Diphtheria, Haemophilus Influenzae Type b Infection, Hepatitis B, Pertussis, Poliomyelitis, Tetanus
Conditions
Keywords
Diphtheria, Tetanus, Pertussis, Haemophilus influenzae type b infection, Hepatitis B, DTaP-IPV-Hep - PRP-T vaccine
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.
Interventions
BIOLOGICALDTaP-IPV-Hep B-PRP~T combined vaccine
0.5 mL, Intramuscular
BIOLOGICALDTaP-IPV//PRP~T and Hepatitis B vaccine
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 6 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with anti-Diphtheria antibody concentrations ≥ 0.01 International Units (IU)/mL | 1 month post third vaccination | 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 | 1 month post third vaccination | 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 | I month post dose 3 | Anti-PT and anti-FHA antibodies will be measured by enzyme-linked immunosorbent assay (ELISA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with anti-Diphtheria antibody concentrations ≥ 0.01 IU/mL and ≥ 0.1 IU/mL International Units (IU)/mL | Day 0 Pre-vaccination | 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 | Day 0 Pre-vaccination | 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 | 1 month post third vaccination | 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 | Day 0 and up to Day 180 post-vaccination | 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 | 1 month post third vaccination | 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 |
Countries
South Korea
Outcome results
None listed