MedDRA version: 21.1 Level: PT Classification code 10069577 Term: Pertussis immunisation System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 21.1 Level: PT Classification code 10054129 Term: Diphtheria immunisation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: SHAN6
Product Code: 525
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: DIPHTHERIA TOXOID
Other descriptive name: DIPHTHERIA TOXOID
Concentration unit: IU internationa
Sponsors
Sanofi Pasteur
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. Are the trial subjects under 18? yes Number of subjects for this age range: 690 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: - 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 4 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 >=0.5mg/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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The first primary objective is to demonstrate the non-inferiority of SHAN6™ compared to the licensed control vaccines SHAN 5® (+ bOPV + IPV) with respect to the 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 3 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 3 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 3 dose primary series.;Secondary Objective: -To describe the immunogenicity profile of SHAN6™ vaccine 3 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 oral rotavirus vaccine (ORV) in terms of sero-response (serum immunoglobulin [Ig]A anti-rotavirus antibody levels) in a randomized subset of participants in each study group -To describe the immune response to co-administered pneumococcal conjugate vaccine (PCV) in terms of serum anti-pneumococcal IgG for the 10 vaccine serotypes in a randomized subset of participants 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 -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 primary series and booster vaccination;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 po | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 2- Number of participants with a vaccine response for pertussis antigens 3- Pertussis antigens vaccine seroconversion 4- Geometric Mean Titers Ratios (GMTRs) of Ab against all the antigens, including anti-rotavirus and anti-S. pneumoniae, in a subset of participants 5- GMCs of Ab against each antigen, including anti rotavirus and anti pneumococcal serotypes, in a subset of participants 6- Number of participants with anti-rotavirus Ab titers above predefined thresholds in a subset of participants 7- Number of participants with anti-pneumococcal Ab titers above predefined thresholds in a subset of participants 8- Number of participants with Ab titers above predefined threshold against diphtheria, tetanus, hepatitis B, Haemophilus influenzae type b and poliovirus antigens 9- Number of participants with a booster response for pertussis antigens 10- Pertussis antigens vaccine seroconversion 11- Number of participants reporting immediate systemic adverse events (AEs) 12- Number of participants reporting solicited injection site and systemic reactions 13- Number of participants reporting unsolicited non-serious AEs 14- Number of participants reporting serious adverse events (SAEs);Timepoint(s) of evaluation of this end point: 1, 2, 3, 4, 5, 6and 7: Day 0 and 28 days after Dose 3 (Day 84) 8, 9 and 10: before (Day 497-862) and 28 days after the booster dose (Day 525-890) 11: Within 30 minutes post-vaccination 12: Up to 7 days post-vaccination 13: Up to 28 days post-vaccination 14: Up to Day 890 | — |
Countries
Kenya
Contacts
Public ContactTrial Transparency Team
Sanofi Pasteur
Outcome results
None listed