A Phase 1 interventional study of Vaccine for the prevention of infections caused by Haemophilus influenza type b and Placebo in Haemophilus Influenzae Infection and Vaccines, sponsored by St. Petersburg Research Institute of Vaccines and Sera. Completed at 1 site in Russian Federation. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-02.
Sponsored by St. Petersburg Research Institute of Vaccines and Sera · Phase 1, Interventional, and Prevention
Trial purpose is to evaluate the safety, tolerability and reactogenicity of the Vaccine for the prevention of infections caused by Haemophilus Influenzae Type b in volunteers aged 18-50.
The trial includes 2 stages (Stage I and Stage II). The aim of the Stage I is to assess the tolerability, reactogenicity and safety of the Hib vaccine in the first 10 volunteers during the first 7 days after vaccination.
The aim of the Stage I is to assess the tolerability, reactogenicity and safety of the Hib vaccine during 28 days after vaccination and also to conduct a comparative assessment of the safety and reactogenicity of the Hib vaccine and placebo during 28 days after vaccination.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 60 is below the median of 120 across 4,200 interventional studies indexed under Infections.
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Exclusion Criteria:
Volunteers will be vaccinated with Vaccine for the prevention of infections caused by Haemophilus influenza type b once intramuscularly at a dose of 0.5 mL. Stage I: 5 volunteers Stage II: 25 volunteers
Biological: Vaccine for the prevention of infections caused by Haemophilus influenza type b
Volunteers will receive a placebo once intramuscularly at a dose of 0.5 mL. Stage I: 5 volunteers Stage II: 25 volunteers
Biological: Placebo
The vaccine is administered into the region of the deltoid muscle
The placebo is administered into the region of the deltoid muscle
Incidence of local adverse events (AEs)
* Pain at the injection site * Hyperemia at the injection site * Infiltrate at the injection site * Injection site edema Severity of an AE was established according to the following classification: 0 - none - No symptoms 1. - mild - Mild symptoms 2. - moderate - Symptoms that disrupt normal daily activities to a certain extent 3. - severe - Symptoms that disrupt normal daily activities Hyperemia/infiltration/edema 0 - none - No symptoms 1. - mild - Hyperemia with a diameter of up to 50 mm or infiltrate/edema with a diameter of up to 25 mm 2. - moderate - Hyperemia with a diameter of up to 50 mm or infiltrate/edema with a diameter of 26-50 mm 3. - severe - Infiltrate/edema more than 50 mm in diameter
Time frame: Days 1-7 post-vaccination
Incidence of systemic adverse events (AEs)
Fever, Irritability, Anxiety, Drowsiness, Fainting, Fatigue, Convulsions, Apnea, Arthralgia, Myalgia, Headache, Dizziness, Nausea, Abdominal pain, Loss of appetite, Vomiting, Diarrhea, Rash Severity of an AE was established according to the following classification: 0 - none - No symptoms 1. - mild - Mild symptoms 2. - moderate - Symptoms that disrupt normal daily activities to a certain extent 3. - severe - Symptoms that disrupt normal daily activities Fever 0 - none \<=37.0°С 1. - mild \> 37.0°С - \<=37.5°С 2. - moderate \> 37.6°С - \<=38.5°С 3. - severe \> 38.6°С
Time frame: Days 1-7 post-vaccination
Incidence of other adverse events (AEs)
0 - none - No symptoms 1. - mild - Mild symptoms 2. - moderate - Symptoms that disrupt normal daily activities to a certain extent 3. - severe - Symptoms that disrupt normal daily activities
Time frame: Days 8-28 post-vaccination
Incidence of immediate adverse events (AEs) (allergic reactions)
* Anaphylaxis * Quincke's edema * Urticaria 0 - none No symptoms 1. - mild Mild symptoms 2. - moderate Symptoms that disrupt normal daily activities to a certain extent 3. - severe Symptoms that disrupt normal daily activities
Time frame: 2 hours after vaccination
Incidence of severe adverse events (SAEs)
Time frame: Days 0-28
Withdrawal of a volunteer from the trial due to development of an AE/SAE associated with the use of the trial products
Time frame: Days 0-28
Number of patients with abnormal results of assessment of vital signs - blood pressure (BP)
BP measurements include the systolic and diastolic blood pressure, using tonometers
Time frame: Days 0-7, 14, 28
Number of patients with abnormal results of assessment of vital signs - heart rate (HR)
HR is measured using a phonendoscope at the apex of the heart (1.5 cm inwards from the left midclavicular line in the 5th intercostal space) during 1 minute.
Time frame: Days 0-7, 14, 28
Number of patients with abnormal results of assessment of vital signs - respiratory rate (RR)
RR is counted with a hand placed on the volunteer's chest or abdomen or by holding a stethoscope at the volunteer's nose. The measurement is carried out during one minute.
Time frame: Days 0-7, 14, 28
Number of patients with abnormal results of assessment of vital signs - body temperature
Body temperature is measured using a non-contact infrared electronic thermometer.
Time frame: 10 minutes before administration; 20 minutes, 2 hours, 5-8 hours after vaccination; Days 1-7, 14, 28
Number of patients with abnormal results of physical examination
Physical examination of volunteers includes an interview, discovery of complaints and symptoms, when required, palpation, auscultation, percussion. It is necessary to conduct an examination and (when applicable) palpation, auscultation, percussion for the following organs and systems: skin, mucosa, eyes, oral cavity and pharynx, lungs/chest, heart/cardiovascular system, abdominal organs, nervous system, lymph nodes, musculoskeletal system, thyroid gland. The palpation analysis of lymph nodes (submandibular, cervical, ulnar, inguinal) includes an assessment of their size, consistency, pain, mobility, adhesion between themselves and with surrounding tissues and skin.
Time frame: Days 0-7, 14, 28
Number of patients with abnormal results of neurological status assessment
Assessment of: * Cranial nerve function * Motor sphere * Reflex sphere * Sensitive sphere * Coordination sphere * Pelvic functions * Higher mental functions
Time frame: Days 0,1,3,28
Number of patients with abnormal ECG findings
Standard 12-lead ECG. Assessment of: PQ, QT,QTc intervals, QRS complex
Time frame: Days 0,3
Number of patients with abnormal results of complete blood counts
Red cells, Hemoglobin, ESR, White cells, Differential Leukocyte Count (segmented and rod neutrophils, lymphocytes, monocytes, eosinophils, basophils), Platelets
Time frame: Days 0,3,14,28
Number of patients with abnormal results biochemical blood tests
ALT, AST, LDH, Alkaline phosphatase, Bilirubin total, Total protein, Urea, Glucose, C-reactive protein, Creatinine, Prothrombin complex, Cholesterol, В-lipoproteins, Thymol
Time frame: Days 0,3,14,28
Number of patients with abnormal results E immunoglobulin tests
Total IgE
Time frame: Days 0,3,14,28
Number of patients with abnormal Urinalysis results
pH, Relative density / specific gravity, Protein, Glucose, Red cells, White cells
Time frame: Days 0,3,14,28
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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St. Petersburg Research Institute of Vaccines and Sera