Study of a Pneumococcal Conjugate Vaccine when Administered Concomitantly with Routine Pediatric Vaccines in Healthy Toddlers and Infants

Phase 1

• Conditions: Pneumococcal infection; MedDRA version: 21.1Level: PTClassification code 10069578Term: Pneumococcal immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2021-002146-33-Outside-EU/EEA
• Lead Sponsor: Sanofi Pasteur Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-04
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

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

Inclusion Criteria

Toddlers and infants:
- Participant and parent/guardian are able to attend all scheduled visits and to comply with all study procedures
- Born at full term of pregnancy (= 37 weeks) and/or with a birth weight = 5.5 lbs or 2.5 kg
Specifically for toddlers:
- Aged 12 to 15 months on the day of the first study visit
- Participant has received 3 doses of Prevnar 13 and 3 doses of diphteria, tetanus, acellular pertussis, poliovirus and Haemophilus influenzae type b antigens in infancy
Specifically for infants:
- Aged 42 to 89 days on the day of the first study visit
Are the trial subjects under 18? yes
Number of subjects for this age range: 840
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:
Toddlers and infants
- Participation at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
- Family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated
- Blood dyscrasias, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems
- Active tuberculosis
- History of S. pneumoniae infection or disease, confirmed either serologically or microbiologically
- History of any neurologic disorder, including any seizures and progressive neurologic disorders
- History of Guillain-Barré syndrome
- Known systemic hypersensitivity to any of the vaccine components or to latex, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances
- Verbal report of thrombocytopenia 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
- Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
- Chronic illness (including, but not limited to, cardiac disorders, congenital heart disease, chronic lung disease, renal disorders, auto-immune disorders, diabetes, psychomotor diseases, and know congenital or genetic diseases) that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion
- Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives
- In an emergency setting, or hospitalized involuntarily
- Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature = 38.0°C / = 100.4°F). A prospective participant should not be included in the study until the condition has resolved or until 3 days after the febrile event has resolved
- Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
Specifically for toddlers
- Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine from enrollment through the last blood sampling Visit (Visit 2), except for influenza vaccination, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- History of diphtheria, tetanus, pertussis, poliomyelitis, and/or H. influenzae type b infection or disease
Specifically for infants
- Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine from enrollment through t

Study & Design

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