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Adverse events evaluation of vaccine against diphtheria, tetanus and whooping cough in children in the city of Goiania - Goias

Evaluation of reactogenicity of vaccine in infants tetravalent Goiânia - Go - Goias Federal University

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6c4c6hk
Enrollment
Unknown
Registered
2021-05-28
Start date
2012-11-12
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Viruses, Vaccination, Pain measurement, Nursing Education, Child Health

Interventions

There are two groups in the study. First group: Experimental group (intervention): application of the vaccine in the ventrogluteal area in 125 children. Second group: Control (comparison): applicati
2012). Composition: diphtheria toxoid (25 Lf)(30 IU))
tetanus toxoid (Lf 2.5 (40 IU))
B. pertussis (whole cell) 16 (4.0 IU))
HBsAg (rDNA) 10 mcg
Purified capsular polysaccharide of Hib (PRP)
conjugated to tetanus toxoid (carrier protein) 10 mcg
adsorbed on aluminum phosphate, Al3 + 1.25 mg and 0.005% as a Thimerosal preservative (MINISTRY OF HEALTH, 2012). Children will receive 0.5 mL of DTP / HB / Hib vaccine intramuscularly in the left

Sponsors

Faculdade de Enfermagem da Universidade Federal de Goiás
Lead Sponsor
Faculdade de Enfermagem da Universidade Federal de Goiás
Collaborator

Eligibility

Age
2 Months to 12 Months

Inclusion criteria

Inclusion criteria: Child must be a resident of the city of Goiânia, Goiás; A legal guardian must be present; Belonging to the age group between 2-12 months; There have been exposed to some intramuscular injection in the last 3 days; It is only vaccinated with the vaccine Serum laboratory.

Exclusion criteria

Exclusion criteria: Weight less than three kilograms; Ggestation than 37 weeks; children vaccinated with the vaccine laboratory Bern.

Design outcomes

Primary

MeasureTime frame
It is believed that the intensity of pain and local adverse events in children vaccinated in the vastus lateralis (VLC) muscle of the thigh can be more intense than in those who are vaccinated in the ventral gluteal (VG) region. The FLACC scale was used in this study to assess the intensity of pain felt by children who receive the pentavalent vaccine applied in the VG and VLC regions at four different times: before, during, one minute post intramuscular injection, and three minutes post injection. The scale is suitable for children from 2 months to 7 years, assessing pain and discomfort. It covers five parameters: facial expression, crying, body activity, leg movement and consolability (Merkel et al, 1997). Each parameter has 3 variables (0, 1 and 2), in the end, all the scores received by the child will be added. The assessment of pain intensity in children`s was performed by a single previously trained researcher. In this study it was found that before to vaccination the two groups were comparable (SD=0.82-0.75; p=70). During and post injection presented significant statistical differences between regions; during vaccine administration (SD =3.94-4.79; p=0.00), one minute post injection (SD=1.49-2.36; p=0.00) and three minutes after the procedure (SD=0.73-1.43; p=0.00), thus confirming that the children who received the vaccine in the VG region registered lower pain intensity during and post injection when compared with the VLC region. At a later time, the children were assessed for adverse events following vaccination (AEFV) associated with the pentavalent vaccine at the injection site: pain intensity, redness, warmth, swelling, hyperesthesia or sensitivity, induration, and skin rash. The collection of data regarding it was made performed in the home of the child. The parent or guardian for child care was interviewed using a standardized questionnaire containing questions about the child's behavior after vaccination, evaluating the propable signs and symptoms

Countries

Brazil

Contacts

Public ContactPriscilla Junqueira Nunes

Universidade Federal de Goiás

priscillajunqueira12@gmail.com+55-062-985721-377

Outcome results

None listed

Source: REBEC (via WHO ICTRP)