Safety and Immunogenicity of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)

Safety and Immunogenicity of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744) in Primary Infant Vaccination

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01248884

Enrollment

721

Registered

2010-11-25

Start date

2010-12-09

Completion date

2012-01-05

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tetanus, Poliomyelitis, Hepatitis B, Haemophilus Influenzae Type b, Acellular Pertussis, Diphtheria

Keywords

combination vaccine, Primary vaccination

Brief summary

This study is designed to evaluate the safety and immunogenicity of new formulations of GSK Biologicals' DTPa-HBV-IPV/Hib vaccine (GSK217744) when administered as a primary vaccination course to healthy infants at 2, 3 and 4 months of age.

Detailed description

This Protocol Posting has been updated following Protocol Amendment 1, February 2011, leading to the update of the exclusion criteria.

Interventions

BIOLOGICALInfanrix hexa™

3 doses, intramuscular into left thigh

BIOLOGICALPrevenar 13®

3 co-administered doses, intramuscular into right thigh

BIOLOGICALGSK217744

3 doses, intramuscular into left thigh

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

60 Days to 90 Days

Healthy volunteers

Yes

Inclusion criteria

* A male or female between, and including, 60 and 90 days of age at the time of the first vaccination. * Born after a gestation period of 37 to 42 weeks inclusive. * Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol. * Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion criteria

* Child in care. * Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs since birth. * Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period, with the exception of oral rotavirus vaccination which is allowed at any time during the study. * 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. * Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, Hib and/or pneumococcal vaccination or disease, with the exception of hepatitis B vaccination at birth. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * Family history of congenital or hereditary immunodeficiency. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). * Major congenital defects or serious chronic illness. * History of any neurological disorders or seizures. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * Acute disease and/or fever at the time of enrolment.

Design outcomes

Primary

Measure	Time frame	Description
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.	At Month 0	A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.	At Month 0	Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).
Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.	At Month 3	A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL)	At Month 3	A seroprotected subject was defined as a vaccinated subject who had anti-HBs antibody concentrations ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.
Concentrations for Anti-HBs Antibodies ≥ 10 and 100 mIU/mL	At Month 3	A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis. Concentrations were expressed as geometric mean concentrations (GMCs) in milli-International units per milliliter (mIU/mL).

Secondary

Measure	Time frame	Description
Number of Subjects With a Vaccine Response to PT and PRN.	At Month 3	Vaccine response defined as: for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL at 1 month post primary vaccination (Month 3); for initially seropositive subjects, antibody concentration at 1 month post primary vaccination (Month 3) ≥ 1 fold the pre-vaccination antibody concentration.
Number of Subjects Reporting Any Solicited Local Symptoms.	During the 8-day (Days 0-7)	Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.	At Months 0 and 3	Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).	Within the 31-day (Days 0-30) follow up period after vaccination.	An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.
Number of Subjects Reporting Any Serious Adverse Events (SAEs).	During the entire study period (Month 0 to Month 3)	SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.
Number of Subjects Reporting Any Solicited General Symptoms.	During the 8-day (Days 0-7)	Solicited local symptoms assessed were drowsiness, irritability, loss of appetite and fever \[axillary temperature above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of any local symptom regardless of intensity grade.
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.	At Months 0 and 3	A seropositive subject was defined as a vaccinated subject who had anti-PT and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
Concentrations for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.	At Month 3	Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was ≥ 0.15 µg/mL.
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	At Month 3	A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Concentrations for Anti-PNE Antibodies.	At Month 3	Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

Countries

Dominican Republic, Finland

Participant flow

Recruitment details

A total of 721 subjects were enrolled in the study.

Participants by arm

Arm	Count
GSK217744 Group 1 Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	240
GSK217744 Group 2 Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	242
Infanrix Hexa Group Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	239
Total	721

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	1	0	0
Overall Study	Withdrawal by Subject	1	3	1

Baseline characteristics

Characteristic	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group	Total
Age, Continuous	9.7 Weeks STANDARD_DEVIATION 1.36	9.8 Weeks STANDARD_DEVIATION 1.29	9.7 Weeks STANDARD_DEVIATION 1.21	9.73 Weeks STANDARD_DEVIATION 1.29
Race/Ethnicity, Customized African heritage /African American	1 Participants	0 Participants	1 Participants	2 Participants
Race/Ethnicity, Customized Unspecified	92 Participants	93 Participants	92 Participants	277 Participants
Race/Ethnicity, Customized White - Arabic / north African heritage	3 Participants	1 Participants	6 Participants	10 Participants
Race/Ethnicity, Customized White - Caucasian / European heritage	144 Participants	148 Participants	140 Participants	432 Participants
Sex: Female, Male Female	119 Participants	138 Participants	99 Participants	356 Participants
Sex: Female, Male Male	121 Participants	104 Participants	140 Participants	365 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	240 / 240	239 / 242	235 / 239
serious Total, serious adverse events	9 / 240	5 / 242	4 / 239

Outcome results

Primary

Concentrations for Anti-HBs Antibodies ≥ 10 and 100 mIU/mL

A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis. Concentrations were expressed as geometric mean concentrations (GMCs) in milli-International units per milliliter (mIU/mL).

Time frame: At Month 3

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.

Arm	Measure	Value (GEOMETRIC_MEAN)
GSK217744 Group 1	Concentrations for Anti-HBs Antibodies ≥ 10 and 100 mIU/mL	639.5 mIU/mL
GSK217744 Group 2	Concentrations for Anti-HBs Antibodies ≥ 10 and 100 mIU/mL	602.6 mIU/mL
Infanrix Hexa Group	Concentrations for Anti-HBs Antibodies ≥ 10 and 100 mIU/mL	799.0 mIU/mL

Primary

Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.

Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).

Time frame: At Month 0

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
GSK217744 Group 1	Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.	Anti-PT	3.3 EL.U/mL
GSK217744 Group 1	Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.	Anti-PRN	5.1 EL.U/mL
GSK217744 Group 2	Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.	Anti-PT	3.4 EL.U/mL
GSK217744 Group 2	Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.	Anti-PRN	4.9 EL.U/mL
Infanrix Hexa Group	Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.	Anti-PT	3.1 EL.U/mL
Infanrix Hexa Group	Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.	Anti-PRN	4.9 EL.U/mL

Primary

Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.

Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).

Time frame: At Month 3

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
GSK217744 Group 1	Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.	Anti-PT	57.7 EL.U/mL
GSK217744 Group 1	Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.	Anti-PRN	76.6 EL.U/mL
GSK217744 Group 2	Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.	Anti-PT	57.5 EL.U/mL
GSK217744 Group 2	Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.	Anti-PRN	65.7 EL.U/mL
Infanrix Hexa Group	Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.	Anti-PT	73.2 EL.U/mL
Infanrix Hexa Group	Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.	Anti-PRN	106.6 EL.U/mL

97.5% CI: [1.11, 1.44]

97.5% CI: [1.14, 1.54]

97.5% CI: [1.1, 1.43]

97.5% CI: [1.37, 1.84]

Primary

Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.

A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).

Time frame: At Month 3

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
GSK217744 Group 1	Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.	Anti-D	214 Participants
GSK217744 Group 1	Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.	Anti-T	214 Participants
GSK217744 Group 2	Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.	Anti-D	217 Participants
GSK217744 Group 2	Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.	Anti-T	217 Participants
Infanrix Hexa Group	Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.	Anti-D	219 Participants
Infanrix Hexa Group	Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.	Anti-T	219 Participants

97.5% CI: [-2.25, 2.3]

97.5% CI: [-2.25, 2.27]

Primary

Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.

A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).

Time frame: At Month 0

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
GSK217744 Group 1	Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.	Anti-D	154 Participants
GSK217744 Group 1	Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.	Anti-T	197 Participants
GSK217744 Group 2	Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.	Anti-T	206 Participants
GSK217744 Group 2	Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.	Anti-D	165 Participants
Infanrix Hexa Group	Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.	Anti-D	160 Participants
Infanrix Hexa Group	Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.	Anti-T	209 Participants

Primary

Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.

A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).

Time frame: At Month 3

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GSK217744 Group 1	Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.	197 Participants
GSK217744 Group 2	Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.	190 Participants
Infanrix Hexa Group	Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.	193 Participants

97.5% CI: [-10.19, 3]

97.5% CI: [-6.53, 7.7]

Primary

Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL)

A seroprotected subject was defined as a vaccinated subject who had anti-HBs antibody concentrations ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.

Time frame: At Month 3

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
GSK217744 Group 1	Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL)	Anti-HBs ≥ 100 mIU/mL (ELISA)	184 Participants
GSK217744 Group 1	Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL)	Anti-HBs ≥ 10 mIU/mL (ELISA)	197 Participants
GSK217744 Group 1	Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL)	Anti-HBs ≥ 10 mIU/mL (CLIA)	197 Participants
GSK217744 Group 2	Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL)	Anti-HBs ≥ 100 mIU/mL (ELISA)	183 Participants
GSK217744 Group 2	Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL)	Anti-HBs ≥ 10 mIU/mL (ELISA)	203 Participants
GSK217744 Group 2	Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL)	Anti-HBs ≥ 10 mIU/mL (CLIA)	201 Participants
Infanrix Hexa Group	Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL)	Anti-HBs ≥ 10 mIU/mL (ELISA)	205 Participants
Infanrix Hexa Group	Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL)	Anti-HBs ≥ 10 mIU/mL (CLIA)	203 Participants
Infanrix Hexa Group	Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL)	Anti-HBs ≥ 100 mIU/mL (ELISA)	196 Participants

Comparison: Immune response non-inferiority - anti-HBs (ELISA)97.5% CI: [-3.27, 4.63]

Comparison: Immune response non-inferiority - anti-HBs (ELISA)97.5% CI: [-4.57, 2.36]

Comparison: Immune response non-inferiority - anti-HBs (CLIA)97.5% CI: [-4.62, 3.8]

Comparison: Immune response non-inferiority - anti-HBs (CLIA)97.5% CI: [-5.07, 3.02]

Secondary

Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.

Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.

Time frame: At Months 0 and 3

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
GSK217744 Group 1	Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.	Anti-D at Month 0	0.292 IU/mL
GSK217744 Group 1	Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.	Anti-D at Month 3	1.499 IU/mL
GSK217744 Group 1	Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.	Anti-T at Month 0	0.936 IU/mL
GSK217744 Group 1	Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.	Anti-T at Month 3	1.761 IU/mL
GSK217744 Group 2	Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.	Anti-T at Month 3	1.726 IU/mL
GSK217744 Group 2	Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.	Anti-D at Month 0	0.281 IU/mL
GSK217744 Group 2	Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.	Anti-T at Month 0	0.920 IU/mL
GSK217744 Group 2	Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.	Anti-D at Month 3	1.704 IU/mL
Infanrix Hexa Group	Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.	Anti-T at Month 3	1.947 IU/mL
Infanrix Hexa Group	Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.	Anti-D at Month 3	1.839 IU/mL
Infanrix Hexa Group	Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.	Anti-T at Month 0	0.907 IU/mL
Infanrix Hexa Group	Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.	Anti-D at Month 0	0.290 IU/mL

Secondary

Concentrations for Anti-PNE Antibodies.

Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

Time frame: At Month 3

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
GSK217744 Group 1	Concentrations for Anti-PNE Antibodies.	Anti- PNE 5	0.79 µg /mL
GSK217744 Group 1	Concentrations for Anti-PNE Antibodies.	Anti- PNE 23F	0.89 µg /mL
GSK217744 Group 1	Concentrations for Anti-PNE Antibodies.	Anti- PNE 9V	1.12 µg /mL
GSK217744 Group 1	Concentrations for Anti-PNE Antibodies.	Anti- PNE 6A	1.63 µg /mL
GSK217744 Group 1	Concentrations for Anti-PNE Antibodies.	Anti- PNE 19F	2.55 µg /mL
GSK217744 Group 1	Concentrations for Anti-PNE Antibodies.	Anti- PNE 7F	2.18 µg /mL
GSK217744 Group 1	Concentrations for Anti-PNE Antibodies.	Anti- PNE 6B	0.66 µg /mL
GSK217744 Group 1	Concentrations for Anti-PNE Antibodies.	Anti- PNE 3	0.91 µg /mL
GSK217744 Group 1	Concentrations for Anti-PNE Antibodies.	Anti- PNE 18C	1.56 µg /mL
GSK217744 Group 1	Concentrations for Anti-PNE Antibodies.	Anti- PNE 19A	2.70 µg /mL
GSK217744 Group 1	Concentrations for Anti-PNE Antibodies.	Anti- PNE 4	1.80 µg /mL
GSK217744 Group 1	Concentrations for Anti-PNE Antibodies.	Anti- PNE 1	1.61 µg /mL
GSK217744 Group 1	Concentrations for Anti-PNE Antibodies.	Anti- PNE 14	7.47 µg /mL
GSK217744 Group 2	Concentrations for Anti-PNE Antibodies.	Anti- PNE 18C	1.55 µg /mL
GSK217744 Group 2	Concentrations for Anti-PNE Antibodies.	Anti- PNE 14	7.80 µg /mL
GSK217744 Group 2	Concentrations for Anti-PNE Antibodies.	Anti- PNE 1	1.48 µg /mL
GSK217744 Group 2	Concentrations for Anti-PNE Antibodies.	Anti- PNE 3	0.91 µg /mL
GSK217744 Group 2	Concentrations for Anti-PNE Antibodies.	Anti- PNE 4	1.62 µg /mL
GSK217744 Group 2	Concentrations for Anti-PNE Antibodies.	Anti- PNE 5	0.77 µg /mL
GSK217744 Group 2	Concentrations for Anti-PNE Antibodies.	Anti- PNE 6A	1.43 µg /mL
GSK217744 Group 2	Concentrations for Anti-PNE Antibodies.	Anti- PNE 6B	0.64 µg /mL
GSK217744 Group 2	Concentrations for Anti-PNE Antibodies.	Anti- PNE 7F	2.30 µg /mL
GSK217744 Group 2	Concentrations for Anti-PNE Antibodies.	Anti- PNE 9V	1.11 µg /mL
GSK217744 Group 2	Concentrations for Anti-PNE Antibodies.	Anti- PNE 19A	2.75 µg /mL
GSK217744 Group 2	Concentrations for Anti-PNE Antibodies.	Anti- PNE 19F	2.53 µg /mL
GSK217744 Group 2	Concentrations for Anti-PNE Antibodies.	Anti- PNE 23F	0.83 µg /mL
Infanrix Hexa Group	Concentrations for Anti-PNE Antibodies.	Anti- PNE 19F	2.79 µg /mL
Infanrix Hexa Group	Concentrations for Anti-PNE Antibodies.	Anti- PNE 9V	1.16 µg /mL
Infanrix Hexa Group	Concentrations for Anti-PNE Antibodies.	Anti- PNE 4	1.69 µg /mL
Infanrix Hexa Group	Concentrations for Anti-PNE Antibodies.	Anti- PNE 18C	1.56 µg /mL
Infanrix Hexa Group	Concentrations for Anti-PNE Antibodies.	Anti- PNE 3	0.94 µg /mL
Infanrix Hexa Group	Concentrations for Anti-PNE Antibodies.	Anti- PNE 14	8.03 µg /mL
Infanrix Hexa Group	Concentrations for Anti-PNE Antibodies.	Anti- PNE 19A	2.68 µg /mL
Infanrix Hexa Group	Concentrations for Anti-PNE Antibodies.	Anti- PNE 1	1.58 µg /mL
Infanrix Hexa Group	Concentrations for Anti-PNE Antibodies.	Anti- PNE 6B	0.69 µg /mL
Infanrix Hexa Group	Concentrations for Anti-PNE Antibodies.	Anti- PNE 6A	1.52 µg /mL
Infanrix Hexa Group	Concentrations for Anti-PNE Antibodies.	Anti- PNE 23F	0.91 µg /mL
Infanrix Hexa Group	Concentrations for Anti-PNE Antibodies.	Anti- PNE 7F	2.48 µg /mL
Infanrix Hexa Group	Concentrations for Anti-PNE Antibodies.	Anti- PNE 5	0.82 µg /mL

Secondary

Concentrations for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.

Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was ≥ 0.15 µg/mL.

Time frame: At Month 3

Arm	Measure	Value (GEOMETRIC_MEAN)
GSK217744 Group 1	Concentrations for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.	0.951 µg/mL
GSK217744 Group 2	Concentrations for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.	0.730 µg/mL
Infanrix Hexa Group	Concentrations for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.	1.082 µg/mL

Secondary

Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.

A seropositive subject was defined as a vaccinated subject who had anti-PT and anti-PRN antibody concentrations ≥ 5 EL.U/mL.

Time frame: At Months 0 and 3

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
GSK217744 Group 1	Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.	Anti-PT at Month 0	33 Participants
GSK217744 Group 1	Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.	Anti-PT at Month 3	215 Participants
GSK217744 Group 1	Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.	Anti-PRN at Month 0	84 Participants
GSK217744 Group 1	Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.	Anti-PRN at Month 3	214 Participants
GSK217744 Group 2	Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.	Anti-PRN at Month 3	215 Participants
GSK217744 Group 2	Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.	Anti-PT at Month 0	38 Participants
GSK217744 Group 2	Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.	Anti-PRN at Month 0	89 Participants
GSK217744 Group 2	Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.	Anti-PT at Month 3	217 Participants
Infanrix Hexa Group	Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.	Anti-PRN at Month 3	219 Participants
Infanrix Hexa Group	Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.	Anti-PT at Month 3	218 Participants
Infanrix Hexa Group	Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.	Anti-PRN at Month 0	76 Participants
Infanrix Hexa Group	Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.	Anti-PT at Month 0	31 Participants

Secondary

Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.

A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

Time frame: At Month 3

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
GSK217744 Group 1	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 1	107 Participants
GSK217744 Group 1	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 14	108 Participants
GSK217744 Group 1	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 6B	97 Participants
GSK217744 Group 1	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 19F	107 Participants
GSK217744 Group 1	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 9V	107 Participants
GSK217744 Group 1	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 7F	107 Participants
GSK217744 Group 1	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 4	108 Participants
GSK217744 Group 1	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 23F	103 Participants
GSK217744 Group 1	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 19A	106 Participants
GSK217744 Group 1	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 5	107 Participants
GSK217744 Group 1	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 3	106 Participants
GSK217744 Group 1	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 18C	106 Participants
GSK217744 Group 1	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 6A	108 Participants
GSK217744 Group 2	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 1	112 Participants
GSK217744 Group 2	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 3	105 Participants
GSK217744 Group 2	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 4	112 Participants
GSK217744 Group 2	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 5	109 Participants
GSK217744 Group 2	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 6A	111 Participants
GSK217744 Group 2	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 6B	104 Participants
GSK217744 Group 2	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 7F	111 Participants
GSK217744 Group 2	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 9V	112 Participants
GSK217744 Group 2	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 14	112 Participants
GSK217744 Group 2	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 18C	112 Participants
GSK217744 Group 2	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 19A	112 Participants
GSK217744 Group 2	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 19F	111 Participants
GSK217744 Group 2	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 23F	104 Participants
Infanrix Hexa Group	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 14	114 Participants
Infanrix Hexa Group	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 5	109 Participants
Infanrix Hexa Group	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 19F	114 Participants
Infanrix Hexa Group	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 18C	109 Participants
Infanrix Hexa Group	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 4	114 Participants
Infanrix Hexa Group	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 1	111 Participants
Infanrix Hexa Group	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 19A	114 Participants
Infanrix Hexa Group	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 7F	114 Participants
Infanrix Hexa Group	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 6B	102 Participants
Infanrix Hexa Group	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 3	107 Participants
Infanrix Hexa Group	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 9V	113 Participants
Infanrix Hexa Group	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 6A	112 Participants
Infanrix Hexa Group	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.	Anti- PNE 23F	108 Participants

Secondary

Number of Subjects Reporting Any Serious Adverse Events (SAEs).

SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.

Time frame: During the entire study period (Month 0 to Month 3)

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GSK217744 Group 1	Number of Subjects Reporting Any Serious Adverse Events (SAEs).	9 Participants
GSK217744 Group 2	Number of Subjects Reporting Any Serious Adverse Events (SAEs).	5 Participants
Infanrix Hexa Group	Number of Subjects Reporting Any Serious Adverse Events (SAEs).	4 Participants

Secondary

Number of Subjects Reporting Any Solicited General Symptoms.

Solicited local symptoms assessed were drowsiness, irritability, loss of appetite and fever \[axillary temperature above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of any local symptom regardless of intensity grade.

Time frame: During the 8-day (Days 0-7)

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
GSK217744 Group 1	Number of Subjects Reporting Any Solicited General Symptoms.	Any loss of appetite	135 Participants
GSK217744 Group 1	Number of Subjects Reporting Any Solicited General Symptoms.	Any drowsiness	188 Participants
GSK217744 Group 1	Number of Subjects Reporting Any Solicited General Symptoms.	Any fever	180 Participants
GSK217744 Group 1	Number of Subjects Reporting Any Solicited General Symptoms.	Any irritability	197 Participants
GSK217744 Group 2	Number of Subjects Reporting Any Solicited General Symptoms.	Any loss of appetite	127 Participants
GSK217744 Group 2	Number of Subjects Reporting Any Solicited General Symptoms.	Any irritability	205 Participants
GSK217744 Group 2	Number of Subjects Reporting Any Solicited General Symptoms.	Any fever	173 Participants
GSK217744 Group 2	Number of Subjects Reporting Any Solicited General Symptoms.	Any drowsiness	185 Participants
Infanrix Hexa Group	Number of Subjects Reporting Any Solicited General Symptoms.	Any fever	140 Participants
Infanrix Hexa Group	Number of Subjects Reporting Any Solicited General Symptoms.	Any drowsiness	171 Participants
Infanrix Hexa Group	Number of Subjects Reporting Any Solicited General Symptoms.	Any irritability	191 Participants
Infanrix Hexa Group	Number of Subjects Reporting Any Solicited General Symptoms.	Any loss of appetite	112 Participants

Secondary

Number of Subjects Reporting Any Solicited Local Symptoms.

Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.

Time frame: During the 8-day (Days 0-7)

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
GSK217744 Group 1	Number of Subjects Reporting Any Solicited Local Symptoms.	Any redness	151 Participants
GSK217744 Group 1	Number of Subjects Reporting Any Solicited Local Symptoms.	Any pain	190 Participants
GSK217744 Group 1	Number of Subjects Reporting Any Solicited Local Symptoms.	Any swelling	124 Participants
GSK217744 Group 2	Number of Subjects Reporting Any Solicited Local Symptoms.	Any redness	140 Participants
GSK217744 Group 2	Number of Subjects Reporting Any Solicited Local Symptoms.	Any pain	183 Participants
GSK217744 Group 2	Number of Subjects Reporting Any Solicited Local Symptoms.	Any swelling	122 Participants
Infanrix Hexa Group	Number of Subjects Reporting Any Solicited Local Symptoms.	Any pain	155 Participants
Infanrix Hexa Group	Number of Subjects Reporting Any Solicited Local Symptoms.	Any swelling	115 Participants
Infanrix Hexa Group	Number of Subjects Reporting Any Solicited Local Symptoms.	Any redness	128 Participants

Secondary

Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).

An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.

Time frame: Within the 31-day (Days 0-30) follow up period after vaccination.

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
GSK217744 Group 1	Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).	153 Participants
GSK217744 Group 2	Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).	165 Participants
Infanrix Hexa Group	Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).	159 Participants

Secondary

Number of Subjects With a Vaccine Response to PT and PRN.

Vaccine response defined as: for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL at 1 month post primary vaccination (Month 3); for initially seropositive subjects, antibody concentration at 1 month post primary vaccination (Month 3) ≥ 1 fold the pre-vaccination antibody concentration.

Time frame: At Month 3

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
GSK217744 Group 1	Number of Subjects With a Vaccine Response to PT and PRN.	Anti- PT	195 Participants
GSK217744 Group 1	Number of Subjects With a Vaccine Response to PT and PRN.	Anti- PRN	181 Participants
GSK217744 Group 2	Number of Subjects With a Vaccine Response to PT and PRN.	Anti- PT	204 Participants
GSK217744 Group 2	Number of Subjects With a Vaccine Response to PT and PRN.	Anti- PRN	194 Participants
Infanrix Hexa Group	Number of Subjects With a Vaccine Response to PT and PRN.	Anti- PT	207 Participants
Infanrix Hexa Group	Number of Subjects With a Vaccine Response to PT and PRN.	Anti- PRN	198 Participants

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026

Safety and Immunogenicity of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Concentrations for Anti-HBs Antibodies ≥ 10 and 100 mIU/mL

Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.

Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.

Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.

Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.

Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.

Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL)

Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.

Concentrations for Anti-PNE Antibodies.

Concentrations for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.

Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.

Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.

Number of Subjects Reporting Any Serious Adverse Events (SAEs).

Number of Subjects Reporting Any Solicited General Symptoms.

Number of Subjects Reporting Any Solicited Local Symptoms.

Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).

Number of Subjects With a Vaccine Response to PT and PRN.