Clinical trial NCT04429295: Study of DTwP-HepB-Hib-IPV (SHAN6™) Vaccine Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in Thailand
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pertussis Immunisation
Diphtheria Immunisation
Polio Immunisation
Hepatitis B Immunisation
Haemophilus Influenzae Type B Immunisation
Tetanus Immunisation
Rotavirus Immunisation
Pneumococcal Immunisation
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2020-06-12
Enrollment: 460
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 28 days after the third dose (Day 148)
measure: Adjusted Geometric Mean Concentrations (aGMCs) of Ab against pertussis antigens
timeFrame: 28 days after the third dose (Day 148)
Secondary outcomes:
measure: Number of participants with Ab titers above predefined thresholds against each antigen diphtheria, tetanus, hepatitis B, Haemophilus influenzae type b and poliovirus antigens
timeFrame: At baseline (Day 0) and 28 days after the third dose (Day 148)
measure: Number of participants with a vaccine response for pertussis antigens
timeFrame: At baseline (Day 0) and 28 days after the third dose (Day 148)
measure: Pertussis antigens vaccine seroconversion
timeFrame: At baseline (Day 0) and 28 days after the third dose (Day 148)
measure: Geometric Mean Concentrations Ratios (GMCRs) of Ab against all the antigens, including anti-rotavirus and anti-S. pneumoniae in a subset of participants
timeFrame: At baseline (Day 0) and 28 days after the third dose (Day 148)
measure: GMCs of Ab against each antigen, including anti-rotavirus and anti-pneumococcal serotypes, in a subset of participants
timeFrame: At baseline (Day 0) and 28 days after the third dose (Day 148)
measure: Number of participants with anti-rotavirus Ab titers above predefined thresholds in a subset of participants
timeFrame: At baseline (Day 0) and 28 days after the third dose (Day 148)
measure: Number of participants with anti-pneumococcal Ab titers above predefined thresholds in a subset of participants
timeFrame: At baseline (Day 0) and 28 days after the third dose (Day 148)
measure: Number of participants with Ab titers above predefined threshold against diphtheria, tetanus, hepatitis B, Haemophilus influenzae type b and poliovirus antigens
timeFrame: Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)
measure: Number of participants with a booster response for pertussis antigens
timeFrame: Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)
measure: Pertussis antigens vaccine seroconversion
timeFrame: Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)
measure: GMCRs of Ab against all the antigens
timeFrame: Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)
measure: GMCs of Ab against each antigen
timeFrame: Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)
measure: aGMCs of Ab against pertussis antigens
timeFrame: Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)
measure: Number of participants reporting immediate systemic adverse events (AEs)
timeFrame: Within 30 minutes post-vaccination
measure: Number of participants reporting solicited injection site and systemic reactions
timeFrame: Up to 7 days post-vaccination
measure: Number of participants reporting unsolicited non-serious AEs
timeFrame: Up to 28 days post-vaccination
measure: Number of participants reporting serious adverse events (SAEs)
timeFrame: Up to Day 416-506
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Investigational Site Number 7640003
city: Bangkok
country: Thailand
facility: Investigational Site Number 7640001
city: Khon Kaen
country: Thailand
facility: Investigational Site Number 7640002
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: