CompletedPhase 2

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

United States, Canada, Honduras852 participantsStarted 2020-05-22

Plain-language summary

Primary objectives: * To assess the safety profile of each SP0202 formulation and Prevnar 13 in toddlers and infants (after each and any injection). * To assess the immune response (serotype specific IgG concentration) of the SP0202 formulations and Prevnar 13 1 month after the administration of one dose in toddlers (Groups 1-4) * To assess the immune response (serotype specific IgG concentration) of the SP0202 formulations and Prevnar 13 1 month after the administration of 3 doses in infants (Groups 5-8) * To assess the immune response (serotype specific IgG concentration) of the SP0202 formulations and Prevnar 13 1 month after administration of a 4-dose schedule in infants (Groups 5-8) Secondary objectives: * To assess the immune response (serotype specific OPA titer) of the SP0202 formulations and Prevnar 13 1 month after the administration of one dose in toddlers (Groups 1-4) * To assess the immune response (serotype specific OPA titer) of the SP0202 formulations and Prevnar 13 1 month after the administration of 3 doses in a subset of infants (Groups 5-8) * To assess the immune response (serotype specific OPA titer) of the SP0202 formulations and Prevnar 13 1 month after administration of a 4-dose schedule in a subset of infants (Groups 5-8) * In toddlers: to describe the Ab responses against Pentacel antigens before and 1 month following injection of Pentacel * In infants: to describe the Ab responses against antigens of the routine pediatric vaccines (Pentacel, RotaTeq, ENGERIX-B, M-M-RII, and VARIVAX) when administered concomitantly with either SP0202 or Prevnar 13 (at pre-Dose 1 (as applicable) for RotaTeq, Diphteria, Tetanus and Pertussis antigens; at PD3 for ENGERIX-B, RotaTeq, and Pentacel; at PD4 for M-M-RII and VARIVAX\])

Who can participate

Age range

42 Days – 15 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 Exclusion criteria: 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 la…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Immediate Adverse Events (AEs)

Timeframe: Up to 30 minutes after each vaccination

Number of Participants With Solicited Injection Site Reactions

Timeframe: Up to 7 days after each vaccination

Number of Participants With Solicited Systemic Reactions

Timeframe: Up to 7 days after each vaccination

Number of Participants With Unsolicited AEs

Timeframe: Up to 30 days after each vaccination

Number of Participants With SAEs and Adverse Event of Special Interest (AESIs)

Timeframe: From first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days

For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-Dose

Timeframe: Day 30

For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3

Trial details

NCT IDNCT04398706

SponsorSanofi Pasteur, a Sanofi Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-08-10

Results submitted2024-08-09

View on ClinicalTrials.gov More Pneumococcal Immunisation trials

Plain-language summary

Who can participate

Age range

42 Days – 15 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Immediate Adverse Events (AEs)

Timeframe: Up to 30 minutes after each vaccination

Number of Participants With Solicited Injection Site Reactions

Timeframe: Up to 7 days after each vaccination

Number of Participants With Solicited Systemic Reactions

Timeframe: Up to 7 days after each vaccination

Number of Participants With Unsolicited AEs

Timeframe: Up to 30 days after each vaccination

Number of Participants With SAEs and Adverse Event of Special Interest (AESIs)

Timeframe: From first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days

For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-Dose

Timeframe: Day 30

For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3