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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01100294
• Other study ID #: FLUVAL P-H-08
• Status: Completed
• Phase: N/A
• First received: March 30, 2010
• Last updated: May 18, 2012
• Start date: September 2009
• Est. completion date: May 2010

Study information

• Verified date: May 2012
• Source: Omninvest Vaccine Manufacturing, Researching and Trading Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial Summary

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

Description:

This is an open, uncontrolled study to assess safety and tolerability of Fluval P monovalent influenza vaccine (whole virus, inactivated, adjuvanted with alumn phosphate gel) containing 6 mcgHA per 0.5mL active ingredient in children of 6-36 months of age. The vaccination is not repeated.

Tolerability and safety (incidence of adverse events) of the study drug is assessed after Day 28 then after Day 180-210 following the vaccination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 36 Months

Eligibility

Inclusion Criteria:

• 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;

• Absence of existence of any exclusion criteria.

Exclusion Criteria:

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Vaccination with FLUVAL P
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.

Locations

Country	Name	City	State
Hungary	"Csolnoky Ferenc" Veszprém County Hospital	Veszprém

Sponsors (1)

Lead Sponsor	Collaborator
Omninvest Vaccine Manufacturing, Researching and Trading Ltd.

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Incidence of adverse events	To assess safety of the study drug after Day 180-210 following the vaccination.	180-210 days after vaccination	Yes
Secondary	Efficacy of the study drug	To assess the efficacy of the study drug by epidemiological follow-up of the participants until Day 180-210 following the vaccination.	180-210 days after vaccination	No