Safety and Immunogenicity of the Quadrivalent Influenza Vaccine Administered via the Intramuscular Route in Children Aged 3 to 8 Years

• Register: EUCTR
• Last refreshed on: 28 August 2014
• Main ID: EUCTR2011-005374-33-FI
• Date of registration: 25/04/2013
• Prospective Registration: Yes
• Primary sponsor: Sanofi Pasteur
• Public title: Safety and Immunogenicity of the Quadrivalent Influenza Vaccine Administered via the Intramuscular Route in Children Aged 3 to 8 Years
• Scientific title: Safety and Immunogenicity of the Quadrivalent Influenza Vaccine Administered via the Intramuscular Route in Children Aged 3 to 8 Years
• Date of first enrolment: 06/06/2013
• Target sample size: 1225
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005374-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 3

Countries of recruitment

Finland, Mexico, Poland, Russian Federation, Taiwan

Contacts

• Name: Director, Clinical Development
• Affiliation: Sanofi Pasteur

• Name: Director, Clinical Development
• Affiliation: Sanofi Pasteur

Key inclusion & exclusion criteria

Inclusion criteria:
Children aged 3 to less than 9 years on the day of inclusion.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1225
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Previous vaccination against influenza with the current seasonal vaccine formulation (as recommended by WHO), with either the trial vaccine or another vaccine.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Prophylaxis of influenza in children aged 3 to 8 years
MedDRA version: 14.1 Level: LLT Classification code 10022001 Term: Influenza (epidemic) System Organ Class: 100000004862

Intervention(s)

Product Code: 481
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: Influenza virus (split virion, inactivated) A/H1N1-like strain
Other descriptive name: INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 30-
INN or Proposed INN: Influenza virus ( split virion, inactivated) A/H3N2-like strain
Other descriptive name: INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 30-
INN or Proposed INN: Influenza virus ( split virion, inactivated) B-like strain (Victoria lineage)
Other descriptive name: INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 30-
INN or Proposed INN: Influenza virus ( split virion, inactivated) B-like strain (Yamagata lineage)
Other descriptive name: INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 30-

Trade Name: Vaxigrip
Product Name: Vaxigrip
Product Code: 314
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: Influenza virus (split virion, inactivated) A/H1N1-like strain
Other descriptive name: INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 30-
INN or Proposed INN: Influenza virus ( split virion, inactivated) A/H3N2-like strain
Other descriptive name: INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 30-
INN or Proposed INN: Influenza virus ( split virion, inactivated) B-like strain (Yamagata or Victoria lineage)
Other descriptive name: INFLUENZA VACCINE (SPLIT VIR

Primary Outcome(s)

Main Objective: To demonstrate non-inferiority of antibody (Ab) responses induced by QIV compared with the TIV.

Timepoint(s) of evaluation of this end point: 28 days after the last vaccination

Primary end point(s): For non-inferiority testing: GMs of anti-HA Ab titers for the four strains, as applicable, 28 days after the last vaccination.

Secondary Objective: • To demonstrate the superiority of the HAI antibody response to each B strain in QIV compared with the TIV that does not contain the corresponding B strain.
• To describe the safety profile of QIV compared with the TIV.
• To describe the immune response by HAI method, influenza virus SN method and the anti-NA immune response per vaccine group.

Secondary Outcome(s)

Secondary end point(s): For superiority testing: GMs of anti-HA Ab titers, as applicable, 28 days after the last vaccination.
Safety description: Occurrence of:
- unsolicited AE reported in the 30 minutes after each/any injection
- solicited injection site reactions and systemic reactions within 7 days following each/any injection
- unsolicited AEs within 28 days following each/any injection
- SAEs (including AESI) throughout the trial
HAI titers, neutralizing Ab titers and anti-NA titers will be measured for each influenza strain on D0 and D28 or D56 according to the vaccination schedule.

Timepoint(s) of evaluation of this end point: 28 days after the last vaccination up to the end of the trial for follow up of SAEs.

Secondary ID(s)

GQM02

Source(s) of Monetary Support

Sanofi Pasteur