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Completed

NCT Number: NCT02096263

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

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.

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Key information

Conditions

Poliomyelitis Acellular Pertussis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Central Nervous System Diseases Central Nervous System Infections Clostridium Infections Communicable Diseases Corynebacterium Infections DNA Virus Infections Digestive System Diseases Diphtheria Enterovirus Infections Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Haemophilus Infections Haemophilus Influenzae Type b Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Myelitis Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pasteurellaceae Infections Picornaviridae Infections RNA Virus Infections Spinal Cord Diseases Tetanus Virus Diseases

Age range

6 week–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Tucson, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Infanrix hexa

Biological

3 doses administered intramuscularly in the right thigh.

Pediarix

Biological

3 doses administered intramuscularly in the right thigh

ActHIB

Biological

4 doses administered intramuscularly in the upper left thigh

Pentacel

Biological

4 doses administered intramuscularly in the right thigh

Engerix-B

Biological

2 or 3 doses administered intramuscularly in the upper left thigh

Infanrix

Biological

1 dose administered intramuscularly in the right thigh

Hiberix

Biological

1 dose administered intramuscularly in the left thigh

Prevnar13

Biological

3 doses administered intramuscularly in the lower left thigh

Rotarix

Biological

2 doses administered orally

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Immunogenicity and Safety Study of GSK Biologicals' Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 26, 2014
Registry last updated
Nov 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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