Overview

This trial is active, not recruiting.

Condition bronchospasm
Treatment biological vaccine
Phase phase 3
Sponsor Inmunotek S.L.
Collaborator Unidad de Investigacion Medica en Epidemiologia Clinica
Start date October 2012
End date May 2016
Trial size 120 participants
Trial identifier NCT01734811, 2012-002450-24, MV130-SLG-002

Summary

The purpose of the study is to evaluate the efficacy of a biological vaccine to prevent episodes of bronchospasm, induced by recurrent respiratory tract infections, in children, compared with a placebo group.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Placebo Comparator)
The subjects will receive daily dose of the biological vaccine during 6 months
biological vaccine
Daily dose
(Experimental)
The subjects will receive daily dose of the biological vaccine during 6 months
biological vaccine
Daily dose

Primary Outcomes

Measure
Recurrent bronchospasm
time frame: 12 months

Secondary Outcomes

Measure
Shortening of the severity of the bronchospasm episodes
time frame: 12 months
Medication consumption
time frame: 12 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: 12 months
Direct costs
time frame: 12 months
Indirect costs
time frame: 12 months

Eligibility Criteria

Male or female participants from 12 months up to 36 months old.

Inclusion Criteria: - Subjects whose parents /legal representative have given written informed consent. - Both gender - Subject up to 36 months of age. - Subjects with recurrent bronchospasms ; 3 or more exacerbations in the last 12 months Exclusion Criteria: - Subjects whose parents/legal representative have not given written informed consent. - Subjects out of aged range - Subjects with malignancies or chemotherapy treatment - Subjects included in another clinical trial in the last 12 months. - Subject in immunosuppressive or immunostimulatory treatment - Subjects who have received iv gamma globulin in the past 12 months. - Subjects diagnosed with candidiasis or fungal recurrent infections. - Subjects diagnosed with malabsorption syndrome - Subjects with clinical allergy to common aeroallergens in the geographical area. - Subjects with hepatitis virus infections, HIV and tuberculosis

Additional Information

Official title Randomized Double-blind Placebo-controlled, Parallel, Single Centre Clinical Trial of Sublingual Bacterial Vaccine in Children With Recurrent Bronchospasm for the Evaluation of Efficacy, Security and Clinical Impact.
Description Double blind parallel placebo controlled study. The subjects will receive medication during 6 months and will be followed up during another six months.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Inmunotek S.L..