An Effectiveness Trial (Phase IV) to Evaluate Protection of Children and Pregnant Women by Influenza Vaccine in Rural Bangladesh

PR-19103

Annually influenza is a leading cause of severe disease and mortality particularly in young children \<5 years old and pregnant women in the low and middle-income countries (LMICs) and both groups are prioritised for vaccination by the World Health Organisation (WHO). In Bangladesh, influenza is responsible for 10% of all childhood pneumonias and 9% of all death. Maternal influenza is associated with an increased risk of hospitalisation and foetal malformation. Influenza is a vaccine preventable disease, however, in most LMICs influenza vaccination is not part of the vaccination programme. This study will evaluate the effectiveness of inactivated influenza vaccine against influenza illness among pregnant women and children in Bangladesh. Influenza vaccine has not yet been studied as combined immunization strategy in a cluster randomized trial. This study is a community-based randomised trial in both pregnant women and young children to assess the impact of inactivated influenza vaccine in preventing influenza in the community as well as population level impact by both direct and indirect effect of vaccination.

2021-04-07

2024-12-31

2024-12-31

Active (not recruiting)

Early phase I

3800

Inclusion Criteria for Pregnant women: * Permanent Resident in selected villages in Matlab HDSS MCH-FP area * Age 18 - 49 years old * 28 to 34 weeks of gestation at the time of enrollment * Willing to stay in the study village for the next 20 months Exclusion Criteria for Pregnant Women: * Refusal to provide consent for participation * Unable to participate in the full length of the study period * Known allergy to egg or any product of vaccine * Sick (has documented fever and respiratory illness) at the time of enrollment * Pregnancy with complications such as chronic pulmonary (including asthma), cardiovascular, renal, hepatic, hematologic (including sickle cell disease), or metabolic disorders (including diabetes mellitus and obesity) or neurologic and neurodevelopment conditions, cancer, immunosuppression, and, multiple pregnancy) * Received any vaccine /immune component in last 2 weeks * Participated in any research study in the last 3 months Inclusion Criteria for Children: * Permanent Resident in selected villages in Matlab HDSS MCH-FP area * Age 6 to 59 months old * Parents/guardians confirm their willingness to stay in the study village for the next 20 months Exclusion Criteria for Children: * Parents refuse to provide consent for participation * Unable to participate in the full length of the study period * Known allergy to egg or any product of vaccine * Sick children (has documented fever and respiratory illness) at the time of enrolment * Chronic illness such as chronic pulmonary (including asthma), cardiovascular, renal, hepatic, hematologic (including sickle cell disease), or metabolic disorders (including diabetes mellitus and obesity) or neurologic and neurodevelopment conditions, cancer, and immunosuppression * Received any vaccine /immune component in last 4 weeks * Participated in any research study in the last 3 months

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 3800, 'type': 'ESTIMATED'}}

2024-04-19