The Transparent Safety Study of the 5 in 1 (DTwP-rHepB-Hib) Combination Vaccine Produced by the Indian Serine Institute in Children of Viet Nam Healthy From 6 to 12 Weeks of Age in a 3-dose Regimen, the Interval Between Doses is 4 Weeks

Learn more about:
Related Clinical Trial
Pertussis Acellular Vaccine Adjuvanted With TQL1055 Seroprevalence of Pertussis Among Healthy Children and Adolescents in Kazakhstan A Multi-center Study to Determine the Prevalence and Influence of Pertussis on Subacute Cough in Shenzhen A Multi-center Study to Determine the Prevalence and Influence of Pertussis on COPD Exacerbation in Shenzhen Assessment, Feedback, Incentive, Exchange (AFIX OB) A Customizable Quality Improvement Intervention to Increase Maternal Vaccine Uptake To Evaluate the Immunogenicity and Safety of DTaP-IPV Vaccine Administered as a Boosting Dose to Healthy Children of 4-6 Years Maternal Pertussis Wholecell Responses Adacel® Booster Vaccination for CMI Assay Development Pathogenic Bordetella Rapid Detection 5-year Follow-up After a Single Dose Acellular Pertussis Vaccination Evaluating a Caregiver SMS Reminder Intervention to Reduce Immunization Drop-out in Arua, Uganda Mobile Phone SMS Messages and Automated Calls in Improving Vaccine Coverage Among Children in Pakistan Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib, Compared to DTPa-HBV-IPV and Hib Administered Separately Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly CD8 Reactivity to Microorganisms in Blood and Breast Milk Testing the Use of Prompts to Increase Adolescent Immunization Rates Randomized Controlled Trial of the Impact of Mobile Phone Delivered Reminders and Travel Subsidies to Improve Childhood Immunization Coverage Rates and Timeliness in Western Kenya Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent (DTwP-Hib-Hep B) Vaccine in Infants 6-8 Weeks of Age Pilot Study Freeze and Transport Immune Cells Increasing Vaccine Uptake Among Veterans at the Atlanta VA Health Care System Seroimmunity 2007 and Sub Study of the Swedish Population Regarding Vaccine Preventable Disease Assess Immune Response Following Primary Vaccination With Tritanrix™-HepB Vaccine Mixed With 3 Formulations of Hib-MenAC Vaccine to Infants Immunogenicity and Safety of Sanofi Pasteur’s Combined Vaccine Given as a Three-Dose Primary Series at 2, 3,4 Months of Age and Followed by a Booster Dose Given at 16 to 17 Months of Age in Vietnamese Infants Who Previously Received a Dose of Hepatitis B Vaccine at Birth or Within 1 Week After Birth Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months. DTaP-IPV-HB-PRP-T Combined Vaccine as a Primary Series and a Second Year of Life Booster in HIV-Exposed Infected and Uninfected Infants Antibody Persistence in Healthy Children After Primary and Booster DTaP-IPV-Hep B-PRP-T Vaccine or Control Vaccine Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Infanrix®Hexa in Healthy Peruvian Infants Retrospective Survey of Safety of Fourth Dose Pentacel® in Children Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar™ and Rotarix™ in Healthy Latin American Infants Comparison of DTaP-IPV-Hep B-PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPV Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants Safety of PENTAXIM® Given as a Three-Dose Primary Vaccination at 2, 3, and 4 Months of Age in Infants in China Pentavalent DTaP-Hep B-IPV DTaP-IPV/Hib Vaccine Primary & Booster Vaccinations Versus Co-administration of DTaP-IPV and Hib Vaccine in Japanese Infants Evaluation of an Infant Immunization Encouragement Program in Nigeria A Study to Compare LBVD to Eupenta and Imovax Polio in Healthy Adults Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™ Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants Study of the Environmental Factors Modulating Children Immune Response in Northern Senegal Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™ How Does the Clinical Tool ‘What’s Going Around’ Affect Clinical Practice Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs Immunology of Non-specific Effects of Vaccine Safety and Immunogenicity of Hexavalent Vaccine(DTwP-HepB-IPV-Hib) in Healthy Infants Antibody Persistence at Age 3.5 and 4.5 Years After Primary and Booster DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccination Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine in Healthy Turkish Infants Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine in South Korean Infants. Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed Infants Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly With Prevnar® Immunogenicity and Safety of Pentaxim as 3 Doses Primary Vaccination Followed by a Booster Dose at 18 Months Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants Immune Memory Foll Pry Vaccination With DTPw-HBV/Hib Vaccine Formulation; Immuno & Reacto of Booster Dose at 15-18 Mths Immunogenicity and Safety of TETRAXIM™ Given as a Booster Dose at 4 to 6 Years of Age A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3111 in Healthy Adults Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Indian Infants Previously Given a Dose of Hepatitis B Vaccine at Birth Immunogenicity and Safety of Pentaxim in South African Infants Immunogenicity and Safety of Pentaxim™ in an Indian Population Boostrix® Pregnancy Registry Immunogenicity and Safety of Sanofi Pasteur Pentaxim Combined Vaccine in Infants in Thailand Safety, Long Term Immunogenicity and Lot Consistency Study of Liquid Pentavalent Combination Vaccine Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule Immunogenicity Study of Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months in Healthy Argentinean Infants Montelukast for Persistent Cough in Young People and Adults Immunogenicity and Safety Study of Proquad® and Infanrix® Hexa When Administered Concomitantly (V221-035) Study to Assess if Quinvaxem Can be Interchanged With Other Pentavalent Vaccines During Standard Childhood Vaccination A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents Assessment of the Immunogenicity and Safety of PENTAXIM™ in Philippines Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL® Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™ Database Surveillance Safety Study of PENTACEL® Vaccine A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject A Study to Assess the Immunogenicity and Safety of GSK Biologicals’ Infanrix-IPV/Hib Vaccine Administered as a Three-dose Vaccination Course at 3, 4.5 and 6 Months of Age and a Booster Dose at 18 Months of Age in Healthy Infants in Russia Effectiveness of a Vaccination Program in the Community Ob/Gyn Setting Protecting Pregnant Women From Infectious Diseases A Study to Assess the Safety of Adacel® Vaccine Immunogenicity and Safety of Tetraxim Versus Local DTP + IPV Immunogenicity and Safety of Adacel Polio Vaccine Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL® Confirmatory Study of BK1310 in Healthy Infants Study of the Tdap Combined Vaccine (ADACEL™) as a Booster Dose in Healthy Adults and Children in China Post-authorization Safety Study of Euforvac-Hib Vaccine for Active Primary Immunization in Infants From 6 Weeks A Study of DTaP//PRP-T Combined Vaccine (ACTACEL) Versus Local DTaP and Act-HIB Monovalent Vaccine in Healthy Infants Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine Study on the Safety and Immunogenicity of Boostrix Vaccine in Pregnant Malian Women and Their Infants Study to Compare Pediacel® to Infanrix®-IPV+Hib When Both Are Co-Administered With Prevenar® in Infants and Toddlers Study of an Investigational Vaccine in Healthy Infants in Taiwan (V441-001)(COMPLETED) Influence of BCG on TDaP-IPV Vaccination A Phase IV Study to Assess the Safety of EupentaTM Inj Phase I Clinical Trial in Healthy Children The Transparent Safety Study of the 5 in 1 (DTwP-rHepB-Hib) Combination Vaccine Produced by the Indian Serine Institute in Children of Viet Nam Healthy From 6 to 12 Weeks of Age in a 3-dose Regimen, the Interval Between Doses is 4 Weeks Safety and Immunogenicity Study of a Liquid Pentavalent Combination Vaccine Concomitant Use of Gardasil (V501) (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diphtheria, Tetanus, Pertussis Vaccine and Meningococcal Conjugate Vaccine in Adolescents (V501-025) Maternal Antibody in Milk After Vaccination Comparison of Safety and Immunogenicity of Pediacel™ and Infanrix™ IPV+Hib (Penta) Given in a 3 Dose Schedule in Infants Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™ Study of Menactra® in Healthy Subjects at 9 Months and Concomitantly With Pentacel® at 15 to 18 Months of Age Safety and Immune Response of Different Pediatric Combination Vaccines. Sanofi Pasteur’s Tdap Combined Vaccine as a Booster Versus Local DT Vaccine in Children or Versus Local Td Vaccine in Adolescents and Adults in China. Concomitant Use of Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diptheria, Tetanus, Pertussis and Poliomyelitis Vaccine in Adolescents (V501-024)(COMPLETED) Tdap Vaccination for Infant Caregivers Assessment of the Reactogenicity of ADACEL® (TdcP Vaccine) in Children and Adolescents 7 to 19 Years of Age Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine Safety and Immunogenicity of Intranasal BPZE1 Vaccination in Healthy Adults An Immunogenicity and Safety Study of Tetanus, Diphtheria and Acellular Pertussis Vaccine Booster Safety and Immunogenicity in Adults of Revaccination With Adacel® Vaccine 10 Years After a Previous Dose Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed in Healthy Subjects Post-licensure, Modified Double-blind, Multi-center Study Evaluating Safety and Immunogenicity of ADACEL® and BOOSTRIX® TDAP Safety in Pregnant Women Safety and Immunogenicity Study of Tetanus, Diphtheria and Acellular Pertussis (Tdap) Vaccine The Safety of Boostrix Following Routine Immunization of Pregnant Women Regulatory Post-Marketing Surveillance Study for TETRAXIM™ Tdap Vaccine in Post-Partum Women Immunogenicity of Adacel® and BOOSTRIX® Vaccines in Adolescents Post Marketing Surveillance for ADACEL™ in South Korea Vouchers to Promote Tdap Vaccination Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age Safety and Immunogenicity Study of Concomitant Versus Non Concomitant Administration of a Diphtheria, Tetanus, Pertussis and Poliomyelitis Vaccine (REPEVAX) and Influenza Vaccine (VAXIGRIP) in Subjects Aged From 60 Years Old Vaccine -diphthEria -tetaNus -Acellular pertUssis-inactivated polioviruS Descriptive, Open-label, Multicenter Study of the Safety of Redosing With ADACEL® Vaccine Persistency Study After aP / Tdap Booster Vaccines in Adult Subjects (V113_01 Extension 1) Descriptive, Post-marketing, Passive Surveillance Safety Study of ADACEL™ Vaccine A Study of the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine Administered Concomitantly With RotaTeq™ (V260) or Rotarix™ (V260-036)(WITHDRAWN) Immunogenicity and Safety of ADACEL™ as Fifth Dose in Taiwan A Trial to Evaluate the Safety and Immunogenicity of ADACEL® Vaccine in Persons 65 Years of Age and Older Study of BK1301 (DTaP Vaccine) as a Booster in Adolescents Intravenous Pertussis Immune Globulin in Patients With Severe Childhood Pertussis Infection Phase IV Interchangeability Study of a Liquid Pentavalent Combination Vaccine Sources of COmplement in Meningococcal and Pertussis Serum Bactericidal Antibody Assays Booster Study of Combined Diphtheria-tetanus-acellular Pertussis Vaccine in Healthy Adults Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age Seroprevalence of Bordetella Pertussis Antibodies and Anti-pertussis Antibodies Response After a Single Dose of Tdap Vaccine in Thai Pregnant Women Viaskin Pertussis Vaccine Trial Study of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (ADACEL®) as a Booster in Adolescents Immune Responses in Adults to Revaccination With ADACEL® 10 Years After a Previous Dose Immunogenicity and Safety Study of a Booster Dose (5th) of Diphteria-Tetanus-Pertussis-Polio Vaccine The Feasibility of Pertussis Immunization in a Canadian Emergency Department Long-term Persistence of Hepatitis B and Pertussis Antibody Responses in Healthy 4 to 5 Year Old Children Previously Vaccinated With Vaxelis® or INFANRIX® Hexa (V419-012) Safety and Immunogenicity Study of a Diphtheria, Tetanus, Acellular Pertussis and Poliomyelitis Vaccine (REPEVAX) Followed by 2 Doses of a Diphtheria, Tetanus and Poliomyelitis Vaccine (REVAXIS) in Subjects of 40 Years of Age or Older Phase III Randomized, Double-Blind, Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines Assessing Contacts’ Decision Making on Reducing the Risk of Pertussis Transmission to Newborns Through Immunisation Phase III Randomized, Double-Blind, Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines Maternal Tdap Immunization in Guatemala Study of Quinvaxem for Vaccination Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by Haemophilus Influenzae Type B Study of SP306 Given Intramuscularly Compared to DT Given Subcutaneously in Japanese Adolescents 11 – 12 Years Old The PertADO Geneva Trial Study of Adacel® Vaccine Administered to Persons 10 Years of Age Pertussis Immunization During Pregnancy & HIV Infection Observational Study Describing the Immune Profile Induced By Pertussis Vaccines Sero-prevalence of Anti-pertussis Antibodies and Disease Awareness Among Spanish Healthcare Professionals Study of Tetanus and Diphtheria Toxoids Adsorbed Combined With Component Pertussis Vaccine and Inactivated Poliomyelitis Pertussis and Meningitis C Concomitant Vaccination in Adolescents Post-marketing Evaluation of Reactions Following Receipt of Recommended Adolescent Pertussis Vaccine 2-year Follow-up After a Single Dose Acellular Pertussis Vaccination Pertussis Vaccine in Healthy Pregnant Women Pertussis Vaccination in Pregnant Women A Study Exploring Whooping Cough Protection in Children and Adults Immunising Mums Against Pertussis 3 3-year Follow-up After a Single Dose Acellular Pertussis Vaccination A Study to Determine the Seroprevalence of Bordetella Pertussis in Adults in Hungary Safety and Dose Ranging Study of Acellular Pertussis and Acellular Pertussis -Tetanus-Diphtheria Booster Vaccines in Healthy Adults Ages 18 to 40 Years Study of BPZE1 (High Dose) Nasal Live Attenuated B. Pertussis Vaccine Optimising the Timing of Whooping Cough Immunisation in MUMs Bordetella Pertussis Colonisation Challenge Study Vaccine Responses in Infants After Acellular Pertussis Vaccination During Pregnancy in Thailand Rates of Pertussis Disease Among Persons Receiving Pentacel® or Other Pertussis Vaccines Gambia Pertussis Study (GaPs) A Phase 1/2 Clinical Trial of a GamLPV, a Live Intranasal Bordetella Pertussis Vaccine Study of BPZE1 Intranasal Pertussis Vaccine (Administered Via VaxINator(TM)), Prime + Boost, in Healthy Adults Vanderbilt Pertussis Exposure Study: PEP in Vaccinated Healthcare Workers Following Pertussis Exposure A Phase I Clinical Study of a GamLPV, a Live Intranasal Bordetella Pertussis Vaccine Study of Adsorption Tetanus-diphtheria-acellular Pertussis (DTaP) Vaccine in Healthy 3 to 5 Months Infants Pertussis Infection in Adolescents and Adults With Prolonged Cough Effectiveness of Maternal Immunization With Boostrix at Preventing Pertussis Among Infants First Adult Safety Trial on Nasal Live Attenuated B. Pertussis Vaccine The Safety and Immunogenicity of Acellular Pertussis Vaccine in Bone Marrow Transplant Recipients Pertussis Immunization During Pregnancy: Effect in Term and Preterm Infants Pertussis (Tdap) Vaccination in Pregnancy

Brief Title

The Transparent Safety Study of the 5 in 1 (DTwP-rHepB-Hib) Combination Vaccine Produced by the Indian Serine Institute in Children of Viet Nam Healthy From 6 to 12 Weeks of Age in a 3-dose Regimen, the Interval Between Doses is 4 Weeks

Official Title

An Open Label, Multicentric, Bridging Study to Assess the Safety of Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus Influenzae Type b Conjugate Vaccine (Adsorbed) Manufactured by Serum Institute of India Pvt. Ltd in Vietnamese Infants Aged 6-12 Weeks, Given as a 3-dose Regime, With 4 Week Intervals Between the Doses

Brief Summary

      The objective of this study is to evaluate safety and tolerability of Diphtheria, Tetanus,
      Pertussis, Hepatitis B and Haemophilus influenzae type b Conjugate Vaccine Adsorbed in
      Vietnamese infants aged 6-12 weeks. This is an open label, single group, bridging study.
    

Detailed Description

      This will be an open label, single group, bridging study. Study subjects will be vaccinated
      with 3 (three) vaccine doses. The first vaccine will be administered intramuscularly starting
      at 6-12 weeks of age followed by two doses at four-week interval.

      This study was performed in strict accordance with Good Clinical Practice.
    


Study Type

Interventional


Primary Outcome

Percent of Participants With Adverse Events Related to DTPw-HB-Hib vaccine Administration

Secondary Outcome

 Percent of Participants With Adverse Events Related to DTPw-HB-Hib vaccine Administration

Condition

Diphtheria

Intervention

Study subjects will be vaccinated with 3 (three) vaccine doses. The first vaccine will be administered intramuscularly starting at 6-12 weeks of age followed by two doses at four-week interval

Study Arms / Comparison Groups

 Vaccination
Description:  DTPw-HB-Hib vaccine

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

222

Start Date

March 1, 2018

Completion Date

July 30, 2018

Primary Completion Date

June 30, 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Healthy infants, both sexes, between 6 and 12 weeks of age on the day of screening and
             enrollment

          -  Subject born at full term of pregnancy (greater or equal to 37 weeks) and Birth weight
             ≥2500 grams

          -  Weight ≥ 3,300 grams at the time of screeningSubject with good health as determined by
             the medical history, physical examination and clinical judgment of the Investigator

          -  Parent / legal representative can understand and be able to comply with the
             requirements of the protocol

          -  Subjects born to mothers who are seronegative to HIV, HBV and HCV through a blood test
             or maternity record.

          -  Parent / legal representative is willing to voluntarily sign the consent form for the
             participant

        Exclusion Criteria:

          -  History of diphtheria, tetanus, pertussis, hepatitis B, or Hib infections (confirmed
             either clinically, serologically or microbiologically)

          -  Fever (temperature ≥37.50C) or hypothermia (≤35.50C) or acute illness / infection that
             requires treatment.

          -  Previous vaccination against diphtheria, tetanus, pertussis and Haemophilus influenzae
             type b diseases.

          -  Known allergy to any component of the vaccine;

          -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality, as determined by physical examination.

          -  Being treated with anticoagulants or at high risk of bleeding.

          -  A family history of SIDS (sudden infant death syndrome)

          -  Have received any blood products, corticosteroids, cytotoxic drugs, immunosuppressive
             therapy, radiation therapy in the last 4 weeks.

          -  Have participated in another clinical trial within 30 days prior to the study
             vaccination or may participate in the course of the study.

          -  A family history of congenital or hereditary immunodeficiency.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Major congenital defects.

          -  History of any neurological disorders or seizures
      

Gender

All

Ages

6 Weeks - 12 Weeks

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 

Location Countries

Vietnam

Location Countries

Vietnam

Administrative Informations


NCT ID

NCT03931239

Organization ID

VABIOTECH-01


Responsible Party

Sponsor

Study Sponsor

Vabiotech

Collaborators

 Vietstar Biomedical Research

Study Sponsor

, , 


Verification Date

April 2019