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