Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
  Purpose
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.

Condition Intervention Phase
Poliomyelitis
Biological: PoliorixTM
Biological: Infanrix+Hib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of a Booster Dose of GlaxoSmithKline Biologicals' IPV (PoliorixTM) in Healthy Chinese Toddlers

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 957
Study Start Date: April 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: PoliorixTM
Single dose, intramuscular administration
Biological: Infanrix+Hib
Single dose, intramuscular injection. Part of the local standard of care. No outcome measures associated.
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.
Biological: Infanrix+Hib
Single dose, intramuscular injection. Part of the local standard of care. No outcome measures associated.

Detailed Description:
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.
  Eligibility

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

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.
  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: NCT01323647

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01323647     History of Changes
Other Study ID Numbers: 114306 
Study First Received: March 24, 2011
Results First Received: October 13, 2016
Last Updated: October 13, 2016
Health Authority: China: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
IPV
PoliorixTM
China

Additional relevant MeSH terms:
Poliomyelitis
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016