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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00290342
Recruitment Status : Completed
First Posted : February 13, 2006
Results First Posted : October 29, 2018
Last Update Posted : October 29, 2018
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 458 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 1, 2006
Actual Primary Completion Date : January 1, 2007
Actual Study Completion Date : January 23, 2007


Arm Intervention/treatment
Experimental: Infanrix-IPV Group
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals` combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
Biological: DTPa-IPV
3 intramuscular injections
Other Name: Infanrix™-IPV

Active Comparator: Infanrix + IMOVAX Polio Group
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals` Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur`s IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.
Biological: DTPa
3 intramuscular injections
Other Name: Infanrix™

Biological: IMOVAX Polio®
3 intramuscular injections




Primary Outcome Measures :
  1. Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T) [ Time Frame: One month (Month 5) post-primary vaccination course ]
    A seroprotected subject was defined as a vaccinated subject with anti-diphteria (anti-D) and anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) the cut-off value of 0.1 international units/milliliter (IU//mL).

  2. Number of Seroprotected Subjects Against Poliovirus (Anti-polio) Types 1, 2 and 3 [ Time Frame: One month (Month 5) post-primary vaccination course ]
    A seroprotected subject was defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 (Anti-Polio 1, 2 and 3) antibody titers greater than or equal to (≥) the cut-off value of 8.

  3. Number of Subjects With a Vaccine Response for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA) [ Time Frame: One month (Month 5) post-primary vaccination course ]
    Vaccine response was defined as: - for initially seronegative subjects, antibody concentrations ≥ 5 EL.U/mL one month after third vaccine dose; - for initially seropositive subjects, at least maintenance of pre-vaccination antibody concentrations one month after third vaccine dose.

  4. Number of Subjects With Vaccine Response to Pertussis Toxoid (PT), Pertactin (PRN) and Filamentous Haemagglutinin (FHA) Antigens [ Time Frame: One month (Month 5) post-primary vaccination course ]
    Vaccine response to pertussis toxoid (PT), pertactin (PRN) and filamentous haemagglutinin (FHA) was defined as the appearance of antibodies in subjects who were initially (i.e. before vaccination) seronegative (i.e. with concentrations < 5 EL.U/mL), or at least as the maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations ≥ 5 EL.U/mL value).


Secondary Outcome Measures :
  1. Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T) [ Time Frame: Before (Pre) and one month after (Post) the primary vaccination course ]
    A seroprotected subject was defined as a vaccinated subject with anti-diphteria (anti-D) and anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) the cut-off value of 1 international units/milliliter (IU//mL).

  2. Concentration of Antibodies Against Diphteria (Anti-D) and Tetanus (Anti-T) [ Time Frame: Before (Pre) and one month after (Post) the primary vaccination course ]
    Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per millilitre (mIU/mL).

  3. Titers for Poliovirus Type 1, 2 and 3 Antibodies [ Time Frame: Before (Pre) and one month after (Post) the primary vaccination course ]
    Titers for anti-polio 1, 2 and 3 are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was greater than or equal to (≥) 8.

  4. Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Pertactin (Anti-PRN) and Filamentous Haemagglutinin (Anti-FHA) [ Time Frame: Before (Pre) and one month after (Post) the primary vaccination course ]
    Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL).

  5. Number of Subjects Reporting Solicited Local Symptoms [ Time Frame: During the 4-day (Days 0-3) post-vaccination period, across doses ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = crying when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.

  6. Number of Subjects Reporting Solicited General Symptoms [ Time Frame: During the 4-day (Days 0-3) post-vaccination period, across doses ]
    Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 Loss of appetite = not eating at all. Related = symptom symptoms considered by the investigator to have a causal relationship to vaccination.

  7. Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day (Days 0-30) post-vaccination period ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

  8. Number of Subjects Reporting Any Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (from Month 0 up to Month 5) ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.



Information from the National Library of Medicine

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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
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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
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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

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00290342     History of Changes
Other Study ID Numbers: 104871
First Posted: February 13, 2006    Key Record Dates
Results First Posted: October 29, 2018
Last Update Posted: October 29, 2018
Last Verified: February 2018
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:
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Diphtheria
Bacterial Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Edetic Acid
Vaccines
Pentetic 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