Trial record 113 of 511 for:    hepatitis b | Open Studies

Study of Sanofi Pasteur's DTaP-IPV Hep B-PRP-T Combined Vaccine in Infants Who Previously Received Hepatitis B Vaccine

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Sanofi
Sponsor:
Collaborator:
National Institute of Hygiene and Epidemiology, Vietnam
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT02428491
First received: April 23, 2015
Last updated: August 16, 2016
Last verified: August 2016
  Purpose

The purpose of this study is to describe the immunogenicity and safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T fully liquid combined hexavalent vaccine (Hexaxim®) administered at 2, 3, and 4 months of age and at 16 to 17 months of age in infants and toddlers who received a dose of Hep B vaccine at birth or within 1 week after birth.

Primary Objective:

  • To describe the safety profile after each and all doses of Sanofi-Pasteur's DTaP-IPV-Hep B-PRP-T combined vaccine in Vietnamese infants and toddlers

Secondary Objective:

  • To evaluate the immunogenicity of the study vaccine one month after the third dose primary series.
  • To demonstrate the non-inferiority of the immune response to all antigens induced by the study vaccine in Vietnamese infants one month after the third dose in a 3 dose primary series with the immune response to all antigens induced by the same study vaccine outside Vietnam
  • To describe the persistence of all antibodies before receipt of the booster vaccination.

Condition Intervention Phase
Diphtheria
Tetanus
Pertussis
Poliomyelitis
Hepatitis B
Haemophilus Influenzae Type b
Biological: DTaP-IPV-Hep B-PRP-T combined vaccine (Hexaxim™)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T Combined Vaccine Given as a Three-Dose Primary Series at 2, 3, and 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of Participants Reporting Solicited Injection-site Reactions, Solicited Systemic Reactions, Unsolicited Systemic Reactions, and Serious Adverse Events Occurring Throughout the Trial [ Time Frame: Day 0 up to Day 90 post-vaccination ] [ Designated as safety issue: No ]
    Solicited injection-site reactions: Tenderness, Erythema, and swelling. Solicited systemic reactions: Fever (temperature), Vomiting, Crying abnormal, Drowsiness, Appetite loss, and Irritability


Secondary Outcome Measures:
  • Number of participants with anti Pertussis toxoid and anti Filamentous Hemagglutinin antibody concentrations ≥ Lower Limit of Quantitation (LLOQ) and ≥ 4 x LLOQ at baseline [ Time Frame: Day 0 (pre-vaccination) ] [ Designated as safety issue: No ]
  • Number of participants with ≥ 4-fold and ≥ 2-fold increase in anti-Pertussis toxoid and anti-Filamentous Hemagglutinin antibody concentrations (EU/mL) from pre-dose 1 to one month post-dose 3 [ Time Frame: Day 21 post-dose 3 ] [ Designated as safety issue: No ]
  • Number of participants with vaccine response for pertussis toxoid and Filamentous Hemagglutinin antigens [ Time Frame: Day 21 post-dose 3 ] [ Designated as safety issue: No ]
    Vaccine response defined as post-third dose anti-Pertussis toxoid and anti-Filamentous Hemagglutinin antibody concentrations ≥ 4 x LLOQ if pre-vaccination concentration is <4 x LLOQ or ≥ pre-vaccination concentration if pre- vaccination concentrations ≥ 4 x LLOQ

  • Number of participants with anti-Diphtheria antibody concentrations ≥ 0.01 and ≥ 0.1 IU/mL International Units (IU)/mL post-third dose vaccination [ Time Frame: Day 21 post-dose 3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 354
Study Start Date: April 2015
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Group I
Participants will receive the primary series vaccinations at 2, 3, and 4 months of age and evaluated for safety and immunogenicity post vaccination.
Biological: DTaP-IPV-Hep B-PRP-T combined vaccine (Hexaxim™)
0.5 mL, Intramuscular
Other Name: Hexaxim™
Experimental: Study Group 2
Participants will receive the primary series vaccinations at 2, 3, and 4 months of age and will be evaluated for safety only.
Biological: DTaP-IPV-Hep B-PRP-T combined vaccine (Hexaxim™)
0.5 mL, Intramuscular
Other Name: Hexaxim™

Detailed Description:
Participants will receive a total of 5 doses of Hep B: One dose of Hep B monovalent vaccine given at birth or within 1 week after birth followed by 3 doses of the Sanofi Pasteur's hexavalent vaccine given at 2, 3, and 4 months of age (Primary Series) and then (at 16 to 17 months of age [booster]) to comply with Vietnamese vaccination recommendations.
  Eligibility

Ages Eligible for Study:   61 Days to 91 Days   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 61 to 91 days on the day of the first study visit
  • Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥2.5 kg
  • Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations)
  • Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
  • Have received one dose of Hep B vaccine at birth or within 1 week after birth (documented according to the national recommendations).

Exclusion Criteria:

  • Participation in the 4 weeks preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
  • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any other vaccine within the period from 8 days before to 8 days after each subsequent trial vaccination except for Bacille Calmette Guerin (BCG) vaccination (any administration of oral poliovirus vaccine (OPV) in the context of oral poliovirus vaccine-national immunization days (NIDs) does not fall within the scope of this exclusion criterion)
  • Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B (except the dose of Hep B vaccine given at birth or within 1 week after birth) diseases or Haemophilus influenzae type b infection with either the trial vaccine or another vaccine (any administration of OPV in the context of OPV-NIDs does not fall within the scope of this exclusion criterion)
  • Past or current receipt of immune globulins, blood or blood-derived products or planned administration during the trial
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy since birth; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth)
  • History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infections (confirmed either clinically, serologically or microbiologically)
  • Known personal or maternal history of Human Immunodeficiency Virus (HIV), or hepatitis C seropositivity
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
  • Known thrombocytopenia, as reported by the parent/legally acceptable representative
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
  • History of seizures
  • In an emergency setting, or hospitalized involuntarily
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
  • Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
  • Identified as a natural or adopted child of the Investigator, relatives or employee with direct involvement in the proposed study.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02428491

Contacts
Contact: Public Registry Sanofi Pasteur RegistryContactUs@sanofipasteur.com

Locations
Vietnam
Preventive Medicine Centre of Thai Binh Province Recruiting
Thai Binh, Vietnam
Contact: Vu Dinh Thiem, MD., PhD,    84-3971 5085    vdt@nihe.org.vn   
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
National Institute of Hygiene and Epidemiology, Vietnam
Investigators
Study Director: Medical Director Sanofi Pasteur SA
  More Information

Additional Information:
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT02428491     History of Changes
Obsolete Identifiers: NCT02821195
Other Study ID Numbers: A3L35  U1111-1143-8177 
Study First Received: April 23, 2015
Last Updated: August 16, 2016
Health Authority: Vietnam: Ministry of Health
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at www.clinicalstudydatarequest.com. While making information available the company continue to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: Clinicalstudydatarequest.com/Sanofi".

Keywords provided by Sanofi:
Diphtheria
Tetanus
Pertussis
Poliomyelitis
Hepatitis B
DTaP-IPV-Hep B-PRP-T Combined Vaccine (Hexaxim™)

Additional relevant MeSH terms:
Hepatitis B
Hepatitis
Hepatitis A
Hepatitis, Viral, Human
Whooping Cough
Tetanus
Diphtheria
Poliomyelitis
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Liver Diseases
Digestive System Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2016