Overview

Primary Objective:

To demonstrate the non-inferiority of the SHAN6 vaccine to the licensed SHAN5 given with bOPV and IPV vaccines when coadministered with PCV and ORV

Secondary Objective:

• To describe the immunogenicity profile of the SHAN6 vaccine 3-dose primary infant vaccination and that of the control vaccines (SHAN5 given with bOPV and IPV)
• To describe the immune response to co-administered ORV-1 (Rotarix) in a subset of participants from each group
• To describe the immune response to co-administered PCV-13 (Prevnar 13) in a subset of participants from each group
• To describe the persistence of the antibodies against SHAN6 antigens following a 3-dose primary series of SHAN6 or SHAN5 given with bOPV and IPV
• To describe the immunogenicity profile of SHAN6 28 days after the single booster dose of SHAN6
• To describe the safety profile of the SHAN6 vaccine and the control vaccines (SHAN5 given with bOPV and IPV), when administered concomitantly with routine pediatric vaccines

Eligibility

Inclusion criteria :

• Aged 2 months (age range of 8 weeks <12 weeks) on the day of the first vaccination
• Born at full term of pregnancy ( 37 weeks) and with a birth weight 2.5 kg or medically stable prematurely born infants (born after a gestational period of 27-36 weeks)
• Infants who have received the birth dose of Bacille Calmette-Gurin vaccine (BCG) at least 4 weeks before the first trial vaccination
• Participant and parent(s)/legally acceptable representative(s) are able to attend all scheduled visits and comply with all study procedures

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 within the period of 4 weeks before to 4 weeks after each trial vaccination, except for oral polio vaccine (OPV) and influenza vaccination. OPV may be received any time during the study while influenza vaccination may be received at a gap of at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
• Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B (except the dose of Hep B vaccine given at birth or at least 4 weeks before the first trial vaccination), Haemophilus influenzae type b, poliomyelitis (except OPV), rotavirus, and Streptococcus pneumoniae with either the trial vaccines or another vaccine
• 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 (hepatitis C virus [HCV] ribonucleic acid [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, rotavirus, or pneumococcal infection(s) confirmed either clinically, serologically, or microbiologically
• History of any neurologic disorders, including encephalopathy, seizures (febrile and non-febrile) and progressive neurologic disorders
• History of intussusception
• In an emergency setting, or hospitalized
• 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
• Thrombocytopenia, as reported by the parent/legally acceptable representative, contraindicating intramuscular vaccination in the Investigator's opinion
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigator's opinion
• Chronic illness that, in the Investigator's opinion, is at a stage where it might interfere with trial conduct or completion
• Any condition which, in the Investigator's opinion, might interfere with the evaluation of the study objectives
• Moderate or severe acute illness/infection (according to the Investigator's judgment) 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

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.