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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: March 21, 2017
Last verified: March 2017

September 24, 2009
March 21, 2017
November 2009
October 2010   (Final data collection date for primary outcome measure)
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.
Occurrence of fever >40.0°C (rectal temperature) [ Time Frame: Within 7 days (Day 0-6) following at least one dose of the primary vaccinations. ]
Complete list of historical versions of study NCT00985751 on ClinicalTrials.gov Archive Site
  • 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.
  • Occurrence of each solicited local and general adverse events [ Time Frame: Within 7 days (Day 0-6) after each vaccination ]
  • Occurrence of unsolicited adverse events [ Time Frame: Within 31 days (Day 0-30) after each vaccination ]
  • Occurrence of serious adverse events [ Time Frame: From the first vaccine dose up to study end ]
  • Evaluation of the immune responses to components of the investigational vaccines [ Time Frame: One month post-dose 2, before booster dose and one month post-booster dose ]
Not Provided
Not Provided
 
Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination
Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Vaccination Regimen in Children Aged 12-23 Months at the Time of First Vaccination.
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).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Prevention
Infections, Streptococcal
  • Biological: Pneumococcal vaccine GSK2189242A (formulation 1)
    Three doses will be administered intramuscularly, at Month 0, 2 and 6.
  • Biological: Pneumococcal vaccine GSK2189242A (formulation 2)
    Three doses will be administered intramuscularly, at Month 0, 2 and 6
  • Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3)
    Three doses will be administered intramuscularly, at Month 0, 2 and 6
  • Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 4)
    Three doses will be administered intramuscularly, at Month 0, 2 and 6
  • Biological: Pneumococcal vaccine GSK1024850A
    Three doses will be administered intramuscularly, at Month 0, 2 and 6
  • Experimental: Group 1
    Intervention: Biological: Pneumococcal vaccine GSK2189242A (formulation 1)
  • Experimental: Group 2
    Intervention: Biological: Pneumococcal vaccine GSK2189242A (formulation 2)
  • Experimental: Group 3
    Intervention: Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3)
  • Experimental: Group 4
    Intervention: Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 4)
  • Experimental: Control Group
    Intervention: Biological: Pneumococcal vaccine GSK1024850A
Prymula R, Pazdiora P, Traskine M, Rüggeberg JU, Borys D. Safety and immunogenicity of an investigational vaccine containing two common pneumococcal proteins in toddlers: a phase II randomized clinical trial. Vaccine. 2014 May 23;32(25):3025-34. doi: 10.1016/j.vaccine.2014.03.066.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
257
March 2011
October 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
12 Months to 23 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
 
NCT00985751
113171
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