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

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ClinicalTrials.gov Identifier: NCT01310400
Recruitment Status : Completed
First Posted : March 8, 2011
Results First Posted : May 20, 2013
Last Update Posted : February 6, 2014
Sponsor:
Information provided by (Responsible Party):
Crucell Holland BV

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.

Condition or disease Intervention/treatment Phase
Influenza Biological: Inflexal V Biological: Agrippal Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1356 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : October 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Immunogenicity, Assessed by the Haemagglutination (HI) Test [ Time Frame: 3 weeks after the 2nd vaccination ]
    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 :
  1. Fold Increase in Geometric Mean Titer (GMT) [ Time Frame: 3 weeks after the 2nd vaccination ]
    GMT-fold increase - calculated as the GMT on Day 49 divided by the baseline GMT value

  2. Seroprotection [ Time Frame: 3 weeks after the 2nd vaccination ]
    Seroprotection rate, defined as a post-vaccination HI titer of 1:40.

  3. 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 ]
    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.



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Ages Eligible for Study:   6 Months to 35 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT01310400     History of Changes
Other Study ID Numbers: TG0826INF
First Posted: March 8, 2011    Key Record Dates
Results First Posted: May 20, 2013
Last Update Posted: February 6, 2014
Last Verified: August 2013

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
Vaccines
Immunologic Factors
Physiological Effects of Drugs