| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Diphtheria, Tetanus, Pertussis, Hepatitis-B, invasive Haemophilus influenzae type b and Poliomyelitis diseases |
|
| E.1.1.1 | Medical condition in easily understood language |
| Diphtheria, Tetanus, Pertussis, Hepatitis-B, invasive Haemophilus influenzae type b and Poliomyelitis diseases |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 21.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10069577 |
| E.1.2 | Term | Pertussis immunisation |
| E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 21.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10054129 |
| E.1.2 | Term | Diphtheria immunisation |
| E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 21.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10054175 |
| E.1.2 | Term | Polio immunisation |
| E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 21.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10054181 |
| E.1.2 | Term | Hepatitis B immunization |
| E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 21.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10069533 |
| E.1.2 | Term | Haemophilus influenzae type b immunisation |
| E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 21.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10054131 |
| E.1.2 | Term | Tetanus immunisation |
| E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 21.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10076886 |
| E.1.2 | Term | Rotavirus immunisation |
| E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 21.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10069578 |
| E.1.2 | Term | Pneumococcal immunisation |
| E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| 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 |
|
| E.2.2 | Secondary objectives of the trial |
-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 |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal 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 |
|
| E.4 | Principal 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 |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
1 - 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 ; Ab titers against D, T, Hep B, Hib and Polio antigens will be measured
Threshold values will be considered
2 - Adjusted Geometric Mean Concentrations (aGMCs) of Ab against pertussis antigens ; Ab against pertussis antigens will be measured, adjusted for baseline value |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| 1, 2 - 28 days after the third dose (Day 148) |
|
| E.5.2 | Secondary end point(s) |
1 - Number of participants with Ab titers above predefined thresholds against each antigen diphtheria, tetanus, hepatitis B, Haemophilus influenzae type b and poliovirus antigens ; Ab titers against D, T, Hep B, Hib and polio antigens will be measured
Threshold values will be considered
2 - Number of participants with a vaccine response for pertussis antigens ; Pertussis antigens vaccine response
Threshold values will be considered
3 - Pertussis antigens vaccine seroconversion ; Ab against pertussis antigens will be measured
4 - Geometric Mean Concentrations Ratios (GMCRs) of Ab against all the antigens, including anti-rotavirus and anti-S. pneumoniae in a subset of participants ; 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)
5 - GMCs of Ab against each antigen, including anti-rotavirus and anti-pneumococcal serotypes, in a subset of participants ; Ab concentrations against each antigen, including anti rotavirus and anti pneumococcal serotypes for a subset of participants, will be measured
6 - Number of participants with anti-rotavirus Ab titers above predefined thresholds in a subset of participants ; Ab against rotavirus will be measured in a subset of participants
Threshold values will be considered
7 - Number of participants with anti-pneumococcal Ab titers above predefined thresholds in a subset of participants ; Anti-pneumococcal Ab will be measured in a subset of participants
Threshold values will be considered
8 - Number of participants with Ab titers above predefined threshold against diphtheria, tetanus, hepatitis B, Haemophilus influenzae type b and poliovirus antigens ; Ab against D, T, Hep B, Hib and polio antigens will be measured
Threshold values will be considered
9 - Number of participants with a booster response for pertussis antigens ; Pertussis antigens booster response
Threshold values will be considered
10 - Pertussis antigens vaccine seroconversion ; Ab against pertussis antigens will be measured
11 -
- GMCRs of Ab against all the antigens ; Ab concentrations against all the antigens will be measured
The ratio calculated will be: (post booster/pre-booster)
- GMCs of Ab against each antigen ; Ab concentrations against each antigen will be measured
- aGMCs of Ab against pertussis antigens ; Ab against pertussis antigens will be measured, adjusted for baseline value
12 - Numberf of participants reporting immediate systemic adverse events (AEs) ; Unsolicited (spontaneously reported) systemic AEs
13 - Number of participants reporting solicited injection site and systemic reactions ; Solicited injection site reactions:
- tenderness, erythema and site swelling
Solicited systemic reactions:
- fever, vomiting, crying abnormal, drowsiness, appetite lost and irritability
14 - Number of participants reporting unsolicited non-serious AEs ; Unsolicited non-serious AEs
15 - Number of participants reporting serious adverse events (SAEs) ; SAEs |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
1, 2, 3, 4, 5, 6, 7 - At baseline (Day 0) and 28 days after the third dose (Day 148)
8, 9, 10, 11 - Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)
12 - Within 30 minutes post-vaccination
13 - Up to 7 days post-vaccination
14 - Up to 28 days post-vaccination
15 - Up to Day 416-506 |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | Yes |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | No |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description |
|
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| E.8.3 |
Will this trial be conducted at a single site globally?
| No |
| E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
| E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
|
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 6 |
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