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

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00976469
First received: September 11, 2009
Last updated: May 11, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Influenza
Pandemic Influenza
Biological: H1N1 pandemic influenza vaccine (whole virion, Vero cell-derived, inactivated)
Biological: Seasonal trivalent influenza vaccine (licensed) for the season 2010/2011
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: September 2009
Study Completion Date: March 2011
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Inflexal V

  Eligibility

Ages Eligible for Study:   6 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00976469

Locations
Austria
General Practice
Eferding, Upper Austria, Austria, 4070
General Practice
Wels, Upper Austria, Austria, 4600
Allgemeines Krankenhaus (AKH) der Stadt Wien (General Hospital Vienna)
Vienna, Austria, 1090
Germany
General Practice
Ettenheim, Germany, 77955
General Practice
Kehl, Germany, 77694
General Practice
Mönchengladbach, Germany, 41236
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Study Director: Eva-Maria Pöllabauer, MD Baxter Healthcare Corporation
  More Information

No publications provided by Baxter Healthcare Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eva Maria Poellabauer, MD; Study Medical Director, Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00976469     History of Changes
Other Study ID Numbers: 820903, EUDRACT Number 2009-013131-38
Study First Received: September 11, 2009
Last Updated: May 11, 2011
Health Authority: Austria: Federal Ministry for Health Family and Youth
Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014