Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Pneumococcal Vaccine (Synflorix™) When Administered to Children Who Are at an Increased Risk of Pneumococcal Infection

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01746108
First received: November 28, 2012
Last updated: April 24, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals' 10Pn-PD-DiT vaccine in children aged between 2 and 17 years of age having asplenia, splenic dysfunction or complement deficiencies.

In addition, this study will include an age-matched control group of healthy children aged 24-59 months in order to descriptively compare the immunogenicity of 10Pn-PD-DiT vaccine in the at-risk population to that of the general, healthy population one month after each pneumococcal vaccination.


Condition Intervention Phase
Infections, Streptococcal
Biological: Synflorix™
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity, Safety and Reactogenicity Study of GSK Biologicals' Pneumococcal Vaccine (Synflorix™) When Administered to Children Who Are at an Increased Risk of Pneumococcal Infection

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Evaluation of immune responses to components of the investigational vaccine. [ Time Frame: 1 month after one vaccine dose in the At-risk-Primed group. ] [ Designated as safety issue: No ]
  • Evaluation of immune responses to components of the investigational vaccine. [ Time Frame: 1 month after two vaccine doses in the At-risk-Unprimed group. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of immune responses to components of the investigational vaccine. [ Time Frame: 1 month after one dose and/or two vaccine doses in the Healthy groups. ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms. [ Time Frame: Within 4 days (Day 0 - Day 3) after each vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events. [ Time Frame: Within 31 days (Day 0 - Day 30) after each vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events. [ Time Frame: From Dose 1 (Month 0) up to study end (approximately Month 3). ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: At-risk-Unprimed Group
Subjects who have not been previously vaccinated with any pneumococcal vaccine and are at an increased risk of pneumococcal infection.
Biological: Synflorix™
1 or 2 doses depending on the priming status, intramuscularly in the non-dominant deltoid muscle or the thigh.
Experimental: At-risk-Primed Group

Subjects who have been previously vaccinated

  • with at least one dose of a pneumococcal conjugate vaccine i.e. either Synflorix (10Pn-PD-DiT), Prevenar or Prevenar13.
  • with plain polysaccharide pneumococcal vaccine more than 2 years and less than 5 years before enrollment.

and are at an increased risk of pneumococcal infection.

Biological: Synflorix™
1 or 2 doses depending on the priming status, intramuscularly in the non-dominant deltoid muscle or the thigh.
Active Comparator: Healthy-Unprimed Group
Subjects who have not been previously vaccinated with any pneumococcal vaccine and are healthy.
Biological: Synflorix™
1 or 2 doses depending on the priming status, intramuscularly in the non-dominant deltoid muscle or the thigh.
Active Comparator: Healthy-Primed Group
Subjects who have been previously vaccinated with at least one dose of a pneumococcal vaccine and are healthy.
Biological: Synflorix™
1 or 2 doses depending on the priming status, intramuscularly in the non-dominant deltoid muscle or the thigh.

Detailed Description:

The protocol has been amended to clarify the definition of priming status to consider for inclusion of subjects in the primed groups.

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [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 and informed assent obtained from the subject, if appropriate, prior to enrollment.
  • Female subjects of non-child bearing potential may be enrolled in the study. (Non-child bearing potential is defined as pre-menarche, current tubal ligation, hysterectomy or ovariectomy).
  • Female subjects of child bearing potential may be enrolled in the study, if the subject:

    • has practiced adequate contraception for 30 days prior to the first vaccination, and
    • has a negative pregnancy test on the day of vaccination, and
    • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Priming status:

  • Children who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, Synflorix (10Pn-PD-DiT), Prevenar or Prevenar13 will be considered for inclusion in the unprimed groups.

Children who have been previously vaccinated with:

  • at least one dose of a pneumococcal conjugate vaccine, i.e. either Synflorix (10Pn-PD-DiT), Prevenar or Prevenar13
  • with plain polysaccharide pneumococcal vaccine more than 2 years and less than 5 years before enrollment.
  • will be considered for inclusion in the primed groups.

Additional inclusion criteria for the At-risk groups:

  • A male or female aged between, and including, 2 and 17 years at the time of first vaccination.
  • For the purpose of this study, at-risk subject is a subject with:

    • Congenital or acquired asplenia such as anatomic, surgical or functional asplenia or
    • Splenic dysfunction, chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc or

Note: All individuals who are diagnosed by the investigator as with splenic dysfunction are eligible for enrollment in the At-risk group. When available, investigator will collect medical documentation for reduced splenic function diagnosed with an appropriate technique in the At-risk subject's medical records. No further assessment will be necessary. A maximum of 35 individuals with sickle-cell disease can be enrolled in the At-risk group. These subjects do not require assessment of the splenic function as sickle-cell disease is invariably associated with severe splenic dysfunction.

- Complement deficiencies. For all subjects defined as At-risk the Investigator will make all efforts to collect information from the subject/subject's parent(s)/LAR(s) during the interview and/or from previously available medical documentation on the date and conditions which have made a child at-risk of pneumococcal infection and/or the results of tests determining spleen dysfunction or complement deficiency. This should be documented in the medical records of the At-risk subject. No originals/copies of medical documentation are needed.

Additional inclusion criteria for the Healthy group:

  • A male or female matched (for age and country) to a subject aged 24-59 months from the At-risk group.
  • 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 first dose of study vaccine, or planned use during the study period.
  • Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of vaccine(s) and ending 30 days after*.

    * In case an emergency mass vaccination for an unforeseen public health threat is organised by the public health authorities, outside the routine immunization program, vaccines can be administered at any time during the study period provided it is licensed and used according to its Summary of Product Characteristics or Prescribing Information and according to the local governmental recommendations and that a written approval of the Sponsor is provided. Vaccines that are recommended for subjects with an increased risk of bacterial infection, can be administered at any time to the subjects enrolled in the At-risk group.

  • 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 (pharmaceutical product or device).
  • History of any neurological disorders or seizures.
  • Acute disease and/or fever at the time of enrollment.
  • History of chronic alcohol consumption and/or drug abuse.
  • Any confirmed or suspected Human Immunodeficiency virus (HIV) infection, based on medical history and physical examination.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • Major congenital defects except medical conditions that define an At-risk subject.
  • Previous vaccination against pneumococcal infection with pneumococcal conjugate vaccine within the last 8 weeks.
  • Previous vaccination against pneumococcal infection with plain polysaccharide vaccine within the last 2 years.

Additional exclusion criteria for the Healthy group:

  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. Inhaled and topical steroids are allowed.
  • Serious chronic illness.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Family history of congenital or hereditary immunodeficiency.
  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: NCT01746108

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
Poland
GSK Investigational Site Recruiting
Krakow, Poland, 31-302
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Warszawa, Poland, 02-127
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Wroclaw, Poland, 50345
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Russian Federation
GSK Investigational Site Recruiting
Barnaul, Russian Federation, 656056
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Novokuznetsk, Russian Federation, 654063
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
St Petersburg, Russian Federation, 197022
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01746108     History of Changes
Other Study ID Numbers: 115884, 2011-006013-34
Study First Received: November 28, 2012
Last Updated: April 24, 2014
Health Authority: Russia: Ministry of Health of the Russian Federation
Poland: Ministry of Health

Keywords provided by GlaxoSmithKline:
Pneumococcal infection
Synflorix
Children
Immunogenicity
Safety

Additional relevant MeSH terms:
Infection
Communicable Diseases
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on October 01, 2014