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Assess if Immune Response of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC Given Without or With Hepatitis B Vaccine at Birth is at Least as Good as Tritanrix™-HepB/Hiberix™ Without Hepatitis B Vaccine at Birth, When Given to Healthy Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00290303
First received: February 10, 2006
Last updated: September 15, 2016
Last verified: September 2016
  Purpose
The purpose of this study is to compare the immune response, safety and reactogenicity of Tritanrix™-HepB/Hib-MenAC vaccine given either with or without a birth dose of hepatitis B vaccine to Tritanrix™-HepB/Hiberix™ when given to healthy infants (born to mothers who do not carry hepatitis B virus) at 6, 10 & 14 weeks of age. This study will also include a small group of infants born to mothers who do carry hepatitis B virus; these infants will receive a birth dose of hepatitis B vaccine and will be vaccinated with Tritanrix™ HepB/Hib-MenAC at 6, 10 & 14 weeks age.

Condition Intervention Phase
Haemophilus Influenzae Type b
Diphtheria
Whole Cell Pertussis
Hepatitis B
Tetanus
Biological: DTPw-HBV/Hib-MenAC conjugate vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Study to Show Non-inferiority of Tritanrix™-HepB/Hib-MenAC (+/- Hepatitis B Vaccine at Birth) Versus Tritanrix™-HepB/Hiberix™ Without Hepatitis B Vacc. at Birth for Antibody Response to All Vaccine Antigens Given in Healthy Infants

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immunogenicity: One month post-dose 3, measurement of serum bactericidal titers against meningococcal serogroups A & C (SBA-MenA; SBA-MenC), anti-PRP, anti-HBs & anti-diphtheria concentrations; & in some subjects anti-tetanus & anti-BPT concentrations.

Secondary Outcome Measures:
  • Reactogenicity and safety: After each vaccination, solicited (day 0-3, local & general) & unsolicited (day 0-30) symptoms. Over the full course of the study: serious adverse events (SAEs)

Enrollment: 996
Study Start Date: May 2004
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Detailed Description:

Randomized study with three groups (subjects born to mothers who do not carry hepatitis B virus) to receive one of the following vaccination regimens: - GSK Biologicals' Tritanrix™-HepB/Hib-MenAC and hepatitis B vaccine at birth

- GSK Biologicals' Tritanrix™-HepB/Hib-MenAC and no hepatitis B vaccine at birth - GSK Biologicals' Tritanrix™-HepB/Hiberix™ There will also be a fourth group (subjects born to mothers who do carry hepatitis B virus) to receive: - GSK Biologicals' Tritanrix™-HepB/Hib-MenAC and hepatitis B vaccine at birth

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Healthy infants aged 3 days or less, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.
  • Result of the maternal blood sample (presence/not of hepatitis B virus) is available.

Exclusion criteria:

  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • A family history of congenital or hereditary immunodeficiency.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (except for immunoglobulins given at birth to infants born to HBsAg seropositive mothers).
  • Acute disease at the time of enrolment.
  • Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease.
  • Hepatitis B vaccine given at birth outside the study.
  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: NCT00290303

Locations
Philippines
GSK Investigational Site
Manila, Philippines, 1000
GSK Investigational Site
Quezon CIty, Philippines, 1109
GSK Investigational Site
Sampaloc, Manila, Philippines, 1008
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 100478
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 100478
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 100478
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 100478
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 100478
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 100478
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00290303     History of Changes
Other Study ID Numbers: 100478 
Study First Received: February 10, 2006
Last Updated: September 15, 2016
Health Authority: Philippines: Bureau of Food and Drugs
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Diphtheria
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 27, 2016