CompletedPhase 1

Safety and Immunogenicity of A/H1N1v Vaccines in Healthy Adults

United Kingdom175 participantsStarted 2009-07

Plain-language summary

The purpose of this study is to evaluate the antibody response to one and two doses of influenza A/H1N1v vaccine in healthy adults.

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Mentally competent adults, who have signed an informed consent form after having received a detailed explanation of the study protocol.
✓. Male or female subjects 18-50 years who are either healthy or have a stable medical condition.
✓. Able to understand and comply with all study procedures and to complete study diaries
✓. Individuals who can be contacted throughout the study and are available for all study visits
✓. Females should either be using secure contraceptive precautions including:

✕. Any clinically significant concurrent illness or unstable medical condition including: malignant tumours, autoimmune illnesses (including rheumatoid arthritis), acute or progressive renal or hepatic pathology, chronic obstructive pulmonary disease requiring oxygen therapy, and any active neurological disorder.
✕. Individuals with a history of anaphylaxis or serious reactions to vaccines; hypersensitivity to influenzal viral protein, neomycin or polymixin, or products containing mercury.
✕. Persons with known immunosuppressive disease or who use systemic immunosuppressive drugs or other drugs listed in section 8 of the British National Formulary (BNF) or chloroquine, gold or penicillamine or other drugs listed in section 10.1.3 of the BNF to suppress a chronic disease process, or have received in the last 6 months radiotherapy or chemotherapy.
✕. Subjects who are at high risk of developing illnesses of the immune system.
✕. Individuals who are taking immunostimulant therapy or interferon
✕. Individuals who have received blood products or immunoglobulins parenterally during the preceding three months.
✕. Women should not be pregnant or lactating.
✕. Women who refuse to use a reliable contraceptive method throughout the study

GMT antibody rises

Timeframe: 42 days

NCT IDNCT00943358

SponsorUniversity Hospitals, Leicester

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-09

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Mentally competent adults, who have signed an informed consent form after having received a detailed explanation of the study protocol.
✓. Male or female subjects 18-50 years who are either healthy or have a stable medical condition.
✓. Able to understand and comply with all study procedures and to complete study diaries
✓. Individuals who can be contacted throughout the study and are available for all study visits
✓. Females should either be using secure contraceptive precautions including:

✕. Any clinically significant concurrent illness or unstable medical condition including: malignant tumours, autoimmune illnesses (including rheumatoid arthritis), acute or progressive renal or hepatic pathology, chronic obstructive pulmonary disease requiring oxygen therapy, and any active neurological disorder.
✕. Individuals with a history of anaphylaxis or serious reactions to vaccines; hypersensitivity to influenzal viral protein, neomycin or polymixin, or products containing mercury.
✕. Persons with known immunosuppressive disease or who use systemic immunosuppressive drugs or other drugs listed in section 8 of the British National Formulary (BNF) or chloroquine, gold or penicillamine or other drugs listed in section 10.1.3 of the BNF to suppress a chronic disease process, or have received in the last 6 months radiotherapy or chemotherapy.
✕. Subjects who are at high risk of developing illnesses of the immune system.
✕. Individuals who are taking immunostimulant therapy or interferon
✕. Individuals who have received blood products or immunoglobulins parenterally during the preceding three months.
✕. Women should not be pregnant or lactating.
✕. Women who refuse to use a reliable contraceptive method throughout the study