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Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00985751
First received: September 24, 2009
Last updated: January 9, 2017
Last verified: January 2017
  Purpose
This study will assess the safety, reactogenicity and immunogenicity of different formulations of GSK Biologicals' pneumococcal vaccine 2189242A when administered alone or in combination with the 10-valent pneumococcal conjugate vaccine (GSK1024850A vaccine) as a 2-dose primary vaccination course followed by a booster dose in healthy children aged 12-23 months at the time of first vaccination. Considering that febrile reactions are frequently observed following pneumococcal vaccination, usually co-administered with other routine paediatric vaccines, the primary study objective will focus on evaluating the increase in grade 3 fever (i.e. rectal temperature >40.0°C).

Condition Intervention Phase
Infections, Streptococcal
Biological: Pneumococcal vaccine GSK2189242A (formulation 1)
Biological: Pneumococcal vaccine GSK2189242A (formulation 2)
Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3)
Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 4)
Biological: Pneumococcal vaccine GSK1024850A
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Vaccination Regimen in Children Aged 12-23 Months at the Time of First Vaccination.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of subjects with fever > 40.0°C (rectal temperature) [ Time Frame: Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccination ]
    The number of subjects with rectal temperature higher (>) than 40.0 degrees Celsius (°C) is reported.


Secondary Outcome Measures:
  • Number of subjects reporting any and grade 3 solicited local symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2 and Booster dose) ]
    Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.

  • Number of subjects reporting any, grade 3 and related solicited general symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2, Booster dose) ]
    Solicited general symptoms assessed include drowsiness, fever (defined as rectally temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness = drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectally temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability = crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite = not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.

  • Number of subjects with unsolicited adverse events (AEs) [ Time Frame: During the 31-day (Days 0-30) follow-up period after each primary dose ]
    An AE is 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. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.

  • Number of subjects with unsolicited adverse events (AEs) [ Time Frame: During the 31-day (Days 0-30) follow-up period after the booster dose ]
    An AE is 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. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.

  • Number of subjects with serious adverse events (SAEs) [ Time Frame: During the entire study period starting at the administration of the first vaccine dose up to study end ]
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  • Anti-pneumococcal dPly and PhtD proteins antibody concentrations [ Time Frame: One month post-dose 2, prior to the booster dose and one month post-booster ]
    Seropositivity status, defined as anti-pneumococcal dPly antibody concentrations ≥ 599 Luminex Units per milliliter (LU/mL) and anti-pneumococcal PhtD antibody concentrations ≥ 391 LU/mL.

  • Anti-pneumococcal serotypes and cross-reactive serotypes antibody concentrations [ Time Frame: One month post-dose 2, prior to the booster dose and one month post-booster ]
    Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and cross-reactive serotype 6A and 19 antibody concentrations ≥ 0.05 microgram per milliliter (µg/mL).

  • Opsonophagocytic activity (OPA) titers against pneumococcal serotypes and cross-reactive serotypes [ Time Frame: One month post-dose 2, prior to the booster dose and one month post-booster ]
    Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and cross-reactive serotypes 6A and 19A ≥ 8.

  • Antibody concentrations to protein D (Anti-PD) [ Time Frame: One month post-dose 2, prior to the booster dose and one month post-booster ]
    Seropositivity status, defined as anti-PD antibody concentrations ≥112 Luminex Units per milliliter (LU/mL).

  • Level of anti-dPly antibodies inhibiting Ply haemolysis activity [ Time Frame: One month post-dose 2, prior to the booster dose and one month post-booster ]
    Inhibition of haemolysis activity of pneumolysin (Ply) by anti-dPly antibodies was measured in vitro by mean of a haemolytic assay. The haemolysis activity could be followed by measuring the level of haemoglobin released. Anti-dPly titers (for inhibition of haemolytic activity) ≥ 140.


Enrollment: 257
Study Start Date: November 2009
Study Completion Date: March 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 Biological: Pneumococcal vaccine GSK2189242A (formulation 1)
Three doses will be administered intramuscularly, at Month 0, 2 and 6.
Experimental: Group 2 Biological: Pneumococcal vaccine GSK2189242A (formulation 2)
Three doses will be administered intramuscularly, at Month 0, 2 and 6
Experimental: Group 3 Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3)
Three doses will be administered intramuscularly, at Month 0, 2 and 6
Experimental: Group 4 Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 4)
Three doses will be administered intramuscularly, at Month 0, 2 and 6
Experimental: Control Group Biological: Pneumococcal vaccine GSK1024850A
Three doses will be administered intramuscularly, at Month 0, 2 and 6

  Eligibility

Ages Eligible for Study:   12 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
  • Male or female between, and including, 12 and 23 months of age at the time of the first vaccination.
  • Written informed consent obtained from the parents/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 within six months prior to the first vaccine dose.
  • Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s).
  • Previous vaccination against S. pneumoniae since birth.
  • History of any hypersensitivity reaction following any previous vaccination.
  • Eczema and any history of allergy
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), including human immunodeficiency virus infection.
  • A family history of congenital or hereditary immunodeficiency.
  • Major congenital defects or any chronic illness.
  • History of any neurologic disorders or seizures.
  • Acute disease and/or fever at the time of enrolment.
  • Fever is defined as temperature >= 37.5°C on oral or axillary setting, or >= 38.0°C on rectal setting.
  • Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
  • Administration of immunoglobulins and/ or any blood products within the 3 months preceding the first dose of study vaccine or planned use during the study period.
  • Child in care.
  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: NCT00985751

Locations
Czech Republic
GSK Investigational Site
Chomutov, Czech Republic, 43003
GSK Investigational Site
Decin, Czech Republic, 405 01
GSK Investigational Site
Nachod, Czech Republic, 547 01
GSK Investigational Site
Odolena voda, Czech Republic, 25070
GSK Investigational Site
Ostrava - Poruba, Czech Republic, 70868
GSK Investigational Site
Pardubice, Czech Republic, 532 03
GSK Investigational Site
Plzen, Czech Republic, 305 99
GSK Investigational Site
Praha 4, Czech Republic, 140 00
GSK Investigational Site
Praha 6, Czech Republic, 1600
GSK Investigational Site
Znojmo, Czech Republic, 669 00
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 113171
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 113171
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 113171
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 113171
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 113171
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00985751     History of Changes
Other Study ID Numbers: 113171 
Study First Received: September 24, 2009
Last Updated: January 9, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
immunogenicity
toddlers
Pneumococcal vaccine
Haemophilus influenzae
safety
Streptococcus pneumoniae
Streptococcus Pneumoniae Vaccines

Additional relevant MeSH terms:
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 24, 2017