At a glance
ClinicalIndex Comparison Record- ✓Healthy adults aged 18-64 years
- ✓Good health as determined by physical examination and medical history; chronic conditions must be stable for 60 days
- ✓Vital signs within acceptable ranges: temperature <100.0°F, pulse 47-100 bpm, systolic BP 85-150 mmHg, diastolic BP 55-95 mmHg
- ✓Women of childbearing potential must use acceptable contraception from 30 days before first vaccination through 60 days after last vaccination
- ✕Acute illness within 72 hours prior to vaccination
- ✕Immunosuppression from underlying illness or immunosuppressive/immunomodulating therapy
- ✕Anticancer chemotherapy or radiation therapy within 3 years prior to vaccination
- ✕Active neoplastic disease or history of hematologic malignancy (non-melanoma skin cancers allowed)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study in Healthy Adults 18-64 Years Old to Assess the Safety, Reactogenicity and Immunogenicity of a Seqirus A/H7N9 Inactivated Influenza Vaccine Administered Intramuscularly With or Without MF59(R) Adjuvant
In Brief
A Phase 2 clinical trial evaluating A/H7N9, MF59, and 1 other intervention for Avian Influenza and Influenza Immunisation. Completed, enrolled 372 participants across 7 sites.
Detailed Summary
This is a randomized, double-blinded, Phase II study in healthy males and non-pregnant females, 18-64 years of age. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of a pre-pandemic 2017 monovalent inactivated influenza A/H7N9 virus vaccine (2017 H7N9 IIV) manufactured by Seqirus Inc (Seqirus) administered at different dosages (3.75 microgram mcg, 7.5 mcg and 15 mcg of hemagglutinin (HA) per dose) given with MF59(R) adjuvant manufactured by Seqirus Inc., or without adjuvant (15 mcg of HA per dose). Phosphate buffered saline (PBS) diluent manufactured by Patheon Manufacturing Services LLC will be used to achieve certain targeted doses. Approximately 371 subjects who are in good health and meet all eligibility criteria will be randomized into one of 4 study groups. The study will be conducted at up to 7 Vaccine and Treatment Unit (VTEU) sites and will last approximately 17 months, with subject participation duration of approximately 13 months. The Primary Objectives of the study are: 1) To assess the safety and reactogenicity following receipt of two doses of 2017 H7N9 IIV administered intramuscularly (IM) at different dosages approximately 21 days apart given with or without MF59(R) adjuvant; 2) To assess the serum hemagglutinin inhibition (HAI) and neutralizing (Neut) antibody responses approximately 21 days following receipt of two doses of 2017 H7N9 IIV administered IM at different dosages approximately 21 days apart with or without MF59(R) adjuvant.
Study Details
Timeline
Interventions
Monovalent inactivated, "subunit" influenza virus vaccine containing the HA and NA from influenza A/Hong Kong/125/2017 (H7N9) and the PB2, PB1, PA, NP, M and NS genes from A/Puerto Rico/8/1934 (H1N1).
Microfluoridized adjuvant 59 (MF59) is an oil-in-water emulsion.
Diluent for Influenza Virus Vaccine.