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Comparison of the Efficacy of Inflexal V With a Commercially Available Influenza Vaccine in Young Children

Primary Purpose

Influenza

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Inflexal V

Agrippal

About this trial

This is an interventional treatment trial for Influenza focused on measuring Influenza, Virus, Vaccination, Immunisation

Eligibility Criteria

6 Months - 35 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

≥6months to ≤35 months-old healthy children (male or female) born at term after normal pregnancy
Recording of medical history and physical examination reveal no abnormality
The parent/legal guardian of the participating child must sign the written informed consent and agree to provide a blood sample taken from the child pre- and post-immunization

Exclusion criteria:

Hypersensitivity to eggs, chicken proteins, polymyxin B, neomycin or any component of the vaccine
Previous vaccination against influenza
At time of enrollment, presentation of clinical symptoms of active infection and/or body temperature ≥38°C
Confirmation or suspicion of immunosuppressed status (including cancer), or confirmation of immunodeficiency disease (congenital or acquired including HIV)
Medical treatment (>2 weeks) with immune suppressant or immune modulating drugs including systemic steroids during the last 3 months before immunization or at present, as follows: long-term oral prednisone or other equivalent steroid: ≥0.5mg/kg/day (note: administration of local or inhaled steroids before or during the study is allowed)
Treatment with immunoglobulins or blood products during the last 3 months before immunization or such treatment scheduled during the study
Participation in other clinical trials during the last 3 months before immunization or intention to participate during this study period
At present or during the last 6 months before immunization: radiotherapy or treatment with cytotoxic drugs
Other vaccination with a killed vaccine within 14 days before immunization or with an attenuated vaccine within 28 days before immunization (note: after subject inclusion vaccines of the immunization program for children are allowed upon the physician's discretion. However, immunization on the same day must be avoided)
Family history of Guillain-Barré Syndrome
Severe congenital deficiency or disease
Antecedent of neurological disease or epileptic attack
Severe cardiopulmonary disease with possibility to influence the study result
Disturbance of coagulation or under anticoagulant treatment, likely to be contraindicated to i.m. injection
Suspected non-compliance

Sites / Locations

Guangxi Zhuang Autonomous Region CDC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Inflexal 0.5 mL

Inflexal 0.25 mL

Agrippal 0.25 mL

Arm Description

Outcomes

Primary Outcome Measures

Immunogenicity, Assessed by the Haemagglutination (HI) Test

Seroconversion rate post-immunization. Seroconversion is defined as a post-vaccination titer of ≥1:40 for those with a pre-vaccination HI titer of <1:10 and as ≥ four-fold increase in HI titer for those with a pre-vaccination HI titer of ≥1:10.

Secondary Outcome Measures

Fold Increase in Geometric Mean Titer (GMT)

GMT-fold increase - calculated as the GMT on Day 49 divided by the baseline GMT value

Seroprotection

Seroprotection rate, defined as a post-vaccination HI titer of 1:40.

Safety: Incidence of Solicited and Unsolicited Adverse Events

Safety assessements were made by the investigator at baseline and on Days 28 and 49, as well as by the subjects themselves (in Subjects Diaries) for the 4-day period following each vaccination.

Full Information

NCT ID

NCT01310400

First Posted

March 7, 2011

Last Updated

January 7, 2014

Sponsor

Crucell Holland BV

1. Study Identification

Unique Protocol Identification Number

NCT01310400

Brief Title

Comparison of the Efficacy of Inflexal V With a Commercially Available Influenza Vaccine in Young Children

Official Title

Observer-blind, Randomized, Controlled Study to Determine the Immunogenicity and Safety of a Two-dose Regimen of Virosomal Subunit Influenza Vaccine Inflexal V in Healthy Young Children (≥6 Months to ≤35 Months) in Comparison With the Subunit Influenza Vaccine Agrippal

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Crucell Holland BV

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

A study to assess whether the Northern Hemisphere 2009/2010 season influenza vaccine Inflexal V is as immunogenic as a locally sourced competitor vaccine in young children.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Influenza, Virus, Vaccination, Immunisation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

1356 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Inflexal 0.5 mL

Arm Type

Experimental

Arm Title

Inflexal 0.25 mL

Arm Type

Experimental

Arm Title

Agrippal 0.25 mL

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Inflexal V

Intervention Description

Inflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose: 15 µg hemagglutinin (HA) antigen of A/Brisbane/59/2007 (H1N1)-like virus 15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus 15 µg HA antigen of B/Brisbane/60/2008-like virus Dose: intramuscular administration (M. deltoideus) of a single dose of 0.5 mL on Days 0 and 28

Intervention Type

Biological

Intervention Name(s)

Inflexal V

Intervention Description

Inflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose: 15 µg HA antigen of A/Brisbane/59/2007 (H1N1)-like virus 15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus 15 µg HA antigen of B/Brisbane/60/2008-like virus Dose: intramuscular administration (M. deltoideus) of a single dose of 0.25 mL on Days 0 and 28

Intervention Type

Biological

Intervention Name(s)

Agrippal

Intervention Description

Agrippal influenza vaccine Dose: intramuscular administration (M. deltoideus) of a single dose of 0.25 mL on Days 0 and 28

Primary Outcome Measure Information:

Title

Immunogenicity, Assessed by the Haemagglutination (HI) Test

Description

Time Frame

3 weeks after the 2nd vaccination

Secondary Outcome Measure Information:

Title

Fold Increase in Geometric Mean Titer (GMT)

Description

GMT-fold increase - calculated as the GMT on Day 49 divided by the baseline GMT value

Time Frame

3 weeks after the 2nd vaccination

Title

Seroprotection

Description

Seroprotection rate, defined as a post-vaccination HI titer of 1:40.

Time Frame

3 weeks after the 2nd vaccination

Title

Safety: Incidence of Solicited and Unsolicited Adverse Events

Description

Safety assessements were made by the investigator at baseline and on Days 28 and 49, as well as by the subjects themselves (in Subjects Diaries) for the 4-day period following each vaccination.

Time Frame

Solicited AEs: Days 1-4 and 28-31, and Days 28 and 49; unsolicited AEs: until study end

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

35 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ≥6months to ≤35 months-old healthy children (male or female) born at term after normal pregnancy Recording of medical history and physical examination reveal no abnormality The parent/legal guardian of the participating child must sign the written informed consent and agree to provide a blood sample taken from the child pre- and post-immunization Exclusion criteria: Hypersensitivity to eggs, chicken proteins, polymyxin B, neomycin or any component of the vaccine Previous vaccination against influenza At time of enrollment, presentation of clinical symptoms of active infection and/or body temperature ≥38°C Confirmation or suspicion of immunosuppressed status (including cancer), or confirmation of immunodeficiency disease (congenital or acquired including HIV) Medical treatment (>2 weeks) with immune suppressant or immune modulating drugs including systemic steroids during the last 3 months before immunization or at present, as follows: long-term oral prednisone or other equivalent steroid: ≥0.5mg/kg/day (note: administration of local or inhaled steroids before or during the study is allowed) Treatment with immunoglobulins or blood products during the last 3 months before immunization or such treatment scheduled during the study Participation in other clinical trials during the last 3 months before immunization or intention to participate during this study period At present or during the last 6 months before immunization: radiotherapy or treatment with cytotoxic drugs Other vaccination with a killed vaccine within 14 days before immunization or with an attenuated vaccine within 28 days before immunization (note: after subject inclusion vaccines of the immunization program for children are allowed upon the physician's discretion. However, immunization on the same day must be avoided) Family history of Guillain-Barré Syndrome Severe congenital deficiency or disease Antecedent of neurological disease or epileptic attack Severe cardiopulmonary disease with possibility to influence the study result Disturbance of coagulation or under anticoagulant treatment, likely to be contraindicated to i.m. injection Suspected non-compliance

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rongcheng Li, MD

Organizational Affiliation

Guangxi Zhuang Autonomous Region CDC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Guangxi Zhuang Autonomous Region CDC

City

Nanning

State/Province

Guangxi

ZIP/Postal Code

530028

Country

China

12. IPD Sharing Statement

Learn more about this trial

Comparison of the Efficacy of Inflexal V With a Commercially Available Influenza Vaccine in Young Children

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