Safety and efficacy of intramuscular vaccination without aspiration before injection: a randomized clinical trial
Not Applicable
- Conditions
- Drug-Related Side Effects and Adverse Reactions. Signals e Symptons.C25.100C23.888
- Registration Number
- RBR-8nkhhk
- Lead Sponsor
- niversidade Federal de Alagoas - UFA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
Healthy volunteers; both genders; age between 18 and 59 years.
Exclusion Criteria
Individuals with immunosuppressive disease or treatment; acute febrile illness; made use anti-inflammatory drug, analgesic or antipyretic 24 hours before vaccination; history of allergic reaction to any of the components of the Hepatitis A vaccine; pregnant women; history of hepatitis A disease; history of vaccination against Hepatitis A; previous titration of antibodies against the Hepatitis A virus (anti-HAV IgG); persons undergoing blood transfusion or use of blood products in the last 28 days; persons who are unable to respond on their own.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Expected outcome 1: occurrence of equal or lesser incidence of post-vaccination adverse events, evaluated through inspection, palpation of the injection site, temperature measurement by means of an infrared sensor thermometer and verbal report of symptoms by the participant, daily, for three consecutive days and on the thirtieth day after vaccination.;Expected outcome 2: seroconversion of antibodies against Hepatitis A virus, evaluated by venous blood collection, chemiluminescent laboratory testing, and anti-HAV (anti-hepatitis A virus) immunoglobulin (IgG) serum levels equal to or greater than 10 mlU / mL, analysis performed before the intervention and thirty days after.
- Secondary Outcome Measures
Name Time Method Secondary outcome 1: decreased pain during vaccination, assessed by the numerical scale of pain intensity (NDT), which assigns points from 0 to 10 to the pain, with 0 being no pain and 10 being the worst possible pain.;Secondary outcome 2: Heartbeat within the normal range (60 to 100 beats per minute - ppm), assessed by a digital pulse oximeter device placed on the participant, recorded one minute before, immediately after administration of the vaccine and five minutes later .;Secondary outcome 3: peripheral oxygen saturation greater than or equal to 95%, assessed by digital pulse oximeter device placed on the participant and recorded one minute before, immediately after administration of the vaccine and five minutes later.