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Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Poliorix™ Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01021293
First received: November 25, 2009
Last updated: March 28, 2013
Last verified: February 2011
History of Changes
  Purpose

The purpose of the study is to evaluate the immunogenicity and safety of Poliorix™ when administered to healthy Chinese infants at 2, 3 and 4 months of age.


Condition Intervention Phase
Poliomyelitis
Poliomyelitis Vaccines
 Biological: Poliorix™
Biological: Oral Poliovirus vaccine
 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 GSK Biologicals' IPV (Poliorix™) in Infants

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immunogenicity with respect to the components of the study vaccines [ Time Frame: One month after the third dose of primary vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity with respect to the components of the study vaccines [ Time Frame: Prior to the first dose and one month after the third dose of primary vaccination ] [ Designated as safety issue: No ]
  • Solicited local and general symptoms [ Time Frame: During the 4-day (Day 0-3) follow-up period following each dose of the study vaccines ] [ Designated as safety issue: No ]
  • Unsolicited symptoms [ Time Frame: During the 31-day (Day 0-30) follow-up period following each dose of the study vaccines ] [ Designated as safety issue: No ]
  • Serious adverse events [ Time Frame: From Dose 1 up to study end ] [ Designated as safety issue: No ]

Enrollment: 1101
Study Start Date: November 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Poliorix Group
Subjects will be administered Poliorix™ at 2, 3 and 4 months of age.
 Biological: Poliorix™
3 doses, intramuscular administration
Active Comparator: Control Group
Subjects will be administered an oral poliovirus vaccine at 2, 3 and 4 months of age.
 Biological: Oral Poliovirus vaccine
3 doses, oral administration

  Eligibility

Ages Eligible for Study:   60 Days to 90 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or female infant between, and including, 60 and 90 days of age at the time of the first vaccination.
  • Born after a gestation period of 36 to 42 weeks inclusive.
  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative (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:

  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with exception of DTP, Hib and/or hepatitis B vaccine(s).
  • 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 or intercurrent poliomyelitis disease or vaccination.
  • 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(s).
  • Major congenital defects or serious chronic illness.
  • Child in care.

The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved and if no other exclusion criteria are met:

• Current febrile illness or axillary temperature > 37.0 ºC or other moderate to severe illness within 24 hours of study vaccine administration.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01021293

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01021293     History of Changes
Other Study ID Numbers: 112679
Study First Received: November 25, 2009
Last Updated: March 28, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Poliorix
IPV

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 June 17, 2013