desktop-slide-1

RSV is a common
virus that affects
60% to 70% of
babies before
1 year of age.1

desktop-slide-2

The younger your
child, the greater
the risk of RSV.2

desktop-slide-3

The highest rates
of RSV infection
occur in babies
6 weeks to
6 months of age.1

desktop-slide-3

Babies less than
3 months of age
are the most
likely to be
hospitalised due
to RSV.3

desktop-slide-5

Babies
hospitalised
for RSV typically
stay in the
hospital for
4 to 9 days.4

desktop-slide-6

RSV is more
likely to lead to
hospitalisation in
babies who3

• Are less than 3 months old
• Were born prematurely
• Have heart or lung disease

tablet-slide

RSV is a common virus that
affects 60% to 70% of babies
before 1 year of age.1

tablet-slide

The younger the child,
the greater the risk of RSV.2,A

tablet-slide

The highest rates of RSV
infection occur in babies 6
weeks to 6 months of age.1,A

tablet-slide

Babies less than 3 months of
age are the more likely to be
hospitalised due to RSV.3,A

tablet-slide

Babies hospitalised for RSV
typically stay in the hospital
for 4 to 9 days.4,A

tablet-slide

RSV is more likely to lead to
hospitalisation in babies who3,A

• Are less than 3 months old
• Were born prematurely
• Have hear or lung disease

mobile-slide

RSV is a common virus
that affects 60% to
70% of babies before
1 year of age.1

mobile-slide

The younger the child,
the greater the risk of
RSV.2

mobile-slide

The highest rates of
RSV infection occur in
babies 6 weeks to
6 months of age.1

mobile-slide

Babies less than
3 months of age are
more likely to be
hospitalised due to RSV.3

mobile-slide

Babies hospitalised
for RSV typically stay
in the hospital for 4 to
9 days.4

mobile-slide

RSV is more likely to
lead to hospitalisation
in babies who3

  • Are less than 3 months old
  • Were born prematurely
  • Have heart or lung disease

    The Impact of RSV Infection on Babies

    • Respiratory syncytial virus (RSV) infection may cause cough, runny or stuffy nose, trouble breathing or fever.5
    • Illness from RSV infection may require hospitalisation.2,6
    • Treatment for RSV is limited.
    • It is possible that some effects of RSV infection may last for years.

    The Impact of RSV Infection on Babies

    The Impact of RSV Infection on Babies

    Respiratory syncytial virus (RSV) infection may cause cough, runny or stuffy nose, trouble breathing or fever.5

    • It may seem similar to the common cold, but can be serious in young babies if they have trouble breathing.
    • How can you tell if your baby is having trouble breathing? You may notice fast breathing, wheezing or grunting noises or see the baby’s nostrils flaring. If you notice these signs, get your baby to the pediatrician.

    Illness from RSV infection may require hospitalisation.2,6

    • While many children will be infected with RSV at least once in their first 2 years of life,6 the younger the child, the greater risk of having a severe disease and needing to be hospitalised2
    • RSV can cause pneumonia or bronchiolitis, which can make breathing difficult for babies.7
    • RSV is more likely to lead to hospitalisation in babies who3
      • + Are <3 months old
      • + Were born prematurely
      • + Have heart or lung disease

    Treatment for RSV is limited.

    • Antibiotics cannot be used to fight viruses like RSV.
    • Babies are generally treated with supportive care such as supplemental oxygen, fever-lowering medications, and fluids.
    • No vaccine is available to prevent RSV illness in children.
    • One drug is approved to treat RSV disease, however it is rarely used.

    It is possible that some effects of RSV infection may last for years.

    • Some children who had RSV infection as a baby may be at greater risk of developing recurrent wheezing or asthma later in life.8

    FIND A PARTICIPATING SITE

    Maternal Immunisation:
    A Proven Strategy for Protection

    • Vaccines are an effective way to keep women healthy during pregnancy.
    • Vaccines given to pregnant women also protect her baby.
    • When a woman gets the flu while pregnant, the baby may be at-risk too.
    • Prevent whooping cough in a young baby by receiving the diphtheria, tetanus, and pertussis (dTpa) vaccine during pregnancy.

    Maternal Immunisation:
    A Proven Strategy for Protection

    Vaccines are an effective way to keep women healthy during pregnancy.

    • Vaccines are given during pregnancy to protect against disease in the mum-to-be and/or in the baby starting at birth.
    • It is recommended that pregnant women receive specific vaccines with each pregnancy, including seasonal influenza, to protect them and their babies from some illnesses.9

    Vaccines given to pregnant women also protect her baby.

    • Vaccines trigger the body to make special proteins called antibodies that protect against illnesses caused by viruses or bacteria. A pregnant woman shares these antibodies with her baby through the placenta, thereby providing both the pregnant mum and the baby protection from illness.10

    When a woman gets the flu while pregnant, the baby may be at-risk too

    • When pregnant women get the flu, they are more likely than women who are not pregnant to have complications that may include pneumonia, and are more likely to need hospitalisation.11
    • The baby may also be at risk; pregnant women who get the flu are more likely to miscarry or give birth prematurely.12

    Prevent whooping cough in a young baby by receiving the diphtheria, tetanus, and pertussis (dTpa) vaccine during pregnancy

    • Pertussis, also called whooping cough is a very contagious bacterial infection that causes cold-like symptoms at first, but worsens over time to include severe, uncontrollable coughing.13
    • Newborns are too young to receive the vaccine that protects against pertussis, as well as diphtheria and tetanus. By getting vaccinated during pregnancy, a mother can protect herself and also transfer protection to her baby.

    FIND A PARTICIPATING SITE


    The Prepare Trial

    Your participation in the Prepare Trial may help reduce the impact RSV has on babies around the world in the future.

    Prepare is an ongoing clinical trial that will find out whether an RSV vaccine given to pregnant women during the 3rd trimester can protect newborn babies from respiratory illness due to RSV infection.


    The Prepare Trial

    Your participation in the Prepare Trial may help reduce the impact RSV has on babies around the world in the future.

    Prepare is an ongoing clinical trial that will find out whether an RSV vaccine given to pregnant women during the 3rd trimester can protect newborn babies from respiratory illness due to RSV infection.

    Novavax has been awarded a grant of up to $89 million from the Bill & Melinda Gates Foundation to support development of the RSV F vaccine phase 3 clinical trial in pregnant women.

    About Clinical Trials

    The Therapeutic Goods Administration (TGA) and the US FDA puts processes in place to try to ensure that new medicines and vaccines are developed to be safe and effective. This process makes certain that the companies developing new medicines and vaccines have succeeded one step at a time before moving on to the next step in the process.

    RSV F Vaccine to Protect Infants via Maternal Immunisation

    The Prepare Trial has been reviewed and approved by an ethics committee referred to as a Human Research Ethics Committee. It is the job of this committee to ensure clinical studies are run in a manner to protect the people who participate in them.

    In addition, the RSV F vaccine being studied in the Prepare Trial has been through several steps in the development process, and is now in a very large Phase 3 trial that will study the effect of this vaccine in pregnant women worldwide.

    Earlier studies helped reveal these key findings:

    • Antibodies shown in animal studies protected against RSV infection.
    • A safe dose of the vaccine was identified for pregnant mothers in their third trimester.
    • Vaccine was shown to trigger the mother’s immune system to create antibodies that are shared with the baby in her womb.

    To date, this RSV F vaccine has been well tolerated in pregnant women.

    • Some women have reported mild to moderate and temporary pain where the vaccine was injected, which may be similar to what may be experienced with other vaccinations.
    • The vaccine has not been shown to have any adverse effects on infant safety.
    • Over several years, a group of expert obstetricians and pediatricians who do not work for Novavax have the job of reviewing all the safety information from the Prepare trial on a regular basis. These doctors have not reported any safety problems in mothers or infants

    FIND A PARTICIPATING SITE

    Eligibility, Participation and FAQs

    Eligibility for the Prepare Trial

    Pregnant women between 18 and 40 years of age may be eligible to join this trial if they meet other required criteria. Additional eligibility criteria include:

    Eligibility, Participation and FAQs

    Eligibility for the Prepare Trial

    Pregnant women between 18 and 40 years of age may be eligible to join this trial if they meet other required criteria. Additional eligibility criteria include:
    • Singleton pregnancy (i.e., not twins or other multiples) and between 28 and 36 weeks gestational age at the time of vaccination.
    • Good general maternal health according to medical history, physical examination, and laboratory assessments
    • Willing and able to comply with study procedures, and provide written informed consent
    • Cannot have symptoms of heart or lung disease, or be treated with medicines for heart or lung disease
    • Cannot have pregnancy complications such as preterm labor, hypertension, or other conditions
    • Cannot have received other vaccines within 14 days at the time of vaccination
    • Cannot have received the RSV vaccine at any time
    • Cannot be severely overweight
    • Cannot have blood disorders or a history of blood clots, poor function of the liver or kidneys, seizures, dieases of the immune system, diabetes or untreated thyroid disease, or certain other diseases that the study doctor will ask about
    • Cannot have a history of major gynecologic or major abdominal surgery (previous Caesarean section is allowed)
    • Cannot have certain infections such as HIV, syphilis, HBV, HCV, or herpes simplex virus
    • Pregnancy cannot be the result of in vitro fertilization, or from rape or incest
    • Cannot enroll if baby will be a ward of the state or be released for adoption
    • Cannot enroll if mother has had a history of premature deliveries, more than 5 prior deliveries, or previous miscarriages or stillbirths
    • Cannot have received investigational drugs or immune globulins within 6 months
    • Cannot be chronically taking immunosuppressants or other immune-modifying drugs within 6 months
    • Cannot have neuropsychiatric illness
    • Cannot be ill at the time of planned vaccination
    • Cannot have had a previous serious adverse reaction (e.g., anaphylaxis) to any prior vaccine

    Requirements of Participation

    • Women who are eligible and agree to participate will receive 1 injection of either the investigational RSV F vaccine or a control between 28 and 36 weeks of pregnancy.
    • She and her newborn infant will be evaluated to see whether the vaccine worked, and will be followed closely for several months for any signs of RSV infection. Mothers will be followed until they deliver, and then for 6 additional months. Babies will be followed until they are one year old.

    Frequently Asked Questions About the Prepare Trial

    What happens during the trial?

    Enrolled pregnant women will receive a single injection of either the investigational RSV F vaccine or the placebo (an inactive control solution). Blood samples will be taken from both the mother and the baby to test the response to the vaccine. Pregnant mothers will have a total of 5 blood draws over a 9-month period, whereas the baby will only have 2-3 blood tests throughout their first year of life. In addition, the mother and the baby will both be monitored for signs of RSV infection.

    Does it cost anything to participate?

    All study examinations are provided free of charge, and the participants will be reimbursed for travel costs.

    Why join the Prepare Trial?

    Clinical research, like this trial, is essential to learn about human health and disease and may lead to safe and effective treatments or preventative measures. Families who participate in this trial may help researchers develop a new vaccine that may protect their baby, and many others, from RSV. Participation in this trial is completely voluntary.

    Some benefits of participation in the Prepare Trial may include:

    • Potential for prevention of medically significant RSV disease in your baby
    • A high level of engagement with the pediatric clinical research team during your baby’s first year of life
    • Opportunity to contribute to the development of a vaccine that could have a significant global impact on infant health

    FIND A PARTICIPATING SITE

    PARTICIPATING SITES: AUSTRALIA

    PARTICIPATING SITES: NEW ZEALAND