Diphtheria Immunisation, Haemophilus Influenzae Type B Immunisation, Hepatitis B Immunisation, Pertussis Immunisation, Pneumococcal Immunisation, Polio Immunisation, Rotavirus Immunisation, Tetanus Immunisation
Conditions
Brief summary
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
Detailed description
The duration of each participant's active participation in the study will be approximately 14-17 months (416-506 days) in addition to the 2 MedDRA terms: Polio immunisation 10054175 Hepatitis B immunisation 10054181 Haemophilus influenzae type B immunisation 10069533 Tetanus immunisation 10054131 Rotavirus immunisation 10076886 Pneumococcal immunisation 10069578
Interventions
BIOLOGICALHuman Rotavirus, live attenuated
Pharmaceutical form:Oral suspension Route of administration: Oral
BIOLOGICALPneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
BIOLOGICALDTwP-HepB-Hib-IPV hexavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b, inactivated poliovirus)
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
BIOLOGICALDTwP-HepB-Hib pentavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b)
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
BIOLOGICALInactivated Poliomyelitis Vaccine
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
BIOLOGICALPoliomyelitis Vaccine bivalent types 1 and 3
Pharmaceutical form:Oral suspension Route of administration: Oral
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Weeks to 11 Weeks
Healthy volunteers
Yes
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-Guérin 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with antibodies (Ab) above predefined threshold against diphtheria (D), tetanus (T), hepatitis B (Hep B), Haemophilus influenzae type b (Hib) and poliovirus (Polio) antigens | 28 days after the third dose (Day 148) | Ab titers against D, T, Hep B, Hib and Polio antigens will be measured Threshold values will be considered |
| Adjusted Geometric Mean Concentrations (aGMCs) of Ab against pertussis antigens | 28 days after the third dose (Day 148) | Ab against pertussis antigens will be measured |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pertussis antigens vaccine seroconversion | At baseline (Day 0) and 28 days after the third dose (Day 148) | Ab against pertussis antigens will be measured |
| Geometric Mean Concentrations Ratios (GMCRs) of Ab against all the antigens, including anti-rotavirus and anti-S. pneumoniae in a subset of participants | At baseline (Day 0) and 28 days after the third dose (Day 148) | Ab concentrations against all the antigens, including anti-rotavirus and anti-S. pneumoniae for a subset of participants, will be measured The ratio calculated will be: (post dose 3/pre-primary) |
| GMCs of Ab against each antigen, including anti-rotavirus and anti-pneumococcal serotypes, in a subset of participants | At baseline (Day 0) and 28 days after the third dose (Day 148) | Ab concentrations against each antigen, including anti rotavirus and anti pneumococcal serotypes for a subset of participants, will be measured |
| Number of participants with anti-rotavirus Ab titers above predefined thresholds in a subset of participants | At baseline (Day 0) and 28 days after the third dose (Day 148) | Ab against rotavirus will be measured in a subset of participants Threshold values will be considered |
| Number of participants with anti-pneumococcal Ab titers above predefined thresholds in a subset of participants | At baseline (Day 0) and 28 days after the third dose (Day 148) | Anti-pneumococcal Ab will be measured in a subset of participants Threshold values will be considered |
| Number of participants with Ab titers above predefined threshold against diphtheria, tetanus, hepatitis B, Haemophilus influenzae type b and poliovirus antigens | Before and 28 days after the booster dose (at Day 388-478 and Day 416-506) | Ab against D, T, Hep B, Hib and polio antigens will be measured Threshold values will be considered |
| Number of participants with a booster response for pertussis antigens | Before and 28 days after the booster dose (at Day 388-478 and Day 416-506) | Pertussis antigens booster response Threshold values will be considered |
| Number of participants with Ab titers above predefined thresholds against each antigen diphtheria, tetanus, hepatitis B, Haemophilus influenzae type b and poliovirus antigens | At baseline (Day 0) and 28 days after the third dose (Day 148) | Ab titers against D, T, Hep B, Hib and polio antigens will be measured Threshold values will be considered |
| GMCs of Ab against each antigen | Before and 28 days after the booster dose (at Day 388-478 and Day 416-506) | Ab concentrations against each antigen will be measured |
| aGMCs of Ab against pertussis antigens | Before and 28 days after the booster dose (at Day 388-478 and Day 416-506) | Ab against pertussis antigens will be measured, adjusted for baseline value |
| Number of participants reporting immediate systemic adverse events (AEs) | Within 30 minutes post-vaccination | Unsolicited (spontaneously reported) systemic AEs |
| Number of participants reporting solicited injection site and systemic reactions | Up to 7 days post-vaccination | Solicited injection site reactions: \- tenderness, erythema and site swelling Solicited systemic reactions: \- fever, vomiting, crying abnormal, drowsiness, appetite lost and irritability |
| Number of participants reporting unsolicited non-serious AEs | Up to 28 days post-vaccination | Unsolicited non-serious AEs |
| Number of participants reporting serious adverse events (SAEs) | Up to Day 416-506 | SAEs |
| GMCRs of Ab against all the antigens | Before and 28 days after the booster dose (at Day 388-478 and Day 416-506) | Ab concentrations against all the antigens will be measured The ratio calculated will be: (post booster/pre-booster) |
| Number of participants with a vaccine response for pertussis antigens | At baseline (Day 0) and 28 days after the third dose (Day 148) | Pertussis antigens vaccine response Threshold values will be considered |
Countries
Thailand
Outcome results
None listed