Diphtheria Immunisation Clinical Trial
Official title:
Immunogenicity and Safety of a DTwP-HepB-Hib-IPV (Shan6™) Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Thailand
| Verified date | May 2022 |
| Source | Sanofi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 460 |
| Est. completion date | November 20, 2021 |
| Est. primary completion date | February 26, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 8 Weeks to 11 Weeks |
| 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-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. |
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Investigational Site Number 7640001 | Bangkok | |
| Thailand | Investigational Site Number 7640003 | Bangkok | |
| Thailand | Investigational Site Number 7640002 | Khon Kaen |
| Lead Sponsor | Collaborator |
|---|---|
| Sanofi Pasteur, a Sanofi Company |
Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 28 days after the third dose (Day 148) | |
| Primary | Adjusted Geometric Mean Concentrations (aGMCs) of Ab against pertussis antigens | Ab against pertussis antigens will be measured | 28 days after the third dose (Day 148) | |
| Secondary | 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 | At baseline (Day 0) and 28 days after the third dose (Day 148) | |
| Secondary | Number of participants with a vaccine response for pertussis antigens | Pertussis antigens vaccine response Threshold values will be considered | At baseline (Day 0) and 28 days after the third dose (Day 148) | |
| Secondary | Pertussis antigens vaccine seroconversion | Ab against pertussis antigens will be measured | At baseline (Day 0) and 28 days after the third dose (Day 148) | |
| Secondary | 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) | At baseline (Day 0) and 28 days after the third dose (Day 148) | |
| Secondary | 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 | At baseline (Day 0) and 28 days after the third dose (Day 148) | |
| Secondary | 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 | At baseline (Day 0) and 28 days after the third dose (Day 148) | |
| Secondary | 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 | At baseline (Day 0) and 28 days after the third dose (Day 148) | |
| Secondary | 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 | Before and 28 days after the booster dose (at Day 388-478 and Day 416-506) | |
| Secondary | Number of participants with a booster response for pertussis antigens | Pertussis antigens booster response Threshold values will be considered | Before and 28 days after the booster dose (at Day 388-478 and Day 416-506) | |
| Secondary | Pertussis antigens vaccine seroconversion | Ab against pertussis antigens will be measured | Before and 28 days after the booster dose (at Day 388-478 and Day 416-506) | |
| Secondary | 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) | Before and 28 days after the booster dose (at Day 388-478 and Day 416-506) | |
| Secondary | GMCs of Ab against each antigen | Ab concentrations against each antigen will be measured | Before and 28 days after the booster dose (at Day 388-478 and Day 416-506) | |
| Secondary | aGMCs of Ab against pertussis antigens | Ab against pertussis antigens will be measured, adjusted for baseline value | Before and 28 days after the booster dose (at Day 388-478 and Day 416-506) | |
| Secondary | Number of participants reporting immediate systemic adverse events (AEs) | Unsolicited (spontaneously reported) systemic AEs | Within 30 minutes post-vaccination | |
| Secondary | 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 |
Up to 7 days post-vaccination | |
| Secondary | Number of participants reporting unsolicited non-serious AEs | Unsolicited non-serious AEs | Up to 28 days post-vaccination | |
| Secondary | Number of participants reporting serious adverse events (SAEs) | SAEs | Up to Day 416-506 |
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