Tolerability and Safety Study of FLUVAL P Monovalent Influenza Vaccine in Children

NCT01100294 | Completed DMC

• 1 other identifier: FLUVAL P-H-08
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the tolerability and safety of FLUVAL P monovalent influenza vaccine in children.

Conditions

Influenza

Keywords

Influenza; Pandemic vaccine; Seasonal vaccine; Prevention; Influenza vaccine; Influenza in humans; Pandemic influenza in humans; Influenza vaccine for children

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  To assess tolerability/safety (incidence of adverse events) of the study drug after Day 28 following the vaccination.

  28 days after vaccination

Secondary Outcomes (2)

• Incidence of adverse events

  180-210 days after vaccination

• Efficacy of the study drug

  180-210 days after vaccination

Study Arms (1)

Vaccination with Fluval P

EXPERIMENTAL

Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant. Dose: 0.25 ml (total 3 μg HA), single dose.

Biological: Vaccination with FLUVAL P

Interventions

Vaccination with FLUVAL P BIOLOGICAL

Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant. Dose: 0.25 ml (total 3 μg HA), single dose.

Also known as: Influenza, Pandemic vaccine, Prevention, Influenza vaccine, Influenza in humans, Vaccination of children

Vaccination with Fluval P

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6 to 36 months, both sexes;
• Are in good health (as determined by vital signs and existing medical condition) or are in stable medical condition. Subjects will not be excluded with known adequately treated clinically significant organ or systemic diseases (e.g. asthma or diabetes), such that, in the opinion of the investigator, the significance of the disease will not compromise the subject's participation in the study;
• Capability of the legitimate representative of the volunteer to understand and comply with planned study procedures;
• Legitimate representative of the volunteer provide written informed consent prior to initiation of study procedures;

You may not qualify if:

• Known allergy to eggs or other components of the vaccine (in particular mercury);
• History of Guillain-Barré syndrome;
• Active neoplasm;
• Former or on-going immunosuppressive therapy;
• Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids;
• Immunoglobulin (or similar blood product) therapy within 3 months prior to vaccination;
• Documented HIV, HBV or HCV infection;
• Chronic illness that, in the opinion of the investigator, may have effect on the participation in the study;
• Acute febrile respiratory illness within one week prior to vaccination;
• Vaccine therapy within 4 weeks prior to vaccination;
• Influenza vaccination within 6 months prior to vaccination;
• Experimental drug therapy within 1 month prior to vaccination;
• Past or current psychiatric disease of the legitimate representative that upon judgement of the investigator may have effect on the objective decision-making of the legitimate representative;
• Alcohol or drug abuse of the legitimate representative.

Sponsors & Collaborators

• Fluart Innovative Vaccine Ltd, Hungary: lead

Study Sites (1)

"Csolnoky Ferenc" Veszprém County Hospital

Veszprém, Veszprém megye, 8200, Hungary

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Vaccination; Influenza Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Immunotherapy, Active; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Anna Ősi, Dr.

  Omninvest Ltd.

  STUDY DIRECTOR

• Éva Szabó, MD

  "Csolnoky Ferenc" Veszprém County Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2010
• First Posted: April 8, 2010
• Study Start: September 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 21, 2012

Record last verified: 2012-05

Locations

HU (1)