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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014