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

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Brief Title

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

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

Brief Summary

      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
    

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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Number of participants with anti-Diphtheria antibody concentrations ≥ 0.01 International Units (IU)/mL

Secondary Outcome

 Number of participants with anti-Diphtheria antibody concentrations ≥ 0.01 IU/mL and ≥ 0.1 IU/mL International Units (IU)/mL

Condition

Diphtheria

Intervention

DTaP-IPV-Hep B-PRP~T combined vaccine

Study Arms / Comparison Groups

 Group A
Description:  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

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

310

Start Date

March 2014

Completion Date

November 2016

Primary Completion Date

April 2016

Eligibility 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.
      

Gender

All

Ages

1 Month - 6 Months

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Medical Director, , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT02094833

Organization ID

A3L31

Secondary IDs

U1111-1127-6896

Responsible Party

Sponsor

Study Sponsor

Sanofi Pasteur, a Sanofi Company


Study Sponsor

Medical Director, Study Director, Sanofi Pasteur SA


Verification Date

April 2017