Infections, Streptococcal Clinical Trial
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.
Verified date | October 2020 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 257 |
Est. completion date | March 2, 2011 |
Est. primary completion date | October 12, 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Months to 23 Months |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Czechia | GSK Investigational Site | Chomutov | |
Czechia | GSK Investigational Site | Decin | |
Czechia | GSK Investigational Site | Nachod | |
Czechia | GSK Investigational Site | Odolena voda | |
Czechia | GSK Investigational Site | Ostrava - Poruba | |
Czechia | GSK Investigational Site | Pardubice | |
Czechia | GSK Investigational Site | Plzen | |
Czechia | GSK Investigational Site | Praha 4 | |
Czechia | GSK Investigational Site | Praha 6 | |
Czechia | GSK Investigational Site | Znojmo |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Czechia,
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. Epub 2014 Apr 1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects With Fever > 40.0°C (Rectal Temperature) | The number of subjects with rectal temperature higher (>) than 40.0 degrees Celsius (°C) is reported. | Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccination | |
Secondary | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | 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. | During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2 and Booster dose) | |
Secondary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | 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. | During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2, Booster dose) | |
Secondary | Number of Subjects With Unsolicited Adverse Events (AEs) | 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. | During the 31-day (Days 0-30) follow-up period after each primary dose | |
Secondary | Number of Subjects With Unsolicited Adverse Events (AEs) | 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. | During the 31-day (Days 0-30) follow-up period after the booster dose | |
Secondary | Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | During the entire study period starting at the administration of the first vaccine dose up to study end (from Day 0 up to Month 7) | |
Secondary | Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations | 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. | One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7) | |
Secondary | Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations | 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). | One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7) | |
Secondary | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes | 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. | One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7) | |
Secondary | Antibody Concentrations to Protein D (Anti-PD) | Seropositivity status, defined as anti-PD antibody concentrations = 112 Luminex Units per milliliter (LU/mL). | One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7) | |
Secondary | Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity | 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. | One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7) |
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