Last updated: 11/03/2018 16:35:20

Immunogenicity and safety study of booster dose of GSK Biologicals’ IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) vaccine

GSK study ID
114386
See study documents
Clinicaltrials.gov ID
NCT01449812
See results summary
EudraCT ID
2012-003324-20
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Immunogenicity and safety of a booster dose of GlaxoSmithKline Biologicals’ IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) in healthy Chinese toddlers
Trial description: 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).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Number of seroprotected subjects against diphtheria (D) and tetanus (T) toxoids

Timeframe: Before the booster vaccination (At Day 0)

Anti-D and anti-T antibody concentrations

Timeframe: Before the booster vaccination (At Day 0)

Number of seroprotected subjects against polyribosyl-ribitol-phosphate (anti-PRP)

Timeframe: Before the booster vaccination (At Day 0)

Anti-PRP antibody concentrations

Timeframe: Before the booster vaccination (At Day 0)

Number of seroprotected subjects against polio type 1, 2 and 3

Timeframe: Before the booster vaccination (At Day 0)

Anti-polio type 1, 2 and 3 antibody titers

Timeframe: 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)

Timeframe: Before the booster vaccination (At Day 0)

Anti-PT, anti-FHA and anti-PRN antibody concentrations

Timeframe: Before the booster vaccination (At Day 0)

Number of seroprotected subjects against diphteria (D) and tetanus (T) toxoids

Timeframe: Before the booster vaccination (At Day 0)

Number of seroprotected subjects against diphteria (D) and tetanus (T) toxoids

Timeframe: One month after the booster vaccination (At Month 1)

Anti-D and anti-T antibody concentrations

Timeframe: Before the booster vaccination (At Day 0)

Anti-D and anti-T antibody concentrations

Timeframe: One month after the booster vaccination (At Month 1)

Number of seroprotected subjects against polyribosyl-ribitol-phosphate (PRP)

Timeframe: Before the booster vaccination (At Day 0)

Number of seroprotected subjects against PRP

Timeframe: One month after the booster vaccination (At Month 1)

Anti-PRP antibody concentrations

Timeframe: Before the booster vaccination (At Day 0)

Anti-PRP antibody concentrations

Timeframe: One month after the booster vaccination (At Month 1)

Number of seroprotected subjects for anti-polio type 1, 2 and 3

Timeframe: Before the booster vaccination (At Day 0)

Number of seroprotected subjects against polio type 1, 2 and 3

Timeframe: One month after the booster vaccination (At Month 1)

Anti-polio type 1, 2 and 3 antibody titers

Timeframe: Before the booster vaccination (At Day 0)

Anti-polio type 1, 2 and 3 antibody titers

Timeframe: One month after the booster vaccination (At Month 1)

Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN

Timeframe: Before the booster vaccination (At Day 0)

Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN

Timeframe: One month after the booster vaccination (At Month 1)

Anti-PT, anti-FHA and anti-PRN antibody concentrations

Timeframe: Before the booster vaccination (At Day 0)

Anti-PT, anti-FHA and anti-PRN antibody concentrattions

Timeframe: One month after the booster vaccination (At Month 1)

Number of subjects with a booster response to anti-PT, anti-FHA and anti-PRN

Timeframe: One month after the booster vaccination (At Month 1)

Secondary outcomes:

Number of subjects with any solicited local symptoms

Timeframe: During the 4-day (Days 0-3) post-vaccination period

Number of subjects with any solicited general symptoms

Timeframe: During the 4-day (Days 0-3) post-vaccination period

Number of subjects with any unsolicited adverse events (AEs)

Timeframe: During the 31-day (Days 0-30) post-vaccination period

Number of subjects with serious adverse events (SAEs)

Timeframe: During the entire study period (from Month 0 up to Month 1)

Interventions:
  • Biological/vaccine: Infanrix+Hib™
  • Biological/vaccine: Poliorix™
    • Enrollment:
    831
    Primary completion date:
    2012-16-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    acellular pertussis, Tetanus, Diphtheria, Haemophilus influenzae type b
    Product
    SB208108, SB213503
    Collaborators
    Not applicable
    Study date(s)
    October 2011 to January 2012
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 24 months
    Accepts healthy volunteers
    Yes
    • 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.
    • 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.
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Wuzhou, Guangxi, China, 543100
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Wuzhou, Guangxi, China, 543002
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2012-16-01
    Actual study completion date
    2012-16-01

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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