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

NCT00976469 | Completed Phase 1 DMC

• 2 other identifiers: 820903EUDRACT Number 2009-013131-38
• Study Type: interventional
• Target: 400
• Locations: 2 countries
• Sites: 6

Brief Summary

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.

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

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)

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 2010/2011 BIOLOGICAL

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

Also known as: Inflexal V

Dose B (7.5µg HA antigen, 0.5 mL)

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (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
• 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

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

Sponsors & Collaborators

• Alachua Government Services, Inc.: lead

Study Sites (6)

General Practice

Eferding, Upper Austria, 4070, Austria

Location

General Practice

Wels, Upper Austria, 4600, Austria

Location

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

Vienna, 1090, Austria

Location

General Practice

Ettenheim, 77955, Germany

Location

General Practice

Kehl, 77694, Germany

Location

General Practice

Mönchengladbach, 41236, Germany

Location

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: 22846396 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Licensure; Inflexal V

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Credentialing; Social Control, Formal; Health Care Economics and Organizations; Quality Assurance, Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Eva-Maria Pöllabauer, MD

  Baxter Healthcare Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• 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 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: March 1, 2011
• Last Updated: October 9, 2015

Record last verified: 2011-05

Locations

AU (3); DE (3)