Clinical trials: Pregnant Women, Influenza
Immunization; Infection, Pregnancy Related
Increasing Influenza and Tdap Vaccination of Pregnant Women
Pregnant women who get influenza are more likely than non-pregnant women to have serious complications, including hospitalizations, death, preterm labor and premature birth.
- Trial name
- NCT04444518
- Testing
- VAX-MOM Intervention, Standard of Care
- Where
- United States
- Volunteers
- 12,760 people, healthy volunteers welcome
- Sponsor
- University of Rochester
Respiratory Syncytial Virus Infections
A Phase III Study to Assess the Lot-to-lot Consistency of GSK's Investigational RSV Maternal Vaccine and the Immune Response and Safety of RSV Maternal Vaccine When Given Alone or Co-administered With GSK's Influenza D-QIV Vaccine in Healthy Non-pregnant Women.
The purpose of this study is to evaluate the clinical lot-to-lot consistency of the respiratory syncytial virus (RSV) maternal (RSV MAT) vaccine administered to healthy non-pregnant women 18-49 years of age (YOA).
- Trial name
- NCT05045144
- Testing
- RSVPreF3(120 μg), Flu Quadrivalent influenza vaccine (15 μg HA)
- Where
- 36 sites in United States, Canada and 3 more
- Volunteers
- 1,586 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Influenza
Influenza Vaccine in Pregnant Women
In pregnant women, flu may cause complications like pneumonia (infection of the lungs) or hospitalization. In the United States (US) it is recommend that all women get flu vaccine if they are going to be pregnant or deliver…
- Trial name
- NCT00905125
- Testing
- Fluzone®, Fluarix®
- Where
- 9 sites in United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections, H1N1 Influenza Virus
Safety of and Immune Response to an H1N1 Influenza Vaccine in HIV Infected Pregnant Women
Both pregnant women and people infected with HIV are at increased risk of viral infection, including influenza infection. Pregnant women infected with HIV may be at particular risk of infection from the new H1N1 influenza virus.
- Trial name
- NCT00992017
- Testing
- Influenza A (H1N1) monovalent vaccine
- Where
- 31 sites in United States, Puerto Rico
- Volunteers
- 130 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Influenza
Novartis H1N1 Vaccine in Pregnant Women
The purpose of this study is to evaluate the safety of a 2009 H1N1 influenza vaccine in pregnant women and to determine how their body reacts to different strengths of the vaccine.
- Trial name
- NCT00992719
- Testing
- Inactivated H1N1 Vaccine
- Where
- 6 sites in United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Safety, Adverse Event Following Immunisation
Safety of RIV4 Versus IIV4 in Pregnant Women
This is a prospective, randomized clinical trial. During the study, pregnant women will be randomized (1:1) to receive RIV4 or IIV4. Vaccines will be administered by licensed providers.
- Conditions
- Safety, Adverse Event Following Immunisation, Birth Outcomes
- Trial name
- NCT03969641
- Testing
- Quadrivalent Recombinant Influenza Vaccine, Quadrivalent Inactivated Influenza Vaccine
- Where
- 3 sites in United States
- Volunteers
- 384 people, healthy volunteers welcome
- Sponsor
- Duke University
Birth Outcomes, Safety
Simultaneous mRNA COVID-19 and IIV Vaccination in Pregnancy Study
This study is a prospective, randomized clinical trial. During this study, pregnant women will be randomly assigned to receive IIV and mRNA COVID-19 vaccine either simultaneously or sequentially (7-14 days apart).
- Conditions
- Birth Outcomes, Safety, Adverse Event Following Immunization
- Trial name
- NCT06503900
- Testing
- mRNA COVID-19 vaccine, IIV4 (quadrivalent inactivated influenza vaccine)
- Where
- 6 sites in United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Duke University
Pregnancy
PregText: Feasibility of Monitoring Influenza Vaccine Safety in Pregnant Women Using Text Messaging
In this study, the investigators will prospectively assess fever rates and other adverse events in pregnant women after administration of inactivated influenza vaccine (IIV) using text messaging.
- Trial name
- NCT01974050
- Testing
- Text message surveillance
- Where
- United States
- Volunteers
- 166 people
- Sponsor
- Columbia University
Influenza
H1N1 Vaccine in Pregnant Women
The purpose of this study is to evaluate an investigational 2009 H1N1 influenza vaccine to determine vaccine safety in pregnant women and the body's immune response (body's defense against disease) to different strengths of the…
- Trial name
- NCT00963430
- Testing
- Inactivated H1N1 Vaccine
- Where
- 5 sites in United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pregnancy
Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women
This is a pilot, prospective, randomized, open-label clinical trial. During the study, pregnant women will be randomized (1:1) to receive co-administration of a single intramuscular (IM) 0.5 mL dose of US-licensed inactivated…
- Trial name
- Tdap/IIV (NCT02783170)
- Testing
- Tetanus, Diphtheria, and Pertussis Vaccine, 2016-2017 Quadrivalent Inactivated Influenza Vaccine, 2017-2018 Quadrivalent Inactivated Influenza Vaccine
- Where
- 3 sites in United States
- Volunteers
- 81 people
- Sponsor
- Duke University
Influenza
2010-2011 Trivalent Influenza Vaccine (TIV) in Pregnant Women
The purpose of this study is to see how much antibody (proteins produced by the immune system that help fight infections) the body makes after getting a flu vaccine.
- Trial name
- NCT01173211
- Testing
- Trivalent inactivated influenza vaccine
- Where
- 5 sites in United States
- Volunteers
- 183 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Influenza
Study of Live, Attenuated Influenza Vaccination in Preterm and Full-Term Infants
Severe influenza respiratory disease is increasingly recognized in children. Influenza hospitalization rates in high-risk infants, such as premature infants, are increased some five-fold over rates in other children.
- Trial name
- NCT01194297
- Testing
- Live attenuated influenza vaccine, Inactivated influenza vaccine
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- University of Rochester
Influenza
Fluarix/ FluLaval/ Fluarix Quadrivalent/ FluLaval Quadrivalent Vaccine Pregnancy Registry
The purpose of this pregnancy registry study is to detect and describe abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with any of GlaxoSmithKline (GSK) Biologicals' seasonal Inactivated Influenza…
- Trial name
- NCT02148211
- Testing
- Data collection
- Where
- United States
- Volunteers
- 507 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline