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GSK Biologicals´ Pneumococcal Conjugate Vaccine

Phase 3

Infections, Streptococcal | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Jan 3, 2020

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment245

FDA Designations

No designations recorded

Clinical trial landscape

GSK Biologicals´ Pneumococcal Conjugate Vaccine · 1 trial · 2 indications

Phase 3 1
NCT00609492Evaluate Safety and Immunogenicity of a Booster Dose of Pneumococcal Conjugate Vaccine in Preterm Born Infants.Infections, Streptococcal
COMPLETED245 Analytics
PHASE3COMPLETED
Evaluate Safety and Immunogenicity of a Booster Dose of Pneumococcal Conjugate Vaccine in Preterm Born Infants.
Infections, Streptococcal
NCT00609492245
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Study Endpoints

Primary Endpoints

Number of Subjects Reporting Fever With Rectal Temperature Above (>) 39.0 Degrees Celsius (°C)
Within 4-days (Day 0-3) after booster vaccination

Fever was measured as rectal temperature. Assessment of occurrences of fever \> 39.0 °C was performed within 4-days (Day 0-3) after booster vaccination of Synflorix™ and Infanrix™-IPV/Hib vaccine.

Secondary Endpoints

Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Within 4-days (Day 0-3) after booster vaccination
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Within 4-days (Day 0-3) after booster vaccination
Number of Subjects With Unsolicited Adverse Events (AEs)
Within 31-days (Day 0-30) after booster vaccination
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Preterm I GroupEXPERIMENTALChildren born after a gestation period of 27-30 weeks
Preterm II GroupEXPERIMENTALChildren born after a gestation period of 31-36 weeks
Full term GroupACTIVE_COMPARATORChildren born after a gestation period of more than 36 weeks

Interventions

NameTypeDescription
GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A)BIOLOGICALSingle dose, intramuscular injection
Infanrix™-IPV/HibBIOLOGICALSingle dose, intramuscular injection
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Eligibility Criteria

Age Range16 Months to 18 Months
SexALL
Healthy VolunteersYes
Study Sites7

Inclusion Criteria: * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female between, and including, 16-18 months of age at the time of the booster vaccination. * A male or fem...

Countries:GreeceSpain
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