Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib, Compared to DTPa-HBV-IPV and Hib Administered Separately

Study to Assess the Immunogenicity and Reactogenicity of DTPa-HBV-IPV Vaccine Mixed With Hib Vaccine to Healthy Infants at 3, 5 and 11 Months of Age, Compared to Each Vaccine Administered Separately

This study will assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' (formerly SB Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared with separate administration of DTPa-HBV-IPV (Infanrix penta™) and Hib (Hiberix™) vaccine administered at 3, 5 and 11 (or 12) 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-HBV-IPV (Infanrix penta™); Biological: Hib (Hiberix™)

• Study Type: Interventional
• Enrollment (Actual): 440
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A male or female 3 months 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:

The following criteria should be checked at the time of study entry. If any apply at the time of study entry, the subject must not be included in the study:

• Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Administration of chronic immunosuppressants or other immune-modifying drugs within three months before vaccination.
• Administration of a vaccine not foreseen by the study within 30 days before each dose of the study vaccines and ending 30 days after.
• Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease.
• History of /or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease or infection.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
• History of allergic disease or reactions 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.
• History of seizures or of any neurological disease at study entry.
• Administration of immunoglobulins and/or any blood products since birth, or planned administration during the study period.
• Acute disease at time of enrolment

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: Group A; Subjects will receive one single injection of DTPa-HBV-IPV vaccine mixed with Hib vaccine.	Biological: DTPa-HBV-IPV/Hib (Infanrix hexa™); Three doses administered intramuscularly
Active Comparator: Group B; Subjects will receive two separate injections of DTPa-HBV-IPV and Hib vaccine.	Biological: DTPa-HBV-IPV (Infanrix penta™); Three doses administered intramuscularly; Biological: Hib (Hiberix™); Three doses administered intramuscularly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with antibody titres greater than or equal to cut off value	One month after the 2nd dose of the primary vaccination course ( Month 3)

Secondary Outcome Measures

Outcome Measure	Time Frame
Immunogenicity with respect to the components of the study vaccines in terms of number of seroprotected subjects	One month after the 2nd dose ( Month 3), before and one month after the 3rd dose of the primary vaccination course ( Month 8 and 9)
Immunogenicity with respect to the 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 ( Month 8 and 9)
Immunogenicity with respect to the components of the study vaccines in terms of antibody titres	One month after the 2nd dose ( Month 3), before and one month after the 3rd dose of the primary vaccination course ( Month 8 and 9)
Immunogenicity with respect to the components of the study vaccines in terms of vaccine response	One month after the 3rd dose ( Month 9), and one month after the 2nd dose of the primary vaccination course ( Month3)
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
Occurrence of unsolicited symptoms	Within 30 days after each vaccination and overall
Occurrence of serious adverse events	Throughout the entire study up to and including 30 days post-vaccination ( Month 0 to Month 9)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Crovari P. et al. Immunogenicity and reactogenicity of combined DTPa-HBV-IPV/Hib vaccine compared to concomitant administered DTPa-HBV-IPV and Hib vaccines given at 3, 5 and 11 months of age. Abstract presented at the 19th Annual Meeting ESPID, Istanbul, Turkey, 26-28 March 2001.
• Gabutti G, Zepp F, Schuerman L, Dentico P, Bamfi F, Soncini R, Habermehl P, Knuf M, Crovari P; Cooperative Italian Group for the Study of Combined Vaccines. Evaluation of the immunogenicity and reactogenicity of a DTPa-HBV-IPV Combination vaccine co-administered with a Hib conjugate vaccine either as a single injection of a hexavalent combination or as two separate injections at 3, 5 and 11 months of age. Scand J Infect Dis. 2004;36(8):585-92. doi: 10.1080/00365540410017572.
• Van Der Meeren O, Kuriyakose S, Kolhe D, Hardt K. Immunogenicity of Infanrix hexa administered at 3, 5 and 11 months of age. Vaccine. 2012 Apr 5;30(17):2710-4. doi: 10.1016/j.vaccine.2012.02.024. Epub 2012 Feb 18.

Study record dates

Study Major Dates

• Study Start: January 1, 1999
• Primary Completion (Actual): March 1, 2000
• Study Completion (Actual): March 1, 2000

Study Registration Dates

• First Submitted: October 20, 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: combination vaccine; Hib; DTPa-HBV-IPV
• 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: 217744/054