Hepatitis B Vaccine (Recombinant)

Generic Name: Hepatitis B Vaccine (Recombinant)

Brand Names: Engerix-B, Heplisav-B, Pediarix, Recombivax, Twinrix, Vaxelis, Heplisav B, Fendrix, PreHevbri

Drug Type: Biotech

Chemical Formula: -

CAS Number: -

Unique Ingredient Identifier: IFJ010MNE4

Background: Hepatitis B Vaccine is an ingredient in the EMA-withdrawn product Quintanrix. It is marketed in Canada as Engerix B. It is also a part of Twinrix (Hep A/Hep B vaccine) available also in Canada.
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Indication: Active immunization against hepatitis B virus infection.
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Associated Conditions: Hepatitis A, Viral Hepatitis B

Associated Therapies: -

Clinical Trials

Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers

Phase 3

Recruiting

Conditions: RSV Immunization

Interventions: Biological: RSVt vaccine
Biological: Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccine
Biological: Streptococcus pneumoniae vaccine
Biological: Diphtheria, tetanus, pertussis, Haemophilus influenzae type b and poliomyelitis vaccine
Biological: Measles, mumps, and rubella vaccine
Biological: Varicella virus vaccine
Biological: Hepatitis B vaccine
Biological: Rotavirus vaccine
Biological: Placebo

First Posted Date: 2024-05-03

Last Posted Date: 2024-12-13

Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Target Recruit Count: 2226

Registration Number: NCT06397768

Locations: 🇺🇸
Alabama Clinical Therapeutics - Birmingham - St. Vincent's Drive- Site Number : 8400007, Birmingham, Alabama, United States
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MedPharmics - Mobile - Dauphin Street- Site Number : 8400017, Mobile, Alabama, United States
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Northwest Arkansas Pediatric Clinic- Site Number : 8400002, Fayetteville, Arkansas, United States

and more 64 locations

B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B

Phase 3

Completed

Conditions: HIV Infection
Hepatitis B

Interventions: Biological: HEPLISAV-B
Biological: ENGERIX-B

First Posted Date: 2019-12-10

Last Posted Date: 2024-11-14

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 640

Registration Number: NCT04193189

Locations: 🇺🇸
UCLA CARE Center CRS, Los Angeles, California, United States
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Rush University CRS, Chicago, Illinois, United States
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Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS, Boston, Massachusetts, United States

and more 42 locations

Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US

Phase 3

Completed

Conditions: Healthy Volunteers (Meningococcal Infection)

Interventions: Biological: MenACYW conjugate vaccine
Biological: MenACYW-135 conjugate vaccine
Biological: DTaP-IPV//Hib vaccine
Biological: Pneumococcal 13-valent conjugate vaccine
Biological: Pentavalent rotavirus vaccine
Biological: Hepatitis B vaccine
Biological: Measles, mumps, rubella (MMR) vaccine
Biological: Varicella vaccine
Biological: Hepatitis A vaccine

First Posted Date: 2018-05-25

Last Posted Date: 2024-10-14

Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Target Recruit Count: 2627

Registration Number: NCT03537508

Locations: 🇺🇸
Helios Clinical Research Site Number : 8400109, Houston, Texas, United States
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Wee Care Pediatrics Syracuse Site Number : 8400024, Syracuse, Utah, United States
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Birmingham Pediatric Associates Site Number : 8400026, Birmingham, Alabama, United States

and more 67 locations

Immunity to Hepatitis B Vaccine

Phase 4

Completed

Conditions: Hepatitis B
Immunization; Infection

Interventions: Drug: Hepatitis B vaccine

First Posted Date: 2017-03-17

Last Posted Date: 2020-11-25

Lead Sponsor: University of British Columbia

Target Recruit Count: 16

Registration Number: NCT03083158

Locations: 🇨🇦
Vaccine Evaluation Center, Vancouver, British Columbia, Canada

A Trial Investigating the Influence of BCG and Hepatitis B Immunisation at Birth on Neonatal Immune Responses: The Early Life Vaccines and Immunity Study

Not Applicable

Completed

Conditions: Innate Immune Response

Interventions: Drug: BCG Vaccine
Drug: Hepatitis B Vaccine

First Posted Date: 2015-05-14

Last Posted Date: 2017-08-31

Lead Sponsor: Murdoch Childrens Research Institute

Target Recruit Count: 185

Registration Number: NCT02444611

Locations: 🇦🇺
Mercy Hospital for Women, Heidelberg, Victoria, Australia

Effects of Persistent Innate Immune Activation on Vaccine Efficacy

Phase 4

Terminated

Conditions: Hepatitis C Infection

Interventions: Drug: Recombivax

First Posted Date: 2015-04-29

Last Posted Date: 2020-03-04

Lead Sponsor: Rockefeller University

Target Recruit Count: 24

Registration Number: NCT02429583

Locations: 🇺🇸
Rockefeller University Hospital, New York, New York, United States

Combination Therapy With Interferon Plus Interleukin 2 and Hepatitis B Vaccine in Chronic Hepatitis B Patients

Phase 4

Completed

Conditions: Hepatitis B, Chronic

Interventions: Drug: Entecavir
Drug: Interferon alfa-2b
Drug: Interleukin 2
Drug: Hepatitis B Vaccine

First Posted Date: 2015-02-10

Last Posted Date: 2018-05-09

Lead Sponsor: Tongji Hospital

Target Recruit Count: 94

Registration Number: NCT02360592

Locations: 🇨🇳
Anhui Provincial Hospital, Hefei, Anhui, China
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BeiJing YouAn Hospital, Capital Medical University, Beijing, Beijing, China
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First Hospital, Beijing University, Beijing, Beijing, China

and more 9 locations

Study of the Safety and Immunogenicity of Pfs230D1M-EPA/Alhydrogel and Pfs25M-EPA/Alhydrogel , a Transmission Blocking Vaccine Against Plasmodium Falciparum Malaria, in Adults in the U.S. and Mali

Phase 1

Completed

Conditions: Malaria

Interventions: Biological: Pfs25M-EPA/Alhydrogel
Biological: Pfs230D1M-EPA/Alhydrogel
Drug: TWINRIX
Drug: Menactra

First Posted Date: 2015-01-08

Last Posted Date: 2019-04-11

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 538

Registration Number: NCT02334462

Locations: 🇲🇱
Malaria Research and Training Center, Bamako, Mali
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National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States