Pneumococcal conjugate vaccine GSK1024850A (different lots)
BiologicalIntramuscular injection, 3 doses
NCT Number: NCT00808444
The purpose of the present study is to demonstrate that the changes in the manufacturing process for the commercial lot of the pneumococcal conjugate vaccine GSK1024850A have no clinical impact and that the immune responses are non-inferior to the immune responses induced by the clinical lot. The study will be conducted in Singapore and Malaysia.
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Notify Me6 week–12 week
All sexes
Interventional
Phase 3
GSK Investigational Site, Kuala Lumpur, Malaysia
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intramuscular injection, 3 doses
Intramuscular injection, 3 doses in Malaysia and 2 doses in Singapore
Other names: DTPa-combined vaccine
Intramuscular injection, only for Visit 2 in Singapore
Other names: DTPa-combined vaccine
Oral, 2 doses
Other names: HRV vaccine
Time frame: One month after primary immunization (month 4)
Concentrations are given as Geometric Mean Concentrations (GMCs) in microgram per milliliter (μg/mL).
Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Time frame: One month after primary immunization (month 4)
Concentration was expressed as GMC in GSK's 22F enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time frame: One month after primary immunization (month 4)
Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Time frame: One month after primary immunization (month 4)
Anti-pneumococcal cross-reactive serotypes were 6A and 19A.
Time frame: One month after primary immunization (month 4)
Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
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 4)
Cross-reactive pneumococcal serotypes were 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 4)
Opsonophagocytic titers were expressed as GMTs.
Cross-reactive pneumococcal serotypes included 6A and 19A.
Time frame: One month after primary immunization (month 4)
Titers were given as Geometric Mean Titers (GMTs).
Time frame: One month after primary immunization (month 4)
Concentrations were defined as GMCs in international units per milliter (IU/mL)
Time frame: One month after primary immunization (month 4)
Concentration was given as GMC in milli international units per milliliter (mIU/mL). As a decrease in the specificity of the anti-HB 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 reanalysis.
Time frame: 3 months after primary immunization (month 4)
Concentration was expressed as GMC in units per milliliter (U/mL).
Time frame: Following vaccination and throughout the entire study period (Month 0 to Month 4)
SAEs assessed include medical occurrences that result in death, is 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: One month after primary immunization (month 4)
Titers are presented as Geometric Mean Titers (GMTs).
Pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Time frame: Within 4 days (day 0-3) after vaccination
Solicited local symptoms were pain, redness and swelling.
Solicited general symptoms were drowsiness, fever, irritability, loss of appetite, diarrhoea and vomiting.
Time frame: One month after primary immunization (month 4)
Concentrations are expressed as GMCs in EL.U/mL.
Time frame: One month after primary immunization (month 4)
Concentrain was expressed as GMC in µg/mL.
Time frame: 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.
GlaxoSmithKline
Industry
Non-inferiority of a Commercial Lot of the Pneumococcal Vaccine GSK1024850A Compared to a Clinical Lot.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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