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

October 7, 2015 updated by: Ology Bioservices

An Open-Label Phase 1/2 Study to Assess the Immunogenicity and Safety of Two Different Dose Levels of H1N1 Pandemic Influenza Vaccine in Healthy Infants, Children and Adolescents Aged 6 Months to 17 Years

The purpose of this study is to determine the preferred dose of H1N1 pandemic influenza vaccine in a pediatric population, aged 6 months to 17 years, based upon assessments of immunogenicity and safety.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Allgemeines Krankenhaus (AKH) der Stadt Wien (General Hospital Vienna)
    • Upper Austria
      • Eferding, Upper Austria, Austria, 4070
        • General Practice
      • Wels, Upper Austria, Austria, 4600
        • General Practice
  • Germany
      • Ettenheim, Germany, 77955
        • General Practice
      • Kehl, Germany, 77694
        • General Practice
      • Mönchengladbach, Germany, 41236
        • General Practice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
  • Subject is 9 to 17 years (Stratum A), 3 to 8 years (Stratum B), 12 to 35 months (Stratum C) or 6 to 11 months of age (Stratum D) at the time of screening
  • Subject was born at full term of pregnancy (>= 37 weeks) with a birth weight >= 2 kg (Strata C and D) Subject / parent(s) / legal guardian(s) understand(s) the nature of the study and is / are willing to comply with the requirements of the protocol (e.g. return for follow-up visits, completion of the subject diary)
  • If female of childbearing potential, subject presents with a negative urine pregnancy test within 24 hours prior to the first vaccination and agrees to employ adequate birth control measures for the duration of the study
  • Subject is generally healthy, as determined by the investigator's clinical judgment through collection of medical history and the performance of a physical examination
  • Subject is physically and mentally capable of participating in the study

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose A (3.75 µg HA antigen, 0.25 mL)
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 (7.5 µg) of H1N1 pandemic influenza vaccine at a 21-day interval.
Biological: H1N1 pandemic influenza vaccine (whole virion, Vero cell-derived, inactivated)
2-dose priming at a 21-day interval, intramuscular injection in either the upper arm or thigh, depending on the subject´s age
Experimental: Dose B (7.5µg HA antigen, 0.5 mL)
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)
2-dose priming at a 21-day interval, intramuscular injection in either the upper arm or thigh, depending on the subject´s age
Biological: Seasonal trivalent influenza vaccine (licensed) for the season 2010/2011
Booster vaccination at Day 360 after first vaccination (only in subjects who received the 7.5 µg dose of the H1N1 pandemic influenza vaccine)
Other Names:
  • Inflexal V

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 42 days
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
Time Frame: Within 7 days after each vaccination
Within 7 days after each vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ology Bioservices

Investigators

  • Study Director: Eva-Maria Pöllabauer, MD, Baxter Healthcare Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

September 11, 2009

First Submitted That Met QC Criteria

September 11, 2009

First Posted (Estimate)

September 14, 2009

Study Record Updates

Last Update Posted (Estimate)

October 9, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 820903
  • EUDRACT Number 2009-013131-38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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