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

NCT01310400 | Completed Phase 3 Results

• 1 other identifier: TG0826INF
• Study Type: interventional
• Target: 1,356
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Keywords

Influenza; Virus; Vaccination; Immunisation

Outcome Measures

Primary Outcomes (1)

• 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.

  3 weeks after the 2nd vaccination

Secondary Outcomes (3)

• Fold Increase in Geometric Mean Titer (GMT)

  3 weeks after the 2nd vaccination

• Seroprotection

  3 weeks after the 2nd vaccination

• Safety: Incidence of Solicited and Unsolicited Adverse Events

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

Study Arms (3)

Inflexal 0.5 mL

EXPERIMENTAL

Biological: Inflexal V

Inflexal 0.25 mL

EXPERIMENTAL

Biological: Inflexal V

Agrippal 0.25 mL

EXPERIMENTAL

Biological: Agrippal

Interventions

Inflexal V BIOLOGICAL

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

Inflexal 0.5 mL

Agrippal BIOLOGICAL

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

Agrippal 0.25 mL

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• ≥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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Crucell Holland BV: lead

Study Sites (1)

Guangxi Zhuang Autonomous Region CDC

Nanning, Guangxi, 530028, China

Location

MeSH Terms

Conditions

Influenza, Human; Virus Diseases

Interventions

Inflexal V

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Respiratory Tract Diseases

Results Point of Contact

• Title: Medical Affairs Director
• Organization: Crucell Switzerland AG

info@crucell.com

+41(0)319806111

Study Officials

• Rongcheng Li, MD

  Guangxi Zhuang Autonomous Region CDC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2011
• First Posted: March 8, 2011
• Study Start: October 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: February 6, 2014
• Results First Posted: May 20, 2013

Record last verified: 2013-08

Locations

CN (1)