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: July 26, 2012
Last verified: February 2012
  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:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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
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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01323647     History of Changes
Other Study ID Numbers: 114306
Study First Received: March 24, 2011
Last Updated: July 26, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
IPV
PoliorixTM
China

Additional relevant MeSH terms:
Poliomyelitis
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on July 09, 2014