Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Indian Infants Previously Given a Dose of Hepatitis B Vaccine at Birth

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Brief Title

Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Indian Infants Previously Given a Dose of Hepatitis B Vaccine at Birth

Official Title

Immunogenicity and Safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T Combined Vaccine Given at 6, 10 and 14 Weeks of Age in Infants From India Who Previously Received a Dose of Hepatitis B Vaccine at Birth

Brief Summary

      The purpose of this study is to describe the immunogenicity and safety of a novel DTaP- IPV-
      Hep B-PRT~T fully liquid combined hexavalent vaccine (Hexaxim™) administered at 6, 10 and 14
      weeks of age in infants born to mothers documented to be serum anti-hepatitis B surface
      antigen (HBsAg) serology negative in India.

      Primary Objective:

        -  To evaluate the immunogenicity of the study vaccine in terms of seroprotection
           [diphtheria toxoid, tetanus toxoid, poliovirus types 1, 2 and 3, Haemophilus influenzae
           type b (Hib) polysaccharide (PRP), hepatitis B (Hep B)] and vaccine response for
           pertussis antigens [pertussis toxoid (PT) and filamentous haemagglutinin (FHA)] one
           month after the third dose.

      Secondary Objectives:

        -  To further describe the immunogenicity of the study vaccine, before the first dose and
           one month after the third dose.

        -  To describe the safety after each and any doses of the study vaccine.
    

Detailed Description

      All participants will receive a total 4 doses of Hep B, i.e. one dose of Hep B monovalent
      vaccine given at birth followed by 3 doses of Sanofi Pasteur's hexavalent vaccine given at 6,
      10 and 14 weeks of age in the context of the study. Participants and parents will attend four
      clinic visits; the expected participation in the study is approximately 3 months.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Percentage of Participants With Seroprotection After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth

Secondary Outcome

 Percentage of Participants With Seroprotection Before and After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth

Condition

Diphtheria

Intervention

Hexaxim™: DTaP-IPV-Hep B-PRP~T combined vaccine

Study Arms / Comparison Groups

 Study Group
Description:  Participants will receive Sanofi Pasteur's DTaP-IPV-Hep B-PRP~T combined vaccine (investigational vaccine) at 6, 10 and 14 weeks 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

177

Start Date

February 2014

Completion Date

June 2015

Primary Completion Date

December 2014

Eligibility Criteria

        Inclusion Criteria:

          -  Aged between 42-56 days (6 to 8 weeks) on the day of inclusion

          -  Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg

          -  Informed consent form signed by the parent(s) or any other legally acceptable
             representative

          -  Subject 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 maternal blood sample performed during last
             trimester of pregnancy available)

          -  Have received one documented dose of Hep B vaccine and oral poliovirus vaccine (OPV)
             from birth as per national recommendations.

        Exclusion Criteria:

          -  Participation in another clinical trial 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 the first trial vaccination (except
             Bacillus Calmette-Guerin [BCG] vaccine) or planned receipt of any other vaccine within
             the period from 8 days before to 8 days after each subsequent trial vaccination

          -  Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis (expect
             the birth dose of OPV as per national recommendations) and hepatitis B (except the
             birth dose of Hep B vaccine) diseases or Hib infection with 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)

          -  History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Hib
             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 trial vaccine or a vaccine containing 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 (axillary temperature ≥38°C) on the day of
             inclusion (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

          -  History of seizures.
      

Gender

All

Ages

6 Weeks - 8 Weeks

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Medical Director, , 

Location Countries

India

Location Countries

India

Administrative Informations


NCT ID

NCT01948193

Organization ID

A3L33

Secondary IDs

U1111-1127-6936

Responsible Party

Sponsor

Study Sponsor

Sanofi Pasteur, a Sanofi Company


Study Sponsor

Medical Director, Study Director, Sanofi Pasteur SA


Verification Date

September 2015