Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants
Public ClinicalTrials.gov record NCT04398706. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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\])
Study identification
- NCT ID
- NCT04398706
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 852 participants
Conditions and interventions
Conditions
Interventions
- Pneumococcal Conjugate Vaccine formulation 1 Biological
- Pneumococcal Conjugate Vaccine formulation 2 Biological
- Pneumococcal Conjugate Vaccine formulation 3 Biological
- Varicella Virus Vaccine Live Biological
- Measles, Mumps, and Rubella Virus Vaccine Live Biological
- Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein] Biological
- Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Biological
- Rotavirus Vaccine, Live, Oral, Pentavalent Biological
- Hepatitis B Vaccine* [Recombinant] *as applicable Biological
Biological
Eligibility (public fields only)
- Age range
- 42 Days to 15 Months
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 22, 2020 (Actual)
- Primary completion
- Aug 10, 2023 (Actual)
- Completion
- Aug 10, 2023 (Actual)
- Last update posted
- Sep 8, 2025
2020 – 2023
United States locations
- U.S. sites
- 49
- U.S. states
- 18
- U.S. cities
- 44
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Children's Clinic Of Jonesboro PA Site Number : 8400143 | Jonesboro | Arkansas | 72401 | — |
| Southland Clinical Research Center Site Number : 8400040 | Bellflower | California | 90706 | — |
| Joint Clinical Trials Huntington Park Site Number : 8400030 | Huntington Park | California | 90255 | — |
| Matrix Clinical Research Huntington Park Site Number : 8400058 | Huntington Park | California | 90255 | — |
| Matrix Clinical Research Site Number : 8400059 | Los Angeles | California | 90057 | — |
| Orange County Research Institute Site Number : 8400060 | Ontario | California | 91762 | — |
| California Research Foundation Site Number : 8400052 | San Diego | California | 92123-1881 | — |
| Meridian Clinical Research Washington DC Site Number : 8400119 | Washington D.C. | District of Columbia | 20016 | — |
| International Research Partners, LLC Site Number : 8400077 | Doral | Florida | 33122 | — |
| Homestead Medical Clinic, P.A. Site Number : 8400032 | Homestead | Florida | 33030 | — |
| Dade Research Center Site Number : 8400122 | Miami | Florida | 33135 | — |
| Miami Clinical Research Site Number : 8400020 | Miami | Florida | 33155 | — |
| Amber Clinical Research, LLC Site Number : 8400019 | Miami | Florida | 33164 | — |
| Jedidiah Clinical Research Site Number : 8400049 | Tampa | Florida | 33617 | — |
| Javara Albany Site Number : 8400140 | Albany | Georgia | 31707 | — |
| Centricity Research Talbotton - DBA IACT Health Research at Talbotton Site Number : 8400062 | Columbus | Georgia | 31904 | — |
| Javara Fayetteville Site Number : 8400139 | Fayetteville | Georgia | 30214 | — |
| Dumog Research Site Number : 8400134 | Smyrna | Georgia | 30080 | — |
| Bingham Memorial Hospital Site Number : 8400067 | Blackfoot | Idaho | 83221 | — |
| Leavitt Clinical Research Site Number : 8400127 | Idaho Falls | Idaho | 83404 | — |
| Hutchinson Clinic Site Number : 8400074 | Hutchinson | Kansas | 67502 | — |
| Qualmedica Research, LLC Site Number : 8400084 | Bowling Green | Kentucky | 42101 | — |
| Michael W. Simon, MD, PSC Site Number : 8400002 | Lexington | Kentucky | 40517 | — |
| Meridian Clinical Research, LLC Site Number : 8400112 | Baton Rouge | Louisiana | 70806 | — |
| Benchmark Research Site Number : 8400012 | Covington | Louisiana | 70433 | — |
| Velocity Clinical Research Lafayette Site Number : 8400132 | Lafayette | Louisiana | 70508 | — |
| Javara Annapolis Site Number : 8400137 | Annapolis | Maryland | 21401 | — |
| Javara Chevy Chase Site Number : 8400138 | Chevy Chase | Maryland | 20815 | — |
| Children's Mercy Hospital Site Number : 8400008 | Kansas City | Missouri | 64108 | — |
| Boeson Research Site Number : 8400004 | Missoula | Montana | 59804 | — |
| Meridian Clinical Research Site Number : 8400102 | Grand Island | Nebraska | 68803 | — |
| Lincoln Pediatric Group Site Number : 8400125 | Lincoln | Nebraska | 68516 | — |
| Pediatric Infectious Diseases Research Site Number : 8400104 | Omaha | Nebraska | 68131 | — |
| Atrium Health Site Number : 8400124 | Charlotte | North Carolina | 28204 | — |
| Ardmore Medical Research Site Number : 8400043 | Winston-Salem | North Carolina | 27103 | — |
| Pediatric Associates of Mt. Carmel Site Number : 8400005 | Cincinnati | Ohio | 45245 | — |
| Cheraw Pediatrics Site Number : 8400017 | Cheraw | South Carolina | 29520 | — |
| Tribe Clinical Research Site Number : 8400025 | Greenville | South Carolina | 29607 | — |
| Javara Dallas Site Number : 8400135 | Dallas | Texas | 75230 | — |
| Pininos Pediatric Services Site Number : 8400121 | El Paso | Texas | 79902 | — |
| North Texas Clinical Trials Site Number : 8400015 | Fort Worth | Texas | 76104 | — |
| Houston Clinical Research Associates Site Number : 8400023 | Houston | Texas | 77090 | — |
| FMC Science, LLC Site Number : 8400086 | Lampasas | Texas | 76550-1820 | — |
| DCOL Center for Clinical Research Site Number : 8400107 | Longview | Texas | 75605 | — |
| Biopharma Informatic Site Number : 8400066 | McAllen | Texas | 78503 | — |
| Benchmark Research San Antonio Site Number : 8400129 | San Antonio | Texas | 78201 | — |
| Sun Research Institute Site Number : 8400011 | San Antonio | Texas | 78205 | — |
| Tekton Research Site Number : 8400076 | San Antonio | Texas | 78244 | — |
| MultiCare Institute for Research & Innovation Site Number : 8400024 | Spokane | Washington | 99202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04398706, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 8, 2025 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04398706 live on ClinicalTrials.gov.