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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
360
Intramuscular injection, 3 doses
Intramuscular injection, 3 doses
Intramuscular injection, 3 doses
GSK Investigational Site
Kolkata, India
GSK Investigational Site
Ludhiana, India
GSK Investigational Site
Pune, India
GSK Investigational Site
Vellore, India
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes
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.
Time frame: One month after primary immunization (month 3)
Concentration of Antibody Against Protein D (PD)
Concentrations were expressed as GMCs GSK's 22F-inhibition in enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time frame: One month after primary immunization (month 3)
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes
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.
Time frame: One month after primary immunization (month 3)
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value
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).
Time frame: One month after primary immunization
Concentrations of Antibodies Against Pneumococcal Cross-reactive Serotypes
Concentrations were expressed as GMCs in µg/mL. Pneumococcal cross-reactive serotypes included 6A and 19A.
Time frame: One month after primary immunization (month 3)
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Intramuscular injection, 3 doses
Number of Subjects Seropositive for Pneumococcal Serotypes
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/mL
Time frame: One month after primary immunization (month 3)
Number of Subjects Seropositive for Protein D (PD)
Seropositivity for PD was defined greater than or equal to 100 EL.U/mL.
Time frame: One month after primary immunization (month 3)
Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP)
Concentration is expressed as GMC in µg/mL.
Time frame: One month after primary immunization (month 3)
Concentration of Antibodies Against Diphteria (Anti-DT) and Tetanus (Anti-TT)
Concentrations were expressed as GMCs in international units per milliliter (IU/mL).
Time frame: One month after primary immunization (month 3)
Concentration of Antibody Against Bordetella Pertussis (B. Pertussis)
Concentration was expressed as GMC in EL.U/mL.
Time frame: One month after primary immunization (month 3)
Concentration of Antibody Against Hepatitis B (Anti-HBs) by Enzyme-Linked ImmunoSorbent Assay (ELISA).
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.
Time frame: One month after primary immunization (month 3)
Number of Subjects Seropostive for B. Pertussis
Seropositivity was defined as and antibody concentration equal to or greater than 15 EL.U/mL.
Time frame: One month after primary immunization (month 3)
Number of Seroprotected Subjects (Anti-DT, Anti-TT, Anti-PRP, Anti-HBs)
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.
Time frame: One month after primary immunization (month 3)
Number of Seroprotected Subjects (Anti-PRP Above the Cut-off of 1.0 µg/mL)
Anti-PRP antibody concentration equal to or greater than 1.0 µg/mL.
Time frame: One month after primary immunization (month 3)
Number of Subjects With Solicited Local and General Symptoms
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.
Time frame: Within 4 days (day 0-3) after vaccination
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. 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
Time frame: Within 31 days (day 0-30) after vaccination
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, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: Following first vaccination (Month 0) throughout the entire study period (month 3)