Simple Blind, Placebo Controlled, Randomized Safety and Reactogenicity Trial of "Baby-Hib [Vaccine for the Prevention of Infections Caused by Haemophilus Influenzae Type b], Lyophilizate for Preparation of Intramuscular Injection Solution, 0.5 mL/Dose", FSUE SPbSRIVS FMBA of Russia, in Volunteers Aged 18-50
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Haemophilus Influenzae Infection
- Sponsor
- St. Petersburg Research Institute of Vaccines and Sera
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Incidence of systemic adverse events (AEs)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy volunteers (men and women) aged 18-50 years;
- •Written informed consent of volunteers to participate in the clinical trial;
- •Volunteers not previously vaccinated with any vaccine to prevent infections caused by Haemophilus influenza type b;
- •Volunteers able to fulfill requirements of the Protocol (i.e. fill out the patient's diary, come to follow-up visits);
- •For fertile women, a negative pregnancy test and consent to observe adequate methods of contraception (if hormonal contraceptives are used, they must be canceled at least 2 months before the start of the trial). All women with childbearing potential must have a negative pregnancy test result during the Data Collection Period. In the course of the trial women should use contraception methods with a reliability exceeding 90 %, or be sterile, or be in a postmenopausal state. Contraception methods with a reliability exceeding 90 % of common use include cervical caps with spermicide, diaphragms with spermicide, condoms, intra-uterine spirals.
- •For the men, are able to conceive - consent to use adequate contraception methods. In the course of the trial, men and their sexual partners should use contraception methods with a reliability exceeding 90 %, or be sterile. Contraception methods with a reliability exceeding 90 % of common use include cervical caps with spermicide, diaphragms with spermicide, condoms, intra-uterine spirals.
Exclusion Criteria
- •A serious post-vaccination reaction (temperature above 40 °C, hyperemia or edema more than 8 cm in diameter) or complications (collapse or shock-like condition that developed within 48 hours after vaccination; convulsions accompanied or not accompanied by a fever due to any previous vaccination);
- •Allergic reactions to vaccine components, especially to tetanus toxoid, or to any previous vaccination for the prevention of infections caused by Haemophilus influenza type b;
- •Guillain-Barré syndrome (acute polyneuropathy) in the medical history;
- •Previous vaccination with rabies vaccines less than 2 months before immunization or scheduled vaccination with rabies vaccines within 1 month after immunization with the trial vaccines;
- •Vaccination with any vaccine within one month before the vaccination;
- •History of leukemia, tuberculosis, cancer, autoimmune diseases;
- •Positive blood test results for HIV, syphilis, hepatitis B/C.
- •Volunteers who received immunoglobulin or blood products or had a blood transfusion during the last three months before the trial;
- •History of long-term use (more than 14 days) of immunosuppressants or other immunomodulatory products for six months before the trial;
- •History of any confirmed or suspected immunosuppressive or immunodeficiency condition;
Outcomes
Primary Outcomes
Incidence of systemic adverse events (AEs)
Time Frame: Days 1-7 post-vaccination
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
Incidence of local adverse events (AEs)
Time Frame: Days 1-7 post-vaccination
* 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
Secondary Outcomes
- Withdrawal of a volunteer from the trial due to development of an AE/SAE associated with the use of the trial products(Days 0-28)
- Incidence of immediate adverse events (AEs) (allergic reactions)(2 hours after vaccination)
- Number of patients with abnormal results of assessment of vital signs - blood pressure (BP)(Days 0-7, 14, 28)
- Incidence of other adverse events (AEs)(Days 8-28 post-vaccination)
- Incidence of severe adverse events (SAEs)(Days 0-28)
- Number of patients with abnormal results of assessment of vital signs - body temperature(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(Days 0-7, 14, 28)
- Number of patients with abnormal ECG findings(Days 0,3)
- Number of patients with abnormal results of assessment of vital signs - heart rate (HR)(Days 0-7, 14, 28)
- Number of patients with abnormal results of assessment of vital signs - respiratory rate (RR)(Days 0-7, 14, 28)
- Number of patients with abnormal results E immunoglobulin tests(Days 0,3,14,28)
- Number of patients with abnormal results of neurological status assessment(Days 0,1,3,28)
- Number of patients with abnormal results of complete blood counts(Days 0,3,14,28)
- Number of patients with abnormal results biochemical blood tests(Days 0,3,14,28)
- Number of patients with abnormal Urinalysis results(Days 0,3,14,28)