Assess the Immune Response Following Primary Vaccination With GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ Given at 6,10 & 14 Wks of Age to Infants Who Received Hepatitis B Vaccine at Birth

NCT00317122 | Completed Phase 3

• 1 other identifier: 759346/007
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 4

Brief Summary

This study will only include infants born to mothers who are tested as seronegative for human immunodeficiency virus (HIV) \& hepatitis B surface antigen (HBsAg). The purpose of this study is to demonstrate in infants who received a birth dose of hepatitis B vaccine that Tritanrix™-HepB/Hib-MenAC vaccine is at least as good as Tritanrix™-HepB/Hiberix™ with respect to immunogenicity of the hepatitis B antigen.

Conditions

Diphtheria; Haemophilus Influenzae Type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Outcome Measures

Primary Outcomes (1)

• One month after the third dose of the primary vaccination, measurement of anti-HBs antibody concentrations.

Secondary Outcomes (2)

• Immunogenicity: One month after the third dose of the primary vaccination, antibody concentrations or titres against all other vaccine antigens.

• Reactogenicity and safety: after each dose: solicited (day 0-3, local & general) & unsolicited (day 0-30) symptoms. Over the full course of the study: serious adverse events (SAEs)"

Interventions

DTPw-HBV/Hib-MenAC conjugate vaccine BIOLOGICAL

Eligibility Criteria

• Age: 4 Days - 10 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants aged 7 days +/- 3 days old born to mothers who are tested as seronegative for HIV \& HBsAg, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.

You may not qualify if:

• Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease since birth.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.
• A family history of congenital or hereditary immunodeficiency.
• Major congenital defects or serious illness.
• Any neurologic disorders or seizures.
• Acute disease at the time of enrolment.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• A birth dose of hepatitis B vaccine given outside the frame of this study.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (4)

GSK Investigational Site

Brits, 0250, South Africa

Location

GSK Investigational Site

Brits, South Africa

Location

GSK Investigational Site

Centurion, South Africa

Location

GSK Investigational Site

Ga-Rankuwa, 0208, South Africa

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Diphtheria; Haemophilus Infections; Hepatitis B; Tetanus

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pasteurellaceae Infections; Gram-Negative Bacterial Infections; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Clostridium Infections

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2006
• First Posted: April 24, 2006
• Study Start: October 1, 2004
• Primary Completion: July 1, 2005
• Study Completion: July 1, 2005
• Last Updated: September 21, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

ZA (4)