Immunogenicity and Safety Study of Booster Dose of GSK Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) Vaccine
Immunogenicity and Safety of a Booster Dose of GlaxoSmithKline Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) in Healthy Chinese Toddlers
1 other identifier
interventional
831
1 country
2
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2011
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 6, 2011
CompletedFirst Posted
Study publicly available on registry
October 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 16, 2012
CompletedResults Posted
Study results publicly available
April 13, 2017
CompletedJune 6, 2018
April 1, 2017
4 months
October 6, 2011
February 28, 2017
May 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (25)
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
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).
Before the booster vaccination (At Day 0)
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥0.1 IU/mL.
Before the booster vaccination (At Day 0)
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (Anti-PRP)
A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).
Before the booster vaccination (At Day 0)
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL.
Before the booster vaccination (At Day 0)
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3
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%.
Before the booster vaccination (At Day 0)
Anti-polio Type 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8.
Before the booster vaccination (At Day 0)
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
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).
Before the booster vaccination (At Day 0)
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
Before the booster vaccination (At Day 0)
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids
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.
Before the booster vaccination (At Day 0)
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.
One month after the booster vaccination (At Month 1)
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL.
Before the booster vaccination (At Day 0)
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were presented as GMCs for the seroprotection cut-off of ≥ 0.1 IU/mL.
One month after the booster vaccination (At Month 1)
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 µg/mL.
Before the booster vaccination (At Day 0)
Number of Seroprotected Subjects Against PRP
A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL.
One month after the booster vaccination (At Month 1)
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 micrograms per milliliter (µg/mL).
Before the booster vaccination (At Day 0)
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL.
One month after the booster vaccination (At Month 1)
Number of Seroprotected Subjects for Anti-polio Type 1, 2 and 3
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%.
Before the booster vaccination (At Day 0)
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3
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%.
One month after the booster vaccination (At Month 1)
Anti-polio Type 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ the value of 8.
Before the booster vaccination (At Day 0)
Anti-polio Type 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8.
One month after the booster vaccination (At Month 1)
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
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).
Before the booster vaccination (At Day 0)
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
One month after the booster vaccination (At Month 1)
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 5 EL.U/mL.
Before the booster vaccination (At Day 0)
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrattions
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
One month after the booster vaccination (At Month 1)
Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN
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.
One month after the booster vaccination (At Month 1)
Secondary Outcomes (4)
Number of Subjects With Any Solicited Local Symptoms
During the 4-day (Days 0-3) post-vaccination period
Number of Subjects With Any Solicited General Symptoms
During the 4-day (Days 0-3) post-vaccination period
Number of Subjects With Any Unsolicited Adverse Events (AEs)
During the 31-day (Days 0-30) post-vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
During the entire study period (from Month 0 up to Month 1)
Study Arms (3)
INFANRIX+HIB/POLIORIX 1 GROUP
EXPERIMENTALHealthy 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.
INFANRIX+HIB/POLIORIX 2 GROUP
EXPERIMENTALHealthy 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.
CONTROL GROUP
ACTIVE COMPARATORHealthy 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.
Interventions
Intramuscular, one dose
Intramuscular, one dose
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Acute disease and/or fever at the time of enrolment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (2)
GSK Investigational Site
Wuzhou, Guangxi, 543002, China
GSK Investigational Site
Wuzhou, Guangxi, 543100, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2011
First Posted
October 10, 2011
Study Start
October 1, 2011
Primary Completion
January 16, 2012
Study Completion
January 16, 2012
Last Updated
June 6, 2018
Results First Posted
April 13, 2017
Record last verified: 2017-04