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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00976469
• Other study ID #: 820903
• Secondary ID: EUDRACT Number 2
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 11, 2009
• Last updated: October 7, 2015
• Start date: September 2009
• Est. completion date: March 2011

Study information

• Verified date: May 2011
• Source: Nanotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health Family and YouthGermany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 2011
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 17 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human
• Pandemic Influenza

Intervention

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
• 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)

Locations

Country	Name	City	State
Austria	General Practice	Eferding	Upper Austria
Austria	Allgemeines Krankenhaus (AKH) der Stadt Wien (General Hospital Vienna)	Vienna
Austria	General Practice	Wels	Upper Austria
Germany	General Practice	Ettenheim
Germany	General Practice	Kehl
Germany	General Practice	Mönchengladbach

Sponsors (1)

Lead Sponsor	Collaborator
Nanotherapeutics, Inc.

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes