Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly

Study to Assess Immunogenicity and Reactogenicity of SB Biologicals' DTPa-HBV-IPV/Hib Vaccine Given as Three-dose Primary Vaccination Course Compared to DTPa-IPV/Hib and HBV Administered Concomitantly at Separate Sites

This study will assess the immunogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared to the separate administration of DTPa-HBV-IPV (Infanrix™ penta) and Hib (Hiberix™) vaccines administered at 3 and 5 months of age.

Study Overview

• Status: Completed
• Conditions: Hepatitis B; Pertussis; Tetanus; Diphtheria; Poliomyelitis; Haemophilus Influenzae Type b (Hib)
• Intervention / Treatment: Biological: DTPa-HBV-IPV/Hib (Infanrix-hexa™); Biological: DTPa-IPV/Hib (Infanrix-IPV/Hib™); Biological: HBV (Engerix™-B)

• Study Type: Interventional
• Enrollment (Actual): 312
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 3 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A male or female between 12 and 16 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 after they have been advised of the risks and benefits of the study in a language which they clearly understood, and before performance of any study procedure.

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 immune-modifying drugs during the study period.
• Administration of a vaccine not foreseen by the study protocol during the period starting from one month before each dose and ending one month after each dose.
• Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib diseases.
• History of/or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
• History of allergic disease or reaction likely to be exacerbated by any component of the vaccine, including allergic reactions to neomycin and polymyxin B.
• Major congenital defects or serious chronic illness.
• Progressive neurological disorders.
• Administration of immunoglobulins and/or any blood products since birth and during the study period.
• Acute febrile illness at the time of planned vaccination.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DTPa 1 Group	Biological: DTPa-HBV-IPV/Hib (Infanrix-hexa™); 3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8
Active Comparator: DTPa 2 Group	Biological: DTPa-IPV/Hib (Infanrix-IPV/Hib™); 3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8; Biological: HBV (Engerix™-B); 3 doses administered intramuscularly into the left thigh at study month 0, 2 and 8

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of subjects with antibody titers equal to or greater than cut-off value.	One month after the 2nd dose of the primary vaccination course (month 3)

Secondary Outcome Measures

Outcome Measure	Time Frame
Occurrence of solicited local symptoms	Within 4 days after each vaccination and overall
Occurrence of solicited general symptoms	Within 4 days after each vaccination and overall
Immunogenicity with respect to components of the study vaccines in terms of number of seropositive subjects	One month after the 2nd dose (Month 3), before and one month after the 3rd dose of the primary vaccination course (Months 8 and 9)
Immunogenicity with respect to components of the study vaccines in terms of antibody titers	One month after the 2nd dose (Month 3), before and one month after the 3rd dose of the primary vaccination course (Months 8 and 9)
Immunogenicity with respect to components of the study vaccines in terms of number of subjects with a vaccine response	One month after the 3rd dose of the primary vaccination course (Month 9)
Occurrence of unsolicited symptoms	Within 30 days after each vaccination, and overall
Occurrence of serious AEs	Throughout the entire study (approximately 9 months per subject) up to and including 30 days post-vaccination

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: September 1, 1998
• Primary Completion (Actual): September 1, 1999
• Study Completion (Actual): September 1, 1999

Study Registration Dates

• First Submitted: October 13, 2011
• First Submitted That Met QC Criteria: October 20, 2011
• First Posted (Estimate): October 24, 2011

Study Record Updates

• Last Update Posted (Actual): June 16, 2017
• Last Update Submitted That Met QC Criteria: June 15, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: safety; Immunogenicity; Infants; HBV; DTPa-HBV-IPV/Hib; DTPa-IPV/Hib; combined vaccine
• 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; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Anticoagulants; Antidotes; Chelating Agents; Sequestering Agents; Iron Chelating Agents; Calcium Chelating Agents; Edetic Acid; Pentetic Acid
• Other Study ID Numbers: 217744/031