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

NCT00879827 | Completed Phase 3

• 1 other identifier: 217744/049
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diphtheria; Poliomyelitis; Hepatitis B; Tetanus; Acellular Pertussis

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• 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

Study Arms (1)

Single Group

EXPERIMENTAL

Biological: Pediarix TM, Infanrix penta TM; Biological: Hiberix TM

Interventions

Pediarix TM, Infanrix penta TM BIOLOGICAL

The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.

Single Group

Hiberix TM BIOLOGICAL

The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.

Single Group

Eligibility Criteria

• Age: 6 Weeks - 8 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

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 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (1)

• 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.

  PMID: 21621155 BACKGROUND

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; Poliomyelitis; Hepatitis B; Tetanus

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; 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: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2009
• First Posted: April 13, 2009
• Study Start: September 1, 2000
• Primary Completion: May 1, 2001
• Study Completion: May 1, 2001
• Last Updated: September 7, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share