Clinical trial NCT01449812: Immunogenicity and Safety Study of Booster Dose of GSK Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) Vaccine
Official title: Immunogenicity and Safety of a Booster Dose of GlaxoSmithKline Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) in Healthy Chinese Toddlers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acellular Pertussis
Tetanus
Diphtheria
Haemophilus Influenzae Type b
Keywords: combination vaccine
booster vaccination
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-10-10
Enrollment: 831
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility 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.

Primary outcomes:
measure: Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
timeFrame: Before the booster vaccination (At Day 0)
measure: Anti-D and Anti-T Antibody Concentrations
timeFrame: Before the booster vaccination (At Day 0)
measure: Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (Anti-PRP)
timeFrame: Before the booster vaccination (At Day 0)
measure: Anti-PRP Antibody Concentrations
timeFrame: Before the booster vaccination (At Day 0)
measure: Number of Seroprotected Subjects Against Polio Type 1, 2 and 3
timeFrame: Before the booster vaccination (At Day 0)
measure: Anti-polio Type 1, 2 and 3 Antibody Titers
timeFrame: Before the booster vaccination (At Day 0)
measure: 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)
measure: Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
timeFrame: Before the booster vaccination (At Day 0)
measure: Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids
timeFrame: Before the booster vaccination (At Day 0)
measure: Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids
timeFrame: One month after the booster vaccination (At Month 1)
measure: Anti-D and Anti-T Antibody Concentrations
timeFrame: Before the booster vaccination (At Day 0)
measure: Anti-D and Anti-T Antibody Concentrations
timeFrame: One month after the booster vaccination (At Month 1)
measure: Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
timeFrame: Before the booster vaccination (At Day 0)
measure: Number of Seroprotected Subjects Against PRP
timeFrame: One month after the booster vaccination (At Month 1)
measure: Anti-PRP Antibody Concentrations
timeFrame: Before the booster vaccination (At Day 0)
measure: Anti-PRP Antibody Concentrations
timeFrame: One month after the booster vaccination (At Month 1)
measure: Number of Seroprotected Subjects for Anti-polio Type 1, 2 and 3
timeFrame: Before the booster vaccination (At Day 0)
measure: Number of Seroprotected Subjects Against Polio Type 1, 2 and 3
timeFrame: One month after the booster vaccination (At Month 1)
measure: Anti-polio Type 1, 2 and 3 Antibody Titers
timeFrame: Before the booster vaccination (At Day 0)
measure: Anti-polio Type 1, 2 and 3 Antibody Titers
timeFrame: One month after the booster vaccination (At Month 1)
measure: Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
timeFrame: Before the booster vaccination (At Day 0)
measure: Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
timeFrame: One month after the booster vaccination (At Month 1)
measure: Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
timeFrame: Before the booster vaccination (At Day 0)
measure: Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrattions
timeFrame: One month after the booster vaccination (At Month 1)
measure: 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:
measure: Number of Subjects With Any Solicited Local Symptoms
timeFrame: During the 4-day (Days 0-3) post-vaccination period
measure: Number of Subjects With Any Solicited General Symptoms
timeFrame: During the 4-day (Days 0-3) post-vaccination period
measure: Number of Subjects With Any Unsolicited Adverse Events (AEs)
timeFrame: During the 31-day (Days 0-30) post-vaccination period
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the entire study period (from Month 0 up to Month 1)
Other outcomes:
Locations:
city: Wuzhou
country: China
facility: GSK Investigational Site
state: Guangxi
city: Wuzhou
country: China
facility: GSK Investigational Site
state: Guangxi
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: