Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Booster Vaccination Study With a Pneumococcal Vaccine in Children Primed With the Same Vaccine

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00911144
First received: May 28, 2009
Last updated: November 10, 2011
Last verified: November 2011
  Purpose

The purpose of this study is to evaluate the reactogenicity, safety and immunogenicity of a booster (fourth) dose of pneumococcal vaccine GSK1024850A when co-administered with Hiberix at 12-18 months of age, in children primed with the same vaccines in primary study NCT00680914.


Condition Intervention Phase
Streptococcus Pneumoniae
Pneumococcal Diseases
Biological: GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A)
Biological: Wyeth-Lederle's Prevenar™
Biological: GSK Biologicals' Hiberix™
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Booster Vaccination With Pneumococcal Vaccine GSK1024850A or Prevenar™ Co-administered With Hiberix™ in Children Primed With the Same Vaccines

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects Reporting Grade 3 Adverse Events [ Time Frame: Within 31 days (Day 0 - Day 30) after booster vaccination. ] [ Designated as safety issue: No ]
    Grade 3 adverse events are severe symptoms that prevent normal, everyday activities.


Secondary Outcome Measures:
  • Number of Subjects Reporting Solicited Symptoms [ Time Frame: Within 4 days (Days 0 to 3) after booster vaccination ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, fever (equal to or above 37.5 degrees Celsius), irritability and loss of appetite.

  • Number of Subjects Reporting Unsolicited Adverse Events [ Time Frame: Within 31 days (Days 0 to 30) after booster vaccination ] [ Designated as safety issue: No ]
    An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.

  • Number of Subjects Reporting Serious Adverse Events [ Time Frame: After booster vaccination up to study end (Month 0 to Month 1) ] [ Designated as safety issue: No ]
    Serious adverse events are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

  • Concentration of Antibodies Against Vaccine Pneumococcal Serotypes [ Time Frame: One month after booster vaccination (Month 1) ] [ Designated as safety issue: No ]

    Concentrations of antibodies are measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations expressed as microgram per milliliter.

    Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.


  • Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes [ Time Frame: One month after booster vaccination (Month 1) ] [ Designated as safety issue: No ]

    Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.

    Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.


  • Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A [ Time Frame: One month after booster vaccination (Month 1) ] [ Designated as safety issue: No ]
    Concentrations of antibodies are measured by 22F-inhibition ELISA and are presented as geometric mean concentrations expressed as microgram per milliliter.

  • Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A [ Time Frame: One month after booster vaccination (Month 1) ] [ Designated as safety issue: No ]
    Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.

  • Concentration of Antibodies Against Protein D (PD) [ Time Frame: One month after booster vaccination (Month 1) ] [ Designated as safety issue: No ]
    Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per milliliter.

  • Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP) [ Time Frame: One month after booster vaccination (Month 1) ] [ Designated as safety issue: No ]
    Concentrations of antibodies are presented as geometric mean concentrations expressed as microgram per milliliter.


Enrollment: 450
Study Start Date: June 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Synflorix Group
Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
Biological: GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A)
Intramuscular injection, administered as a single dose
Other Name: Pneumococcal vaccine GSK1024850A
Biological: GSK Biologicals' Hiberix™
Intramuscular injection, administered as a single dose
Other Name: Hib
Active Comparator: Prevenar Group
Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
Biological: Wyeth-Lederle's Prevenar™
Intramuscular injection, administered as a single dose
Biological: GSK Biologicals' Hiberix™
Intramuscular injection, administered as a single dose
Other Name: Hib

  Eligibility

Ages Eligible for Study:   12 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or female between, and including, 12-18 months of age at the time of booster vaccination.
  • Subjects for whom the investigator believes that their parent(s)/ guardian(s) can and will comply with the requirements of the protocol.
  • Subjects who received three doses of pneumococcal conjugate vaccine in study NCT00680914.
  • Written informed consent obtained from the parent(s)/guardian(s) of the child/ward.
  • 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 (drug or vaccine) within 30 days preceding the vaccination, or planned use 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 (pharmaceutical product or device).
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
  • Administration of immunoglobulins and/or any blood products within three months preceding the vaccination or planned administration during the study period.
  • Administration of any pneumococcal and/or Hib vaccine since the end of study NCT00680914.
  • Planned administration/administration of a vaccine not allowed by the study protocol during the period starting 1 month (30 days) before the administration of the booster dose of the study vaccines (Visit 1) and up to the follow-up visit (Visit 2) with the exception of vaccines included in the Korean routine immunization which can be given at least one week before the administration of the study vaccines or after study end.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of reactions or allergic disease likely to be exacerbated by any component of the study vaccines.
  • Known hypersensitivity to any component of the study vaccines including anaphylactic reactions following the administration of the study vaccines.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Tympanic or axillary/ oral temperature >= 37.5°C or rectal temperature >= 38.0°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
  • Acute disease 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: NCT00911144

Locations
Korea, Republic of
GSK Investigational Site
Ansan, Korea, Republic of, 425-707
GSK Investigational Site
Bucheon-Si, GyeongGi-do,, Korea, Republic of, 420-767
GSK Investigational Site
Daejeon, Korea, Republic of, 301-723
GSK Investigational Site
Gyeonggi-do, Korea, Republic of, 411-706
GSK Investigational Site
GyeongSangNam-do, Korea, Republic of, 641-560
GSK Investigational Site
Iksan, Korea, Republic of, 570-711
GSK Investigational Site
Jeju City, Korea, Republic of, 690-121
GSK Investigational Site
Jeonju Jeonbuk, Korea, Republic of, 561-712
GSK Investigational Site
Pusan, Korea, Republic of, 602-739
GSK Investigational Site
Seoul, Korea, Republic of, 130-702
GSK Investigational Site
Seoul, Korea, Republic of, 158-710
GSK Investigational Site
Seoul, Korea, Republic of, 150-719
GSK Investigational Site
Suwon City, Gyeonggi-do, Korea, Republic of, 442-723
GSK Investigational Site
Wonju-si Kangwon-do, Korea, Republic of, 220-701
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00911144     History of Changes
Other Study ID Numbers: 112933
Study First Received: May 28, 2009
Results First Received: January 6, 2011
Last Updated: November 10, 2011
Health Authority: Korea: Korea Food & Drug Administration

Keywords provided by GlaxoSmithKline:
Safety
Pneumococcal vaccine
Immunogenicity
Pneumococcal disease
Booster vaccination

ClinicalTrials.gov processed this record on November 25, 2014