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GSK Biologicals´ Pneumococcal Conjugate Vaccine GSK1024850A

Phase 3

Infections, Streptococcal | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Jun 26, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment780

FDA Designations

No designations recorded

Clinical trial landscape

GSK Biologicals´ Pneumococcal Conjugate Vaccine GSK1024850A · 1 trial · 1 indication

Phase 3 1
NCT00652951Co-administration of Pneumococcal Conjugate Vaccine With DTPa-IPV-Hib Versus Co-administration With DTPa-HBV-IPV/HibInfections, Streptococcal
COMPLETED780 Analytics
PHASE3COMPLETED
Co-administration of Pneumococcal Conjugate Vaccine With DTPa-IPV-Hib Versus Co-administration With DTPa-HBV-IPV/Hib
Infections, Streptococcal
NCT00652951780
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Study Endpoints

Primary Endpoints

Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) - Primary Vaccination
At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccine

Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were measured by 22F-inhibition Enzyme-Linked ImmunSorbent Assay (ELISA); presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was greater than or equal to (≥) 0.05 μg/mL.

Antibody Concentration Against Protein D (PD) - Primary Vaccination
At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccine

Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.

Secondary Endpoints

Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Primary Vaccination
At Month 3, one month after the administration of the third vaccine dose
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination
At Month 3, one month after the administration of the third vaccine dose
Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Primary Vaccination.
At Month 3, one month after the administration of the third vaccine dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Synflorix + Infanrix hexa GroupACTIVE_COMPARATORSubjects received 3 doses of SynflorixTM vaccine co-administered with Infanrix hexaTM at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (SynflorixTM) or left (Infanrix hexaTM) thigh or deltoid.
Synflorix + Pediacel GroupEXPERIMENTALSubjects received 3 doses of SynflorixTM vaccine co-administered with PediacelTM at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (SynflorixTM) or left (PediacelTM) thigh or deltoid.thigh or deltoid.
Prevenar + Pediacel GroupACTIVE_COMPARATORSubjects received 3 doses of PrevenarTM co-administered with PediacelTM vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (PrevenarTM) or left (PediacelTM) thigh or deltoid.

Interventions

NameTypeDescription
GSK Biologicals´ Pneumococcal Conjugate Vaccine GSK1024850A (Synflorix™)BIOLOGICALIntramuscular injection, 3 doses in the primary vaccination and 1 dose in the booster vaccination
Infanrix™ hexa.BIOLOGICALIntramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination
Pediacel™BIOLOGICALIntramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination
Prevenar™BIOLOGICALIntramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination
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Eligibility Criteria

Age Range6 Weeks to 12 Weeks
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subjects who the investigator believes that their parents/guardian(s) can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study. * A male or female between, and including, 6-12 w...

Countries:Netherlands
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