Trials Sponsors Conditions Drugs Pricing

Conditions

Influenza Pandemic Influenza

Outcome Measures

Primary Outcomes (2)

To assess the immune response to two different dose levels of a H1N1 pandemic influenza vaccine in healthy infants, children and adolescents aged 6 months to 17 years
42 days
To assess the safety of two different dose levels of a H1N1 pandemic influenza vaccine in healthy infants, children and adolescents aged 6 months to 17 years
Within 7 days after each vaccination

Study Arms (2)

Dose A (3.75 µg HA antigen, 0.25 mL)

EXPERIMENTAL

Biological: H1N1 pandemic influenza vaccine (whole virion, Vero cell-derived, inactivated)

Dose B (7.5µg HA antigen, 0.5 mL)

EXPERIMENTAL

Within each age stratum (4 age strata) subjects will be randomized 1:1 to receive two vaccinations of either Dose A (3.75 µg) or Dose B (7.5µg) of H1N1 pandemic influenza vaccine at a 21-day interval. A booster vaccination with a licensed seasonal trivalent influenza vaccine for the season 2010/2011 will be administered to at least 30 subjects in each age stratum (who have received Dose B) at 360 days after the first vaccination.

Biological: H1N1 pandemic influenza vaccine (whole virion, Vero cell-derived, inactivated)Biological: Seasonal trivalent influenza vaccine (licensed) for the season 2010/2011

Interventions

H1N1 pandemic influenza vaccine (whole virion, Vero cell-derived, inactivated)Biological

2-dose priming at a 21-day interval, intramuscular injection in either the upper arm or thigh, depending on the subject´s age

Dose A (3.75 µg HA antigen, 0.25 mL)Dose B (7.5µg HA antigen, 0.5 mL)

Seasonal trivalent influenza vaccine (licensed) for the season 2010/2011Biological

Booster vaccination at Day 360 after first vaccination (only in subjects who received the 7.5 µg dose of the H1N1 pandemic influenza vaccine)

Eligibility Criteria

Age6 Months - 17 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

You may qualify if:

Written informed consent provided by subject's parent(s) / legal guardian(s) (according to national law)
Written assent provided by subject according to age and capacity of understanding

Sponsors & Collaborators

Alachua Government Services, Inc.
Industrylead

Study Sites (6)

General Practice

Eferding, Upper Austria, 4070, Austria

General Practice

Wels, Upper Austria, 4600, Austria

Allgemeines Krankenhaus (AKH) der Stadt Wien (General Hospital Vienna)

Vienna, 1090, Austria

General Practice

Ettenheim, 77955, Germany

General Practice

Kehl, 77694, Germany

General Practice

Mönchengladbach, 41236, Germany

Related Publications (1)

Loew-Baselli A, Pavlova BG, Fritsch S, Poellabauer EM, Draxler W, Kistner O, Behre U, Angermayr R, Neugebauer J, Kirsten K, Forster-Waldl E, Koellges R, Ehrlich HJ, Barrett PN. A non-adjuvanted whole-virus H1N1 pandemic vaccine is well tolerated and highly immunogenic in children and adolescents and induces substantial immunological memory. Vaccine. 2012 Sep 7;30(41):5956-66. doi: 10.1016/j.vaccine.2012.07.039. Epub 2012 Jul 28.
PMID: 22846396DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

LicensureInflexal V

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CredentialingSocial Control, FormalHealth Care Economics and Organizations

Study Officials

Eva-Maria Pöllabauer, MD
Baxter Healthcare Corporation
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

September 11, 2009

First Posted

September 14, 2009

Study Start

September 2009

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2010

Actual (reported)

You may not qualify if:

Subject has participated in another clinical study involving an investigational drug, biological product or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an investigational drug, biological product or device during the course of this study
Subject has a history of exposure to A/H1N1/California/07/2009 virus or a history of vaccination with A/H1N1/California/07/2009 antigen or a closely related influenza virus antigen
Subject has any inherited or acquired immune deficiency
Subject currently has or has a recent history of significant neurological, cardiovascular or pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder
Subject has a history of testing positive for Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HBsAg) or Hepatitis C Virus (HCV). No confirmatory testing for previous infection with these viruses will be conducted as part of this clinical study.
Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that could be expected to influence immune response. Such treatment includes, but is not limited to systemic or high dose inhaled corticosteroids, radiation treatment, or other immunosuppressive or cytotoxic drugs.
Subject has a history of severe allergic reactions or anaphylaxis
Subject has a rash, dermatologic condition or tattoos which might interfere with injection site reaction rating
Subject has received a blood transfusion or immunoglobulins within 90 days of study entry
Subject has received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study Subject has functional or surgical asplenia
Subject has a known or suspected problem with alcohol or drug abuse
Subject or one of subject's parent(s) / legal guardian(s) is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (i.e., children, siblings, partner/spouse, parents) as well as employees of the investigator or site personnel conducting the study
Subject is pregnant or lactating

A/H1N1 Immunogenicity and Safety in Infants, Children and Adolescents

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Dose A (3.75 µg HA antigen, 0.25 mL)

Dose B (7.5µg HA antigen, 0.5 mL)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

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

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Dose A (3.75 µg HA antigen, 0.25 mL)

Dose B (7.5µg HA antigen, 0.5 mL)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations