Clinical trials: Maternal Immunization
Pertussis (Whooping Cough), Tetanus
Safety Monitoring of Boostagen® Vaccine in Thailand
This study is designed to monitor the safety of Boostagen® after it has been approved for use in Thailand. The study follows people who receive the vaccine in routine medical practice to identify and record any side effects.
- Conditions
- Pertussis (Whooping Cough), Tetanus, Diphtheria
- Trial name
- BOOSTg001 (NCT07444502)
- Where
- Thailand
- Volunteers
- 10,727 people, healthy volunteers welcome
- Sponsor
- BioNet-Asia Co., Ltd.
Respiratory Syncytial Virus Infections
A Study of Outcomes and Events of Interest in Pregnant Women, Neonates and Infants and of RSV Surveillance
The purpose of this study is to assess pregnancy outcomes, and maternal, as well as neonatal events of interest in healthy pregnant women and their new-borns.
- Trial name
- PEPNI (NCT03614676)
- Testing
- Blood sample collection, Cord blood sample collection, Maternal Diary Card
- Where
- 40 sites in Argentina, Bangladesh and 8 more
- Volunteers
- 4,493 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
SARS-CoV-2 Infection, COVID-19
To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older
Results will be submitted, however please note that data are not yet available for all serology outcome measures. This will be a Phase 2/3, randomized, placebo-controlled, observer-blind study evaluating the safety, tolerability…
- Conditions
- SARS-CoV-2 Infection, COVID-19, Maternal Immunization
- Trial name
- NCT04754594
- Testing
- BNT162b2
- Where
- 90 sites in United States, Brazil and 3 more
- Volunteers
- 726 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Respiratory Syncytial Virus Infections
A Follow-up Study to Describe the Safety of Study Participants Who Received RSVPreF3 Maternal Vaccination (Any Dose) or Controls From Previous RSV MAT Studies During Any Pregnancy Conceived Post Vaccination/Control
The purpose of this follow-up study was to describe the safety in subsequent pregnancies in participants who were previously administered the RSVPreF3 maternal vaccine or control during any prior RSV MAT study.
- Trial name
- NCT05705440
- Testing
- RSVPreF3 vaccine, Control
- Where
- 138 sites in United States, Argentina and 21 more
- Volunteers
- 3,855 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Respiratory Syncytial Virus (RSV)
Evaluating ABRYSVO Maternal Vaccine Effectiveness Among Infants
To generate critical evidence to support vaccine policy and implementation, Pfizer will collaborate with Kaiser Permanente Northern California (KPNC) to study the vaccine effectiveness (VE) of ABRYSVO vaccination during pregnancy…
- Trial name
- NCT07249320
- Testing
- ABRYSVO
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Pfizer
Respiratory Syncytial Virus Infections
RSV F Vaccine Maternal Immunization Study in Healthy Third-trimester Pregnant Women.
The purpose of this study is to evaluate the safety and immunogenicity of an RSV-F protein nanoparticle vaccine, with aluminum, in healthy third-trimester pregnant women and to assess the impact of maternal immunization on infant…
- Trial name
- NCT02247726
- Testing
- RSV F vaccine (0.5mL injection)
- Where
- 7 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Novavax
Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus
STudy of Real World vaccinE Effectiveness of maTernal RSVpreF vaccinatiON Against Respiratory Syncytial Virus (RSV) in Hospitalised Infants in Australia (STREETON)
This Pfizer-sponsored real-world retrospective non-interventional study will be conducted within a research network comprised of independent hospitals across Australia using data collected during routine standard of care clinical…
- Conditions
- Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus, Lower Respiratory Tract Disease, Respiratory Tract Diseases
- Trial name
- STREETON (NCT07122661)
- Testing
- ABRYSVO
- Where
- Australia
- Volunteers
- 1 people
- Sponsor
- Pfizer
Healthy
BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies
BEATRIX (group B strEptococcus mATeRnal and Infant VaX study) The purpose of this study is to learn about the safety and how the group B streptococcus (GBS) vaccine works in pregnant women and their babies.
- Trial name
- NCT07160244
- Testing
- Multivalent Group B streptococcus vaccine, Infanrix hexa, Prevenar 20
- Where
- 216 sites in United States, Argentina and 13 more
- Volunteers
- 6,000 people, healthy volunteers welcome
- Sponsor
- Pfizer
Respiratory Syncytial Virus Infections
A Study to Determine the Safety and Efficacy of the RSV F Vaccine to Protect Infants Via Maternal Immunization
The purpose of this study is to determine the efficacy of maternal immunization during the third trimester of pregnancy with the RSV F vaccine against medically-significant RSV lower respiratory tract infection (LRTI), as defined…
- Trial name
- NCT02624947
- Testing
- RSV F vaccine with adjuvant, Formulation buffer
- Where
- 88 sites in United States, Argentina and 9 more
- Volunteers
- 4,636 people, healthy volunteers welcome
- Sponsor
- Novavax
Contraception
Integrating Family Planning With Immunization to Improve Maternal and Child Health
The proposed project will help in assessing the effectiveness of a demand-side financing project that provides family planning services bundled in a package of postnatal care and infant immunization services.
- Trial name
- NCT02447913
- Testing
- Voucher
- Where
- Pakistan
- Volunteers
- 28,000 people
- Sponsor
- Greenstar Social Maketing
Diphtheria, Acellular Pertussis
Impact of Boostrix™ Maternal Vaccination on Morbidity and Mortality of Pertussis Disease in Infants ≤6 Weeks of Age, in Bogota, Colombia.
This study is being conducted to assess impact of maternal immunisation against pertussis in infants ≤12 months of age before and after introduction of pertussis maternal immunisation in Bogota, Colombia from January…
- Conditions
- Diphtheria, Acellular Pertussis, Tetanus, Aspergillosis, Allergic Bronchopulmonary
- Trial name
- NCT02569879
- Testing
- Pertussis maternal immunization
- Where
- Colombia
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline
Healthy
Dose-finding Study of LFB-R593, A Monoclonal Anti-RhD Antibody, in Healthy RhD Negative Volunteers
This phase II study is designed to demonstrate the ability of LFB-R593 to effectively eliminate exogenously-administered RhD-positive red blood cells from the circulation of an RhD-negative individual, thereby preventing…
- Trial name
- NCT00952575
- Testing
- polyclonal anti-D immunoglobulin, monoclonal anti-D immunoglobulin
- Where
- Germany
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
Hepatitis B
Follow-up Study 16-20 Years After Primary Vaccination Against Hepatitis B of Newborns From HBeAg+ & HBsAg+ Mothers
The purpose of this study is to evaluate the persistence of anti-hepatitis B surface antigen (anti-HBs) antibodies 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine.
- Trial name
- NCT00240500
- Testing
- Engerix™-B
- Where
- Thailand
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
RSV Infection
A Phase 3 Study of Revaccination in Subsequent Pregnancies With Bivalent RSV Vaccine and Duration of Protection of a Single Dose
This study aims to check how safe and well-tolerated a second dose of RSVpreF is when given during later pregnancies, and to see how long the immunity lasts from a single dose given during a previous pregnancy by examining the…
- Trial name
- NCT06866405
- Testing
- RSVpreF
- Where
- 97 sites in United States, Argentina and 2 more
- Volunteers
- 550 people, healthy volunteers welcome
- Sponsor
- Pfizer
Respiratory Syncytial Virus Infections
Evaluating the Benefits of RSV Maternal Vaccination Using a Scottish National Dataset
This study will use a retrospective cohort design and will be conducted within routinely collected national healthcare and statutory demographic datasets held by PHS and National Records of Scotland (NRS).
- Trial name
- BORLAND (NCT07235397)
- Testing
- ABRYSVO
- Volunteers
- 1 people
- Sponsor
- Pfizer
Respiratory Syncytial Virus Infections
A Study of Safety, Reactogenicity and Immune Response of the Repeat Vaccination Against RSV When Given to Female Participants of 18-49 Years of Age During Their Subsequent Uncomplicated Pregnancy
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a single intramuscular dose of the investigational respiratory syncytial virus (RSV) maternal (RSV MAT) vaccine during subsequent…
- Trial name
- NCT05229068
- Testing
- RSV MAT
- Where
- 2 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Respiratory Syncytial Virus, Respiratory Tract Diseases
Impact and Effectiveness of ABRYSVO® Vaccination During Pregnancy
This study will be conducted in collaboration with a research network of independent hospital sites to evaluate the vaccine effectiveness (VE) and impact of ABRYSVO vaccination during pregnancy in a real-world population over…
- Trial name
- BERNI (NCT06647654)
- Testing
- ABRYSVO
- Where
- Argentina
- Volunteers
- 1 people
- Sponsor
- Pfizer
Hepatitis B
Long Term Follow-Up Study 16-20 Years After Hepatitis B Vaccination in Newborns of Mothers Who Were Seropositive for Hepatitis B Envelope Antigen (HBeAg) & Hepatitis B Surface Antigen (HBsAg)
This study is performed to evaluate the persistence of anti-hepatitis B surface antigen (HBs) antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine, Engerix-B™.
- Trial name
- NCT00240539
- Testing
- Blood sampling
- Where
- Thailand
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria
A Post-marketing, Observational, Retrospective Study to Assess the Safety of RefortrixTM (Tdap) When Administered During Pregnancy in a Maternal Immunization Program in Brazil.
The purpose of this study is to assess the safety of RefortrixTM (Tdap) when administered during pregnancy in a maternal immunization program in Brazil.
- Trial name
- NCT02757950
- Testing
- Combined diphtheria, tetanus and tricomponent acellular pertussis vaccine [Refortrix (Tdap)]
- Where
- Brazil
- Volunteers
- 2,462 people
- Sponsor
- GlaxoSmithKline
Hepatitis B
Immunogenicity and Safety of Primary and Booster Vaccination With DTPa-HBV-IPV/Hib Vaccine
This study will assess the immunogenicity, safety and reactogenicity of GSK Biological's DTPa-HBV-IPV/ Hib vaccine as compared to GSK's DTPa-IPV/Hib vaccine co-administered with HBV according to a three-dose immunisation course…
- Trial name
- NCT00880477
- Testing
- DTPa-HBV-IPV/Hib vaccine, DTPa-IPV/Hib vaccine, EngerixTM-B
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline