Immunogenicity and Reactogenicity Study of BoostrixTM (dTpa) and Boostrix-IPV (dTpa-IPV)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01294605
First received: February 10, 2011
Last updated: February 17, 2011
Last verified: February 2011
  Purpose

This purpose of the study is to evaluate the immunogenicity and reactogenicity of Boostrix™ (when used in a primary schedule (0, 1, 6-month) or a single dose of Boostrix-IPV followed by two doses of Td vaccines (DitanrixTM Adult, TedivaxTM), as compared to three doses of licensed Td vaccines in adults.


Condition Intervention Phase
Diphtheria
Tetanus and Pertussis
Biological: Boostrix™ (dTpa)
Biological: GSK Biologicals' reduced-antigen-content combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine (dTpa-IPV; BoostrixTM)
Biological: Ditanrix™ Adult, TedivaxTM (Td)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Double-blind, Randomized, Phase III Clinical Trial to Evaluate the Immunogenicity and Reactogenicity of Three Consecutive Doses of dTpa, or of dTpa-IPV Followed by Two Doses of Td Vaccine , and Compared to Three Consecutive Doses of Td Vaccine Administered to Healthy Adults in a 0,1,6-month Schedule

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immunogenicity with respect to components of the study vaccines [ Time Frame: One month after the third dose (Month 7) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity with respect to components of the study vaccines [ Time Frame: One month after each dose (Months 1, 2 and 7) ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms [ Time Frame: Within 15 days (day 0 -14) after each vaccine dose. ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited symptoms [ Time Frame: Within 31 days (day 0-30) after each vaccine dose. ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: Until 31 days (day 0-30) after the last vaccine dose. ] [ Designated as safety issue: No ]
  • Occurrence of large local swelling reported [ Time Frame: Within 15 days (day 0-14) after each vaccine dose ] [ Designated as safety issue: No ]
  • Use of concomitant medication taken [ Time Frame: Within 31 days (day 0-30) after each vaccine dose ] [ Designated as safety issue: No ]

Enrollment: 460
Study Start Date: April 2003
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: Boostrix™ (dTpa)
Intramuscular, 3 doses
Experimental: Group B Biological: GSK Biologicals' reduced-antigen-content combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine (dTpa-IPV; BoostrixTM)
Intramuscular, single dose
Biological: Ditanrix™ Adult, TedivaxTM (Td)
Intramuscular, 2 doses
Active Comparator: Group C Biological: Ditanrix™ Adult, TedivaxTM (Td)
Intramuscular, 3 doses

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Only subjects for whom the investigator believes the requirements of the protocol will be complied with will be enrolled in the study
  • A male or female adult >= 40 years of age
  • Written informed consent to be obtained from the subject prior to study entry
  • No history of diphtheria or tetanus toxoid containing vaccination in the last 20 years, including those who have never been vaccinated and those with an unknown vaccination status.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • subject should not be pregnant or plan to become pregnant.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
  • Pregnant or lactating female
  • Female planning to become pregnant or planning to discontinue contraceptive precautions
  • Previous vaccination with a meningococcal-conjugate vaccine, Prevenar™ or other experimental conjugated pneumococcal vaccines
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
  • Any confirmed or suspected immunosuppressive or immunodeficient condition
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01294605

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01294605     History of Changes
Other Study ID Numbers: 263855/034
Study First Received: February 10, 2011
Last Updated: February 17, 2011
Health Authority: Netherlands: Minister van VWS Medische Technologie
Spain: Agencia Española del Medicamento y Productos Sanitarios
Belgium: Agence Fédérale des Medicaments et des Produits de la Santé

Keywords provided by GlaxoSmithKline:
DTPa
Td
IPV

Additional relevant MeSH terms:
Diphtheria
Whooping Cough
Tetanus
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Pentetic Acid
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antidotes
Protective Agents
Physiological Effects of Drugs
Iron Chelating Agents

ClinicalTrials.gov processed this record on July 23, 2014