Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants

• ClinicalTrials.gov Identifier: NCT02096263
• Recruitment Status: Completed
• First Posted: March 26, 2014
• Results First Posted: August 1, 2018
• Last Update Posted: November 27, 2019
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

Brief Summary:

The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' Infanrix hexa vaccine when administered to healthy infants as primary vaccination at 2, 4 and 6 months of age, co-administered with Prevnar and Rotarix with a booster dose of GSK Biologicals' Infanrix and Hiberix vaccines at 15-18 months of age.

Condition or disease	Intervention/treatment	Phase
Poliomyelitis; Diphtheria; Haemophilus Influenzae Type b; Tetanus; Acellular Pertussis; Hepatitis B	Biological: Infanrix hexa; Biological: Pediarix; Biological: ActHIB; Biological: Pentacel; Biological: Engerix-B; Biological: Infanrix; Biological: Hiberix; Biological: Prevnar13; Biological: Rotarix	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 585 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Immunogenicity and Safety Study of GSK Biologicals' Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants
• Actual Study Start Date: April 16, 2014
• Actual Primary Completion Date: February 6, 2015
• Actual Study Completion Date: November 13, 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Infanrix hexa Group; Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Biological: Infanrix hexa; 3 doses administered intramuscularly in the right thigh.; Biological: Infanrix; 1 dose administered intramuscularly in the right thigh; Biological: Hiberix; 1 dose administered intramuscularly in the left thigh; Biological: Prevnar13; 3 doses administered intramuscularly in the lower left thigh; Biological: Rotarix; 2 doses administered orally
Active Comparator: Pediarix Group; Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Biological: Pediarix; 3 doses administered intramuscularly in the right thigh; Biological: ActHIB; 4 doses administered intramuscularly in the upper left thigh; Biological: Infanrix; 1 dose administered intramuscularly in the right thigh; Biological: Prevnar13; 3 doses administered intramuscularly in the lower left thigh; Biological: Rotarix; 2 doses administered orally
Active Comparator: Pentacel Group; Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Biological: Pentacel; 4 doses administered intramuscularly in the right thigh; Biological: Engerix-B; 2 or 3 doses administered intramuscularly in the upper left thigh; Biological: Prevnar13; 3 doses administered intramuscularly in the lower left thigh; Biological: Rotarix; 2 doses administered orally

Outcome Measures

Primary Outcome Measures :

1. Antibody Concentrations for Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN). [ Time Frame: At Month 5, one month after the third dose of the primary vaccination. ]
   Concentrations were expressed as geometric mean concentrations (GMCs) for the following cut-offs:2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN. The results for the Infanrix hexa Group and Pediarix Group were the primary outcome variables.

Secondary Outcome Measures :

1. Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. [ Time Frame: At Month 5, one month after the third dose of the primary vaccination. ]
   A seropositive subject was defined as a subject with antibody concentrations above to or equal to (≥) 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.
2. Number of Seroprotected Subjects Against Tetanus (T). [ Time Frame: At Month 5, one month after the third dose of the primary vaccination. ]
   A seroprotected subject was defined a a subject with antibody concentrations ≥ 0.1 IU/mL.
3. Number of Seroprotected Subjects Against Diphtheria (D). [ Time Frame: At Month 5, one month after the third dose of the primary vaccination. ]
   A seroprotected subject was defined a a subject with antibody concentrations ≥ 0.1 IU/mL.
4. Antibody Concentrations for Anti-T. [ Time Frame: At Month 5, one month after the third dose of the primary vaccination ]
   Concentrations were expressed as GMCs for the seroprotection cut-off of 0.1 IU/mL.
5. Antibody Concentrations for Anti-D. [ Time Frame: At Month 5, one month after the third dose of the primary vaccination ]
   Concentrations were expressed as GMCs for the seroprotection cut-off of 0.1 IU/mL.
6. Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3. [ Time Frame: At Month 5, one month after the third dose of the primary vaccination ]
   A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titres ≥ 8 dilution.
7. Antibody Titres for Anti-polio Types 1, 2 and 3. [ Time Frame: At Month 5, one month after the third dose of the primary vaccination ]
   Titres were expressed as geometric mean titres (GMTs) for the cut-off of 8 dilution.
8. Number of Seroprotected Subjects Against Polyribosyl Ribitol Phosphate (Anti-PRP). [ Time Frame: At Month 5, one month after the third dose of the primary vaccination ]
   A seroprotected subject was defined as a subject with anti-PRP concentrations ≥ 0.15 µg/mL.
9. Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL. [ Time Frame: At Month 5, one month after the third dose of the primary vaccination ]
   The cut-off for this assay was an anti-PRP concentration ≥ 1 µg/mL.
10. Antibody Concentrations for Anti-PRP. [ Time Frame: At Month 5, one month after the third dose of the primary vaccination ]
    Antibody concentrations were expressed as GMCs for the assay cut-off of 1 µg/mL.
11. Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs). [ Time Frame: At Month 5, one month after the third dose of the primary vaccination ]
    A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mili-International units per mililiter (mIU/mL).
12. Antibody Concentrations for Anti-HBs. [ Time Frame: At Month 5, one month after the third dose of the primary vaccination ]
    Antibody concentrations were expressed as GMCs for the seroprotection cut-off of 10 mIU/mL.
13. Number of Subjects With Solicited Local Symptoms. [ Time Frame: During the 4-day (Days 0-3) post-vaccination period following Dose 1 ]
    The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness/Swelling: > 5 millimeters (mm); Grade 3 Redness/Swelling: > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.
14. Number of Subjects With Solicited Local Symptoms. [ Time Frame: During the 4-day (Days 0-3) post-vaccination period following Dose 2 ]
    The solicited local symptoms assessed were pain, redness (Red) and swelling (Swe). Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness/Swelling: > 5 millimeters (mm); Grade 3 Redness/Swelling: > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.
15. Number of Subjects With Solicited Local Symptoms. [ Time Frame: During the 4-day (Days 0-3) post-vaccination period following Dose 3 ]
    The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness/Swelling: > 5 millimeters (mm); Grade 3 Redness (Red)/Swelling (Swe): > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA
16. Number of Subjects With Solicited Local Symptoms. [ Time Frame: During the 4-day (Days 0-3) post-vaccination period following any dose. ]
    The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness (Red)/Swelling (Swe): > 5 millimeters (mm); Grade 3 Redness/Swelling: > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.
17. Number of Subjects With Solicited General Symptoms. [ Time Frame: During the 4-day (Days 0-3) post-vaccination period following Dose 1. ]
    The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: > 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.
18. Number of Subjects With Solicited General Symptoms. [ Time Frame: During the 4-day (Days 0-3) post-vaccination period following Dose 2. ]
    The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: > 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.
19. Number of Subjects With Solicited General Symptoms. [ Time Frame: During the 4-day (Days 0-3) post-vaccination period following Dose 3. ]
    The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Feve:r > 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.
20. Number of Subjects With Solicited General Symptoms. [ Time Frame: During the 4-day (Days 0-3) post-vaccination period following any dose. ]
    The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: > 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.
21. Number of Subjects With Specific Adverse Events (AEs). [ Time Frame: From Month 0 up to 6 months post primary-vaccination (Month 10) ]
    Occurrence of specific adverse events, i.e., new onset chronic diseases (e.g. autoimmune disorders, asthma, type I diabetes and allergies)
22. Number of Subjects With Unsolicited AEs. [ Time Frame: During the 31-day (Days 0-30) post-primary vaccination period. ]
    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.
23. Number of Subjects With Serious Adverse Events (SAEs). [ Time Frame: From Month 0 up to 6 months post-primary vaccination (Month 10) ]
    SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
24. Number of Seroprotected Subjects Against Anti-T. [ Time Frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 (At Month 14-17 one month after the booster dose (Dose 4)] ]
    A seroprotected subject was defined a subject with antibody concentrations ≥ 0.1 IU/mL.
25. Number of Seroprotected Subjects Against Anti-D. [ Time Frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 (At Month 14-17 one month after the booster dose (Dose 4)] ]
    A seroprotected subject was defined a subject with antibody concentrations ≥ 0.1 IU/mL.
26. Antibody Concentrations for Anti-T. [ Time Frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)] ]
    Concentrations were expressed as GMCs for the seropositivity cut-off of 0.1 IU/mL.
27. Antibody Concentrations for Anti-D. [ Time Frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)] ]
    Concentrations were expressed as GMCs for the seropositivity cut-off of 0.1 IU/mL.
28. Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. [ Time Frame: At Visit 5 [Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [Month 14-17 one month after the booster dose (Dose 4)] ]
    A seropositive subject was defined as a subject with antibody concentrations above to or equal to (≥) 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.
29. Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN. [ Time Frame: At Visit 5 [Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [Month 14-17 one month after the booster dose (Dose 4)] ]
    Concentrations were expressed as geometric mean concentrations (GMCs) for the following cut-offs:2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.
30. Number of Subjects With a Booster Response for Anti-PT, Anti-FHA and Anti-PRN. [ Time Frame: At Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)] ]

    Booster response to PT, FHA and PRN antigens was defined as:

    • For subjects with pre-vaccination antibody concentration below the assay cut off, post-vaccination antibody concentration equal or above 4 times the assay cut-off.
    • For subjects with pre-vaccination antibody concentration between the assay cut off and below 4 times the assay cut-off, post-vaccination antibody concentration equal or above 4 times the pre-vaccination antibody concentration.
    • For subjects with pre-vaccination antibody concentration equal or above 4 times the assay cut-off, post-vaccination antibody concentration of at least two times the pre-vaccination antibody concentration.

    The assay cut off is 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.

31. Number of Seroprotected Subjects Against Anti-PRP. [ Time Frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose4)] ]
    A seroprotected subject was defined as a subject with anti-PRP concentrations ≥ 0.15 µg/mL.
32. Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL. [ Time Frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose4)] ]
    The cut-off for this assay was an anti-PRP concentration ≥ 1 µg/mL.
33. Antibody Concentrations for Anti-PRP. [ Time Frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)] ]
    Antibody concentrations were expressed as GMCs for the seroprotection cut-off of 1 µg/mL.
34. Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3. [ Time Frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] ]
    A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titres ≥ 8 dilution.
35. Antibody Titres for Anti-polio Types 1, 2 and 3. [ Time Frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] ]
    Titres were expressed as geometric mean titres (GMTs) for the cut-off of 8 dilution.
36. Number of Seroprotected Subjects Against Anti-HBs. [ Time Frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] ]
    A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
37. Antibody Concentrations for Anti-HBs. [ Time Frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] ]
    Antibody concentrations were expressed as GMCs for the seroprotection cut-off of 10 mIU/mL.
38. Number of Subjects With Solicited Local Symptoms. [ Time Frame: During the 4-day (Days 0-3) post-booster vaccination. ]
    The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness (Red)/Swelling (Swe): > 5 millimeters (mm); Grade 3 Redness/Swelling: > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.
39. Number of Subjects With Solicited General Symptoms. [ Time Frame: During the 4-day (Days 0-3) post-booster vaccination. ]
    The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: > 39.0 °C and ≤ 40.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.
40. Number of Subjects With Specific AEs. [ Time Frame: During the 31-day (Days 0-30) post-booster vaccination. ]
    Occurrence of specific adverse events, i.e., new onset chronic diseases (e.g. autoimmune disorders, asthma, type I diabetes and allergies)
41. Number of Subjects With Unsolicited AEs. [ Time Frame: During the 31-day (Days 0-30) post-booster 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.
42. Number of Subjects With SAEs. [ Time Frame: During the 31-day (Days 0-30) post-booster vaccination. ]
    SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.

Eligibility Criteria

• Ages Eligible for Study: 6 Weeks to 12 Weeks (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Subjects' parent(s)/ Legally Acceptable Representative(s) (LARs) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
• A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
• Born full-term (i.e. after a gestation period of 37 weeks to less than 42 completed weeks [259 to 293 days]).
• Written informed consent obtained from parent(s)/LAR(s) of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrolment.

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 first dose of study vaccines, or planned use during the study period.
• Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.

• Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting from 30 days before the first vaccination until 30 days after Dose 3 (Epoch 001, primary vaccination) and from 30 days before the booster Dose 4 until 30 days after booster Dose 4 (Epoch 002, booster vaccination), i.e. the end of the study:

  • Inactivated influenza and hepatitis A vaccines are allowed throughout the study.
  • Routine administration(s) of vaccines are allowed from 30 days after the last dose of primary vaccination until 30 days before the booster dose and after post-booster blood sampling. Routine administration of measles-mumps-rubella vaccine, varicella, pneumococcal vaccines are allowed from 30 days after last dose of primary vaccine until 30 days before booster dose and from post-booster blood sampling, as well as according to the recommended immunization schedule in US.
• 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 (pharmaceutical product or device).
• History of Hib, diphtheria, tetanus, pertussis, pneumococcal, rotavirus, poliovirus and hepatitis B diseases.
• Previous vaccination against Hib, diphtheria, tetanus, pertussis, pneumococcus, rotavirus and/or poliovirus; more than one previous dose of hepatitis B vaccine.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• Family history of congenital or hereditary immunodeficiency.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines (including yeast).
• Hypersensitivity to latex.
• Major congenital defects or serious chronic illness.
• History of any neurological disorders including seizures.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• History of intussusception or of any uncorrected congenital malformation of the gastrointestinal tract that would predispose the infant to intussusception.
• History of Severe Combined Immunodeficiency Disease (SCID).

• Acute disease and/or fever at the time of enrolment.

  • Fever is defined as temperature ≥38.0°C /100.4°F by any route. The preferred route for recording temperature in this study will be rectal for Epoch 001 and axillary for Epoch 002.
  • Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.

Contacts and Locations

Locations

United States, Arizona

GSK Investigational Site

Tucson, Arizona, United States, 85741

United States, Arkansas

GSK Investigational Site

Fayetteville, Arkansas, United States, 72703

United States, California

GSK Investigational Site

Anaheim, California, United States, 92804

GSK Investigational Site

Daly City, California, United States, 94015

GSK Investigational Site

Fresno, California, United States, 93726

GSK Investigational Site

Hayward, California, United States, 94545

GSK Investigational Site

Oakland, California, United States, 94611

GSK Investigational Site

Pleasanton, California, United States, 94588

GSK Investigational Site

Roseville, California, United States, 95661

GSK Investigational Site

Sacramento, California, United States, 95815

GSK Investigational Site

Sacramento, California, United States, 95823

GSK Investigational Site

San Jose, California, United States, 95119

GSK Investigational Site

Santa Clara, California, United States, 95051

GSK Investigational Site

Walnut Creek, California, United States, 94596

United States, Colorado

GSK Investigational Site

Colorado Springs, Colorado, United States, 80922

United States, Florida

GSK Investigational Site

Altamonte Springs, Florida, United States, 32701

GSK Investigational Site

Orange City, Florida, United States, 32763

United States, Georgia

GSK Investigational Site

Marietta, Georgia, United States, 30062

GSK Investigational Site

Woodstock, Georgia, United States, 30189

United States, Idaho

GSK Investigational Site

Nampa, Idaho, United States, 83686

United States, Kansas

GSK Investigational Site

Augusta, Kansas, United States, 67010

GSK Investigational Site

Newton, Kansas, United States, 67114

GSK Investigational Site

Topeka, Kansas, United States, 66604

GSK Investigational Site

Wichita, Kansas, United States, 67205

United States, Kentucky

GSK Investigational Site

Louisville, Kentucky, United States, 40202

GSK Investigational Site

Louisville, Kentucky, United States, 40291

GSK Investigational Site

Nicholasville, Kentucky, United States, 40356

United States, Maryland

GSK Investigational Site

Columbia, Maryland, United States, 21045

United States, Missouri

GSK Investigational Site

Kansas City, Missouri, United States, 64108

United States, New York

GSK Investigational Site

Syracuse, New York, United States, 13210

United States, Ohio

GSK Investigational Site

Dayton, Ohio, United States, 45414

United States, Pennsylvania

GSK Investigational Site

Erie, Pennsylvania, United States, 16505

GSK Investigational Site

Sellersville, Pennsylvania, United States, 18960

United States, Tennessee

GSK Investigational Site

Kingsport, Tennessee, United States, 37660

United States, Utah

GSK Investigational Site

Layton, Utah, United States, 84041

GSK Investigational Site

Payson, Utah, United States, 84651

GSK Investigational Site

Provo, Utah, United States, 84604

GSK Investigational Site

Saint George, Utah, United States, 84790

GSK Investigational Site

Salt Lake City, Utah, United States, 84109

GSK Investigational Site

South Jordan, Utah, United States, 84095

GSK Investigational Site

West Jordan, Utah, United States, 84088

United States, Virginia

GSK Investigational Site

Charlottesville, Virginia, United States, 22902

United States, Washington

GSK Investigational Site

Ellensburg, Washington, United States, 98926

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

Additional Information:

Full CSR redacted with additional report posting on GSK. 

Publications:

Klein NP, Abu-Elyazeed R, Cheuvart B, Janssens W, Mesaros N. Immunogenicity and safety following primary and booster vaccination with a hexavalent diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b vaccine: a randomized trial in the United States. Hum Vaccin Immunother. 2019;15(4):809-821. doi: 10.1080/21645515.2018.1549449. Epub 2019 Jan 4.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT02096263
• Other Study ID Numbers: 117119; 2013-004304-19 ( EudraCT Number )
• First Posted: March 26, 2014
• Results First Posted: August 1, 2018
• Last Update Posted: November 27, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• URL: https://www.clinicalstudydatarequest.com/Posting.aspx?ID=19670

Keywords provided by GlaxoSmithKline:

Infants; Safety; Healthy; Infanrix Hexa; Immunogenicity

Additional relevant MeSH terms:

Diphtheria; Hepatitis B; Poliomyelitis; Hepatitis; Liver Diseases; Digestive System Diseases; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Bacterial Infections; Gram-Positive Bacterial Infections; Corynebacterium Infections; Actinomycetales Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Myelitis; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuromuscular Diseases; Heptavalent Pneumococcal Conjugate Vaccine; Immunologic Factors; Physiological Effects of Drugs