ProVac:Probiotic adjuvant to enhance the efficacy of pnemococcal vaccination: A pilot study.

Phase 1

• Conditions: Healthy infant immune response to the PCV13 pneumococcal vaccination; Inflammatory and Immune System - Normal development and function of the immune system

• Registration Number: ACTRN12613000368730
• Lead Sponsor: Associate Professor Mimi Tang

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1) Healthy, term infants (post-delivery) will be recruited from the postnatal maternity ward at the Royal Women's Hospital, Melbourne.
2 )The infant must be 4 weeks of age.
3) The infant must be born via a vaginal birth at 37 weeks or greater gestation.
4) The mother cannot have been on antibiotic treatment 2 weeks prior to delivery.

Exclusion Criteria

1) Mothers who were taking probiotics during pregnancy or are on probiotic supplements.
2) Mothers who have a proven or suspected immunodeficiency.
3) Infants must not have had a probiotic.
4) Infants who have a significant foetal abnormality.
5) Infants who have or a proven or suspected immunodeficiency.
6)Significant maternal illness or disability such that study participation would impose an unacceptable additional burden.
7) Planning or likely to leave the area before the study finishes.

Study & Design

• Study Type: Interventional
• Study Design: Not specified