Trials: Adverse Event Following Immunisation

N/A N=7,645 Surveillance for Adverse Events Following Influenza Immunization

Influenza · Vaccines Adverse Reaction

Primary: Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in a Medical Consultation — 153 participants

PHAC/CIHR Influenza Research Network Results Aug 2012 0.1% serious AE View details

N/A N=23,939 Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England

Influenza, Human

Primary: Weekly Incidence Rates of Any Adverse Events of Interest (AEIs) Reported Via Adverse Drug Reaction (ADR) Card, by Vaccine Group — 0.00; 0.00; 0.00; 10.10 Percentage of…

GlaxoSmithKline Results Jan 2020 0.2% serious AE View details

N/A N=19,334 Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines

Influenza, Human

Primary: Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction…

GlaxoSmithKline Results Feb 2019 0.0% serious AE View details

N/A N=327,293 Descriptive, Post-marketing, Passive Surveillance Safety Study of ADACEL™ Vaccine

Pertussis

Primary: Twenty One Pre-specified Outcomes of Interest as Obtained From International Coding of Diseases (ICD-9) Codes Captured After Adacel Vaccination in Clinical Database — 0…

Sanofi Pasteur, a Sanofi Company Results Apr 2016 0.0% serious AE View details

Phase 4 N=215 Post-marketing Evaluation of Reactions Following Receipt of Recommended Adolescent Pertussis Vaccine

Pertussis · Diphtheria · Tetanus

Primary: Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine — 89; 87; 85; 87 Participants

Sanofi Pasteur, a Sanofi Company Results Apr 2011 0.0% serious AE View details

N/A N=23,427 A Surveillance Study of Diseases Specified as Adverse Events of Special Interest, of Other Adverse Events Leading to Hospitalisation or Death, and of Meningitis in Children in Africa Prior to Implementation of the RTS,S/AS01E Candidate Vaccine

Malaria

Primary: Number of Participants With at Least One Adverse Events of Specific Interest (AESI) From Month 0 to Month 79 — 12; 11; 16 Participants

GlaxoSmithKline Results Sep 2024 0.0% serious AE View details

Phase 4 N=1,060 Enhanced Safety Surveillance of GlaxoSmithKline's (GSK's) Quadrivalent Seasonal Influenza Vaccines During the 2018/19 Influenza Season

Influenza, Human

Primary: Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by…

GlaxoSmithKline Results Apr 2020 0.0% serious AE View details

Phase 3 N=287 Safety and Immunogenicity of an Adjuvanted Trivalent Influenza Vaccine in Children 6 to <72 Months of Age in Mexico.

Influenza

Primary: Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. — 35; 20; 21…

Novartis Vaccines Results Feb 2016 0.0% serious AE View details

Phase 4 N=10,000 Post-licensure Safety Study of IMOJEV® in Thailand

Japanese Encephalitis

Primary: Number of Participants Experiencing a Grade 3 Immediate Systemic Adverse Events and Serious Adverse Events Following Any Vaccination With IMOJEV® — 0; 0; 204; 59…

Sanofi Pasteur, a Sanofi Company Results May 2016 2.6% serious AE View details

Phase 4 N=687 Post Marketing Surveillance for ADACEL™ in South Korea

Diphtheria · Tetanus · Pertussis

Primary: Summary of Adverse Events Reported in Participants That Received a Single Intramuscular Dose of Adacel™ — 168; 1; 68 Participants

Sanofi Pasteur, a Sanofi Company Results Jan 2017 0.2% serious AE View details

N/A N=6,525 Surveillance for Adverse Events Following Pandemic H1N1 Immunization

Novel Influenza A/H1N1

Primary: Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in a Medical Consultation. — 234…

PHAC/CIHR Influenza Research Network Results Aug 2012 1.1% serious AE View details

Phase 3 N=300 A Safety and Immunogenicity Study of IVACFLU-A/H5N1

Avian Influenza

Primary: Number and Percentage of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer of ≥1:40 — 0; 0; 0; 0 Participants

Institute of Vaccines and Medical Biologicals… Results Apr 2019 1.4% serious AE View details

Phase 3 N=30 A Study to Assess the Safety of Adacel® Vaccine

Diphtheria · Tetanus · Pertussis

Primary: Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine — 27; 27; 0; 1 Participants

Sanofi Pasteur, a Sanofi Company Results Mar 2011 0.0% serious AE View details

N/A N=1,143 Prevenar Special Use-result Surveillance in Japan (Regulatory PostMarketing Commitment Plan)

Pneumococcal Vaccine · Streptococcus Pneumoniae

Primary: Number of Participants With Adverse Reactions — 126 participants

Pfizer Results Jan 2016 1.8% serious AE View details

Phase 4 N=423 Immunogenicity of Adacel® and BOOSTRIX® Vaccines in Adolescents

Tetanus · Diphtheria · Pertussis

Primary: Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine — 172; 177; 196; 194…

Sanofi Pasteur, a Sanofi Company Results Oct 2013 0.0% serious AE View details

Phase 4 N=644 Post-licensure, Modified Double-blind, Multi-center Study Evaluating Safety and Immunogenicity of ADACEL® and BOOSTRIX®

Pertussis · Tetanus · Diphtheria

Primary: Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® — 273; 257; 5; 4…

Sanofi Results Oct 2010 0.0% serious AE View details

Phase 3 N=132 Immunogenicity and Safety of Adacel Polio Vaccine

Diphtheria · Tetanus · Pertussis

Primary: Number of Participants With Seroprotection to Vaccine Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine. — 131; 131; 131; 131 Participants

Sanofi Results Nov 2012 1.5% serious AE View details

Phase 3 N=100 Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries

Encephalitis

Primary: Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Day 56 After the First Vaccination — 33.3; 20.7; 3.4 percentage of participants

Valneva Austria GmbH Results Dec 2014 3.0% serious AE View details

Phase 2 N=82 Immune Response to Yellow Fever Vaccination in Adults With Atopic Dermatitis

Atopic Dermatitis

Primary: Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralization Index (LNI): YFV-17D TC- (AD) Participants Compared to YFV-17D TC- (Non-AD) Participants…

National Institute of Allergy and Infectious… Results Sep 2013 0.0% serious AE View details

Phase 3 N=112 Immunogenicity and Safety of ADACEL™ as Fifth Dose in Taiwan

Diphtheria · Tetanus · Pertussis

Primary: Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination — 95; 99; 55; 99 Percentage of…

Sanofi Pasteur, a Sanofi Company Results Jun 2009 0.0% serious AE View details

N/A N=1,258 Post Market Surveillance for Infanrix™

Diphtheria · Acellular Pertussis · Tetanus

Primary: Number of Subjects Reporting Serious Adverse Events — 3 Subjects

GlaxoSmithKline Results Jul 2009 0.2% serious AE View details

Phase 3 N=394 Immunogenicity and Safety of Havrix™ Co-Administered With a Diphtheria, Tetanus and Pertussis and a Haemophilus b Vaccine in Children Aged 15 Months

Hepatitis A

Primary: Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the Second Dose of Havrix — 88; 84; 77 Participants

GlaxoSmithKline Results Jul 2009 View details

Phase 4 N=120 Tolerability and Immunogenicity Study of Fluval AB Suspension for Injection

Influenza Prophylaxis

Primary: Change in Geometric Mean Titre Ratio, A/H1N1 Strain — 3.13; 3.17 Ratio of Day 0 and Day 21-28 titres

Fluart Innovative Vaccine Ltd, Hungary Results Apr 2021 0.0% serious AE View details

Phase 3 N=2,044 A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age

Influenza, Human

Primary: Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio of Hemagglutination Inhibition (HI) Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and…

Seqirus Results Sep 2023 3.0% serious AE View details

Phase 3 N=152 Immunogenicity and Safety of Inactivated Vero Cell Derived Japanese Encephalitis Vaccine in Thai Children

Encephalitis, Japanese B

Primary: Seroconversion Rate After Primary Vaccination — 100 percentage of seroconversion

Mahidol University Results Nov 2014 13.8% serious AE View details

Phase 3 N=1,869 Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population

Encephalitis

Primary: Rate of Subjects With Serious Adverse Events and Medically Attended Adverse Events Until Day 56 After First Vaccination — 16.1; 14.2; 38.2; 42.2 percentage of…

Valneva Austria GmbH Results Feb 2014 1.8% serious AE View details

Phase 3 N=1,503 Immunogenicity and Safety of Quadrivalent Influenza Vaccine (NBP607-QIV) in Adults and Elderly Subjects

Influenza

Primary: Geometric Mean HI Titers (GMTs) After Vaccination in All Subjects — 329.76; 334.98; 334.98; 401.21 titers

SK Chemicals Co., Ltd. Results May 2020 1.0% serious AE View details

N/A N=300 Adherence to Guidelines VAccination in Type 1 DIabetes Mellitus Patients (AVADI-1).

Type 1 Diabetes Mellitus

Primary: Adherence to Regional Guidelines for the Immunization of Adults With Type 1 Diabetes Mellitus (T1DM — 165; 54; 51; 30 Participants

Jesús Moreno Fernández Results Jan 2021 View details

N/A N=530 FeverText: Assessing Fever Rates After Vaccination During the 2011-12 Influenza Season Using Text Messaging

Fever

Primary: Fever >= 100.4 — 7.5; 37.6; 9.5 percentage of participants

Columbia University Results Jul 2014 0.0% serious AE View details

Phase 3 N=1,241 Immunogenicity & Safety of Hepatitis A Vaccine Co-admin With a Measles/Mumps/Rubella & a Varicella Vaccine in Children

Hepatitis A

Primary: Anti-hepatitis A Virus (HAV) Antibody Concentrations in HAV and HAV+MMR+V Groups. — 1390.4; 1895.2 mIU/mL

GlaxoSmithKline Results Apr 2010 2.8% serious AE View details

Clinical Trial Search

N/A N=7,645 Surveillance for Adverse Events Following Influenza Immunization

N/A N=23,939 Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England

N/A N=19,334 Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines

N/A N=327,293 Descriptive, Post-marketing, Passive Surveillance Safety Study of ADACEL™ Vaccine

Phase 4 N=215 Post-marketing Evaluation of Reactions Following Receipt of Recommended Adolescent Pertussis Vaccine

N/A N=23,427 A Surveillance Study of Diseases Specified as Adverse Events of Special Interest, of Other Adverse Events Leading to Hospitalisation or Death, and of Meningitis in Children in Africa Prior to Implementation of the RTS,S/AS01E Candidate Vaccine

Phase 4 N=1,060 Enhanced Safety Surveillance of GlaxoSmithKline's (GSK's) Quadrivalent Seasonal Influenza Vaccines During the 2018/19 Influenza Season

Phase 3 N=287 Safety and Immunogenicity of an Adjuvanted Trivalent Influenza Vaccine in Children 6 to <72 Months of Age in Mexico.

Phase 4 N=10,000 Post-licensure Safety Study of IMOJEV® in Thailand

Phase 4 N=687 Post Marketing Surveillance for ADACEL™ in South Korea

N/A N=6,525 Surveillance for Adverse Events Following Pandemic H1N1 Immunization

Phase 3 N=300 A Safety and Immunogenicity Study of IVACFLU-A/H5N1

Phase 3 N=30 A Study to Assess the Safety of Adacel® Vaccine

N/A N=1,143 Prevenar Special Use-result Surveillance in Japan (Regulatory PostMarketing Commitment Plan)

Phase 4 N=423 Immunogenicity of Adacel® and BOOSTRIX® Vaccines in Adolescents

Phase 4 N=644 Post-licensure, Modified Double-blind, Multi-center Study Evaluating Safety and Immunogenicity of ADACEL® and BOOSTRIX®

Phase 3 N=132 Immunogenicity and Safety of Adacel Polio Vaccine

Phase 3 N=100 Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries

Phase 2 N=82 Immune Response to Yellow Fever Vaccination in Adults With Atopic Dermatitis

Phase 3 N=112 Immunogenicity and Safety of ADACEL™ as Fifth Dose in Taiwan

N/A N=1,258 Post Market Surveillance for Infanrix™

Phase 3 N=394 Immunogenicity and Safety of Havrix™ Co-Administered With a Diphtheria, Tetanus and Pertussis and a Haemophilus b Vaccine in Children Aged 15 Months

Phase 4 N=120 Tolerability and Immunogenicity Study of Fluval AB Suspension for Injection

Phase 3 N=2,044 A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age

Phase 3 N=152 Immunogenicity and Safety of Inactivated Vero Cell Derived Japanese Encephalitis Vaccine in Thai Children

Phase 3 N=1,869 Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population

Phase 3 N=1,503 Immunogenicity and Safety of Quadrivalent Influenza Vaccine (NBP607-QIV) in Adults and Elderly Subjects

N/A N=300 Adherence to Guidelines VAccination in Type 1 DIabetes Mellitus Patients (AVADI-1).

N/A N=530 FeverText: Assessing Fever Rates After Vaccination During the 2011-12 Influenza Season Using Text Messaging

Phase 3 N=1,241 Immunogenicity & Safety of Hepatitis A Vaccine Co-admin With a Measles/Mumps/Rubella & a Varicella Vaccine in Children