Vaccines

About Vaccines Clinical Trials (Click to Open)

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Vaccine Clinical TrialsGeneral Purpose:

Vaccine clinical trials will evaluate the immune response and reactogenicity of certain vaccinations within specific populations. Other trials may compare different vaccinations strategies for the same disease. Comparisons may be made between a live attenuated version of a vaccine versus an inactivated version, as well as comparisons between different vaccination schedules.

Clinical trials may assess the effect of age and prior immunity on certain vaccines and across various populations. Some observational studies may attempt to develop a potential predictor of resistance to vaccines within a specific population.

Given the vast and diverse array of vaccines, the purposes will likely vary based upon the specific vaccine that is being studied. These trials intend to advance the scientific body of knowledge surrounding vaccinations in order to promote health and improve quality of life, particularly within an immune-compromised population who are more susceptible to contracting various diseases.

What will Vaccine Clinical Trials be like?

As there are innumerable types of vaccines, inclusion criteria will vary according to the vaccine being evaluated in a trial. The goal is to ensure that you are the proper fit for a trial.

Clinical trials for vaccines will conduct screenings of each potential participant, which may include medical history or clinical diagnosis of a specific virus, such as HIV infection. Alternatively, studies may require only healthy participants, which will be assessed by trial doctors.

Studies may require priming with the vaccine in question, which would involve documentation of previous vaccination. Women of childbearing age may be required to abstain from sex or take contraceptive measures during the clinical trial.

There is an extensive range of prevention and interventional methods being evaluated. As a result, you must make sure to pick a clinical trial that you feel comfortable participating in after reading the informed consent and learning about what it will entail. Inclusion criteria are intended to provide benefit and avoid wasting your time.

Typical Vaccine Clinical Trial Protocol:

Due to the diverse nature of vaccine clinical trials, it is difficult to pinpoint a general outline Vaccine Clinical Trialsregarding trial protocols. However, interventional trials will either randomly or non-randomly assign participants to different treatment groups receiving various vaccines.

If comparison is being made between primed versus immunologically naïve participants, outcome measures may involve cell-mediated immunity and antibody response at certain time points throughout the duration of the trial.

Within a virus infected population with immunosuppression, participants may be given different vaccine strategies or dosages at the beginning of the trial, with certain treatment groups receiving a second dose within a specific time frame thereafter.

At specified times after vaccination, the antibody concentrations will be determined, the rate of formation of antigen-to-antibody binding will be measured, safety of both vaccines will be assessed, and other relevant treatment outcomes will be measured based on that particular trial.

Observational studies will likely administer different vaccines and obtain data at specified time points afterwards in order to perform statistical analyses; this will likely be with the intention of developing statistical models to predict vaccination titer levels based on demographic characteristics and relevant biomarkers.

All vaccine clinical trials intend to help expand the scientific body of knowledge regarding the interplay between vaccination and the immune response. Trials will often work toward the improvement of quality of life within the more susceptible populations, such as immune-compromised and geriatric populations.

Suggested Search Terms:

Vaccination in an Immunosuppressed Population, Geriatric Vaccine Hypo-response, Safety and Efficacy of Pneumococcal Vaccines, Live Attenuated versus Inactivated Influenza Vaccines, H1N1 Vaccine Study

Current Search Term:

“Vaccines”

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Flu Vaccine Responses in the Setting of Melanoma Treatment


Condition:   Viral Vaccines
Intervention:   Biological: Inactivated influenza vaccine
Sponsor:   University of Pennsylvania
Not yet recruiting


Immunogenicity of Hepatitis B Vaccination in HIV-infected Adults


Condition:   Hepatitis B Vaccine
Interventions:   Biological: 60 µg dose hepatitis B vaccine;   Biological: 20 µg dose hepatitis B vaccine
Sponsors:   Suping Wang;   Centers for Disease Control and Prevention, China
Active, not recruiting


Non Inferiority Trial of Locally Manufactured Meningococcal ACWY Vaccine 'Ingovax ACWY' in Bangladesh.


Condition:   Meningococcal Vaccine
Interventions:   Biological: Ingovax ACWY;   Biological: Menomune® - A/C/Y/W-135
Sponsors:   International Centre for Diarrhoeal Disease Research, Bangladesh;   Incepta Vaccine Limited
Not yet recruiting


Systems Biology to Identify Biomarkers of Neonatal Vaccine Immunogenicity


Condition:   Newborn Vaccine Immunogenicity
Interventions:   Biological: Hepatitis B vaccine (HBV);   Biological: Bacillus Calmette-Guérin (BCG)
Sponsors:   Boston Children’s Hospital;   Medical Research Council Unit, The Gambia;   University of British Columbia
Recruiting


A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age.


Condition:   Meningococcal Vaccine
Interventions:   Biological: MenABCWY;   Biological: Saline;   Biological: rLP2086;   Biological: MenACWY-CRM
Sponsor:   Pfizer
Recruiting


Active Surveillance for Adverse Events Following Immunization With the Influenza Vaccine Produced at Butantan Institute


Condition:   Influenza Vaccines
Intervention:   Biological: Seasonal Influenza vaccine
Sponsor:   Butantan Institute
Recruiting


Malaria Vaccine Safety and Immunogenicity Study in Healthy Adults


Condition:   Malaria Vaccine
Interventions:   Biological: RTS,S/AS01B Fractional dose;   Biological: Double RTS,S/AS01E Fractional dose;   Biological: RTS,S/AS01E Standard dose;   Biological: RTS,S/AS01E + DHA-PIP+PQ Standard dose;   Biological: RTS,S/AS01E Fractional dose;   Biological: RTS,S/AS01E + DHA-PIP+PQ Fractional dose;   Biological: RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose
Sponsor:   University of Oxford
Recruiting


Immunogenicity of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients


Condition:   Hepatitis B Vaccine
Interventions:   Biological: 60 µg dose hepatitis B vaccine;   Biological: 20 µg dose hepatitis B vaccine
Sponsors:   Shanxi Medical University;   Centers for Disease Control and Prevention, China
Active, not recruiting


Immunogenicity of Hepatitis B Vaccination in Hemodialysis Patients


Condition:   Hepatitis B Vaccine
Interventions:   Biological: 60 µg dose hepatitis B vaccine;   Biological: 20 µg dose hepatitis B vaccine
Sponsors:   Suping Wang;   Centers for Disease Control and Prevention, China
Active, not recruiting


Imiquimod and Influenza Vaccine for Immunocompromised Patients


Condition:   Influenza Vaccine
Interventions:   Biological: Intanza;   Biological: Mutagrip;   Drug: Aldara
Sponsor:   University of Lausanne Hospitals
Completed


Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks


Condition:   Rotavirus Vaccines
Interventions:   Biological: HRV PCV-free liquid vaccine;   Biological: Rotarix
Sponsor:   GlaxoSmithKline
Recruiting


Factors Associated With Parental Observation of Side Effects Following the Child Flu Vaccine


Condition:   Influenza Vaccine, Influenza
Intervention:   Other: No intervention
Sponsor:   King's College London
Active, not recruiting



Study of Meninigococcal Conjugate Vaccine Containing Serogroups A,C,Y,W and X (MCV5) in Healthy Adults


Condition:   Meningococcal Vaccines
Interventions:   Biological: MCV-5 with adjuvant;   Biological: MCV-5 without adjuvant;   Biological: Menactra
Sponsor:   PATH
Active, not recruiting


Study of the Long Term Efficacy of Recombinant Hepatitis B Vaccine in Nile Delta of Egypt


Condition:   Hepatitis B Vaccines
Intervention:   Other: Detection of anti HBs antibody titer
Sponsor:   Sherief Abd-Elsalam
Recruiting


Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation


Condition:   Staphylococcal Vaccine
Interventions:   Biological: Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine;   Other: Placebo
Sponsor:   Pfizer
Recruiting


Randomized, Controlled Single-blind Clinical Study to Assess Vaccine Interchangeability Between RV5 and RV1 Using Seven Combined Anti-rotavirus Prevention Programs


Condition:   Rotavirus Vaccine
Interventions:   Biological: Rotarix;   Biological: RotaTeq
Sponsors:   National Institute of Pediatrics, Mexico;   Centro Nacional para la Salud de la Infancia y la Adolescencia;   Merck Sharp & Dohme Corp.
Active, not recruiting


A Case Control Study of the Effectiveness of Q/LAIV Versus Inactivated Influenza Vaccine and No Vaccine in Subjects 2-17 Years of Age


Condition:   Influenza Vaccine Effectiveness
Intervention:  
Sponsors:   MedImmune LLC;   AstraZeneca
Suspended


Trial of Pneumococcal Vaccine Schedules in Ho Chi Minh City, Vietnam


Condition:   Pneumococcal Vaccines
Interventions:   Biological: PCV10;   Biological: PCV13
Sponsors:   Murdoch Childrens Research Institute;   National Health and Medical Research Council, Australia;   GlaxoSmithKline;   Institut Pasteur
Active, not recruiting


H1N1 Vaccine in Pregnancy: a Registry for the Fall and Winter of 2009


Condition:   Vaccine Exposure During Pregnancy
Intervention:  
Sponsors:   Dalhousie University;   Li Ka Shing Foundation;   PHAC/CIHR Influenza Research Network
Terminated


Immune Responses to Yellow Fever Vaccine


Condition:   Yellow Fever Vaccine
Intervention:  
Sponsors:   Emory University;   National Institutes of Health (NIH)
Recruiting


Safety and Immunogenicity of Two Doses of Monovalent Inactivated Influenza Vaccine That is Adjuvanted With MF59C.1 (MF59) and Uses a Surface Antigen From a Potential Pandemic Virus Strain Candidate (H5N1) in Adult and Elderly Subjects


Condition:   Prepandemic Influenza Vaccine
Intervention:   Biological: Monovalent inactivated influenza vaccine
Sponsor:   Novartis Vaccines
Completed


Safety and Immunogenicity of Trivalent Split Influenza Vaccine Using the Strain Composition 2008/2009


Condition:   Seasonal Influenza, Vaccine
Intervention:   Biological: Seasonal Influenza Vaccine
Sponsor:   Novartis Vaccines
Completed


Long-term Persistence of Immunity Against Hepatitis B in 7-8 Years Old Children After Hepatitis B Vaccination.


Condition:   Hepatitis B Vaccine
Intervention:   Biological: Engerix™-B Kinder
Sponsor:   GlaxoSmithKline
Completed


Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Adults Unprimed and Primed With Adjuvanted or Non-adjuvanted Influenza Vaccines


Condition:   Prophylaxis of Avian Influenza Vaccine
Intervention:   Biological: Fluad H5N1 Pandemic Influenza Vaccine
Sponsor:   Novartis Vaccines
Completed

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