Study of Full Schedule (3-Dose of Shan6™) or Shan6™-Shan5®-Shan6™ Versus the Licensed Vaccine Shan5® With bOPV and IPV When Administered Per National Immunization Schedule in Healthy Kenyan Infants

Phase 1

• Conditions: MedDRA version: 21.1Level: PTClassification code 10069577Term: Pertussis immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 21.1Level: PTClassification code 10054129Term: Diphtheria immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2022-003923-17-Outside-EU/EEA
• Lead Sponsor: Sanofi Pasteur

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-26
• Last Update Posted: 30 January 2023

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified