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Completed

NCT Number: NCT01453998

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

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.

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Key information

Conditions

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 Poliomyelitis RNA Virus Infections Spinal Cord Diseases Tetanus Virus Diseases

Age range

12 month–15 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Santo Domingo, Dominican Republic

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Who can participate

Healthy volunteers accepted: Yes

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

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

  • 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.

Treatment and study plan

Infanrix hexa

Biological

Single dose, licensed formulation, intramuscular into right thigh

Other names: DTPa-HBV-IPV/Hib

Prevenar 13

Biological

Single co-administered dose, intramuscular into left thigh

Other names: Pfizer's 13-valent pneumococcal polysaccharide conjugate vaccine

GSK217744

Biological

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

Primary outcomes

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

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

    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).

  2. Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies

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

    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).

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

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

    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).

  4. Number of Seroprotected Subjects Against Anti-HBs Antigens

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

    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).

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

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

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

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

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

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

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

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

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

  8. Number of Seroprotected Subjects for Anti-PRP

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

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

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

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

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

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

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

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

Secondary outcomes

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

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

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

  2. Concentrations for Anti-D and Anti-T Antibodies

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

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

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

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

    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).

  4. Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies

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

    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).

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

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

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

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

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

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

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

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

    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).

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

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

    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).

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

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

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

  10. Anti-HBs Antibody Concentrations

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

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

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

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

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

  12. Anti-HBs Antibody Concentrations

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

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

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

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

    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).

  14. Number of Seroprotected Subjects Against Anti-HBs Antigens

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

    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).

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

  21. Concentrations for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies

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

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

  22. Concentrations for Anti-PRP Antibodies

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

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

  23. Concentrations for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies

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

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

  24. Concentrations for Anti-polyribosyl-ribitol Phosphate Antibodies

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

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

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

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

    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).

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

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

    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).

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

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

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

  28. Number of Seroprotected Subjects for Anti-PRP

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

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

  29. Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies

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

    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.

  30. Concentrations for Anti-PNE Antibodies

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

    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.

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

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

    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.

  32. Number of Seropositive Subjects for Anti-PNE Serotypes

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

    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.

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

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

    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

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

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

    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

  35. Number of Subjects Reporting Any Solicited Local Symptoms

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

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

  36. Number of Subjects Reporting Any Solicited Local Symptom

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

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

  37. Number of Subjects Reporting Any Solicited General Symptoms

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

    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.

  38. Number of Subjects Reporting Any Solicited General Symptom

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

    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.

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

    Time frame: Within the 31-day (Days 0-30) follow up period after vaccination. (subjects enrolled before protocol amendment 2)

    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.

  40. Number of Subjects Reporting Any Unsolicited AEs

    Time frame: Within the 31-day (Days 0-30) follow up period after vaccination. (subjects enrolled after protocol amendment 2)

    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.

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

    Time frame: During the entire study period (Days 0-30). (subjects enrolled before protocol amendment 2)

    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.

  42. Number of Subjects Reporting Any SAEs

    Time frame: During the entire study period (Days 0-30). (subjects enrolled after protocol amendment 2)

    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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 18, 2011
Registry last updated
Jul 17, 2020

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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