphtheria, tetanus, pertussis, hepatitis B, Hib vaccine

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What researchers measure

Primary outcomes

  1. GMC of anti-BPT Ab

Secondary outcomes

  1. anti-HBs, anti-diphtheria, anti-tetanus, anti-BPT & anti-PRP conc. & GMCs; vaccine response to BPT

  2. Solicited & unsolicited symptoms, SAEs "

07

Study locations

1 site
  • GSK Investigational Site
    Santo Domingo, Dominican Republic
08

References and documents

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00316680
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Apr 21, 2006
Start date
Mar 2006
Completion
Nov 2006
Last update
Oct 7, 2016

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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