Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants

Immunogenicity and Reactogenicity of GSK Biologicals' DTPa-HBV-IPV and Hib Vaccines When Administered Concomitantly to Healthy Infants Administered as a Three-dose Primary Vaccination Course at the Age of 1.5, 3.5 and 6 Months

The purpose of this study is to evaluate the immune response and reactogenicity of GSK Biologicals' DTPa-HBV-IPV combined pentavalent vaccine and Hib tetanus conjugate vaccine, administered concomitantly as a three-dose primary vaccination course.

Study Overview

• Status: Completed
• Conditions: Hepatitis B; Tetanus; Diphtheria; Acellular Pertussis; Poliomyelitis
• Intervention / Treatment: Biological: Pediarix TM, Infanrix penta TM; Biological: Hiberix TM

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A male or female infant between 6 and 8 weeks of age at the time of the first vaccination.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.
• Written informed consent obtained from the parents or guardians of the subject.
• Born after a normal gestation period (between 36 and 42 weeks).

Exclusion Criteria:

• Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
• Administration of chronic immunosuppressants or other immune-modifying drugs since birth or planned administration during the study.
• Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after.
• Previous vaccination against diphtheria, tetanus, pertussis, polio or Haemophilus influenzae type b.
• History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, polio and/or Haemophilus influenzae type b.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
• Major congenital defects
• Serious chronic illness
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• Acute disease at the time of enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Group	Biological: Pediarix TM, Infanrix penta TM; The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.; Biological: Hiberix TM; The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Anti-PT, anti-FHA and anti-PRN antibody titers.	One month after the 3rd dose of the primary vaccination course
Anti-diphtheria toxoid and anti-tetanus toxoid antibody titers	One month after the 3rd dose of the primary vaccination course
Anti-HBs antibody titers	One month after the 3rd dose of the primary vaccination course
Anti-polio virus types 1, 2 and 3 antibody titers	One month after the 3rd dose of the primary vaccination course
Anti-PRP antibody titers	One month after the 3rd dose of the primary vaccination course

Secondary Outcome Measures

Outcome Measure	Time Frame
Occurrence of solicited adverse events	During the 4-day follow-up period after each dose
Occurrence of unsolicited adverse events	During the 30-day follow-up period after each dose
Occurrence of Serious Adverse Events	Over the course of the study

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Shao PL, Lu CY, Hsieh YC; Taiwan Infanrix-049 Study Group, Bock HL, Huang LM. Immunogenicity and reactogenicity of diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus and Haemophilus influenzae type B. J Formos Med Assoc. 2011 May;110(5):336-41. doi: 10.1016/S0929-6646(11)60050-8.

Helpful 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2000
• Primary Completion (Actual): May 1, 2001
• Study Completion (Actual): May 1, 2001

Study Registration Dates

• First Submitted: April 9, 2009
• First Submitted That Met QC Criteria: April 9, 2009
• First Posted (Estimate): April 13, 2009

Study Record Updates

• Last Update Posted (Estimate): September 7, 2016
• Last Update Submitted That Met QC Criteria: September 6, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Neuromuscular Diseases; Central Nervous System Infections; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Corynebacterium Infections; Hepatitis; Myelitis; Hepatitis B; Diphtheria; Poliomyelitis; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; PENTA
• Other Study ID Numbers: 217744/049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.

Study Data/Documents

1. Dataset Specification
   Information identifier: 217744/049
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Individual Participant Data Set
   Information identifier: 217744/049
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Study Protocol
   Information identifier: 217744/049
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Informed Consent Form
   Information identifier: 217744/049
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Clinical Study Report
   Information identifier: 217744/049
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register