Clinical trials: Adverse Event Following Immunisation
Quality of Life, Injection Site Reaction
Simultaneous mRNA COVID-19 and IIV4 Vaccination Study
This study is a prospective, randomized clinical trial. During this study, participants will be randomly assigned to receive quadrivalent inactivated influenza vaccine (IIV4) and mRNA COVID-19 vaccine either simultaneously or…
- Conditions
- Quality of Life, Injection Site Reaction, Adverse Drug Event, Systemic Reaction
- Trial name
- NCT05028361
- Testing
- mRNA COVID-19, IIV4
- Where
- 3 sites in United States
- Volunteers
- 348 people, healthy volunteers welcome
- Sponsor
- Duke University
Adverse Event Following Immunisation
A Study to Evaluate the Safety and Immunogenicity of Oral Polio Vaccine Type 2 in Infants and Children
Sabin 2 will be withdrawn from routine use globally from April 2016 as per the SAGE recommendations at the time of writing this protocol.
- Trial name
- M2-ABMG (NCT02521974)
- Testing
- SABIN monovalent OPV2
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- Fidec Corporation
Adverse Events in COVID-19 Vaccination
App-based Symptom Tracking After Corona Vaccination (CoCoV)
The study investigates the side effects of different COVID-19 vaccines.
- Trial name
- NCT04686409
- Testing
- COVID-19 vaccines
- Where
- Germany
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- University of Ulm
Japanese Encephalitis
Safety Surveillance After Immunization With IXIARO
This is an active electronic surveillance using data from the Defense Medical Surveillance System (DMSS) to detect and characterize serious, rare adverse events occurring within 42 days after vaccination with the Japanese…
- Trial name
- NCT01335412
- Testing
- Japanese Encephalitis Virus vaccine, inactivated, adsorbed
- Where
- United States
- Volunteers
- 20,000 people
- Sponsor
- Valneva Austria GmbH
Novel Influenza A/H1N1
Surveillance for Adverse Events Following Pandemic H1N1 Immunization
Influenza vaccines are continuously modified to adjust to the virus antigenic shifts or drifts, and its safety profile may vary.
- Trial name
- NCT01289418
- Volunteers
- 6,525 people, healthy volunteers welcome
- Sponsor
- PHAC/CIHR Influenza Research Network
Adverse Reaction to Cholera Vaccine, Cholera Vaccination Reaction
Extended Dose Intervals With Oral Cholera Vaccine in Cameroon
The primary aim of this project is to determine changes in the vibriocidal geometric mean titers (GMT) in subjects who receive the second dose of oral cholera vaccine (OCV) at different intervals: 2 weeks, 6 months, or 11 months…
- Trial name
- NCT03719066
- Testing
- killed whole cell oral cholera vaccine
- Where
- Cameroon
- Volunteers
- 181 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
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
Influenza, Human, Orthomyxoviridae Infections
Active Surveillance for Adverse Events Following Immunization With the Butantan Trivalent Influenza Vaccine (2018)
Rationale and Background: Since 2013, Butantan Institute has been performing passive pharmacovigilance activities related to its triavalent, fragmented and inactivated vaccine (IB TIV).
- Conditions
- Influenza, Human, Orthomyxoviridae Infections, RNA Virus Infections, Respiratory Tract Infections
- Trial name
- FLU-06-IB (NCT03392207)
- Testing
- Seasonal Influenza Vaccine
- Where
- 2 sites in Brazil
- Volunteers
- 403 people
- Sponsor
- Butantan Institute
Adverse Reaction to Drug
Explore Active Surveillance Mode of the Community's Adverse Event Following Immunization(AEFI)
The investigators would remind the guardians of observation after immunization via sending short message and collect the information of AEFI by two ways, short message/telephone and website questionnaire.
- Trial name
- AEFI (NCT01830257)
- Testing
- sending message
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Beijing Center for Disease Control and Prevention
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
Meningococcal Infections
Bexsero™and Routine Infant Vaccines: Effect of Coadministration on the Safety of Immunization
Bexsero™ is a four component serogroup B meningococcal vaccine (4CMenB) licensed in Europe, Canada, and Australia in 2014. Prelicensure studies and post marketing surveillance data showed that 4CMenB has a high reactogenicity…
- Trial name
- NCT02712177
- Testing
- 4CMenb, diphtheria,tetanus,pertussis+polio+Hepatitis B+HiB, conjugated pneumococcal vaccine
- Volunteers
- 4,535 people, healthy volunteers welcome
- Sponsor
- CHU de Quebec-Universite Laval
Mortality, Hospitalization
Randomized Study of Not Giving Diphteria-tetanus-pertussis Vaccination With or After Measles Vaccination
In non-randomized studies, routine childhood vaccinations have been observed to have non-targeted effects. Difteria-tetanus-pertussis (DTP) vaccine provided with or after measles vaccine (MV) is associated with increased…
- Conditions
- Mortality, Hospitalization, Adverse Events
- Trial name
- NCT00244673
- Testing
- DTP3/4+OPV+MV versus OPV+MV or DTP4+OPV4 versus OPV4
- Where
- Guinea-Bissau
- Volunteers
- 6,534 people
- Sponsor
- Bandim Health Project
Influenza Vaccines
Active Surveillance for Adverse Events Following Immunization With the Influenza Vaccine Produced at Butantan Institute
Rationale and background: Since 2013, IB has been performing passive pharmacovigilance activities related to TIV. Objetive: To implement an active surveillance study as part of our pharmacovigilance plan while passive…
- Trial name
- FLU-05-IB (NCT03057483)
- Testing
- Seasonal Influenza vaccine
- Where
- 2 sites in Brazil
- Volunteers
- 533 people, healthy volunteers welcome
- Sponsor
- Butantan Institute
COVID-19
Incidence of COVID-19 Following Vaccination in Botswana Against SARS CoV 2
The AstraZeneca Study is a single-arm, open-label, interventional, Phase 3b study to determine the incidence of laboratory-confirmed COVID-19 hospitalizations, disease severity, and deaths and attributable adverse events (AEs) in…
- Trial name
- NCT05715944
- Testing
- AZD 1222
- Where
- Botswana
- Volunteers
- 10,888 people, healthy volunteers welcome
- Sponsor
- Botswana Harvard AIDS Institute Partnership
Pneumococcal Vaccine Adverse Reaction
Post-marketing Safety Evaluation of Pneumococcal Vaccines Among Children and Elderly Adults.
The purpose of this observational study is to examine the risk of adverse events following vaccination with 10 or 13-valent pneumococcal conjugate vaccine (PCV10 or PCV13) among infants or children age <59 months and 23-valent…
- Trial name
- NCT04551248
- Testing
- 10 or 13-valent pneumococcal conjugate vaccine, 23-valent pneumococcal polysaccharide vaccine, Influenza vaccine
- Where
- South Korea
- Volunteers
- 1,000,000 people, healthy volunteers welcome
- Sponsor
- Sungkyunkwan University
Drug-Related Side Effects and Adverse Reactions
Investigation of Serious Adverse Events Following Vaccination Against Yellow Fever: Emphasis on Genetic Basis and Biological Markers
It concerns an investigation aiming to investigate genetic biological(s) marker(s) which allow to identify individuals who have risk of serious adverse events to the yellow fever vaccine.
- Trial name
- NCT03938597
- Where
- Brazil
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Measles
Participant Centered Active Surveillance for Adverse Event Following Measles Immunization in Gedeo Zone, Ethiopia, 2022. A Multi-center Open-label Randomized Control Trial
Introduction Participant centered active adverse event following immunization (AEFI) surveillance can offer real time vaccine safety data and help in signal detection.
- Trial name
- NCT05803538
- Testing
- SMS, telephone interview or diary card
- Where
- Ethiopia
- Volunteers
- 391 people, healthy volunteers welcome
- Sponsor
- Dilla University
Dengue Fever
A Study to Monitor the Adverse Events of QDENGA Vaccine in Participants in Malaysia
The main aim of this study is to collect the number and type of medical problems (adverse events) after vaccination with QDENGA in Malaysia and to learn more about such medical problems after vaccination.
- Trial name
- PRIME-Q (NCT06388785)
- Testing
- No Intervention
- Where
- 2 sites in Malaysia
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Takeda
Fever, Adverse Event Following Immunisation
Safety of RSV Preventive Monoclonal Antibody
This is a prospective, randomized, open-label clinical trial to evaluate the safety of administration of respiratory syncytial virus (RSV) preventive monoclonal antibody and other routine childhood vaccines given simultaneously…
- Trial name
- NCT07158814
- Testing
- Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody
- Where
- 6 sites in United States
- Volunteers
- 524 people, healthy volunteers welcome
- Sponsor
- Duke University
Cervical Intraepithelial Neoplasia
A Post Marketing Surveillance (PMS) Study to Monitor the Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine in Female Chinese Subjects
The purpose of this prospective, multi-centre, PMS cohort study was to monitor the safety of Cervarix, which is the first HPV vaccine licensed for use in China, to help prevent cervical cancer caused by HPV types 16 and 18.
- Trial name
- NCT03438006
- Testing
- Safety data collection (following routine vaccination)
- Where
- 7 sites in China
- Volunteers
- 3,016 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline