Clinical trials: Vaccine Adverse Reaction
Adverse Drug Reactions
A Pharmacovigilance Study for AdimFlu-S (A/H1N1) Influenza Vaccine in Pregnant Women
This was a retrospective cohort study of pregnant women who had received the AdimFlu-S (A/H1N1) influenza vaccine during gestation period. Eligibility into the study was confirmed by chart review.
- Trial name
- NCT01354730
- Volunteers
- 398 people, healthy volunteers welcome
- Sponsor
- Adimmune Corporation
Smallpox Vaccine Adverse Reaction
VA-006 Vaccinia Vaccine (ACAM2000) for the Production of VIGIV
The purpose of this study is to vaccinate plasma donors with ACAM2000 smallpox vaccine for collection of plasma to be used in the manufacturing of Vaccinia Immune Globulin Intravenous (VIGIV).
- Trial name
- NCT01158157
- Testing
- ACAM2000
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
COVID-19, SARS-CoV-2 Infection
A Trial Investigating the Safety and Effects of One or Two Additional Doses of Comirnaty or One Dose of BNT162b2s01 in BNT162-01 or BNT162-04 Trial Subjects
Trial to evaluate the safety and immunogenicity of one or two boosting doses of Comirnaty or one dose of BNT162b2s01 (Variant of concern [VOC] strain B.1.351) in BNT162-01 trial participants, or two boosting doses of Comirnaty in…
- Trial name
- NCT04949490
- Testing
- BNT162b2s01, BNT162b2
- Where
- 4 sites in Germany
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Vaccine Adverse Reaction, Vaccine Reaction
Phase I/II, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV Vaccine (Bio Farma) in Indonesian Infants
This trial is open label, comparative, randomized, phase I/II study, experimental, randomized, open-label, three arm parallel group study.
- Trial name
- NCT06690515
- Testing
- DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A, DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B, Registered DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac)®
- Where
- 3 sites in Indonesia
- Volunteers
- 465 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Rabies Vaccine Adverse Reaction
A Clinical Trial of Freeze-dried Human Rabies Vaccine (MRC-5 Cells)
This trial is a randomized, blind, similar vaccine controlled, single center, non-inferiority design phase III clinical trial, with a study population of 10 to 60 years old, conducted in two stages.Phase 1 and Phase 2
- Trial name
- NCT06078423
- Testing
- Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 5-dose program, Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 4-dose program, Freeze-dried human rabies vaccine (MRC-5 cells) Kanghua - 5-dose program
- Where
- China
- Volunteers
- 1,880 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
COVID-19, Vaccine Adverse Reaction
National Vaccine Adverse Event Reporting Survey and Etiology
If your serious vaccine-induced adverse event has been entered in the CDC Vaccine Adverse Event Reporting System (VAERS) we are interested in enrolling you for this study in order to log your symptoms.
- Conditions
- COVID-19, Vaccine Adverse Reaction, Vaccine Reaction, Vaccine or Biological Substance, Unspecified Causing Adverse Effects in Therapeutic Use
- Trial name
- NVAERS (NCT05095844)
- Testing
- vaccinated
- Where
- United States
- Volunteers
- 100,000 people
- Sponsor
- Neuroganics LLC
Vaccine Reaction, Vaccine Adverse Reaction
Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III)
This is a phase 3, experimental, randomized, observer-blind, lot to lot consistency study. The primary objective of this study is to assess the protectivity of In-House Recombinant Hepatitis B vaccine 28 days after 3 doses…
- Trial name
- NCT05482295
- Testing
- In-House Recombinant Hepatitis B (Bio Farma) vaccine, Registered Hepatitis B vaccine recombinant (Engerix-B)
- Volunteers
- 540 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Rabies Vaccine Adverse Reaction, Safety and Efficacy
A Clinical Trial of Freeze-dried Human Rabies Vaccine (Vero Cells)
This clinical trial is carried out in two phases. The first phase adopts an open design, and the second phase adopts a randomized, blinded, and similar vaccine-controlled non-inferiority trial design.
- Trial name
- NCT04852068
- Testing
- Freeze-dried human rabies vaccine (Vero cells) Zhifeilongkoma - 5-dose program, Freeze-dried human rabies vaccine (Vero cells) Zhifeilongkoma - 4-dose program, Freeze-dried human rabies vaccine (Vero cells) Chengda - 5-dose program
- Where
- China
- Volunteers
- 2,480 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Smallpox Vaccine Adverse Reaction
VA-008 ACAM2000® Vaccination of Plasma Donors for the Production of VIGIV
Objectives: To vaccinate plasma donors with the ACAM2000 smallpox vaccine thereby inducing an immune response resulting in high anti-vaccinia antibody titers.
- Trial name
- NCT02443623
- Testing
- Vaccination with ACAM2000
- Where
- Canada
- Volunteers
- 3,032 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Vaccine Reaction, Vaccine Adverse Reaction
Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children
A Phase III, Observer-blind, randomized, active-controlled prospective intervention study
- Trial name
- NCT05546502
- Testing
- SARS-CoV-2 Protein Subunit Recombinant Vaccine, Active Comparator
- Where
- 10 sites in Indonesia
- Volunteers
- 1,050 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
COVID-19 Infection, COVID-19 Vaccine Adverse Reaction
Evaluation of Safety and Immunogenicity of a SARS-CoV-2(Severe Acute Respiratory Syndrome Coronavirus 2) Booster Vaccine (LEM-mR203)
A dose-escalation, double-blinded, randomized, placebo-controlled phase 1 study to assess the safety, reactogenicity, and immunogenicity of a SARS-CoV-2 Booster Vaccine (LEM-mR203) in healthy adults aged at 19 to 55 years
- Trial name
- NCT06032000
- Testing
- LEM-mR203
- Where
- South Korea
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Lemonex
Infections, Respiratory, Virus Diseases
A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-19 in Healthy and Immunocompromised Adults
Originally, the study was planned to include two parts, i.e., Part A and Part B, however Part B was cancelled due to changes in the overall clinical development plan.
- Conditions
- Infections, Respiratory, Virus Diseases, Infection Viral, Vaccine Adverse Reaction
- Trial name
- NCT04380701
- Testing
- BNT162a1, BNT162b1, BNT162b2
- Where
- 5 sites in Germany
- Volunteers
- 512 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Diphtheria Vaccine Adverse Reaction, Tetanus Vaccine Adverse Reaction
Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma)
This bridging study is a randomized, double-blind, two arms parallel group, prospective intervention study. The primary objective of this study is to evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B…
- Conditions
- Diphtheria Vaccine Adverse Reaction, Tetanus Vaccine Adverse Reaction, Pertussis Vaccine Adverse Reaction, Haemophilus Influenzae Type B Vaccine Adverse Reaction
- Trial name
- NCT05482282
- Testing
- Recombinant Hepatitis B new Bulk vaccine, DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine, Recombinant Hepatitis B vaccine (Registered BioFarma)
- Where
- 3 sites in Indonesia
- Volunteers
- healthy volunteers welcome
- Sponsor
- PT Bio Farma
Vaccine Response Impaired, Vaccine Adverse Reaction
Vaccine Observation to Include All Communities for Equitable Science
VOICES is a longitudinal, prospective, observational study that will enroll up to 10,000 subjects of diverse racial backgrounds being administered an emergency use authorized COVID-19 vaccine, for collection and analysis of stool…
- Trial name
- VOICES (NCT04770649)
- Testing
- COVID-19 vaccine
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Persephone Biosciences
Influenza
Post-authorisation Safety Study (PASS) of Influenza Vaccine in United Kingdom (UK)
The purpose of this study is to conduct a pilot study to explore the potential use of routinely collected data in General Practitioner (GP) practices to conduct enhanced safety surveillance of seasonal influenza vaccines in the…
- Trial name
- NCT02567721
- Testing
- Vaccine safety surveillance
- Where
- United Kingdom
- Volunteers
- 11,530 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline