Bacterial infections and mycoses Paediatrics
Conditions
Interventions
Group A1
Group A2
Group B1
Group B2
Group C1
Group C2
Sponsors
Sanofi Pasteur Europe
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Aged 42 to 56 days on the day of the first study visit. - Born at full term of pregnancy (= 37 weeks) and/or with a birth weight = 2.5 kg OR medically stable prematurely born infants (born after a gestation period of 27-36 weeks). - Infants who have received the birth dose of OPV and Bacille Calmette-Guérin vaccine (BCG) vaccine per Kenya NIS recommendations. - Participants and parent(s)/LAR are able to attend all scheduled visits and to comply with all study procedures.
Exclusion criteria
Exclusion criteria: - Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) 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 or planned receipt of any vaccine in the 4 weeks following the last trial vaccination except for routine vaccinations included in the Kenyan NIS (eg., BCG) which may be received less than 4 weeks before study vaccine. - Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B (except the dose of Hep B vaccine given at birth) diseases or Haemophilus influenzae type b infection, poliomyelitis (except the OPV) or rotavirus infection apart from trial vaccines in the four weeks following trial vaccination. - Receipt of immune globulins, blood or blood-derived products since birth. - 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 at >=0.5 mg/kg/day for more than 2 consecutive weeks since birth). - Known personal or maternal history of Human Immunodeficiency Virus (HIV), hepatitis B (HBsAg positive) or hepatitis C (HCV RNA positive). - Individuals with blood dyscrasias, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems. - History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b, or rotavirus infection(s), confirmed either clinically, serologically, or microbiologically. - History of seizures, encephalopathy, or any evolving or suspected neurological condition. - History of intussusception. - 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 contraindicating IM vaccination. - Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination. - Chronic illness that, is at a stage where it might interfere with trial conduct or completion. - Moderate or severe acute illness/infection on the day of vaccination or febrile illness (axillary 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). - Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw. - Identified as a natural or adopted child of the Investigator, relatives or employee with direct involvement in the proposed study. - Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The first primary objective is to demonstrate the non-inferiority of SHAN6™ compared to the licensed control vaccines SHAN 5® (+ bOPV + IPV) with respect tothe adjusted Geometric Mean Concentration (aGMC) ratio for anti-pertussis toxoid (PT) and anti-fimbriae (FIM) for pertussis and seroprotection rates for all other antigens 28 days after a three-dose primary series (6, 10 and 14 weeks). ;If the first objective is reached, the second primary objective is to demonstrate the non-inferiority of mixed schedule administration of SHAN6™ and SHAN 5® (+ bOPV) compared to SHAN 5® (+ bOPV + IPV) as a three dose primary series with respect to the aGMC ratio for anti-PT and anti-FIM for pertussis and seroprotection rates for all other antigens 28 days after a three-dose primary series. | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity • To describe the immunogenicity profile of SHAN6™ vaccine three dose series and that of the control vaccines SHAN 5® (+ bOPV + IPV). • To describe the immunogenicity profile of mixed schedule administration of SHAN6™ and SHAN 5® (+ bOPV). • To describe the immune response to co-administered ORV in terms of seroresponse (serum immunoglobulin [Ig]A anti-rotavirus antibody levels) in a randomized subset of subjects in each study group. • To describe the immune response to co-administered PCV in terms of serum antipneumococcal IgG for the 10 vaccine serotypes in a randomized subset of subjects in each study group. • To describe the immunogenicity profile, 28 days after the single booster dose of SHAN6™ or SHAN 5® (+ bOPV) in each study group.;Safety To describe the safety profile, 28 days after each and any dose of SHAN6™ vaccine and that of the control vaccines SHAN 5® (+ bOPV + IPV), following the primaryseries and booster vaccination. | — |
Countries
Kenya
Contacts
Public ContactTirhani Maluleke
Sponsor Clinical Trial Application Regulatory Manager
Outcome results
None listed