Trials Sponsors Conditions Drugs Pricing

Conditions

Influenza Influenza A Virus, H1N1 Subtype Pandemic Influenza

Keywords

InfluenzaPandemic InfluenzaSwine-Origin Influenza A/H1N1 Non-adjuvanted VaccineInfluenza A Virus, H1N1 subtypeAdults

Outcome Measures

Primary Outcomes (1)

To provide information concerning the safety profile in terms of solicited injection site reactions, systemic events, and serious adverse events after administration of A/H1N1 pandemic influenza vaccine.
7 days post-vaccination and entire study duration

Secondary Outcomes (2)

To provide information concerning the immune response to A/H1N1 pandemic influenza vaccine.
21 days post-vaccination
To provide information concerning antibody persistence 6 months after vaccination with A/H1N1 pandemic influenza vaccine.
6 months post-vaccination

Study Arms (1)

Study Group

EXPERIMENTAL

Participants aged 18 years and older at enrollment.

Biological: A/H1N1 pandemic influenza vaccine (non- adjuvanted)

Interventions

A/H1N1 pandemic influenza vaccine (non- adjuvanted)Biological

0.5 mL, Intramuscular

Study Group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Provision of informed consent form signed by the participant. If the participant is illiterate, an independent witness is required to sign the consent form.
Participant able to attend all scheduled visits and comply with all trial procedures

Sponsors & Collaborators

Sanofi Pasteur, a Sanofi Company
Industrylead

Study Sites (3)

Chandigarh, 160012, India

New Delhi, 110001, India

Pune, 411043, India

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

Medical Director
Sanofi Pasteur Inc.
STUDY DIRECTOR

Enrollment

100 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: PREVENTION
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 19, 2010

First Posted

January 21, 2010

Study Start

January 2010

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination
Planned participation in another clinical trial during the present trial period
Receipt of any vaccine in the 4 weeks preceding the trial vaccination
Planned receipt of any vaccine during the study period (except 6 months follow up)
Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C as reported by the participant / parent or legal representative and/or based on medical history
Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
Known thrombocytopenia, contraindicating intramuscular vaccination
Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
Employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees or the Investigator
Previous participation in a trial investigating a vaccine with the swine-origin A/H1N1 influenza strain
History of influenza infection in 2009-2010
Receipt of any allergy shots and/or seasonal allergy medication in the 7-day period prior to enrollment (vaccination), or scheduled to receive any allergy shots and/or seasonal allergy medication in the 7-day period after enrollment (vaccination)
+5 more criteria

Study of Swine-Origin A/H1N1 Influenza Non-Adjuvanted Vaccine in Healthy Adults in India

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Study Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Study Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations