Immunogenicity and Safety of Quadrivalent Influenza Vaccine (VaxigripTetra™) in Pregnant Women

• Register: EUCTR
• Last refreshed on: 23 July 2018
• Main ID: EUCTR2016-004763-40-FI
• Date of registration: 16/03/2017
• Prospective Registration: Yes
• Primary sponsor: Sanofi Pasteur
• Public title: Immunogenicity and Safety of Quadrivalent Influenza Vaccine (VaxigripTetra™) in Pregnant Women
• Scientific title: Immunogenicity and Safety of Quadrivalent Influenza Vaccine (VaxigripTetra™) in Pregnant Women
• Date of first enrolment: 05/04/2017
• Target sample size: 729
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-004763-40
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: yes; Other trial design description: blind observer; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Finland

Contacts

• Name: Global Medical Affairs,
• Affiliation: Sanofi Pasteur

• Name: Global Medical Affairs,
• Affiliation: Sanofi Pasteur

Key inclusion & exclusion criteria

Inclusion criteria:
- Aged at least 18 years on the day of inclusion
- Pregnant women with estimated gestational age of 20 to 32 weeks
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 729
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 2017-2018 Northern hemisphere formulation with either the trial vaccines or another vaccine
- Pregnancy complications (in the current pregnancy)
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion



Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Prophylaxix of influenza in Pregnant Women

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

Intervention(s)

Trade Name: VaxigripTetra
Product Name: VaxigripTetra
Product Code: 481
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED) A/H1N1-like strain
Other descriptive name: INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
Concentration unit: mg/l milligram(s)/litre
Concentration type: not less then
Concentration number: 30-
INN or Proposed INN: INFLUENZA VACCINE (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 VACCINE (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-
INN or Proposed INN: INFLUENZA VACCINE (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-

Trade Name: Vaxigrip
Product Name: Vaxigrip
Product Code: 314
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: INFLUENZA VACCINE (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 VACCINE (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 VACCINE (SPLIT VIRION, INACTIVATED) B-like strain (Victoria lineage or Yamaga

Primary Outcome(s)

Main Objective: Immunogenicity
To demonstrate the non-inferiority of immunogenicity response induced by one dose of VaxigripTetra compared with one dose of Vaxigrip in pregnant women.

Safety
To describe the safety profile of one dose of VaxigripTetra or Vaxigrip

Primary end point(s): Immunogenicity
Hemagglutination inhibition antibody titers obtained on Day (D)21. The GMT will be used as the main parameter

Safety
-Occurrence of unsolicited systemic adverse events (AEs) reported in the 30 minutes following vaccination
-Occurrence of solicited (prelisted in the subject diary card [DC] and the electronic Case Report Form [eCRF]) injection site reactions and systemic reactions occurring between D0 and D7 after vaccination
-Occurrence of unsolicited (spontaneously reported) non-serious AEs from D0 to D21 after vaccination
-Occurrence of serious adverse events (SAEs) (including adverse events of specific interest [AESIs]) up to delivery

Secondary Objective: Immunogenicity
-To demonstrate the superiority of the immune response induced by one dose of VaxigripTetra compared with one dose of Vaxigrip for the B strain not contained in Vaxigrip
-To describe the immune response induced by one dose of VaxigripTetra or Vaxigrip in pregnant women
-To evaluate the transplacental transfer of antibody from mother to newborn from the cord blood after one dose of VaxigripTetra or one dose of Vaxigrip

Safety
Descriptive analysis of the safety profile of VaxigripTetra and Vaxigrip in terms of pregnancy and birth outcomes

Timepoint(s) of evaluation of this end point: 21 days after the vaccination

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: - 21 days after the vaccination
- At the time of delivery for transplacental transfer of antibodies

Secondary end point(s): Immunogenicity
The derived secondary endpoints for the description of the immune response will be based on D0 and on D21 as follows:
-Individual titers on D0 and on D21
-Individual titer ratio D21/D0
-Detectable titer = 10 (1/dilution [1/dil]) on D0 and on D21
-Titer = 40 (1/dil) on D0 and on D21
-Seroconversion or significant increase: Seroconversion: titer < 10 (1/dil) on D0 and post-injection titer = 40 (1/dil) on D21, or significant increase: titer = 10 (1/dil) on D0 and = 4-fold increase of post-injection titer on D21.

Safety
Pregnancy and birth outcomes will be described.

Secondary ID(s)

GQM14

Source(s) of Monetary Support

Sanofi Pasteur