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NCT04398706 · ClinicalTrials.gov registry record · Phase 2
Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants
A Phase 2 study of Diphtheria Immunisation and Tetanus Immunisation, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 852
- Enrollment target
- 20
- Study locations
NCT04398706: Completed Phase 2 study of Diphtheria Immunisation and Tetanus Immunisation, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT04398706 is a Phase 2 study of Diphtheria Immunisation and Tetanus Immunisation that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 852 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (541% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04398706, a Phase 2 study of Diphtheria Immunisation and Tetanus Immunisation, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 852 participants
- Enrollment target
- 20
- Study locations
Study 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\])
Primary Outcome
An AE was any untoward medical occurrence in a participant or in a clinical investigation participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. Immediate events were recorded to capture medically relevant unsolicited systemic AEs (including those related to the product administered) that occurred within the first 30 minutes after vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in
Conditions Studied
Interventions
- BIOLOGICAL Varicella Virus Vaccine Live
- BIOLOGICAL Pneumococcal Conjugate Vaccine formulation 1
- BIOLOGICAL Pneumococcal Conjugate Vaccine formulation 2
- BIOLOGICAL Pneumococcal Conjugate Vaccine formulation 3
- BIOLOGICAL Measles, Mumps, and Rubella Virus Vaccine Live
Study Locations (20)
California
- Southland Clinical Research Center Site Number : 8400040 - Bellflower
- Joint Clinical Trials Huntington Park Site Number : 8400030 - Huntington Park
- Matrix Clinical Research Huntington Park Site Number : 8400058 - Huntington Park
- Matrix Clinical Research Site Number : 8400059 - Los Angeles
- Orange County Research Institute Site Number : 8400060 - Ontario
- California Research Foundation Site Number : 8400052 - San Diego
Florida
- International Research Partners, LLC Site Number : 8400077 - Doral
- Homestead Medical Clinic, P.A. Site Number : 8400032 - Homestead
- Dade Research Center Site Number : 8400122 - Miami
- Miami Clinical Research Site Number : 8400020 - Miami
- Amber Clinical Research, LLC Site Number : 8400019 - Miami
- Jedidiah Clinical Research Site Number : 8400049 - Tampa
Georgia
- Javara Albany Site Number : 8400140 - Albany
- Centricity Research Talbotton - DBA IACT Health Research at Talbotton Site Number : 8400062 - Columbus
- Javara Fayetteville Site Number : 8400139 - Fayetteville
- Dumog Research Site Number : 8400134 - Smyrna
Idaho
- Bingham Memorial Hospital Site Number : 8400067 - Blackfoot
- Leavitt Clinical Research Site Number : 8400127 - Idaho Falls
Arkansas
- The Children's Clinic Of Jonesboro PA Site Number : 8400143 - Jonesboro
District of Columbia
- Meridian Clinical Research Washington DC Site Number : 8400119 - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 852 participants |
| Start Date | 2020-05-22 |
| Est. Completion | 2023-08-10 |
| Phase | Phase 2 |
What the finished NCT04398706 record still lists
NCT04398706 is an interventional study that assigns participants to a tested intervention. The registered 852 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (541% higher).
The record links to 10 conditions, with Diphtheria Immunisation appearing as the primary indexed condition, and to 5 interventions - of which Varicella Virus Vaccine Live is the first listed.
NCT04398706 names 20 study sites across 6 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT04398706 about?
NCT04398706 is a clinical study titled "Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants". 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 on...
What is the current status of trial NCT04398706?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 852 participants. The study started on 2020-05-22. Estimated completion is 2023-08-10.
What conditions does trial NCT04398706 study?
This clinical trial studies the following conditions: Diphtheria Immunisation, Tetanus Immunisation, Pertussis Immunisation, Pneumococcal Immunisation, Hepatitis B Immunisation.
What interventions are being tested in trial NCT04398706?
The interventions under investigation include: Varicella Virus Vaccine Live (BIOLOGICAL), Pneumococcal Conjugate Vaccine formulation 1 (BIOLOGICAL), Pneumococcal Conjugate Vaccine formulation 2 (BIOLOGICAL), Pneumococcal Conjugate Vaccine formulation 3 (BIOLOGICAL), Measles, Mumps, and Rubella Virus Vaccine Live (BIOLOGICAL).
Who is sponsoring clinical trial NCT04398706?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04398706 being conducted?
This trial has 20 study locations across Arkansas, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04398706's enrollment target sits among peer trials
852 35th of 2000 higher than 1,966 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
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