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Status:

COMPLETED

Study of DTwP-HepB-Hib-IPV (SHAN6™) Vaccine Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in Thailand

Lead Sponsor:

Sanofi Pasteur, a Sanofi Company

Conditions:

Pertussis Immunisation

Diphtheria Immunisation

Eligibility:

All Genders

8-11 years

Phase:

PHASE3

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 de...

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 immun...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    June 28 2020

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    November 20 2021

    Estimated Enrollment :

    460 Patients enrolled

    Trial Details

    Trial ID

    NCT04429295

    Start Date

    June 28 2020

    End Date

    November 20 2021

    Last Update

    September 22 2025

    Active Locations (3)

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    Page 1 of 1 (3 locations)

    1

    Investigational Site Number 7640003

    Bangkok, Thailand, 10330

    2

    Investigational Site Number 7640001

    Bangkok, Thailand, 10700

    3

    Investigational Site Number 7640002

    Khon Kaen, Thailand, 4002