Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06736041 · ClinicalTrials.gov registry record · Phase 3
Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
A Phase 3 study of Pneumococcal Immunization, sponsored by Sanofi Pasteur, a Sanofi Company.
- Active
- Registry status
- Phase 3
- Development phase
- 1,714
- Enrollment target
- 20
- Study locations
NCT06736041: Active Phase 3 study of Pneumococcal Immunization, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT06736041 is a Phase 3 study of Pneumococcal Immunization that is active but no longer recruiting, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 1,714 participants, above the 1,025-participant average among 3 other Pneumococcal Immunization trials with a reported enrollment target (67% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06736041, a Phase 3 study of Pneumococcal Immunization, is active but no longer recruiting, sponsored by Sanofi Pasteur, a Sanofi Company.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,714 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is a Phase 3, randomized, modified double-blind study which aims to measure whether PCV21 vaccine (investigational pneumococcal conjugate vaccine) is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) compared with 20-valent pneumococcal vaccine (Prevnar 20, licensed pneumococcal conjugate vaccine) when they are administered with routine pediatric vaccines in infants aged from approximately 2 months (42 to 89 days). The study duration per participant will be up to approximately 19 months. The study vaccines (either PCV21 or 20-valent pneumococcal vaccines) will be administered at approximately 2, 4, 6 and 12 to 15 months of age. Routine pediatric vaccines will be given at the same timepoints. There will be 6 study visits: -Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age until 15 months of age, V06 separated from V05 by 30 days.
Primary Outcome
Serotype specific IgG concentration ≥ 0.35 µg/mL
Conditions Studied
Interventions
- BIOLOGICAL PCV21 vaccine
- BIOLOGICAL Prevnar 20 vaccine
- BIOLOGICAL M-M-R II vaccine
- BIOLOGICAL RotaTeq
- BIOLOGICAL Vaxelis vaccine
Study Locations (20)
Florida
- PAS Research- Site Number : 8400123 - Clearwater
- Prohealth Research Center- Site Number : 8400159 - Doral
- NurtureGen Research- Site Number : 8400205 - Homestead
- EMDA Clinical Research- Site Number : 8400237 - Miami
- Dade Research Center- Site Number : 8400007 - Miami
- Acevedo Clinical Research Associates- Site Number : 8400089 - Miami
- Miami Clinical Research Tower- Site Number : 8400189 - Miami
- Vasconcello-Cohen MD Research, LLC- Site Number : 8400248 - Miami
- Bio-Medical Research- Site Number : 8400147 - Miami
California
- Southland Clinical Research Center- Site Number : 8400243 - Fountain Valley
- Century Research Institute- Site Number : 8400065 - Huntington Park
- Matrix Clinical Research - Huntington Park- Site Number : 8400012 - Huntington Park
- Matrix Clinical Research - Los Angeles- Site Number : 8400013 - Los Angeles
- University of California Los Angeles Medical Center- Site Number : 8400238 - Los Angeles
- Pasadena Clinical Trials - Pasadena - North Madison Avenue- Site Number : 8400259 - Pasadena
- FOMAT Medical Research - Pediatric, Infant & Adolescence Medicine- Site Number : 8400063 - Ventura
Arizona
- Sun City Clinical Research- Site Number : 8400247 - Glendale
- Eclipse Clinical Research- Site Number : 8400029 - Tucson
Arkansas
- Northwest Arkansas Pediatric Clinic- Site Number : 8400030 - Fayetteville
District of Columbia
- Velocity Clinical Research - Washington DC- Site Number : 8400049 - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,714 participants |
| Start Date | 2024-12-18 |
| Est. Completion | 2027-05-17 |
| Phase | Phase 3 |
What the registry record for NCT06736041 still lists
NCT06736041 is an interventional study that assigns participants to a tested intervention. Its 1,714 participants enrollment target places it among the larger protocols in the corpus, above the 1,025-participant average among 3 other Pneumococcal Immunization trials with a reported enrollment target (67% higher).
The record links to 1 condition, with Pneumococcal Immunization appearing as the primary indexed condition, and to 5 interventions - of which PCV21 vaccine is the first listed.
NCT06736041 names 20 study sites across 5 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT06736041 about?
NCT06736041 is a clinical study titled "Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age". This study is a Phase 3, randomized, modified double-blind study which aims to measure whether PCV21 vaccine (investigational pneumococcal conjugate vaccine) is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) compared with 20-valent pneumococcal vaccin...
What is the current status of trial NCT06736041?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,714 participants. The study started on 2024-12-18. Estimated completion is 2027-05-17.
What conditions does trial NCT06736041 study?
This clinical trial studies the following conditions: Pneumococcal Immunization.
What interventions are being tested in trial NCT06736041?
The interventions under investigation include: PCV21 vaccine (BIOLOGICAL), Prevnar 20 vaccine (BIOLOGICAL), M-M-R II vaccine (BIOLOGICAL), RotaTeq (BIOLOGICAL), Vaxelis vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT06736041?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06736041 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pneumococcal Immunization
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
RECRUITING · Phase 3
-
Study of Mixed Vaccination Schedules With a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
ACTIVE NOT RECRUITING · Phase 3
-
Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine Candidate in Healthy Adults (19-49 Years)
COMPLETED · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04291612 · 1,715 participants
Observational Study of Women With Endometrial Cancer Who Receive the Standard Treatment for Their Disease
- NCT05303636 · 1,710 participants · Phase 4
LF111 or Drospirenone Chew vs Non-hormonal Contraceptive Methods on Bone Mineral Density in Adolescent and Adult Women
- NCT07304531 · 1,705 participants
First To Know Pregnancy Test - Clinical Evaluation Protocol
- NCT06898034 · 1,725 participants
Postpartum Ultrasound Evaluation to Assess Risk of Hemorrhage
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI