Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 10 Weeks of Age
- Conditions
- Streptococcus PneumoniaeInfections, Streptococcal
- Interventions
- Biological: Pneumococcal conjugate vaccine GSK1024850ABiological: HiberixBiological: Tritanrix-HepB/HibBiological: Tritanrix-HepB
- Registration Number
- NCT00814710
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Indian infants with pneumococcal conjugate vaccine GSK1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine during the first 4 months of life. The study will be conducted in India.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 360
- Male or female subjects between, and including 6-10 weeks of age at the time of the first vaccination.
- Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
- Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
- Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study).
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, 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 since birth.
- A family history of congenital or hereditary immunodeficiency.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (with the exception of hepatitis B immunoglobulins at birth).
- Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception of hepatitis B vaccination at birth or at least 30 days before the subject's first study visit).
- History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, Streptococcus and Haemophilus influenzae type b disease.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- History of any neurological disorders or seizures.
- Major congenital defects or serious chronic illness.
- Acute disease at the time of enrolment.
- Babies for which birth weight is < 2 kilogram.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Synflorix & Tritanrix-HebB/Hib Group Tritanrix-HepB/Hib Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2) Synflorix & Tritanrix-HebB/Hib Group Pneumococcal conjugate vaccine GSK1024850A Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2) Hiberix group & Tritanrix-HebB Group Hiberix Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2) Hiberix group & Tritanrix-HebB Group Tritanrix-HepB Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
- Primary Outcome Measures
Name Time Method Concentration of Antibody Against Protein D (PD) One month after primary immunization (month 3) Concentrations were expressed as GMCs GSK's 22F-inhibition in enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes One month after primary immunization (month 3) Concentrations were expressed as Geometric Mean Concentrations (GMCs) in microgram per milliliter (µg/mL).
Pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
- Secondary Outcome Measures
Name Time Method Concentrations of Antibodies Against Pneumococcal Cross-reactive Serotypes One month after primary immunization (month 3) Concentrations were expressed as GMCs in µg/mL. Pneumococcal cross-reactive serotypes included 6A and 19A.
Number of Seroprotected Subjects (Anti-PRP Above the Cut-off of 1.0 µg/mL) One month after primary immunization (month 3) Anti-PRP antibody concentration equal to or greater than 1.0 µg/mL.
Concentration of Antibody Against Hepatitis B (Anti-HBs) by Enzyme-Linked ImmunoSorbent Assay (ELISA). One month after primary immunization (month 3) Concentration was expressed as GMC in milli international units per milliliter (mIU/mL). As a decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table shows results following partial or complete retesting/reanalysis.
Number of Subjects Seropositive for Protein D (PD) One month after primary immunization (month 3) Seropositivity for PD was defined greater than or equal to 100 EL.U/mL.
Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP) One month after primary immunization (month 3) Concentration is expressed as GMC in µg/mL.
Concentration of Antibodies Against Diphteria (Anti-DT) and Tetanus (Anti-TT) One month after primary immunization (month 3) Concentrations were expressed as GMCs in international units per milliliter (IU/mL).
Number of Subjects Seropostive for B. Pertussis One month after primary immunization (month 3) Seropositivity was defined as and antibody concentration equal to or greater than 15 EL.U/mL.
Concentration of Antibody Against Bordetella Pertussis (B. Pertussis) One month after primary immunization (month 3) Concentration was expressed as GMC in EL.U/mL.
Number of Subjects Seropositive for Pneumococcal Serotypes One month after primary immunization (month 3) Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A.
Seropositivity was defined as a titer equal to or greater than 0.05 µg/mLNumber of Subjects With Serious Adverse Events (SAEs) Following first vaccination (Month 0) throughout the entire study period (month 3) SAEs assessed include 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.
Number of Seroprotected Subjects (Anti-DT, Anti-TT, Anti-PRP, Anti-HBs) One month after primary immunization (month 3) Seroprotection was defined as:
Anti-DT antibody concentration equal to or greater than 0.1 IU/mL. Anti-TT antibody concentration equal to or greater than 0.1 IU/mL. Anti-PRP antibody concentration equal to or greater than 0.15 µg/mL Anti-HBs antibody concentration greater than or equal to 10 mIU/mL.Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes One month after primary immunization (month 3) Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Cross-reactive pneumococcal serotypes included 6A and 19A.
Opsonophagocytic activity was defined as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer equal to or greater than 8.Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value One month after primary immunization Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A.
The cut-off was defined as 0.20 microgram per milliliter (µg/mL).Number of Subjects With Solicited Local and General Symptoms Within 4 days (day 0-3) after vaccination Solicited local symptoms included pain, redness and swelling. Solicited general symptoms included drowsiness, fever (equal to or above 38 degrees Celsius and above 39 degrees Celsius), irritability and loss of appetite.
Number of Subjects With Unsolicited Adverse Events (AEs) Within 31 days (day 0-30) after vaccination 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.
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms
Trial Locations
- Locations (1)
GSK Investigational Site
🇮🇳Vellore, India