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Clinical Trials associated with Diphtheria (D), Tetanus (T), Pertussis (Acellular, Component) (Pa), Hepatitis B (Rdna) (Hbv), Poliomyelitis (Inactivated) (Ipv) And Haemophilus Influenzae Type-B (Hib) Conjugate Vaccine(Glaxosmithkline Plc)A Phase 3, Randomized, Placebo-Controlled, Double-Blinded Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Multivalent Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Infants
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.
This study is seeking healthy pregnant participants:
* aged 49 or younger who can join.
* between 24 and 36 weeks of gestation ("Gestational age" is a medical term used to describe how far along your pregnancy is)
* had a fetal ultrasound examination performed with no major fetal abnormalities observed
* documented negative for HIV, syphilis and Hepatitis B All participants in this study will receive only 1 shot in an arm. This could either be a group B streptococcus 6-valent polysaccharide conjugate vaccine (GBS6) or placebo. Placebo is an inactive substance used in the study for comparison purposes; in this study, the placebo injection will be saline (saltwater). The pregnant participants may take part in this study for a maximum of 14 months (6 months after delivery) , and their babies for about 12 months after they are born. The pregnant participants will need to visit the research site at least 3 to 4 times with some visits permitted to occur over the telephone.
A subset of infants will be asked to take part in the study for up to 19 months. The subset will receive diphtheria toxoid-containing vaccine and/or pneumococcal vaccine following each country's standard immunization plan and have blood drawn 1 month after completion of the primary and/or toddler (booster) doses.
/ Active, not recruitingPhase 1/2 A Parallel-group Prevention, Phase II, Partially Blinded, Multi-stage Study to Investigate the Immunogenicity and Safety of Pentavalent Meningococcal ABCYW Vaccine Formulations Compared With Licensed Meningococcal Vaccines When Administered Alone in Healthy Children (2 to 9 Years of Age) or Concomitantly With Routine Pediatric Vaccines in Toddlers (12 to 15 Months of Age) and Infants (2 Months of Age).
This study is the first study of Sanofi's Pentavalent Meningococcal ABCYW vaccine clinical development program to be conducted in the pediatric population below 10 years of age. The aim of the study is to assess 2 formulations of the MenPenta vaccine compared to licensed meningococcal vaccines when administered alone in children (Stage 1) or concomitantly with routine pediatric vaccines in toddlers (Stage 2) and infants (Stage 3).
Study details include:
The study duration per participant will be up to 12 months for children in Stage 1 and toddlers in Stage 2 and 16 to-19 months for infants in Stage 3.
A Phase IV, Single-blind, Randomised, Controlled, Multi-country Study to Evaluate the Immunogenicity and Safety of GSK's Infanrix Hexa (DTPa-HBV-IPV/Hib) Versus MCM Vaccine BV's Vaxelis (DTaP5-HBV-IPV Hib), When Administered Intramuscularly According to a 2-, 4- and 12-month Schedule in Healthy Infants and Toddlers
The purpose of this study was to assess the safety and immunogenicity of GSK's combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b conjugate vaccine (DTPa-HBV-IPV/Hib) versus MCM Vaccine BV's DTaP5-HBV-IPV-Hib vaccine administered to healthy infants and toddlers, between 6 and 12 weeks of age at the time of first vaccination, based on a 2-, 4-, and 12-months of age vaccination schedule.
100 Clinical Results associated with Diphtheria (D), Tetanus (T), Pertussis (Acellular, Component) (Pa), Hepatitis B (Rdna) (Hbv), Poliomyelitis (Inactivated) (Ipv) And Haemophilus Influenzae Type-B (Hib) Conjugate Vaccine(Glaxosmithkline Plc)
100 Translational Medicine associated with Diphtheria (D), Tetanus (T), Pertussis (Acellular, Component) (Pa), Hepatitis B (Rdna) (Hbv), Poliomyelitis (Inactivated) (Ipv) And Haemophilus Influenzae Type-B (Hib) Conjugate Vaccine(Glaxosmithkline Plc)
100 Patents (Medical) associated with Diphtheria (D), Tetanus (T), Pertussis (Acellular, Component) (Pa), Hepatitis B (Rdna) (Hbv), Poliomyelitis (Inactivated) (Ipv) And Haemophilus Influenzae Type-B (Hib) Conjugate Vaccine(Glaxosmithkline Plc)
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Literatures (Medical) associated with Diphtheria (D), Tetanus (T), Pertussis (Acellular, Component) (Pa), Hepatitis B (Rdna) (Hbv), Poliomyelitis (Inactivated) (Ipv) And Haemophilus Influenzae Type-B (Hib) Conjugate Vaccine(Glaxosmithkline Plc)01 May 2025·PEDIATRIC INFECTIOUS DISEASE JOURNAL
Acellular Pertussis Vaccine Given in the Week After Birth Does Not Impair Antibody Responses to Later Childhood Doses
Article
Author: Marshall, Helen S. ; Richmond, Peter ; McAlister, Sonia M. ; McIntyre, Peter ; van den Biggelaar, Anita H.J. ; Wood, Nicholas ; Thornton, Ruth ; Nolan, Terry ; Cooper, Matthew N.
Background::A birth acellular pertussis vaccine may be a valuable alternative for immunity against infant pertussis when a pregnancy pertussis vaccine has not been administered. We assessed whether a birth dose may impair immunoglobulin G (IgG) responses to childhood pertussis boosters.
Methods::Children from our previous randomized controlled trial who received a monovalent 3-component aP and hepatitis B vaccine at birth (aP group) or hepatitis B only (control group) followed by Infanrix hexa at 2, 4 and 6 months of age were randomized to receive either high or low-dose diphtheria-tetanus acellular pertussis combination vaccine (DTPa—Infanrix/dTpa—Boostrix) at 18 months and 4 years of age. Serum DTPa-specific IgG was measured pre- and postboost at 18 months and 4 years to determine immunogenicity and potential hyporesponsiveness across vaccination schedules.
Results::Children who received a neonatal aP dose had improved pertussis toxin-IgG persistence and enhanced postvaccination pertactin and filamentous hemagglutinin-IgG responses at 18 months. Hyporesponsiveness was not detected across the study period, and all schedules showed good immunogenicity to subsequent boosters. The high-dose DTPa vaccine consistently induced higher antibody titers than the low-dose dTpa vaccine. Either booster dose was able to bridge immunity between 6 months and 4 years.
Conclusions::A birth dose of acellular pertussis vaccine does not impair antibody responses to booster doses of pertussis vaccines and may be an alternative for protection against early infant pertussis when pertussis booster has not been administered during pregnancy.
12 Apr 2024·JOURNAL OF INFECTIOUS DISEASES
Modeling Poliovirus Transmission and Responses in New York State
Article
Author: Routh, Janell A ; Burns, Cara C ; Rosenberg, Eli S ; Zucker, Jane R ; Thompson, Kimberly M ; Badizadegan, Kamran ; Sugerman, David E ; Brenner, I Ravi ; Langdon-Embry, Marisa ; Kalkowska, Dominika A
Background:In July 2022, New York State (NYS) reported a case of paralytic polio in an unvaccinated young adult, and subsequent wastewater surveillance confirmed sustained local transmission of type 2 vaccine-derived poliovirus (VDPV2) in NYS with genetic linkage to the paralyzed patient.
Methods:We adapted an established poliovirus transmission and oral poliovirus vaccine evolution model to characterize dynamics of poliovirus transmission in NYS, including consideration of the immunization activities performed as part of the declared state of emergency.
Results:Despite sustained transmission of imported VDPV2 in NYS involving potentially thousands of individuals (depending on seasonality, population structure, and mixing assumptions) in 2022, the expected number of additional paralytic cases in years 2023 and beyond is small (less than 0.5). However, continued transmission and/or reintroduction of poliovirus into NYS and other populations remains a possible risk in communities that do not achieve and maintain high immunization coverage.
Conclusions:In countries such as the United States that use only inactivated poliovirus vaccine, even with high average immunization coverage, imported polioviruses may circulate and pose a small but nonzero risk of causing paralysis in nonimmune individuals.
01 Apr 2024·The Lancet. Infectious diseases
The oral poliovirus vaccine—a solution and a concern for eradication
Article
Author: Fernandez-Garcia, Maria Dolores ; Faye, Martin
A review.Large-scale administration of the oral polio vaccine (OPV) has been a key pillar of polio eradication efforts.However, when used in under-immunized communities, OPV can circulate for an extended period, reverting the attenuating mutations and acquiring the neurovirulence of wild-type poliovirus.These viruses are known as circulating vaccine-derived polioviruses (cVDPVs).A tool to break this vicious cycle when responding to VDPV2 outbreaks is the novel oral polio vaccine type 2 (nOPV2).This vaccine was specifically engineered to improve the genetic stability of OPV2 during gut replication and reduce the risk of its evolution to a VDPV (and thus reduce its potential to revert to neurovirulence) compared with the existing mOPV2.
100 Deals associated with Diphtheria (D), Tetanus (T), Pertussis (Acellular, Component) (Pa), Hepatitis B (Rdna) (Hbv), Poliomyelitis (Inactivated) (Ipv) And Haemophilus Influenzae Type-B (Hib) Conjugate Vaccine(Glaxosmithkline Plc)