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Phase 2 Completed N=312 Randomized Double-blind Prevention

Study to Evaluate the Immunogenicity and Reactogenicity of a Booster Dose of GSK2036874A Vaccine in Healthy Toddlers

Haemophilus influenzae type b · Tetanus · Hepatitis B · Whole Cell Pertussis
Source: ClinicalTrials.gov NCT01106092 ↗
Enrolled (actual)
312
Serious AEs
2.2%
Results posted
Apr 2017
Primary outcomePrimary: Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 — 78; 77; 78; 77 Participants

Summary

The purpose of the study is to assess the immunogenicity and safety of three formulations of GSK Biologicals' GSK2036874A vaccine compared to Zilbrix™/Hib and Poliorix™ vaccines administered concomitantly, when administered as a single booster dose to healthy poliovirus-primed toddlers aged 12-24 months.

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
76; 70; 74; 75; 77; 75
PRIMARY
Anti-polio Types 1, 2 and 3 Antibody Titers
2218.4; 1486.7; 1245.1; 3760.2; 1598.8; 1056.4
PRIMARY
Anti-polio Types 1, 2 and 3 Antibody Titers
2218.4; 1486.7; 1245.1; 3760.2; 1598.8; 1056.4
SECONDARY
Number of Seroconverted Subjects for Anti-polio Types 1, 2 and 3
70; 64; 60; 69; 68; 66
SECONDARY
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
76; 70; 74; 75; 77; 75
SECONDARY
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)
69; 69; 69; 65; 78; 78
SECONDARY
Anti-D and Anti-T Antibody Concentrations
0.301; 0.331; 0.330; 0.374; 6.519; 7.687
SECONDARY
Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs)
71; 70; 73; 73; 78; 77
SECONDARY
Anti-HBs Antibody Concentrations
59.9; 46.9; 61.9; 88.5; 2713.4; 2395.1
SECONDARY
Number of Seroprotected Subjects Against Polyribosil-ribitol-phosphate (PRP)
28; 27; 30; 35; 77; 76
SECONDARY
Anti-PRP Antibody Concentrations
0.134; 0.137; 0.152; 0.171; 2.871; 2.243
SECONDARY
Number of Seropositive Subjects for Anti-Bordetella Pertussis (Anti-BPT)
50; 50; 51; 49; 76; 73
SECONDARY
Anti-BPT Antibody Concentrations
19.6; 20.1; 18.9; 19.5; 161.8; 182.9
SECONDARY
Number of Subjects With a Booster Response for Anti-BPT
72; 72; 77; 72
SECONDARY
Number of Subjects With Any Solicited Local Symptoms
67; 65; 66; 68; 28; 29
SECONDARY
Number of Subjects With Any Solicited General Symptoms
43; 42; 46; 41; 53; 60
SECONDARY
Number of Subjects With Any Unsolicited Adverse Events (AEs)
30; 44; 30; 40
SECONDARY
Number of Subjects With Serious Adverse Events (SAEs)
1; 3; 2; 1

Eligibility Criteria

Inclusion Criteria

  • A male or female subject, between and including 12 and 24 months of age at the time of booster vaccination.
  • Subjects who have received three doses of polio vaccine as primary vaccination along with the routine vaccinations indicated during the first year of life.
  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative (s) can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the parent(s)/Legally Acceptable Representative (s) of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria

  • Use of any investigational or non-registered product other than the study vaccine(s) 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 booster vaccination, or planned administration during the active study period (up to Visit 2).
  • 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.
  • History of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or Haemophilus influenza type b diseases.
  • Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or H. influenzae diseases.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • A family history of congenital or hereditary immunodeficiency.
  • Major congenital defects or serious chronic illness.
  • History of neurologic disorders or seizures.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
  • Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
  • Child in care.
  • Occurrence of any of the following adverse events after a previous administration of a diphtheria-tetanus-pertussis vaccine:
  • encephalopathy of unknown aetiology occurring within seven days following previous vaccination with pertussis-containing vaccine,
  • fever >= 40 °C within 48 hours of vaccination not due to another identifiable cause,
  • collapse or shock-like state within 48 hours of vaccination,
  • convulsions with or without fever, occurring within 3 days of vaccination.
  • 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°C on rectal setting.
  • Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.
  • Other conditions which, in the opinion of the investigator, may potentially interfere with interpretation of study results.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01106092). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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