Helmvacc

Not Applicable

• Conditions: Paediatrics; Helminth infection

• Registration Number: PACTR201303000434188
• Lead Sponsor: Dr. Ayola Akim Adegnika, MD, PhD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-12
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Other
• Sex: All
• Target Recruitment: 312

Inclusion Criteria

¿Aged from 6 to 10 years (primary schoolchildren) who give assent to participate.
¿Written (signed or in case of illiteracy witnessed by an impartial witness) informed consent obtained from parent(s) or guardian(s) of the child.
¿Good general health upon clinical examination
¿Resident in the area until the end of the study

Exclusion Criteria

¿Participation in another clinical trial.
¿Contraindication to antihelminthic treatment or to the administration of one of the chosen vaccines including i.m. or s.c. administration
¿Known immunization against the vaccine Ags.
¿Known infection with the pathogen of one of the vaccine Ags in the past except influenza because the influenza vaccine contains the actual strains recommended by the WHO each year.
¿Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g.,malignancy, HIV infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders). However subjects who have received less than 15 days of immunosuppressants or other immune modifying drugs should not be contraindicated from receiving subsequent vaccinations. Also, for corticosteroids, prednisone <20 mg/day, or equivalent, is allowed. Inhaled and topical steroids are allowed.
¿Acute disease at the beginning of the study and before vaccination, determined by physical examinations at these time points.
¿Known chronic disease and chronic infection*1.

If a child is only febrile at the time of the vaccination the child will be vaccinated when infection is cured
¿Signs of symptoms of geohelminth infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified