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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03931239
Recruitment Status : Completed
First Posted : April 30, 2019
Last Update Posted : May 3, 2019
Sponsor:
Collaborator:
Vietstar Biomedical Research
Information provided by (Responsible Party):
Vabiotech

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.

Condition or disease Intervention/treatment Phase
Diphtheria Tetanus Pertussis Hepatitis B Haemophilus Influenzae Type B Biological: 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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : July 30, 2018


Arm Intervention/treatment
Experimental: Vaccination
DTPw-HB-Hib vaccine
Biological: 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
An openlabel, 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




Primary Outcome Measures :
  1. Percent of Participants With Adverse Events Related to DTPw-HB-Hib vaccine Administration [ Time Frame: Days 0 to 28 post-vaccination ]

Secondary Outcome Measures :
  1. Percent of Participants With Adverse Events Related to DTPw-HB-Hib vaccine Administration [ Time Frame: Baseline to 30 minutes post-vaccination ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Weeks to 12 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931239


Locations
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Vietnam
Hung Yen, Kim Dong
Hung Yen, Vietnam
Sponsors and Collaborators
Vabiotech
Vietstar Biomedical Research
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Responsible Party: Vabiotech
ClinicalTrials.gov Identifier: NCT03931239    
Other Study ID Numbers: VABIOTECH-01
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Whooping Cough
Tetanus
Diphtheria
Influenza, Human
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Orthomyxoviridae Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Hepadnaviridae Infections
DNA Virus Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Infection
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs