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Evaluation of the Immunogenicity, Safety and Reactogenicity of the Combined DTPa-IPV Vaccine in Healthy Infants

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ClinicalTrials.gov Identifier: NCT00290342
Recruitment Status : Completed
First Posted : February 13, 2006
Last Update Posted : October 12, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
DTPa and IPV vaccines are recommended for immunization of infants in Korea. The use of combination vaccines simplifies routine paediatric vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Condition or disease Intervention/treatment Phase
Tetanus Acellular Pertussis Diphtheria Biological: DTPa-IPV Biological: DTPa Biological: IMOVAX Polio® Phase 3

Detailed Description:
Participants in this Phase IIIb study will either receive GSK Biologicals' combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus (DTPa-IPV) vaccine or co-administration of GSK Biologicals' combined diphtheria-tetanus-acellular pertussis (DTPa) vaccine and Sanofi-Pasteurs' inactivated poliovirus vaccine. Vaccines for both groups will be administered at 2, 4 and 6 months of age. Two blood samples will be collected during the course of the study: prior to vaccination and one month after the third vaccine dose.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 452 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Multicentric Study to Compare the Immunogenicity, Safety & Reactogenicity of GSK Biologicals' DTPa-IPV Vaccine vs. Co-administration of GSK's DTPa Vaccine & Sanofi-Pasteurs' IPV Vaccine at Different Injection Sites, to Healthy Children
Study Start Date : January 2006
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Group A Biological: DTPa-IPV
3 intramuscular injections
Other Name: Infanrix™-IPV
Active Comparator: Group B Biological: DTPa
3 intramuscular injections
Other Name: Infanrix™
Biological: IMOVAX Polio®
3 intramuscular injections



Primary Outcome Measures :
  1. Anti-diphtheria antibody concentration [ Time Frame: One month after the three-dose primary vaccination course ]
  2. Anti-tetanus antibody concentration [ Time Frame: One month after the three-dose primary vaccination course ]
  3. Anti-poliovirus type 1 titre [ Time Frame: One month after the three-dose primary vaccination course ]
  4. Anti- poliovirus type 2 titre [ Time Frame: One month after the three-dose primary vaccination course ]
  5. Anti- poliovirus type 3 titre [ Time Frame: One month after the three-dose primary vaccination course ]
  6. Anti-pertussis antibody concentrations [ Time Frame: One month after the three-dose primary vaccination course ]
  7. Vaccine response to pertussis antigens [ Time Frame: One month after the three-dose primary vaccination course ]

Secondary Outcome Measures :
  1. Geometric mean concentration or titre of antibodies for all vaccine antigens [ Time Frame: Before and one month after the three-dose primary vaccination course ]
  2. Occurrence of solicited local adverse events [ Time Frame: During the 4 day follow-up period after vaccination ]
  3. Occurrence of solicited general adverse events [ Time Frame: During the 4 day follow-up period after vaccination. ]
  4. Occurrence of unsolicited local and general adverse events [ Time Frame: During the 31-day follow-up period after vaccination ]
  5. Occurrence of serious adverse events. [ Time Frame: During the entire study period ]


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Ages Eligible for Study:   8 Weeks to 12 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol .
  • A male or female between, and including, 8 and 12 weeks (56-90 days) of age at the time of the first vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Born after a gestation period of 36 to 42 weeks inclusive.

Exclusion criteria:

  • Use of any investigational or non-registered product (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.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
  • Administration of any vaccine within 30 days (i.e.30 days to 1 day) before the first dose of the study vaccine.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the study period (i.e. Day 0 to Month 7), with the exception of Bacille Calmette-Guérin (BCG) vaccine, hepatitis B vaccine, pneumococcal vaccine, flu vaccine and Hib vaccine.
  • Planned administration/ administration of a vaccine foreseen by the study protocol (i.e. BCG vaccine, hepatitis B vaccine, pneumococcal, flu vaccine and Hib vaccine) during the period 30 days before and one week after the study vaccine dose.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • Previous vaccination against diphtheria, tetanus, pertussis and/or poliovirus disease.
  • History of diphtheria, tetanus, pertussis and/or poliovirus diseases.
  • Known exposure to diphtheria, tetanus, pertussis and/or poliovirus before the study period.
  • Any anaemia/ thrombocytopenia or blood clot that leads to prohibition from intramuscular injection.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
  • 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 since birth or planned administration during the study period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00290342


Locations
Korea, Republic of
GSK Investigational Site
Bucheon-si,, Korea, Republic of, 420-767
GSK Investigational Site
Daegu, Korea, Republic of, 700-712
GSK Investigational Site
Gwangju, Korea, Republic of
GSK Investigational Site
Incheon, Korea, Republic of, 400-711
GSK Investigational Site
Jeonju, Korea, Republic of, 561-712
GSK Investigational Site
Seoul, Korea, Republic of, 130-702
GSK Investigational Site
Seoul, Korea, Republic of, 139-707
GSK Investigational Site
Seoul, Korea, Republic of, 150-719
GSK Investigational Site
Seoul, Korea, Republic of
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 104871
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 104871
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 104871
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 104871
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 104871
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 104871
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00290342     History of Changes
Other Study ID Numbers: 104871
First Posted: February 13, 2006    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Additional relevant MeSH terms:
Diphtheria
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Pentetic Acid
Edetic Acid
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Iron Chelating Agents
Anticoagulants
Calcium Chelating Agents