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

NCT01457495 | Completed Phase 2

• 1 other identifier: 217744/031
• Study Type: interventional
• Target: 312
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hepatitis B; Diphtheria; Haemophilus Influenzae Type b (Hib); Poliomyelitis; Pertussis; Tetanus

Keywords

Infants; combined vaccine; DTPa-HBV-IPV/Hib; DTPa-IPV/Hib; safety; Immunogenicity; HBV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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 solicited local symptoms

  Within 4 days after each vaccination and overall

• Occurrence of solicited general symptoms

  Within 4 days after each vaccination and overall

Study Arms (2)

DTPa 1 Group

EXPERIMENTAL

Biological: DTPa-HBV-IPV/Hib (Infanrix-hexa™)

DTPa 2 Group

ACTIVE COMPARATOR

Biological: DTPa-IPV/Hib (Infanrix-IPV/Hib™); Biological: HBV (Engerix™-B)

Interventions

DTPa-HBV-IPV/Hib (Infanrix-hexa™) BIOLOGICAL

3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8

DTPa 1 Group

DTPa-IPV/Hib (Infanrix-IPV/Hib™) BIOLOGICAL

3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8

DTPa 2 Group

HBV (Engerix™-B) BIOLOGICAL

3 doses administered intramuscularly into the left thigh at study month 0, 2 and 8

DTPa 2 Group

Eligibility Criteria

• Age: 12 Weeks - 16 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Hepatitis B; Diphtheria; Haemophilus Infections; Poliomyelitis; Whooping Cough; Tetanus

Interventions

diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Pasteurellaceae Infections; Gram-Negative Bacterial Infections; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Bordetella Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Clostridium Infections

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2011
• First Posted: October 24, 2011
• Study Start: September 1, 1998
• Primary Completion: September 1, 1999
• Study Completion: September 1, 1999
• Last Updated: June 16, 2017

Record last verified: 2017-06