Phase 2
Completed N=312
Study to Evaluate the Immunogenicity and Reactogenicity of a Booster Dose of GSK2036874A Vaccine in Healthy Toddlers
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
| Outcome | Result | p-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.
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.