DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed Infants

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT02094833
First received: March 20, 2014
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

The aim of this study is to evaluate the immunogenicity and safety of a novel DTaP-IPV-Hep B-PRP~T fully liquid combined hexavalent vaccine (study vaccine) administered at 2, 4, and 6 months of age compared to Sanofi Pasteur's DTaP-IPV//PRP~T combined vaccine (Pentaxim™) given at 2, 4, and 6 months of age and Hep B vaccine (Euvax B®) given at 1 and 6 months of age in South Korean infants that received a birth dose of Hep B and born to mothers documented to be serum anti-HBs Ag negative.

Primary Objective

  • To demonstrate the non-inferiority in terms of seroprotection (Diphtheria, Tetanus, poliovirus types 1, 2, and 3, PRP-T, Hep B) and vaccine response for pertussis antigens (pertussis toxoid [PT] and filamentous haemagglutinin [FHA]) of Group A versus Group B, one month after the third dose of combined vaccines.

Secondary Objectives:

  • To further study the immunogenicity of the two vaccination schemes, before the first dose and one month after the last dose of vaccines.
  • To study the safety after each and any dose of vaccines administered in the two vaccination schemes

Condition Intervention Phase
Diphtheria
Tetanus
Pertussis
Haemophilus Influenzae Type b Infection
Poliomyelitis
Hepatitis B
Biological: DTaP-IPV-Hep B-PRP~T combined vaccine
Biological: DTaP-IPV//PRP~T and Hepatitis B vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: 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 at 2, 4, and 6 Months of Age Versus Sanofi Pasteur's DTaP IPV//PRP~T Combined Vaccine at 2, 4, and 6 Months of Age + Hep B Vaccine at 1 and 6 Months of Age, in South Korean Infants Primed With Hep B at Birth

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of participants with anti-Diphtheria antibody concentrations ≥ 0.01 International Units (IU)/mL [ Time Frame: 1 month post third vaccination ] [ Designated as safety issue: No ]
    Anti-Diphtheria antibodies will be measured by a toxin neutralization test

  • Number of participants with anti-Tetanus antibody concentrations ≥ 0.1 International unit (IU)/mL [ Time Frame: 1 month post third vaccination ] [ Designated as safety issue: No ]
    Anti-Tetanus antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).

  • Number of participants with ≥ 4 fold increase in anti-PT and anti-FHA antibody concentrations (EU/mL) from 1 month pre-dose 1 to 1 month post-dose 3 [ Time Frame: I month post dose 3 ] [ Designated as safety issue: No ]
    Anti-PT and anti-FHA antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).


Secondary Outcome Measures:
  • Number of participants with anti-Diphtheria antibody concentrations ≥ 0.01 IU/mL and ≥ 0.1 IU/mL International Units (IU)/mL [ Time Frame: Day 0 Pre-vaccination ] [ Designated as safety issue: No ]
    Anti-Diphtheria antibodies will be measured by a toxin neutralization test

  • Number of participants with anti-Hepatitis B antibody concentrations ≥ 10 mIU/mL international unit (IU)/mL [ Time Frame: Day 0 Pre-vaccination ] [ Designated as safety issue: No ]
    Anti-Hepatitis B antibodies will be measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System using chemiluminescence detection technology

  • Number of participants with anti Diphtheria antibody concentrations ≥ 0.1 IU/mL International Units (IU)/mL [ Time Frame: 1 month post third vaccination ] [ Designated as safety issue: No ]
    Anti-Diphtheria antibodies will be measured by a toxin neutralization test

  • Number of participants reporting solicited injection site and solicited systemic reactions, unsolicited adverse events, and serious adverse events following vaccination with either DTaP-IPV-Hep B-PRP~T combined vaccine or Pentaxim™ and Euvax B® vaccine [ Time Frame: Day 0 and up to Day 180 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.

  • Number of participants with response to vaccine Pertussis toxoid (PT) and Filamentous Haemagglutinin (FHA) antigens [ Time Frame: 1 month post third vaccination ] [ Designated as safety issue: No ]
    Vaccine response defined as: Post-dose 3 anti-PT and anti-FHA antibody concentrations in ELISA units (EU)/mL ≥ 4 x Lower Limit of Quantitation (LLOQ) if pre-vaccination concentration is < 4 x LLOQ or ≥ pre-vaccination concentration if pre-vaccination concentrations ≥ 4 x LLOQ


Estimated Enrollment: 458
Study Start Date: March 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Participants will receive 3 injections of the study vaccine (DTaP-IPV-Hep B-PRP~T combined vaccine) at 2, 4, and 6 months of age
Biological: DTaP-IPV-Hep B-PRP~T combined vaccine
0.5 mL, Intramuscular
Active Comparator: Group B
Participants will receive 2 injections of monovalent Hep B vaccine (Euvax B®) at age 1 and 6 months and 3 injections of DTaP IPV//PRP~T vaccine (Pentaxim™) at age 2, 4, and 6 months
Biological: DTaP-IPV//PRP~T and Hepatitis B vaccine
0.5 mL, Intramuscular
Other Names:
  • Pentaxim™
  • Euvax B®

Detailed Description:

Study participants who received a first dose of recombinant Hep B vaccine at birth will receive either DTaP-IPV-Hep B-PRP~T combined vaccine at 2, 4, and 6 months of age + 3 doses of Hep B vaccine or Hep B vaccine (Euvax B®) at 1 and 6 months of age and DTaP IPV//PRP~T combined vaccine (Pentaxim™) at 2, 4, and 6 months of age, according to the official vaccination schedule for Hep B, DTaP, poliovirus, and Hib vaccinations in South Korea.

  Eligibility

Ages Eligible for Study:   1 Month to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 30 to 40 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
  • Participant and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
  • Born to known hepatitis B surface antigen (HBsAg) seronegative mother (documented laboratory result of HBsAg assay from the maternal blood sample is available)
  • Have received one documented dose of Hep B vaccine at birth according to the national recommendations.

Exclusion Criteria:

  • Participation in the 4 weeks preceding the trial inclusion 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 any trial vaccination (except Bacille Calmette Guerin (BCG) vaccine) or planned receipt of any vaccine in the 8 days following any trial vaccination
  • Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B (except the dose of Hep B vaccine given at birth) diseases or Haemophilus influenzae type b infection with either the trial vaccine or another vaccine
  • 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)
  • Known personal or maternal history of Human Immunodeficiency Virus (HIV) or hepatitis C seropositivity
  • History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infection, confirmed either clinically, serologically, or microbiologically
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines 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
  • 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 participant 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 or employee with direct involvement in the proposed study
  • History of seizures.
  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: NCT02094833

Contacts
Contact: Medical Director RegistryContactUs@sanofipasteur.com

Locations
Korea, Republic of
Recruiting
Daejeon, Korea, Republic of, 301 724
Recruiting
Gyeonggi do, Korea, Republic of, 425 707
Recruiting
Gyeonggi Do, Korea, Republic of
Recruiting
Gyeongsangnam do, Korea, Republic of
Recruiting
Gyeongsangnam do, Korea, Republic of, 641 560
Recruiting
Jeollabuk do, Korea, Republic of, 570 711
Recruiting
Jeonbuk, Korea, Republic of, 561 712
Recruiting
Kangwon do, Korea, Republic of, 220 701
Recruiting
Kyunggi Do, Korea, Republic of, 420 717
Recruiting
Seoul, Korea, Republic of, 158 710
Recruiting
Seoul, Korea, Republic of, 137 701
Recruiting
Seoul, Korea, Republic of, 120 752
Recruiting
Seoul, Korea, Republic of, 139 709
Recruiting
Seoul, Korea, Republic of, 130 87
Recruiting
Seoul, Korea, Republic of
Recruiting
Suwon Gyeonggi do, Korea, Republic of, 442 723
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur SA
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT02094833     History of Changes
Other Study ID Numbers: A3L31, U1111-1127-6896
Study First Received: March 20, 2014
Last Updated: March 25, 2014
Health Authority: South Korea: Ministry of Food and Drug Safety (MFDS)

Keywords provided by Sanofi:
Diphtheria
Tetanus
Pertussis
Haemophilus influenzae type b infection
Hepatitis B
DTaP-IPV-Hep - PRP-T vaccine

Additional relevant MeSH terms:
Poliomyelitis
Infection
Hepatitis
Hepatitis B
Diphtheria
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Myelitis
Central Nervous System Viral Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on September 18, 2014