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Immunogenicity and Safety of Booster Dose of PoliorixTM Vaccine in Previously Vaccinated Toddlers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01323647
First received: March 24, 2011
Last updated: October 13, 2016
Last verified: October 2016

March 24, 2011
October 13, 2016
April 2011
September 2011   (final data collection date for primary outcome measure)
  • Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value [ Time Frame: One month after Poliorix™ booster vaccination. ] [ Designated as safety issue: No ]
    A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 ED50. This outcome measure concerns subjects in the Poliorix Group only.
  • Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value [ Time Frame: Before booster vaccination. ] [ Designated as safety issue: No ]
    A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 ED50.
  • Antibody Titres Against Poliovirus Type 1, 2 and 3 [ Time Frame: One month after Poliorix™ booster vaccination. ] [ Designated as safety issue: No ]
    Antibody titers were summarized by geometric mean titers (GMTs) with their 95% CIs. This outcome measure concerns subjects in the Poliorix Group only.
  • Antibody Titres Against Poliovirus Type 1, 2 and 3. [ Time Frame: Before booster vaccination. ] [ Designated as safety issue: No ]
    Antibody titers were summarized by geometric mean titers (GMTs) with their 95% CIs.
  • Immunogenicity with respect to components of the study vaccine [ Time Frame: Before vaccination (Day 0) ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the study vaccine [ Time Frame: One month after booster vaccination in Group A ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01323647 on ClinicalTrials.gov Archive Site
  • Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: Within 4-days (Days 0-3) post Poliorix™ booster vaccination. ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 pain = Cry when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. This outcome measure concerns subjects in the Poliorix Group only.
  • Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. [ Time Frame: Within 4-days (Days 0-3) post Poliorix™ booster vaccination. ] [ Designated as safety issue: No ]
    Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever (defined as axillary temperature ≥37.0°C). Any was defined as incidence of the specified symptoms regardless of intensity or relationship to study vaccine. Grade 3 drowsiness was defined as drowsiness that prevents normal activities. Grade 3 fever was defined as fever (axillary temperature) >39.0°C. Grade 3 irritability was defined as crying more than usual/ interferes with normal activities. Grade 3 loss of appetite was defined as not eating at all. Related = symptom assessed by the investigator as related to the vaccination. This outcome measure concerns subjects only in the Poliorix Group.
  • Number of Subjects Reporting Any Unsolicited Adverse Event (AE) [ Time Frame: Within the 31-day follow-up period after the Poliorix™ booster vaccination. ] [ Designated as safety issue: No ]
    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. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. This outcome measure concerns subjects in the Poliorix Group only.
  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (Day 0 to Month 01). ] [ Designated as safety issue: No ]
    Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
  • Occurrence of solicited local and general symptoms [ Time Frame: During the 4-day (Day 0-3) follow-up period after booster vaccination in Group A ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events [ Time Frame: During the 31-day (Day 0-30) follow-up period after IPV booster vaccination in Group A ] [ Designated as safety issue: No ]
  • Serious adverse events [ Time Frame: From Day 0 up to 30 days following vaccination ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Immunogenicity and Safety of Booster Dose of PoliorixTM Vaccine in Previously Vaccinated Toddlers
Immunogenicity and Safety of a Booster Dose of GlaxoSmithKline Biologicals' IPV (PoliorixTM) in Healthy Chinese Toddlers
This study aims to evaluate the persistence of anti-poliovirus antibodies in toddlers aged 18 months who were primed with oral polio vaccine (OPV) or inactivated polio vaccine (IPV) in the primary study. The study will also assess the immunogenicity and reactogenicity of a booster dose of IPV in subjects primed with three doses of IPV.
All subjects will also receive a booster dose of GSK Biologicals' DTPa/Hib vaccine (Infanrix+Hib) at Day 0. This vaccine will be provided as part of the local standard of care and will not be associated with any study endpoint.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Poliomyelitis
  • Biological: PoliorixTM
    Single dose, intramuscular administration
  • Biological: Infanrix+Hib
    Single dose, intramuscular injection. Part of the local standard of care. No outcome measures associated.
  • Experimental: Group A
    Subjects in this group will receive the GSK Biologicals' IPV vaccine at 18 months of age. Subjects will also receive a dose of DTPa/Hib (Infanrix+Hib) as part of the local standard of care.
    Interventions:
    • Biological: PoliorixTM
    • Biological: Infanrix+Hib
  • Active Comparator: Group B
    Subjects in this group will receive only a booster dose of GSK Biologicals' DTPa/Hib vaccine (Infanrix+Hib) as part of the local standard of care and will not be associated with any study endpoint.
    Intervention: Biological: Infanrix+Hib
Li R, Li CG, Li Y, Liu Y, Zhao H, Chen X, Kuriyakose S, Van Der Meeren O, Hardt K, Hezareh M, Roy-Ghanta S. Primary and booster vaccination with an inactivated poliovirus vaccine (IPV) is immunogenic and well-tolerated in infants and toddlers in China. Vaccine. 2016 Mar 14;34(12):1436-43. doi: 10.1016/j.vaccine.2016.02.010.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
957
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
  • Subjects who received the complete three-dose primary vaccination course in study NCT01021293.
  • Healthy male or female toddlers 18 to 24 months of age at the time of Visit 1 (Day 0).
  • Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(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 study vaccine(s), or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to Visit 1 (Day 0).
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding Visit 1 (Day 0) or planned administration during the study period.
  • Administration of a vaccine not foreseen by the study protocol within 30 days of Visit 1 (Day 0) 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.
  • Evidence of previous booster vaccination against poliomyelitis or the disease since the conclusion visit of Study NCT01021293.
  • History of seizures or progressive neurological disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
  • Major congenital defects or serious chronic illness.
  • Acute disease and/or fever at the time of enrolment.
Both
18 Months to 24 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01323647
114306
Not Provided
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP