Influenza Clinical Trial
Official title:
Post Authorization Safety Study of the Intramuscular Inactivated, Split Virion Pandemic A/H1N1 Influenza Vaccines in Children Aged Over 2 Months and in Adult Populations
This study is designed to assess the safety of the approved and licensed HUMENZA (adjuvanted
A/H1N1 pandemic influenza vaccine) and PANENZA (non-adjuvanted A/H1N1 pandemic influenza
vaccine) to meet regulatory requirements for post-marketing safety monitoring.
Primary objective:
To describe the incidence of serious adverse events and adverse events of special interest
(AESIs) after HUMENZA or PANENZA administration throughout the study in different age
groups.
Secondary objective:
To describe the incidence of non-serious cutaneous allergic reactions after HUMENZA or
PANENZA administration in different age groups up to 21 days after the last vaccination.This
study is designed to assess the safety of the approved and licensed HUMENZA (adjuvanted
A/H1N1 pandemic influenza vaccine) and PANENZA (non-adjuvanted A/H1N1 pandemic influenza
vaccine) to meet regulatory requirements for post-marketing safety monitoring.
Status | Completed |
Enrollment | 3934 |
Est. completion date | July 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 2 Months and older |
Eligibility |
Inclusion Criteria : - Aged 2 months and above on the day of inclusion - Having received HUMENZA or PANENZA - Provision of the Contact Order Form (COF) signed by the participant or the participant's parent(s)/guardians(s) - Participant or the participant's parent(s)/legal representative(s) are able to attend all scheduled visits and to comply with all study procedures Exclusion Criteria : - Participant previously vaccinated with another A/H1N1 pandemic vaccine |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sanofi Pasteur, a Sanofi Company |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety: To provide information concerning the safety of HUMENZA and PANENZA vaccines. | 21 days post-vaccination and entire study duration | Yes |
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