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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: April 19, 2017
Last verified: March 2017

November 25, 2009
April 19, 2017
November 1, 2009
July 5, 2010   (Final data collection date for primary outcome measure)
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 [ Time Frame: At Month 3, one month after the third vaccine dose ]
A seroprotected subject was defined as a vaccinated subject with anti-polio types 1, 2 and 3 titers greater than or equal to (≥) 8 effective dose 50 (ED50).
Immunogenicity with respect to the components of the study vaccines [ Time Frame: One month after the third dose of primary vaccination ]
Complete list of historical versions of study NCT01021293 on ClinicalTrials.gov Archive Site
  • Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 [ Time Frame: At Day 0, prior to the first vaccine dose ]
    A seroprotected subject was defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 titers ≥ 8 ED50.
  • Anti-poliovirus Types 1, 2 and 3 Antibody Titers [ Time Frame: Prior to the first vaccine dose (Day 0) and one month after the third vaccine dose (Month 3) ]
    Antibody titers were presented as geometric mean titers (GMTs).
  • Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 4-day (Days 0-3) post-vaccination period following each vaccine dose and across doses ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried 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 from the Poliorix Group only.
  • Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 4-day (Days 0-3) post-vaccination period following each vaccine dose and across doses ]
    Assessed solicited general symptoms were drowsiness, gastrointestinal symptoms, irritability/fussiness, loss of appetite and fever [defined as axillary temperature higher than (>) 37.0°C degrees Celsius]. Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = subject did not eat at all. Grade 3 gastrointestinal symptoms = gastrointestinal symptoms that prevented normal activity. Grade 3 fever= temperature > 39°C. Related = symptom assessed by the investigator as causally related to the vaccination.
  • Number of Subjects With Any Unsolicited Adverse Events (AEs) [ Time Frame: Within the 31-day (Days 0-30) post-vaccination period ]
    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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (from Day 0 to Month 3) ]
    Serious adverse events (SAEs) assessed include medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity.
  • 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 ]
  • Solicited local and general symptoms [ Time Frame: During the 4-day (Day 0-3) follow-up period following each dose of the study vaccines ]
  • Unsolicited symptoms [ Time Frame: During the 31-day (Day 0-30) follow-up period following each dose of the study vaccines ]
  • Serious adverse events [ Time Frame: From Dose 1 up to study end ]
Not Provided
Not Provided
 
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Poliorix™ Vaccine
Immunogenicity and Safety of GSK Biologicals' IPV (Poliorix™) in Infants
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Prevention
Poliomyelitis
  • Biological: Poliorix™
    3 doses, intramuscular administration
  • Biological: Oral Poliovirus vaccine
    3 doses, oral administration
  • Experimental: Poliorix Group
    Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
    Intervention: Biological: Poliorix™
  • Active Comparator: Control Group
    Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
    Intervention: Biological: Oral Poliovirus vaccine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1101
July 5, 2010
July 5, 2010   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
60 Days to 90 Days   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01021293
112679
Not Provided
Not Provided
Yes
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2017

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