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Assess Feasibility of an Acellular Pertussis Vaccine (Pa) Given Soon After Birth, Followed by 3-dose Primary Vaccination With the DTPa-HBV-IPV/Hib Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00289796
First received: February 9, 2006
Last updated: October 9, 2014
Last verified: November 2011
  Purpose

This study will assess immunogenicity, safety and reactogenicity of primary and booster vaccination.


Condition Intervention Phase
Hepatitis B
Biological: Pertussis vaccine
Biological: DTPa-HBV-IPV/Hib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Assess the Feasibility of an Investigational Vaccination Regimen, Compared to a 3-dose Primary Vaccination With GSK Bio's Infanrix Hexa™ (DTPa-HBV-IPV/Hib Vaccine) Following Hepatitis B Vaccination at Birth. Primary Vaccination is Followed in the 2nd Year of Life by a Booster Dose of Infanrix-hexa

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Enrollment: 121
Study Start Date: July 2004
Study Completion Date: December 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Detailed Description:

"There will be two groups in this study:

  • one group will receive a birth dose of Pa vaccine and 3 doses of DTPa-HBV-IPV/Hib vaccine as primary vaccination and a dose of DTPa-HBV-IPV/Hib vaccine as booster vaccination
  • the control group will receive a birth dose of hepatitis B vaccine and 3 doses of DTPa-HBV-IPV/Hib vaccine as primary vaccination and a dose of DTPa-HBV-IPV/Hib vaccine as booster vaccination".
  Eligibility

Ages Eligible for Study:   up to 5 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria For the primary vaccination phase

  • Healthy newborn male or female infant 2 to 5 days old at the time of the first vaccination & written informed consent taken from the parents/guardians of the subject
  • Born at term (gestational age 37-42 weeks) after an uncomplicated pregnancy
  • Birth weight >= 2.5 kg and 5 minute Apgar >= 7
  • Mother seronegative for Hepatitis B surface antigen (HBsAg) For the booster vaccination phase
  • A healthy male or female between, and including, 12 and 23 months of age at the time of booster vaccination who has completed the primary vaccination course in the primary vaccination phase with written informed consent obtained from the parent or guardian of the subject

Exclusion criteria For the primary vaccination phase

  • Mother known or suspected to be seropositive for HIV (testing not required for inclusion)
  • Planned use of any investigational or non-registered product (drug or vaccine) other than the study vaccines during the study
  • Planned administration of immuno-suppressants or other immune-modifying drugs, administration of immunoglobulins and/or any blood products since birth or planned administration during the study.
  • Administration of immunoglobulins and/or any blood products to the mother during pregnancy
  • Neonatal jaundice requiring parenteral treatment (light therapy for physiological jaundice is allowed)
  • At risk of pneumococcal disease or planning to receive Prevenar™ during the study period
  • Administration or planned administration of BCG vaccination during the study period
  • Acute disease at the time of vaccination. For the booster vaccination phase
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose, or planned use during the booster phase.
  • Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib booster vaccination since the study conclusion visit of the primary vaccination phase.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • Administration/ planned administration of a vaccine not foreseen by the study protocol, administration/ planned administration of immunoglobulins and/or any blood products during the period starting 30 days before the administration of the booster dose and ending 30 days after the booster dose.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose."
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289796

Locations
Germany
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00289796     History of Changes
Other Study ID Numbers: 210602-002, 105752
Study First Received: February 9, 2006
Last Updated: October 9, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014