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Immunogenicity and Safety Study of Booster Dose of GSK Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01449812
First received: October 6, 2011
Last updated: April 13, 2017
Last verified: April 2017
  Purpose

The purpose of this booster study is to evaluate the immune persistence in healthy Chinese subjects primed in study NCT01086423 with GSK Biologicals' Infanrix-IPV+Hib™ (DTPa-IPV/Hib) vaccine. The study will also evaluate the safety and immune response of these subjects to a booster dose of Infanrix-Hib™ (DTPa/Hib) and Poliorix™ (IPV) vaccine.

This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT01086423).


Condition Intervention Phase
Acellular Pertussis
Tetanus
Diphtheria
Haemophilus Influenzae Type b
Biological: Infanrix+Hib™
Biological: Poliorix™
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 a Booster Dose of GlaxoSmithKline Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) in Healthy Chinese Toddlers

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids [ Time Frame: Before the booster vaccination (At Day 0) ]
    A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).

  • Anti-D and Anti-T Antibody Concentrations [ Time Frame: Before the booster vaccination (At Day 0) ]
    Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥0.1 IU/mL.

  • Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (Anti-PRP) [ Time Frame: Before the booster vaccination (At Day 0) ]
    A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).

  • Anti-PRP Antibody Concentrations [ Time Frame: Before the booster vaccination (At Day 0) ]
    Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL.

  • Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 [ Time Frame: Before the booster vaccination (At Day 0) ]
    A seroprotected subject was defined as a vaccinated subject with anti-polio type 1, 2 and 3 antibody concentrations ≥ the cut-off value of 8 Estimated Dose 50% (ED50). ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.

  • Anti-polio Type 1, 2 and 3 Antibody Titers [ Time Frame: Before the booster vaccination (At Day 0) ]
    Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8.

  • Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) [ Time Frame: Before the booster vaccination (At Day 0) ]
    A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml).

  • Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations [ Time Frame: Before the booster vaccination (At Day 0) ]
    Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.

  • Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids [ Time Frame: Before the booster vaccination (At Day 0) ]
    A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL.

  • Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids [ Time Frame: One month after the booster vaccination (At Month 1) ]
    A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.

  • Anti-D and Anti-T Antibody Concentrations [ Time Frame: Before the booster vaccination (At Day 0) ]
    Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL.

  • Anti-D and Anti-T Antibody Concentrations [ Time Frame: One month after the booster vaccination (At Month 1) ]
    Antibody concentrations were presented as GMCs for the seroprotection cut-off of ≥ 0.1 IU/mL.

  • Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) [ Time Frame: Before the booster vaccination (At Day 0) ]
    A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 µg/mL.

  • Number of Seroprotected Subjects Against PRP [ Time Frame: One month after the booster vaccination (At Month 1) ]
    A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL.

  • Anti-PRP Antibody Concentrations [ Time Frame: Before the booster vaccination (At Day 0) ]
    Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 micrograms per milliliter (µg/mL).

  • Anti-PRP Antibody Concentrations [ Time Frame: One month after the booster vaccination (At Month 1) ]
    Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL.

  • Number of Seroprotected Subjects for Anti-polio Type 1, 2 and 3 [ Time Frame: Before the booster vaccination (At Day 0) ]
    A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentration ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.

  • Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 [ Time Frame: One month after the booster vaccination (At Month 1) ]
    A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentrations ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.

  • Anti-polio Type 1, 2 and 3 Antibody Titers [ Time Frame: Before the booster vaccination (At Day 0) ]
    Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ the value of 8.

  • Anti-polio Type 1, 2 and 3 Antibody Titers [ Time Frame: One month after the booster vaccination (At Month 1) ]
    Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8.

  • Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN [ Time Frame: Before the booster vaccination (At Day 0) ]
    A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA units per milliliter (EL.U/mL).

  • Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN [ Time Frame: One month after the booster vaccination (At Month 1) ]
    A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.

  • Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations [ Time Frame: Before the booster vaccination ]
    Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 5 EL.U/mL.

  • Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrattions [ Time Frame: One month after the booster vaccination (At Month 1) ]
    Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.

  • Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN [ Time Frame: One month after the booster vaccination (At Month 1) ]
    Booster response was defined as the appearance of antibodies in subjects who were initially seronegative (i.e. with concentrations < cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies.


Secondary Outcome Measures:
  • 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: During the 4-day (Days 0-3) post-vaccination period ]
    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.1 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination.

  • 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 entire study period (from Month 0 up 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: 831
Study Start Date: October 1, 2011
Study Completion Date: January 16, 2012
Primary Completion Date: January 16, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INFANRIX+HIB/POLIORIX 1 GROUP
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Biological: Infanrix+Hib™
Intramuscular, one dose
Other Name: DTPa /Hib
Biological: Poliorix™
Intramuscular, one dose
Other Name: IPV
Experimental: INFANRIX+HIB/POLIORIX 2 GROUP
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Biological: Infanrix+Hib™
Intramuscular, one dose
Other Name: DTPa /Hib
Biological: Poliorix™
Intramuscular, one dose
Other Name: IPV
Active Comparator: CONTROL GROUP
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Biological: Infanrix+Hib™
Intramuscular, one dose
Other Name: DTPa /Hib
Biological: Poliorix™
Intramuscular, one dose
Other Name: IPV

  Eligibility

Ages Eligible for Study:   18 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or female child between, and including, 18 and 24 months of age at the time of the booster vaccination.
  • Subjects who completed the full three-dose primary vaccination course in study NCT01086423.
  • Subjects who the investigator believes that their parent(s)/ Legally Acceptable Representative(s) LAR(s) can and will comply with the requirements of the protocol
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

  • Child in care
  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of the 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 dose.
  • Administration of a vaccine not foreseen by the study protocol within 30 days prior to the booster vaccination, or planned administration during the study period.
  • Participation in another clinical study within three months prior to enrolment in the present booster study or at any time during the present booster study, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Evidence of previous diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b, vaccination or disease since the conclusion visit of primary study NCT01086423.
  • Serious chronic illness.
  • Administration of immunoglobulins and/or any blood products within the 90 days preceding the booster dose of study vaccine or planned administration during the study period.
  • Occurrence of any of the following adverse events after a previous administration of a DTP vaccine.
  • Encephalopathy
  • Temperature of ≥ 40.0°C (axillary temperature) within 48 hours of vaccination, not due to another identifiable cause.
  • Collapse or shock-like state within 48 hours of vaccination.
  • Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting ≥ 3 hours.
  • Seizures with or without fever occurring within 3 days of vaccination.

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:

  • Acute disease and/or fever at the time of enrolment.
  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: NCT01449812

Locations
China, Guangxi
GSK Investigational Site
Wuzhou, Guangxi, China, 543002
GSK Investigational Site
Wuzhou, Guangxi, China, 543100
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01449812     History of Changes
Other Study ID Numbers: 114386
Study First Received: October 6, 2011
Results First Received: February 28, 2017
Last Updated: April 13, 2017

Keywords provided by GlaxoSmithKline:
combination vaccine
booster vaccination

Additional relevant MeSH terms:
Diphtheria
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2017