Pregnancy Registry

FLUCELVAX QUADRIVALENT®
(Influenza Vaccine) pregnancy registry

Background

Pregnant women have a higher risk for serious complications from influenza than nonpregnant women.1 To help prevent influenza and influenza-related complications in pregnant women, in 2004 the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) began recommending routine immunization of pregnant women with the seasonal flu shot at any stage of pregnancy.1,2 Pregnant women now routinely receive flu vaccines, and studies of these women have been reassuring.1 Safety assessment is ongoing and the FLUCELVAX QUADRIVALENT Pregnancy Registry (“Registry”) is one of the ways that pregnancy outcomes of women vaccinated against the flu are monitored.

This Registry is an observational study being conducted in the United States (US) to evaluate pregnancy outcomes in women vaccinated with FLUCELVAX QUADRIVALENT at any time during pregnancy. The purpose of the Registry is to collect information on pregnant women and the outcome of the pregnancy for mother and baby. The information collected will provide healthcare providers with a better understanding of the effect (if any) of FLUCELVAX QUADRIVALENT exposure during pregnancy.

Objective

The Registry’s objective is to evaluate pregnancy outcomes along a minimum of 600 women vaccinated with FLUCELVAX QUADRIVALENT at any time during pregnancy.

Outcomes of interest?

The primary outcomes of interest are major congenital malformations, preterm birth, and low birth weight. Other pregnancy outcomes of interest include spontaneous abortions and stillbirths. Pregnant women may self-enroll in the Registry if the eligibility criteria are met. It is desirable to obtain information as early as possible in the pregnancy, following informed consent.

How can healthcare providers help?

The success of the Registry relies on pregnant women and healthcare providers to report a pregnancy if FLUCELVAX QUADRIVALENT was given at any time during the pregnancy. With your permission, we will send the study brochure and any other study materials to you to facilitate participant enrollment.

Healthcare providers and pregnant women are encouraged to contact Seqirus for more information about participation in the Registry:

Seqirus Medical Information
email: us.medicalinformation@seqirus.com
toll free phone: 1-855-358-8966

References: 1. Pregnant women & influenza (flu). Centers for Disease Control and Prevention website. http://www.cdc.gov/flu/protect/vaccine/pregnant.htm. Accessed July 22, 2016. 2. Grohskopf LA, Olsen SJ, Sokolow LZ, et al; Centers for Disease Control and Prevention. Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP)—United States, 2014-15 influenza season. MMWR Morb Mortal Wkly Rep. 15;63(32):691-697.

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Indication and Usage for FLUCELVAX QUADRIVALENT® (Influenza Vaccine)

FLUCELVAX QUADRIVALENT is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. FLUCELVAX QUADRIVALENT is approved for use in persons
4 years of age and older.

IMPORTANT SAFETY INFORMATION

Indication and Usage for FLUCELVAX QUADRIVALENT® (Influenza Vaccine)

FLUCELVAX QUADRIVALENT is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. FLUCELVAX QUADRIVALENT is approved for use in persons 4 years of age and older.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION

  • Do not administer FLUCELVAX QUADRIVALENT to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine.

WARNINGS & PRECAUTIONS

  • Guillain-Barré Syndrome (GBS): If GBS has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FLUCELVAX QUADRIVALENT should be based on careful consideration of the potential benefits and risks.
  • Preventing and Managing Allergic Reactions: Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
  • Syncope: Syncope (fainting) can occur in association with administration of injectable vaccines, including FLUCELVAX QUADRIVALENT. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia,
    and tonic-clonic limb movements. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope by maintaining a supine or Trendelenburg position.
  • Altered Immunocompetence: After vaccination with FLUCELVAX QUADRIVALENT, immunocompromised individuals, including those receiving immunosuppressive therapy, may have a reduced immune response.
  • Limitations of Vaccine Effectiveness: Vaccination with FLUCELVAX QUADRIVALENT may not protect all vaccine recipients against influenza disease.

MOST COMMON ADVERSE REACTIONS

  • The most common (≥10%) local and systemic reactions in adults 18-64 years of age were injection site pain (45.4%),
    headache (18.7%), fatigue (17.8%), myalgia (15.4%), injection site erythema (13.4%), and induration (11.6%).
  • The most common (≥10%) local and systemic reactions in adults ≥65 years of age were injection site pain (21.6%) and injection site erythema (11.9%).
  • The most common (≥10%) local and systemic reactions in children 4 to <6 years of age were tenderness at the injection site (46%), injection site erythema (18%), sleepiness (19%), irritability (16%), injection site induration (13%), and change in eating habits (10%).
  • The most common (≥10%) local and systemic reactions in children 6 through 8 years of age were pain at the injection site (54%), injection site erythema (22%), injection site induration (16%), headache (14%), fatigue (13%), and myalgia (12%).
  • The most common (≥10%) local and systemic reactions in children and adolescents 9 through 17 years of age were pain at the injection site (58%), headache (22%), injection site erythema (19%), fatigue (18%), myalgia (16%), and injection site induration (15%).

Please see accompanying US full Prescribing Information for FLUCELVAX QUADRIVALENT.

Reference: 1. FLUCELVAX QUADRIVALENT [package insert]. Holly Springs, NC: Seqirus Inc; 2016.