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CompletedNCT01453998Updated Jul 17, 2020Results posted

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

A Phase 2 interventional study of Infanrix hexa and Prevenar 13 in Acellular Pertussis, Hepatitis B and Haemophilus Influenzae Type b, sponsored by GlaxoSmithKline. Completed at 16 sites in 2 countries. Open to participants aged 12 Months to 15 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-17.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
657
Allocation
Non-randomized
Ages
12 Months to 15 Months
Sex
All
01

Study summary

The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the booster vaccine dose of 2 new formulations of DTPa-HBV-IPV/Hib administered between 12 and 15 months of age, and the immune persistence following the primary series. All children in this booster study received a primary vaccination at 2, 3 and 4 months of age in study 113948 (NCT01248884). No new subjects will be enrolled in this booster study.

02

Conditions studied

  • Acellular Pertussis
  • Hepatitis B
  • Haemophilus Influenzae Type b
  • Tetanus
  • Diphtheria
  • Poliomyelitis
03

In context

Hepatitis B

1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.

This study's enrollment of 657 is above the median of 120 across 1,187 interventional studies indexed under Hepatitis B.

Browse Hepatitis B studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Months to 15 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Subjects who participated in the study 113948 (NCT01248884) and received three doses of the new or licensed DTPa-HBV-IPV/Hib study vaccine.
  • A male or female child between, and including, 12 and 15 months of age at the time of the booster vaccination.
  • Subjects who the investigator believes that parent(s)/ Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visit).
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion criteria

Exclusion Criteria:

  • Child in care.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.
  • Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period.
  • Participation in another clinical study within three months prior to enrolment in the present booster study or at any time during the present booster study, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • Evidence of previous or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Hib vaccination or disease since the conclusion visit of study 113948 (NCT01248884).
  • Serious chronic illness.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
  • History of any neurological disorders or seizures.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the booster dose of study vaccine or planned administration during the study period.

  • Occurrence of any of the following events following previous administration of the study vaccine constitutes an absolute contraindication to further dosing.

    • Anaphylactic or other hypersensitivity reaction.
    • Encephalopathy defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours.
    • Temperature of ≥ 40.0°C (axillary) or 40.5°C (rectal) within 48 hours of vaccination, not due to another identifiable cause.
    • Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination.
    • Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting ≥ 3 hours.
    • Seizures with or without fever occurring within 3 days of vaccination.

The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:

  • Acute disease and/or fever at the time of enrolment.
  • Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting, or ≥ 38.0° on rectal setting.
  • Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
657 participants (actual)

Study arms

  • Experimental
    GSK217744 Group 1

    Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.

    Biological: Infanrix hexa · Biological: Prevenar 13 · Biological: GSK217744

  • Experimental
    GSK217744 Group 2

    Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.

    Biological: Infanrix hexa · Biological: Prevenar 13 · Biological: GSK217744

  • Active comparator
    Infanrix hexa Group

    Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.

    Biological: Infanrix hexa · Biological: Prevenar 13

Interventions

  • BiologicalInfanrix hexa

    Single dose, licensed formulation, intramuscular into right thigh

    Also known as: DTPa-HBV-IPV/Hib

  • BiologicalPrevenar 13

    Single co-administered dose, intramuscular into left thigh

    Also known as: Pfizer's 13-valent pneumococcal polysaccharide conjugate vaccine

  • BiologicalGSK217744

    Single dose, investigational formulation A or B, intramuscular into right thigh

06

What researchers measure

Primary outcomes

  1. 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: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

  2. Number of Seroprotected Subjects for Anti-D and 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: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

  3. Number of Seroprotected Subjects Against Anti-Hepatitis B (Anti-HBs) Antigens

    A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).

    Time frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

  4. Number of Seroprotected Subjects Against Anti-HBs Antigens

    A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).

    Time frame: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

  5. Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3

    A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.

    Time frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

  6. Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3

    A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.

    Time frame: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

  7. Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP)

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

    Time frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

  8. Number of Seroprotected Subjects for Anti-PRP

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

    Time frame: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

  9. Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)

    Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.

    Time frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

  10. Concentrations for Anti-PT, Anti-FHA and Anti-PRN

    Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.

    Time frame: 1 month post booster vaccination (subjects enrolled after protocol amendment 2)

Secondary outcomes

  1. 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: Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

  2. Concentrations for Anti-D and 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: Before (PRE) 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

  3. 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: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)

  4. Number of Seroprotected Subjects for Anti-D and 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: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)

  5. Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)

    Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.

    Time frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)

  6. Concentrations for Anti-PT, Anti-FHA and Anti-PRN

    Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.

    Time frame: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)

  7. Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)

    A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).

    Time frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

  8. Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN

    A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).

    Time frame: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

  9. Anti-Hepatitis B (Anti-HBs) Antibody Concentrations

    Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.

    Time frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2))

  10. Anti-HBs Antibody Concentrations

    Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.

    Time frame: 1 month post booster vaccination (POST) ( subjects enrolled after protocol amendment 2)

  11. Anti-Hepatitis B (Anti-HBs) Antibody Concentration

    Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.

    Time frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)

  12. Anti-HBs Antibody Concentrations

    Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.

    Time frame: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)

  13. Number of Seroprotected Subjects Against Anti-Hepatitis B (Anti-HBs) Antigens

    A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).

    Time frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)

  14. Number of Seroprotected Subjects Against Anti-HBs Antigens

    A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).

    Time frame: Before (PRE) booaster vaccination (subjects enrolled after protocol amendment 2)

  15. Concentrations for Anti-poliovirus Types 1, 2, 3

    Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.

    Time frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)

  16. Concentration for Anti-poliovirus Types 1, 2, 3

    Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.

    Time frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

  17. Concentrations for Anti-poliovirus Types 1, 2 and 3

    Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.

    Time frame: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

  18. Concentration for Anti-poliovirus Type 1, 2 and 3

    Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.

    Time frame: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)

  19. Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3

    A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.

    Time frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)

  20. Number of Seroprotected Subjects Against Anti-Poliovirus Type 1, 2 and 3

    A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.

    Time frame: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)

  21. 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: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

  22. Concentrations for 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: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

  23. 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: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)

  24. Concentrations for Anti-polyribosyl-ribitol Phosphate Antibodies

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

    Time frame: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2))

  25. Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)

    A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).

    Time frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)

  26. Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN

    A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).

    Time frame: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)

  27. Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP)

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

    Time frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)

  28. Number of Seroprotected Subjects for Anti-PRP

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

    Time frame: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)

  29. Concentrations for Anti-pneumococcal (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: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

  30. 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: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

  31. 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: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

  32. Number of Seropositive Subjects for 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: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

  33. Number of Subjects With Booster Response to Anti-pertussis Antigens (Anti-PT, Anti-FHA and Anti-PRN)

    Booster response defined as : - For initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month after booster vaccination - For initially seropositive subjects, antibody concentration at Post-booster ≥ 2 fold the pre-vaccination antibody concentration

    Time frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

  34. Number of Subjects With Booster Response to Anti-pertussis Antigens

    Booster response defined as : - For initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month after booster vaccination - For initially seropositive subjects, antibody concentration at Post-booster ≥ 2 fold the pre-vaccination antibody concentration

    Time frame: 1 month poste booster vaccination (POST) (subjects enrolled after protocol amendment 2)

  35. 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 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2)

  36. Number of Subjects Reporting Any Solicited Local Symptom

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

    Time frame: During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2)

  37. Number of Subjects Reporting Any Solicited General Symptoms

    Solicited local symptoms assessed were drowsiness, irritability/fussiness, 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 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2)

  38. Number of Subjects Reporting Any Solicited General Symptom

    Solicited local symptoms assessed were drowsiness, irritability/fussiness, 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 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2)

  39. 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. (subjects enrolled before protocol amendment 2)

  40. Number of Subjects Reporting Any Unsolicited 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. (subjects enrolled after protocol amendment 2)

  41. 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 (Days 0-30). (subjects enrolled before protocol amendment 2)

  42. Number of Subjects Reporting Any 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 (Days 0-30). (subjects enrolled after protocol amendment 2)

07

Results

Posted Jul 28, 2014

Participant flow

A total of 272 subjects were enrolled in the study before the second protocol amendment and total of 385 after the amendment. After amendment 2, all subjects yet to receive a booster dose of a GSK217744 formulation, were administered the Infanrix hexa vaccine.

Before Protocol Amendment 2
Participant flow — Before Protocol Amendment 2
MilestoneGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Started858899
Completed858899
Not completed000
After Protocol Amendment 2.
Participant flow — After Protocol Amendment 2.
MilestoneGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Started131130124
Completed130130124
Not completed100
Withdrew: Withdrawal by subject100

Outcome measures

PrimaryNumber 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:
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Reported as:
Count of participants · Participants
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
ParticipantsGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Anti-D, POST818290
Anti-T, POST818290
PrimaryNumber of Seroprotected Subjects for Anti-D and 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:
1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Reported as:
Count of participants · Participants
Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies
ParticipantsGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Anti-D, POST123122118
Anti-T, POST123122118
PrimaryNumber of Seroprotected Subjects Against Anti-Hepatitis B (Anti-HBs) Antigens

A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).

Time frame:
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Reported as:
Count of participants · Participants
Number of Seroprotected Subjects Against Anti-Hepatitis B (Anti-HBs) Antigens
ParticipantsGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Number of Seroprotected Subjects Against Anti-Hepatitis B (Anti-HBs) Antigens787884
PrimaryNumber of Seroprotected Subjects Against Anti-HBs Antigens

A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).

Time frame:
1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Reported as:
Count of participants · Participants
Number of Seroprotected Subjects Against Anti-HBs Antigens
ParticipantsGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Number of Seroprotected Subjects Against Anti-HBs Antigens121113114
PrimaryNumber of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3

A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.

Time frame:
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Reported as:
Count of participants · Participants
Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3
ParticipantsGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Anti-Polio 1, POST767285
Anti-Polio 2, POST626076
Anti-Polio 3, POST646371
PrimaryNumber of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3

A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.

Time frame:
1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Reported as:
Count of participants · Participants
Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3
ParticipantsGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Anti-Polio 1, POST111107102
Anti-Polio 2, POST969687
Anti-Polio 3, POST11310398
PrimaryNumber of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP)

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

Time frame:
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Reported as:
Count of participants · Participants
Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP)
ParticipantsGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP)818290
PrimaryNumber of Seroprotected Subjects for Anti-PRP

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

Time frame:
1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Reported as:
Count of participants · Participants
Number of Seroprotected Subjects for Anti-PRP
ParticipantsGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Number of Seroprotected Subjects for Anti-PRP122122117
PrimaryConcentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)

Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.

Time frame:
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Reported as:
Geometric mean · EL.U/mL
Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)
EL.U/mLGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Anti-PT, POST76.1 (66.1 to 87.6)74.3 (62.6 to 88.1)96.0 (83.5 to 110.3)
Anti-FHA, POST393.7 (346.4 to 447.6)372.4 (332.7 to 416.7)423.0 (368.1 to 485.9)
Anti-PRN, POST213.0 (178.1 to 254.7)180.0 (154.2 to 210.1)372.9 (309.3 to 449.5)
PrimaryConcentrations for Anti-PT, Anti-FHA and Anti-PRN

Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.

Time frame:
1 month post booster vaccination (subjects enrolled after protocol amendment 2)
Reported as:
Geometric mean · EL.U/mL
Concentrations for Anti-PT, Anti-FHA and Anti-PRN
EL.U/mLGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Anti-PT, POST92.4 (80.6 to 106.0)93.6 (83.1 to 105.5)132.6 (114.9 to 153.0)
Anti-FHA, POST467.3 (417.3 to 523.3)446.2 (402.3 to 494.9)582.9 (517.1 to 657.1)
Anti-PRN, POST253.2 (216.9 to 295.6)181.0 (154.8 to 211.7)401.1 (342.2 to 470.0)
SecondaryConcentrations 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:
Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Reported as:
Geometric mean · IU/mL
Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
IU/mLGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Anti-D, POST5.652 (4.985 to 6.408)5.494 (4.891 to 6.171)6.772 (5.897 to 7.777)
Anti-T, POST5.015 (4.341 to 5.794)5.034 (4.366 to 5.803)5.571 (4.869 to 6.374)
Anti-D, PRE0.357 (0.305 to 0.419)0.445 (0.381 to 0.520)0.401 (0.343 to 0.468)
Anti-T, PRE0.358 (0.301 to 0.427)0.362 (0.306 to 0.428)0.394 (0.337 to 0.459)
SecondaryConcentrations for Anti-D and 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:
Before (PRE) 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Reported as:
Geometric mean · IU/mL
Concentrations for Anti-D and Anti-T Antibodies
IU/mLGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Anti-D, POST6.327 (5.698 to 7.025)5.452 (4.956 to 5.998)7.192 (6.419 to 8.059)
Anti-T, POST5.986 (5.204 to 6.885)5.316 (4.716 to 5.992)5.993 (5.222 to 6.878)
Anti-D, PRE0.247 (0.213 to 0.287)0.278 (0.244 to 0.317)0.304 (0.258 to 0.360)
Anti-T, PRE0.364 (0.313 to 0.422)0.332 (0.289 to 0.380)0.331 (0.285 to 0.383)
SecondaryNumber 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:
Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Reported as:
Count of participants · Participants
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
ParticipantsGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Anti-D, PRE788084
Anti-T, PRE767885
SecondaryNumber of Seroprotected Subjects for Anti-D and 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:
Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Reported as:
Count of participants · Participants
Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies
ParticipantsGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Anti-D, PRE107114104
Anti-T, PRE116114111
SecondaryConcentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)

Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.

Time frame:
Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Reported as:
Geometric mean · EL.U/mL.
Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)
EL.U/mL.GSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Anti-PT, PRE10.5 (8.8 to 12.6)9.5 (7.9 to 11.4)12.7 (10.8 to 15.0)
Anti-FHA, PRE41.7 (35.4 to 49.2)36.9 (31.5 to 43.3)47.1 (40.3 to 55.1)
Anti-PRN, PRE12.8 (10.4 to 15.7)10.8 (8.9 to 13.1)18.2 (15.0 to 22.1)
SecondaryConcentrations for Anti-PT, Anti-FHA and Anti-PRN

Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.

Time frame:
Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Reported as:
Geometric mean · EL.U/mL
Concentrations for Anti-PT, Anti-FHA and Anti-PRN
EL.U/mLGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Anti-PT, PRE8.3 (7.2 to 9.7)7.9 (6.8 to 9.1)9.9 (8.5 to 11.5)
Anti-FHA, PRE37.6 (32.5 to 43.4)34.0 (28.7 to 40.4)45.7 (38.8 to 53.9)
Anti-PRN, PRE11.6 (9.7 to 13.9)9.7 (8.1 to 11.7)15.6 (13.0 to 18.7)
SecondaryNumber of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)

A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).

Time frame:
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Reported as:
Count of participants · Participants
Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)
ParticipantsGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Anti-PT, POST798189
Anti-FHA, POST818290
Anti-PRN, POST818189
SecondaryNumber of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN

A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).

Time frame:
1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Reported as:
Count of participants · Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN
ParticipantsGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Anti-PT, POST118121116
Anti-FHA, POST123122117
Anti-PRN, POST122122117
SecondaryAnti-Hepatitis B (Anti-HBs) Antibody Concentrations

Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.

Time frame:
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2))
Reported as:
Geometric mean · mIU/mL
Anti-Hepatitis B (Anti-HBs) Antibody Concentrations
mIU/mLGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Anti-Hepatitis B (Anti-HBs) Antibody Concentrations2233.3 (1479.7 to 3370.8)2026.3 (1389.4 to 2955.2)2685.7 (1868.8 to 3859.7)
SecondaryAnti-HBs Antibody Concentrations

Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.

Time frame:
1 month post booster vaccination (POST) ( subjects enrolled after protocol amendment 2)
Reported as:
Geometric mean · mIU/mL
Anti-HBs Antibody Concentrations
mIU/mLGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Anti-HBs Antibody Concentrations2229.3 (1625.5 to 3057.5)1729.8 (1240.6 to 2411.9)3711.4 (2729.7 to 5046.1)
SecondaryAnti-Hepatitis B (Anti-HBs) Antibody Concentration

Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.

Time frame:
Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Reported as:
Geometric mean · mIU/mL
Anti-Hepatitis B (Anti-HBs) Antibody Concentration
mIU/mLGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Anti-Hepatitis B (Anti-HBs) Antibody Concentration130.3 (91.2 to 186.0)124.4 (89.5 to 173.0)166.4 (112.8 to 245.5)
SecondaryAnti-HBs Antibody Concentrations

Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.

Time frame:
Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Reported as:
Geometric mean · mIU/mL
Anti-HBs Antibody Concentrations
mIU/mLGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Anti-HBs Antibody Concentrations94.9 (72.2 to 124.8)61.8 (45.7 to 83.5)125.9 (94.6 to 167.7)
SecondaryNumber of Seroprotected Subjects Against Anti-Hepatitis B (Anti-HBs) Antigens

A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).

Time frame:
Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Reported as:
Count of participants · Participants
Number of Seroprotected Subjects Against Anti-Hepatitis B (Anti-HBs) Antigens
ParticipantsGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Number of Seroprotected Subjects Against Anti-Hepatitis B (Anti-HBs) Antigens687478
SecondaryNumber of Seroprotected Subjects Against Anti-HBs Antigens

A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).

Time frame:
Before (PRE) booaster vaccination (subjects enrolled after protocol amendment 2)
Reported as:
Count of participants · Participants
Number of Seroprotected Subjects Against Anti-HBs Antigens
ParticipantsGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Number of Seroprotected Subjects Against Anti-HBs Antigens108100106
SecondaryConcentrations for Anti-poliovirus Types 1, 2, 3

Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.

Time frame:
Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Reported as:
Geometric mean · Titers
Concentrations for Anti-poliovirus Types 1, 2, 3
TitersGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Anti-Polio 1, PRE18.2 (13.7 to 24.1)17.8 (13.5 to 23.5)22.4 (16.8 to 29.9)
Anti-Polio 2, PRE12.7 (9.5 to 16.9)17.1 (12.3 to 23.8)16.6 (12.0 to 22.8)
Anti-Polio, 3 PRE24.7 (17.1 to 35.8)16.8 (12.0 to 23.5)26.6 (19.2 to 36.9)
SecondaryConcentration for Anti-poliovirus Types 1, 2, 3

Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.

Time frame:
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Reported as:
Geometric mean · Titers
Concentration for Anti-poliovirus Types 1, 2, 3
TitersGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Anti-Polio 1, POST572.9 (435.5 to 753.6)558.3 (422.0 to 738.8)902.1 (698.4 to 1165.0)
Anti-Polio 2, POST629.7 (452.6 to 876.1)668.7 (489.9 to 912.7)1184.9 (901.1 to 1558.1)
Anti-Polio 3, POST1147.5 (846.2 to 1556.0)614.0 (453.9 to 830.6)1120.7 (793.0 to 1583.9)
SecondaryConcentrations for Anti-poliovirus Types 1, 2 and 3

Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.

Time frame:
1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Reported as:
Geometric mean · Titers
Concentrations for Anti-poliovirus Types 1, 2 and 3
TitersGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Anti-Polio 1, POST1121.0 (904.2 to 1389.8)1099.6 (905.2 to 1335.8)1386.2 (1091.8 to 1760.0)
Anti-Polio 2, POST1485.3 (1182.4 to 1865.8)1215.6 (973.8 to 1517.4)1537.2 (1191.0 to 1984.1)
Anti-Polio 3, POST1851.2 (1473.2 to 2326.1)1960.4 (1574.0 to 2441.5)2376.4 (1874.2 to 3013.2)
SecondaryConcentration for Anti-poliovirus Type 1, 2 and 3

Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.

Time frame:
Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Reported as:
Geometric mean · Titers
Concentration for Anti-poliovirus Type 1, 2 and 3
TitersGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Anti-Polio 1, PRE53.5 (39.6 to 72.4)50.7 (37.2 to 69.2)70.8 (52.4 to 95.8)
Anti-Polio 2, PRE76.6 (50.3 to 116.7)55.0 (38.2 to 79.3)82.7 (55.6 to 122.9)
Anti-Polio, 3 PRE67.8 (47.3 to 97.2)73.8 (52.2 to 104.2)93.9 (64.4 to 136.8)
SecondaryNumber of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3

A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.

Time frame:
Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Reported as:
Count of participants · Participants
Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3
ParticipantsGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Anti-Polio 1, PRE505456
Anti-Polio 2, PRE384444
Anti-Polio, 3 PRE514361
SecondaryNumber of Seroprotected Subjects Against Anti-Poliovirus Type 1, 2 and 3

A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.

Time frame:
Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Reported as:
Count of participants · Participants
Number of Seroprotected Subjects Against Anti-Poliovirus Type 1, 2 and 3
ParticipantsGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Anti-Polio 1, PRE959192
Anti-Polio 2, PRE788174
Anti-Polio, 3 PRE969991
SecondaryConcentrations 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:
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Reported as:
Geometric mean · µg /mL
Concentrations for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies
µg /mLGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Concentrations for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies12.765 (9.300 to 17.520)15.904 (11.723 to 21.576)17.099 (12.966 to 22.550)
SecondaryConcentrations for 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:
1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Reported as:
Geometric mean · µg /mL
Concentrations for Anti-PRP Antibodies
µg /mLGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Concentrations for Anti-PRP Antibodies21.462 (16.650 to 27.664)15.903 (12.132 to 20.848)17.429 (13.429 to 22.620)
SecondaryConcentrations 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:
Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Reported as:
Geometric mean · µg /mL
Concentrations for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies
µg /mLGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Concentrations for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies0.173 (0.138 to 0.216)0.175 (0.142 to 0.216)0.236 (0.182 to 0.307)
SecondaryConcentrations for Anti-polyribosyl-ribitol Phosphate Antibodies

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

Time frame:
Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2))
Reported as:
Geometric mean · µg /mL
Concentrations for Anti-polyribosyl-ribitol Phosphate Antibodies
µg /mLGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Concentrations for Anti-polyribosyl-ribitol Phosphate Antibodies0.328 (0.262 to 0.409)0.288 (0.227 to 0.365)0.334 (0.254 to 0.439)
SecondaryNumber of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)

A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).

Time frame:
Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Reported as:
Count of participants · Participants
Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)
ParticipantsGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Anti-PT, PRE686578
Anti-FHA, PRE818188
Anti-PRN, PRE686983
SecondaryNumber of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN

A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).

Time frame:
Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Reported as:
Count of participants · Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN
ParticipantsGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Anti-PT, PRE959497
Anti-FHA, PRE122117116
Anti-PRN, PRE9892105
SecondaryNumber of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP)

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

Time frame:
Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Reported as:
Count of participants · Participants
Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP)
ParticipantsGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP)414552
SecondaryNumber of Seroprotected Subjects for Anti-PRP

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

Time frame:
Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Reported as:
Count of participants · Participants
Number of Seroprotected Subjects for Anti-PRP
ParticipantsGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Number of Seroprotected Subjects for Anti-PRP927881
SecondaryConcentrations for Anti-pneumococcal (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:
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Reported as:
Geometric mean · µg /mL
Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies
µg /mLGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Anti- PNE 12.07 (1.69 to 2.53)2.16 (1.75 to 2.68)2.27 (1.84 to 2.80)
Anti- PNE 30.76 (0.62 to 0.93)0.87 (0.66 to 1.15)0.88 (0.69 to 1.14)
Anti- PNE 41.87 (1.51 to 2.32)1.83 (1.46 to 2.28)2.14 (1.72 to 2.66)
Anti- PNE 51.18 (0.97 to 1.42)1.10 (0.92 to 1.33)1.21 (0.99 to 1.49)
Anti- PNE 6A7.71 (6.49 to 9.16)6.92 (5.53 to 8.64)8.63 (6.79 to 10.96)
Anti- PNE 6B4.24 (3.39 to 5.30)4.21 (3.17 to 5.59)4.58 (3.45 to 6.08)
Anti- PNE 7F3.27 (2.75 to 3.89)3.42 (2.94 to 3.97)4.27 (3.58 to 5.08)
Anti- PNE 9V1.68 (1.33 to 2.11)1.52 (1.25 to 1.85)1.63 (1.29 to 2.06)
Anti- PNE 148.22 (6.27 to 10.77)8.80 (7.01 to 11.06)8.97 (7.29 to 11.02)
Anti- PNE 18C1.50 (1.13 to 1.99)1.63 (1.32 to 2.01)1.64 (1.33 to 2.02)
Anti- PNE 19A7.00 (5.76 to 8.51)8.05 (6.39 to 10.13)6.70 (5.14 to 8.73)
Anti- PNE 19F7.15 (5.86 to 8.74)7.34 (5.89 to 9.15)6.72 (5.32 to 8.48)
Anti- PNE 23F3.74 (2.87 to 4.88)4.54 (3.67 to 5.63)3.94 (2.97 to 5.23)
SecondaryConcentrations 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:
1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Reported as:
Geometric mean · µg /mL
Concentrations for Anti-PNE Antibodies
µg /mLGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Anti- PNE 12.54 (1.93 to 3.34)2.47 (1.83 to 3.35)3.47 (2.23 to 5.41)
Anti- PNE 30.76 (0.59 to 0.96)0.82 (0.60 to 1.13)0.92 (0.66 to 1.30)
Anti-PNE 42.03 (1.53 to 2.68)2.10 (1.59 to 2.79)2.57 (1.65 to 4.01)
Anti-PNE 51.26 (0.97 to 1.63)1.24 (0.98 to 1.57)1.29 (0.89 to 1.87)
Anti-PNE 6A10.64 (7.94 to 14.25)7.67 (6.18 to 9.53)7.47 (4.76 to 11.70)
Anti-PNE 6B5.04 (3.74 to 6.79)4.56 (3.16 to 6.59)6.62 (3.90 to 11.24)
Anti-PNE 7F4.20 (3.45 to 5.11)3.97 (2.98 to 5.29)4.67 (3.16 to 6.89)
Anti-PNE 9V2.20 (1.66 to 2.93)1.42 (1.10 to 1.85)1.85 (1.21 to 2.83)
Anti-PNE 147.47 (5.68 to 9.83)8.12 (6.04 to 10.93)9.28 (6.15 to 14.01)
Anti-PNE 18C1.80 (1.34 to 2.40)1.52 (1.09 to 2.11)2.09 (1.41 to 3.11)
Anti-PNE 19A8.79 (6.53 to 11.82)6.22 (4.99 to 7.76)9.10 (5.23 to 15.84)
Anti-PNE 19F8.09 (5.48 to 11.95)7.11 (5.21 to 9.70)5.56 (3.38 to 9.14)
Anti-PNE 23F5.31 (4.29 to 6.57)4.00 (3.05 to 5.24)5.82 (3.59 to 9.44)
SecondaryNumber 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:
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Reported as:
Count of participants · Participants
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes
ParticipantsGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Anti- PNE 1505053
Anti- PNE 3404343
Anti- PNE 4505053
Anti- PNE 5505053
Anti- PNE 6A505053
Anti- PNE 6B504953
Anti- PNE 7F505053
Anti- PNE 9V505053
Anti- PNE 14495053
Anti- PNE 18C495053
Anti- PNE 19A495053
Anti- PNE 19F505053
Anti- PNE 23F504752
SecondaryNumber of Seropositive Subjects for 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:
1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Reported as:
Count of participants · Participants
Number of Seropositive Subjects for Anti-PNE Serotypes
ParticipantsGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Anti- PNE 1232120
Anti- PNE 3211816
Anti-PNE 4232120
Anti-PNE 5232120
Anti-PNE 6A232120
Anti-PNE 6B232120
Anti-PNE 7F232120
Anti-PNE 9V232120
Anti-PNE 14232120
Anti-PNE 18C232120
Anti-PNE 19A232119
Anti-PNE 19F232120
Anti-PNE 23F232120
SecondaryNumber of Subjects With Booster Response to Anti-pertussis Antigens (Anti-PT, Anti-FHA and Anti-PRN)

Booster response defined as : - For initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month after booster vaccination - For initially seropositive subjects, antibody concentration at Post-booster ≥ 2 fold the pre-vaccination antibody concentration

Time frame:
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Reported as:
Count of participants · Participants
Number of Subjects With Booster Response to Anti-pertussis Antigens (Anti-PT, Anti-FHA and Anti-PRN)
ParticipantsGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Anti-PT727786
Anti-FHA798187
Anti-PRN818087
SecondaryNumber of Subjects With Booster Response to Anti-pertussis Antigens

Booster response defined as : - For initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month after booster vaccination - For initially seropositive subjects, antibody concentration at Post-booster ≥ 2 fold the pre-vaccination antibody concentration

Time frame:
1 month poste booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Reported as:
Number · Subjects
Number of Subjects With Booster Response to Anti-pertussis Antigens
SubjectsGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Anti-PT118119110
Anti-FHA120115113
Anti-PRN121120115
SecondaryNumber 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 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2)
Reported as:
Count of participants · Participants
Number of Subjects Reporting Any Solicited Local Symptoms
ParticipantsGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Any pain566763
Any redness555659
Any swelling454348
SecondaryNumber of Subjects Reporting Any Solicited Local Symptom

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

Time frame:
During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2)
Reported as:
Count of participants · Participants
Number of Subjects Reporting Any Solicited Local Symptom
ParticipantsGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Any pain766664
Any redness473640
Any swelling433438
SecondaryNumber of Subjects Reporting Any Solicited General Symptoms

Solicited local symptoms assessed were drowsiness, irritability/fussiness, 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 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2)
Reported as:
Count of participants · Participants
Number of Subjects Reporting Any Solicited General Symptoms
ParticipantsGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Any drowsiness544747
Any irritability/fussiness697374
Any loss of appetite434546
Any fever424137
SecondaryNumber of Subjects Reporting Any Solicited General Symptom

Solicited local symptoms assessed were drowsiness, irritability/fussiness, 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 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2)
Reported as:
Count of participants · Participants
Number of Subjects Reporting Any Solicited General Symptom
ParticipantsGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Any drowsiness524040
Any irritability/fussiness665862
Any loss of appetite423734
Any fever585052
SecondaryNumber 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. (subjects enrolled before protocol amendment 2)
Reported as:
Count of participants · Participants
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
ParticipantsGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)423967
SecondaryNumber of Subjects Reporting Any Unsolicited 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. (subjects enrolled after protocol amendment 2)
Reported as:
Count of participants · Participants
Number of Subjects Reporting Any Unsolicited AEs
ParticipantsGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Number of Subjects Reporting Any Unsolicited AEs382731
SecondaryNumber 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 (Days 0-30). (subjects enrolled before protocol amendment 2)
Reported as:
Count of participants · Participants
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
ParticipantsGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Number of Subjects Reporting Any Serious Adverse Events (SAEs)000
SecondaryNumber of Subjects Reporting Any 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 (Days 0-30). (subjects enrolled after protocol amendment 2)
Reported as:
Count of participants · Participants
Number of Subjects Reporting Any SAEs
ParticipantsGSK217744 Group 1GSK217744 Group 2Infanrix Hexa Group
Number of Subjects Reporting Any SAEs020

Adverse events

Collected over Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
GSK217744 Group 1(Before Protocol Amendment2)0/85 (0%)0/85 (0%)85/85 (100%)
GSK217744 Group 2(Before Protocol Amendment2)0/88 (0%)0/88 (0%)85/88 (96.6%)
Infanrix Hexa Group(Before Protocol Amendment2)0/99 (0%)0/99 (0%)96/99 (97%)
GSK217744 Group 1(After Protocol Amendment2)0/131 (0%)0/131 (0%)118/131 (90.1%)
GSK217744 Group 2(After Protocol Amendment2)0/130 (0%)2/130 (1.5%)103/130 (79.2%)
Infanrix Hexa Group(After Protocol Amendment2)0/124 (0%)0/124 (0%)104/124 (83.9%)
Most frequent serious events
Most frequent serious events
EventGSK217744 Group 1(Before Protocol Amendment2)GSK217744 Group 2(Before Protocol Amendment2)Infanrix Hexa Group(Before Protocol Amendment2)GSK217744 Group 1(After Protocol Amendment2)GSK217744 Group 2(After Protocol Amendment2)Infanrix Hexa Group(After Protocol Amendment2)
PneumoniaInfections and infestations0/850/880/990/1312/1300/124
DehydrationMetabolism and nutrition disorders0/850/880/990/1311/1300/124
Most frequent other events
Showing 10 of 14
Most frequent other events
EventGSK217744 Group 1(Before Protocol Amendment2)GSK217744 Group 2(Before Protocol Amendment2)Infanrix Hexa Group(Before Protocol Amendment2)GSK217744 Group 1(After Protocol Amendment2)GSK217744 Group 2(After Protocol Amendment2)Infanrix Hexa Group(After Protocol Amendment2)
IrritabilityPsychiatric disorders69/8573/8874/9966/13158/13062/124
PainGeneral disorders56/8567/8863/9976/13166/13064/124
ErythemaSkin and subcutaneous tissue disorders55/8556/8859/9947/13136/13040/124
SomnolenceNervous system disorders54/8547/8847/9952/13140/13040/124
SwellingGeneral disorders45/8543/8848/9943/13134/13038/124
PyrexiaGeneral disorders44/8545/8839/9959/13151/13052/124
Decreased appetiteMetabolism and nutrition disorders43/8545/8846/9942/13137/13034/124
Otitis mediaInfections and infestations6/8511/8811/993/1313/1302/124
NasopharyngitisInfections and infestations4/852/885/9913/1319/1308/124
Upper respiratory tract infectionInfections and infestations6/857/889/991/1311/1304/124

Baseline characteristics

Age, Continuous
Age, Continuous(Months)GSK217744 Group 1GSK217744 Group 2Infanrix Hexa GroupTotal
Mean12.9 ± 0.713.0 ± 0.713.0 ± 0.812.97 ± 0.71
Age, Continuous
Age, Continuous(Months)GSK217744 Group 1GSK217744 Group 2Infanrix Hexa GroupTotal
Mean14.1 ± 0.613.9 ± 0.614.0 ± 0.614.00 ± 0.61
Sex: Female, Male
Sex: Female, Male(Participants)GSK217744 Group 1GSK217744 Group 2Infanrix Hexa GroupTotal
Female474938134
Male383961138
Sex: Female, Male
Sex: Female, Male(Participants)GSK217744 Group 1GSK217744 Group 2Infanrix Hexa GroupTotal
Female617653190
Male705471195
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)GSK217744 Group 1GSK217744 Group 2Infanrix Hexa GroupTotal
White - Arabic / north African heritage2136
White - Caucasian / European heritage798391253
Other: Mixed44513
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)GSK217744 Group 1GSK217744 Group 2Infanrix Hexa GroupTotal
African heritage / African American1012
White - Arabic / north African heritage0033
White - caucasian / European heritage494639134
Other: Mixed818481246
08

Study locations

16 sites
  • GSK Investigational Site
    Santo Domingo, Distrito Nacional, Dominican Republic
  • GSK Investigational Site
    Santo Domingo, Dominican Republic
  • GSK Investigational Site
    Espoo, 02100, Finland
  • GSK Investigational Site
    Helsinki, 00100, Finland
  • GSK Investigational Site
    Helsinki, 00930, Finland
  • GSK Investigational Site
    Jarvenpaa, 04400, Finland
  • GSK Investigational Site
    Kokkola, 67100, Finland
  • GSK Investigational Site
    Kuopio, 70210, Finland
  • GSK Investigational Site
    Lahti, 15140, Finland
  • GSK Investigational Site
    Oulu, 90220, Finland
  • GSK Investigational Site
    Pori, 28100, Finland
  • GSK Investigational Site
    Seinajoki, 60100, Finland
  • GSK Investigational Site
    Tampere, 33100, Finland
  • GSK Investigational Site
    Turku, 20520, Finland
  • GSK Investigational Site
    Vantaa, 01300, Finland
  • GSK Investigational Site
    Vantaa, 01600, Finland
09

References and documents

Publications

  • Vesikari T, Rivera L, Korhonen T, Ahonen A, Cheuvart B, Hezareh M, Janssens W, Mesaros N. Immunogenicity and safety of primary and booster vaccination with 2 investigational formulations of diphtheria, tetanus and Haemophilus influenzae type b antigens in a hexavalent DTPa-HBV-IPV/Hib combination vaccine in comparison with the licensed Infanrix hexa. Hum Vaccin Immunother. 2017 Jul 3;13(7):1505-1515. doi: 10.1080/21645515.2017.1294294. Epub 2017 Mar 24. PubMed 28340322 ↗

Individual participant data

Plan to share: Yes — IPD is available via the Clinical Study Data Request site (click on the link provided below)

Supporting information: Study protocol, Sap, Icf, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01453998
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Oct 18, 2011
Start date
Oct 14, 2011
Primary completion
Nov 12, 2012
Completion
Nov 12, 2012
Results posted
Jul 28, 2014
Last update
Jul 17, 2020

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

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