Respiratory Tract Infection Clinical Trial
Official title:
A PHASE 2b, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE WHEN ADMINISTERED CONCOMITANTLY WITH TETANUS, DIPHTHERIA, AND ACELLULAR PERTUSSIS VACCINE (TDAP) IN HEALTHY NONPREGNANT WOMEN 18 THROUGH 49 YEARS OF AGE
This phase 2b study will evaluate safety, tolerability, and immunogenicity of an RSV vaccine when given together with Tdap in approximately 710 healthy nonpregnant women 18 through 49 years of age. This study will evaluate non-inferiority of RSV vaccine when given with Tdap and vice-versa.
This Phase 2b study will evaluate safety, tolerability, and immunogenicity of an RSV vaccine when given together with Tdap in approximately 710 healthy nonpregnant women 18 through 49 years of age. The participants will be equally split into 5 treatment groups: One of a possible two dose levels of RSV vaccine (the higher dose level will be formulated with an aluminum hydroxide adjuvant) with either the Tdap or Placebo, or a Tdap and placebo combination. This study will evaluate non-inferiority of the Tdap when co-administered with RSV vaccine candidate and vice-versa by measuring participants' immune response through appropriate antibody and component levels 1 month after vaccination. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00240461 -
Use of COLD-fX to Prevent Respiratory Infections in Community Dwelling Seniors
|
Phase 3 | |
| Completed |
NCT03524118 -
Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002)
|
Phase 1/Phase 2 | |
| Recruiting |
NCT02568800 -
Prolonged Infusion Cefepime and Nosocomial Infections
|
Phase 3 | |
| Completed |
NCT00427141 -
A Three-Part Study Of GSK580416 In Healthy Subjects
|
Phase 1 | |
| Completed |
NCT00688610 -
Antibiotics in Patients With Acute Respiratory Tract Infection With Procalcitonin as Parameter
|
Phase 2 | |
| Completed |
NCT01549938 -
Cholecalciferol Intervention to Prevent Respiratory Infections Study
|
Phase 2 | |
| Completed |
NCT01789268 -
Impact of Respiratory Pathogens in Infants
|
||
| Terminated |
NCT03572062 -
A Study to Evaluate the Safety and Immunogenicity of an Adjuvanted RSV Vaccine in Healthy Older Adults
|
Phase 2 | |
| Completed |
NCT04424316 -
A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.
|
Phase 3 | |
| Completed |
NCT01129765 -
Home Usability of a Nasal Lavage System in Children
|
N/A | |
| Completed |
NCT01787227 -
A Two Arm, Multi-Centre Clinical Evaluation of the NxTAG Respiratory Pathogen Panel
|
N/A | |
| Completed |
NCT02210156 -
Effects of a Supplement on Acute Respiratory Infections
|
N/A | |
| Completed |
NCT01075204 -
Clarithromycin Modified Release Observational Study for Evaluation of Treatment, Tolerability & Recovery Time in Saudi & Egyptian Clinical Settings (CLOSER)
|
N/A | |
| Completed |
NCT00585481 -
Incidence of Severe Respiratory Syncytial Virus Infections in Preterm Brazilian Children
|
N/A | |
| Completed |
NCT05337163 -
A Multicenter Clinical Trial of Sputum DNA Testing for Lung Cancer in China
|
||
| Completed |
NCT00812422 -
The Efficacy and Safety of Dexibuprofen Syrup
|
Phase 3 | |
| Active, not recruiting |
NCT02087761 -
A Multi-Site Clinical Evaluation of the ARIES Flu Assay in Symptomatic Patients
|
N/A | |
| Completed |
NCT01076153 -
Recovery Time in Thai Patients With Upper or Lower Respiratory Tract Infections Treated With Klacid MR
|
N/A | |
| Completed |
NCT00265187 -
The Prevalence and Clinical Manifestations of Human Metapneumovirus Among Children With Bronchiolitis.
|
N/A | |
| Completed |
NCT04032093 -
A PHASE 2B PLACEBO-CONTROLLED, RANDOMIZED STUDY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN
|
Phase 2 |