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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Crucell Holland BV
ClinicalTrials.gov Identifier:
NCT01310400
First received: March 7, 2011
Last updated: January 7, 2014
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Influenza
Biological: Inflexal V
Biological: Agrippal
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Crucell Holland BV:

Primary Outcome Measures:
  • Immunogenicity, Assessed by the Haemagglutination (HI) Test [ Time Frame: 3 weeks after the 2nd vaccination ] [ Designated as safety issue: No ]
    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) [ Time Frame: 3 weeks after the 2nd vaccination ] [ Designated as safety issue: No ]
    GMT-fold increase - calculated as the GMT on Day 49 divided by the baseline GMT value

  • Seroprotection [ Time Frame: 3 weeks after the 2nd vaccination ] [ Designated as safety issue: No ]
    Seroprotection rate, defined as a post-vaccination HI titer of 1:40.

  • Safety: Incidence of Solicited and Unsolicited Adverse Events [ Time Frame: Solicited AEs: Days 1-4 and 28-31, and Days 28 and 49; unsolicited AEs: until study end ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 1356
Study Start Date: October 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inflexal 0.5 mL Biological: Inflexal V

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

Experimental: Inflexal 0.25 mL Biological: Inflexal V

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

Experimental: Agrippal 0.25 mL Biological: Agrippal

Agrippal influenza vaccine

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


  Eligibility

Ages Eligible for Study:   6 Months to 35 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01310400

Locations
China, Guangxi
Guangxi Zhuang Autonomous Region CDC
Nanning, Guangxi, China, 530028
Sponsors and Collaborators
Crucell Holland BV
Investigators
Principal Investigator: Rongcheng Li, MD Guangxi Zhuang Autonomous Region CDC
  More Information

No publications provided

Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT01310400     History of Changes
Other Study ID Numbers: TG0826INF
Study First Received: March 7, 2011
Results First Received: October 23, 2012
Last Updated: January 7, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Crucell Holland BV:
Influenza
Virus
Vaccination
Immunisation

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014