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Immunogenicity and Safety of Boostrix Polio Vaccine as a Booster Dose in 5 to 6-year-old Children.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00871000
First received: March 26, 2009
Last updated: March 7, 2017
Last verified: March 2017
  Purpose

This phase 3b study will compare the immunogenicity and reactogenicity of the dTpa-IPV vaccine to that of a DTPa-IPV vaccine when administered as a booster dose in healthy children 5-6 years of age who have received three primary vaccination doses of DTPa-based vaccine according to the "3-5-11" month schedule recommended in Italy.

In this study, MMRV vaccine will also be co-administered to all children.


Condition Intervention Phase
Acellular Pertussis
Tetanus
Diphtheria
Poliomyelitis
Biological: Boostrix Polio™ 711866
Biological: Priorix Tetra TM 208136
Biological: Tetravac TM
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of GSK Biologicals' dTpa-IPV Vaccine (Boostrix Polio) as a Booster Dose in 5 to 6-year-old Children.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations [ Time Frame: At Month 1, one month post-vaccination ]
    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). The reference cut-off value was greater than or equal to (≥) 0.1 IU/mL.

  • Anti-poliovirus Types 1, 2 and 3 Antibody Titres [ Time Frame: At Month 1, one month post-vaccination ]
    Antibody titers were presented as geometric mean titers (GMTs) for the cut-off value ≥ the value of 8.

  • Number of Seroprotected Subjects Against Polio Types 1, 2 and 3 [ Time Frame: At Month 1, one month post-vaccination ]
    A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titers ≥ the value of 8. Antibody titers have been assessed by neutralization assay.

  • Number of Seropositive Subjects for Anti-D and Anti-T Antibodies [ Time Frame: At Month 1, one month post-vaccination ]
    A seropositive subject was defined as a subject with anti-D and anti-T concentrations ≥ 0.1 IU/mL. Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA).


Secondary Outcome Measures:
  • Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens [ Time Frame: At Month 1, one month post-vaccination ]
    A seroprotected subject was defined as a subject with anti-D and anti-T concentrations ≥ 1.0 IU/mL. Antibody concentrations have been assessed by ELISA.

  • Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations [ Time Frame: At Month 1, one month post-vaccination ]
    Antibody concentrations were presented as geometric mean concentrations, expressed in ELISA units per milliliter (EL.U/mL). The reference cut-off value was ≥ 5 EL.U/mL.

  • Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies [ Time Frame: At Month 1, one month post-vaccination ]
    A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN concentrations ≥ 5.0 IU/mL. Antibody concentrations have been assessed by ELISA.

  • Number of Seropositive Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella [ Time Frame: At Month 1, one month post-vaccination ]
    Seropositivity was defined as: subjects with antibody concentrations ≥ 150 milli-international units per milliliter (mIU/mL), ≥ 231 units per milliliter (U/mL), ≥ 4 international units per milliliter (IU/mL) and ≥ 50 mIU/mL for anti-measles, anti-mumps, anti-rubella and anti-varicella antibodies, respectively.

  • Anti-measles and Anti-varicella Antibody Concentrations [ Time Frame: At Month 1, one month post-vaccination ]
    Antibody concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in mIU/mL.

  • Anti-mumps Antibody Concentrations [ Time Frame: At Month 1, one month post-vaccination ]
    Antibody concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in U/mL.

  • Anti-rubella Antibody Concentrations [ Time Frame: At Month 1, one month post-vaccination ]
    Antibody concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in IU/mL.

  • Number of Subjects With Booster Responses to Anti-D and Anti-T [ Time Frame: At Month 1, one month post-vaccination ]
    Booster responses to anti-D and anti-T were defined as: For initially seronegative subjects (pre-vaccination concentration < cut-off of 0.1 IU/mL), antibody concentrations at least four times the assay cut-off (post-vaccination concentration ≥ 0.4 IU/mL). For initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL), an increase in antibody concentrations of at least four times the pre-vaccination concentration.

  • Number of Subjects With Booster Responses to Anti-polio Type 1, 2 and 3 [ Time Frame: At Month 1, one month post-vaccination ]
    Booster response to the poliovirus antigens was defined as: For initially seronegative subjects (pre-vaccination antibody titre < cut-off of 8), antibody titre ≥ 32. For initially seropositive subjects (pre-vaccination antibody titres ≥ 8), an increase in antibody titres of at least four times the pre-vaccination titre.

  • Number of Subjects With Booster Responses to Anti-PT, Anti-FHA and Anti-PRN [ Time Frame: At Month 1, one month post-vaccination ]
    Booster response to the PT, FHA and PRN antigens was defined as: For initially seronegative subjects (pre-vaccination concentration < cut-off of 5 EL.U/mL), antibody concentrations at least four times the cut-off (post-vaccination concentration ≥ 20 EL.U/mL). For initially seropositive subjects with pre-vaccination concentration ≥ 5 EL.U/mL and < 20 EL.U/mL, an increase in antibody concentrations of at least four times the pre-vaccination concentration. For initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL, an increase in antibody concentrations of at least two times the pre-vaccination concentration.

  • Number of Seroconverted Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella [ Time Frame: At Month 1, one month post-vaccination ]
    Seroconversion for anti-measles, anti-mumps, anti-rubella and anti-varicella was defined as the appearance of antibodies after vaccination in subjects who were seronegative before vaccination.

  • Number of Subjects With Any Solicited Local Symptoms [ Time Frame: During the 4-day (Days 0-3) post-vaccination period ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

  • Number of Subjects With Any Solicited General Symptoms [ Time Frame: At Month 1, one month post-vaccination ]
    Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.

  • Number of Subjects With 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.

  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the whole study period (from Month 0 to Month 1) ]
    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.


Enrollment: 303
Study Start Date: April 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BOOSTRIX POLIO GROUP
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Biological: Boostrix Polio™ 711866
Single dose, intramuscular administration.
Other Name: dTpa-IPV
Biological: Priorix Tetra TM 208136
Single dose, subcutaneously.
Other Name: MMRV
Active Comparator: TETRAVAC GROUP
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Biological: Priorix Tetra TM 208136
Single dose, subcutaneously.
Other Name: MMRV
Biological: Tetravac TM
Single dose, intramuscular administration.
Other Name: DTPa-IPV

  Eligibility

Ages Eligible for Study:   5 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or female child of 5 and 6 years of age at the time of vaccination.
  • Subjects who received a complete 3-dose vaccination with a DTPa-based combined vaccine according to a 3-5-11 month schedule in line with recommendations in Italy.
  • Subjects who received a first dose of a live attenuated measles-mumps-rubella vaccine in the second year of life, in line with recommendations in Italy.
  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
  • 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.

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 booster vaccine dose.
  • Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period.
  • 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.
  • Previous booster vaccination against tetanus, diphtheria, pertussis and/or poliomyelitis since vaccination in the first two years of life.
  • Previous measles, mumps, rubella and/or varicella second dose vaccination.
  • Known history of diphtheria, tetanus, pertussis, poliomyelitis, measles, mumps, rubella and/or varicella disease.
  • Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to study start.
  • Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Administration of immunoglobulin and/or any blood products within the three months preceding vaccination or planned administration during the study period.
  • Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
  • Occurrence of any of the following adverse events after a previous administration of a DTP vaccine:

    • Hypersensitivity reaction to any component of the vaccine;
    • Encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine;
    • Fever >= 40°C within 48 hours of vaccination, not due to another identifiable cause;
    • Collapse or shock-like state within 48 hours of vaccination;
    • Convulsions with or without fever, occurring within 3 days of vaccination.
  • Residence in the same household as a person high risk for varicella
  • The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:

    • Current febrile illness or axillary temperature ≥ 38.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration.
  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: NCT00871000

Locations
Italy
GSK Investigational Site
Genova, Liguria, Italy, 16132
GSK Investigational Site
Milano, Lombardia, Italy, 20122
GSK Investigational Site
Novara, Piemonte, Italy, 28100
GSK Investigational Site
Cagliari, Sardegna, Italy, 09127
GSK Investigational Site
Catania, Sicilia, Italy, 95129
GSK Investigational Site
Modica (RG), Sicilia, Italy, 97100
GSK Investigational Site
Ragusa, Sicilia, Italy, 97100
GSK Investigational Site
Vittoria (RG), Italy
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Ferrera G et al. A comparison of the immunogenicity and safety of a booster dose of reduced-antigen-content with full-strength DTPa-IPV vaccines administered with MMRV to children 5-6 years of age. Abstract presented at the 44th Congresso Nazionale Societa Italiana di Igiene, Medicina Preventiva e Sanita Pubblica (SITI). Venezia, Italia, 3-6 October, 2010.
Ferrera G et al. Immunogenicity and safety of Booster vaccination with reduced-antigen-content or full-strength Diphtheria-Tetanus-Acellular-Pertussis-IPV vaccines in pre-school children, primed with a 2+1 schedule. Abstract presented at the 29th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). The Hague, The Netherlands, 7-11 June 2011.

Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 111815
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 111815
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: 111815
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 111815
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: 111815
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 111815
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: 111815
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00871000     History of Changes
Other Study ID Numbers: 111815
Study First Received: March 26, 2009
Results First Received: March 7, 2017
Last Updated: March 7, 2017
Individual Participant Data  
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.

Keywords provided by GlaxoSmithKline:
Boostrix Polio
dTpa-IPV

Additional relevant MeSH terms:
Poliomyelitis
Diphtheria
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 21, 2017