MedPath

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

Phase 2
Completed
Conditions
Hepatitis B Immunisation
Haemophilus Influenzae Type b Immunisation
Varicella Immunisation
Pertussis Immunisation
Polio Immunisation
Pneumococcal Immunisation
Diphtheria Immunisation
Mumps Immunisation
Tetanus Immunisation
Measles Immunisation
Interventions
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: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
Biological: Varicella Virus Vaccine Live
Biological: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]
Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
Biological: Hepatitis B Vaccine* [Recombinant] *as applicable
Registration Number
NCT04398706
Lead Sponsor
Sanofi Pasteur, a Sanofi Company
Brief 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\])

Detailed Description

For toddlers, the duration of each participant's participation in the study will be approximately 6 months for subjects enrolled in Groups 1, 2, 3, and 4.

For infants, the duration of each participant's participation in the study will be approximately 16 to 19 months for subjects enrolled in Groups 5, 6, 7, and 8.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
852
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group 8Measles, Mumps, and Rubella Virus Vaccine LiveFour doses of Prevnar 13 at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Group 1Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)One dose of SP0202-IIb and one dose of DTaP-IPV// Hib vaccine in toddlers aged 12-15 months who have previously received the 3-dose primary series of Prevnar13
Group 4Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)One dose of Prevnar 13 and one dose of DTaP-IPV// Hib vaccine in toddlers aged 12-15 months who have previously received the 3-dose primary series of Prevnar13
Group 5Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)Four doses of SP0202-IIb at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Group 5Pneumococcal Conjugate Vaccine formulation 1Four doses of SP0202-IIb at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Group 5Varicella Virus Vaccine LiveFour doses of SP0202-IIb at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Group 5Rotavirus Vaccine, Live, Oral, PentavalentFour doses of SP0202-IIb at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Group 6Measles, Mumps, and Rubella Virus Vaccine LiveFour doses of SP0202-VI at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Group 6Rotavirus Vaccine, Live, Oral, PentavalentFour doses of SP0202-VI at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Group 5Measles, Mumps, and Rubella Virus Vaccine LiveFour doses of SP0202-IIb at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Group 6Pneumococcal Conjugate Vaccine formulation 2Four doses of SP0202-VI at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Group 7Hepatitis B Vaccine* [Recombinant] *as applicableFour doses of SP0202-VII at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Group 8Varicella Virus Vaccine LiveFour doses of Prevnar 13 at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Group 8Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]Four doses of Prevnar 13 at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Group 8Hepatitis B Vaccine* [Recombinant] *as applicableFour doses of Prevnar 13 at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Group 7Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)Four doses of SP0202-VII at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Group 8Rotavirus Vaccine, Live, Oral, PentavalentFour doses of Prevnar 13 at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Group 1Pneumococcal Conjugate Vaccine formulation 1One dose of SP0202-IIb and one dose of DTaP-IPV// Hib vaccine in toddlers aged 12-15 months who have previously received the 3-dose primary series of Prevnar13
Group 2Pneumococcal Conjugate Vaccine formulation 2One dose of SP0202-VI and one dose of DTaP-IPV// Hib vaccine in toddlers aged 12-15 months who have previously received the 3-dose primary series of Prevnar13
Group 2Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)One dose of SP0202-VI and one dose of DTaP-IPV// Hib vaccine in toddlers aged 12-15 months who have previously received the 3-dose primary series of Prevnar13
Group 3Pneumococcal Conjugate Vaccine formulation 3One dose of SP0202-VII and one dose of DTaP-IPV// Hib vaccine in toddlers aged 12-15 months who have previously received the 3-dose primary series of Prevnar13
Group 3Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)One dose of SP0202-VII and one dose of DTaP-IPV// Hib vaccine in toddlers aged 12-15 months who have previously received the 3-dose primary series of Prevnar13
Group 4Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]One dose of Prevnar 13 and one dose of DTaP-IPV// Hib vaccine in toddlers aged 12-15 months who have previously received the 3-dose primary series of Prevnar13
Group 5Hepatitis B Vaccine* [Recombinant] *as applicableFour doses of SP0202-IIb at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Group 6Varicella Virus Vaccine LiveFour doses of SP0202-VI at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Group 6Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)Four doses of SP0202-VI at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Group 6Hepatitis B Vaccine* [Recombinant] *as applicableFour doses of SP0202-VI at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Group 7Pneumococcal Conjugate Vaccine formulation 3Four doses of SP0202-VII at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Group 7Varicella Virus Vaccine LiveFour doses of SP0202-VII at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Group 7Measles, Mumps, and Rubella Virus Vaccine LiveFour doses of SP0202-VII at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Group 7Rotavirus Vaccine, Live, Oral, PentavalentFour doses of SP0202-VII at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Group 8Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)Four doses of Prevnar 13 at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Primary Outcome Measures
NameTimeMethod
Number of Participants With Immediate Adverse Events (AEs)Up to 30 minutes after each vaccination

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 the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination and included both serious adverse events (SAEs) and non-serious unsolicited AEs.

Number of Participants With Solicited Injection Site ReactionsUp to 7 days after each vaccination

A solicited reaction was an "expected" adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted in the protocol and CRB and were considered to be related to the product administered. An injection site reaction was an adverse reaction at and around the injection site which were commonly inflammatory reactions. Solicited injection site reactions included tenderness, erythema and swelling around the injection site and were planned to be collected and reported for SP0202/Prevnar 13 for both toddlers and infants.

Number of Participants With Solicited Systemic ReactionsUp to 7 days after each vaccination

A solicited reaction was an "expected" adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB and considered as related to the product administered. Solicited systemic reactions included fever, vomiting, abnormal crying, drowsiness, appetite loss, and irritability. Reported AEs for each arm were presented as pre-specified in protocol.

Number of Participants With Unsolicited AEsUp to 30 days after each vaccination

An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product, and which did not necessarily have a causal relationship with this treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination. Unsolicited AEs included both SAEs and non-serious unsolicited AEs. Reported AEs for each arm were presented as pre-specified in protocol.

Number of Participants With SAEs and Adverse Event of Special Interest (AESIs)From first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days

An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI (serious or non-serious) was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. The following AE were captured as AESI throughout the study: Anaphylaxis defined as per the Brighton collaboration case definition, convulsions including febrile convulsions, hypotonic-hyporesponsive episode and apnea. Reported AEs for each arm were presented as pre-specified in protocol.

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

The GMCs for serotype specific pneumococcal IgG antibodies were measured using pneumococcal capsular polysaccharide-electro-chemiluminescent assay (PnPS-ECL), a multiplexed serological assay which allows for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.

For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Day 150

Percentage of infants with serotype specific IgG concentration \>=0.35 mcg/mL for each pneumococcal serotype included in the SP0202 formulations were measured using ECL, a multiplexed serological assay which allows for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.

For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Day 150

The GMCs for serotype-specific pneumococcal IgG antibodies were measured using PnPS-ECL, a multiplexed serological assay which allows for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.

For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Day 330

The GMCs for serotype specific pneumococcal IgG antibodies were measured using PnPS-ECL, a multiplexed serological assay which allows for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.

Secondary Outcome Measures
NameTimeMethod
For Infants: Percentage of Participants With Antibody Responses to M-MRII and Varivax Antigens 30 Days Post-Dose 4Day 330

Anti-measles antibodies were determined by bulk measles IgG enzyme immunoassay (EIA); anti-mumps antibodies by ELISA, anti-rubella antibodies by bulk rubella IgG EIA and anti-varicella antibodies were determined by glycoprotein ELISA to detect total IgG antibody to respective virus before and after vaccination with a virus-containing vaccine. Percentage of participants with anti-measles antibody concentrations \>=255 mIU/mL, anti-mumps antibody concentrations: \>=10 antibody units/mL, anti-rubella antibody concentrations \>=10 IU/mL and anti-varicella concentrations \>=5 units/mL is reported in this outcome measure.

For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseDay 30

The GMs for serotype specific OPA titers were measured using multiplex opsonophagocytic assay (MOPA) which is used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination.

For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Day 150

The GMs for serotype specific OPA titers were measured using MOPA which is used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination.

For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Day 330

The GMs for serotype specific OPA titers were measured using MOPA which is used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination.

For Infants: GMC of Anti-Rotavirus Serum Immunoglobulin A (IgA) Antibodies 30 Days Post-Dose 3Day 150

Anti-rotavirus IgA antibodies in human serum were measured by enzyme linked immunosorbent assay (ELISA). A reference standard assayed on each plate was used to calculate the amount of specific anti-rotavirus IgA antibody in the units assigned by the reference standard.

For Infants: Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens 30 Days Post-Dose 3Day 150

Percentage of participants with toxoid concentration \>=0.10 mcg/mL for diphtheria and tetanus and \>=0.15 mcg/mL for PRP are presented. Anti-diphtheria and anti-tetanus concentrations were measured using electro-chemiluminescence assay (ECL) and anti-PRP concentrations were measured using a Farr-type radioimmunoassay.

For Infants: Percentage of Participants With Antibody Responses to Poliovirus 1, 2 and 3 30 Days Post-Dose 3Day 150

Anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. Response was defined as a titer \>=8.

For Infants: GMCs of Antibodies to Pertussis Antigens 30 Days Post-Dose 3Day 150

Serum samples were collected for analysis by ECL to determine the GMC of antibodies to the following Pertussis antigens: Pertussis toxoid/toxin, Filamentous hemagglutinin, Pertactin and Fimbriae types 2 and 3.

For Infants: Percentage of Participants With Antibody Responses to Hepatitis-B Antigens 30 Days Post-Dose 3Day 150

Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ immunodiagnostic system using chemiluminescence detection technology. The VITROS ECi immunodiagnostic system uses an antibody mediated antigen sandwich formation to detect the presence of anti-hepatitis B surface antigen total immunoglobulin in human serum. The threshold presented is \>=10 milli international units (mIU).

Trial Locations

Locations (57)

Pediatric Associates of Mt. Carmel Site Number : 8400005

🇺🇸

Cincinnati, Ohio, United States

Lincoln Pediatric Group Site Number : 8400125

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Lincoln, Nebraska, United States

Tribe Clinical Research Site Number : 8400025

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Greenville, South Carolina, United States

Dade Research Center Site Number : 8400122

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Miami, Florida, United States

Joint Clinical Trials Huntington Park Site Number : 8400030

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Huntington Park, California, United States

The Children's Clinic Of Jonesboro PA Site Number : 8400143

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Jonesboro, Arkansas, United States

Matrix Clinical Research Site Number : 8400059

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Los Angeles, California, United States

Orange County Research Institute Site Number : 8400060

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Ontario, California, United States

Homestead Medical Clinic, P.A. Site Number : 8400032

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Homestead, Florida, United States

International Research Partners, LLC Site Number : 8400077

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Doral, Florida, United States

Miami Clinical Research Site Number : 8400020

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Miami, Florida, United States

California Research Foundation Site Number : 8400052

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San Diego, California, United States

Southland Clinical Research Center Site Number : 8400040

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Bellflower, California, United States

Meridian Clinical Research, LLC Site Number : 8400112

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Baton Rouge, Louisiana, United States

Hutchinson Clinic Site Number : 8400074

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Hutchinson, Kansas, United States

Michael W. Simon, MD, PSC Site Number : 8400002

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Lexington, Kentucky, United States

Atrium Health Site Number : 8400124

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Charlotte, North Carolina, United States

Benchmark Research Site Number : 8400012

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Covington, Louisiana, United States

Ardmore Medical Research Site Number : 8400043

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Winston-Salem, North Carolina, United States

Sun Research Institute Site Number : 8400011

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San Antonio, Texas, United States

Javara Dallas Site Number : 8400135

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Dallas, Texas, United States

North Texas Clinical Trials Site Number : 8400015

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Fort Worth, Texas, United States

Investigational Site Number : 3400001

🇭🇳

San Pedro Sula, Honduras

Investigational Site Number : 1240006

🇨🇦

Hamilton, Ontario, Canada

Amber Clinical Research, LLC Site Number : 8400019

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Miami, Florida, United States

Javara Fayetteville Site Number : 8400139

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Fayetteville, Georgia, United States

DCOL Center for Clinical Research Site Number : 8400107

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Longview, Texas, United States

Meridian Clinical Research Washington DC Site Number : 8400119

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Washington, District of Columbia, United States

Javara Albany Site Number : 8400140

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Albany, Georgia, United States

Matrix Clinical Research Huntington Park Site Number : 8400058

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Huntington Park, California, United States

Centricity Research Talbotton - DBA IACT Health Research at Talbotton Site Number : 8400062

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Columbus, Georgia, United States

Children's Mercy Hospital Site Number : 8400008

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Kansas City, Missouri, United States

Dumog Research Site Number : 8400134

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Smyrna, Georgia, United States

Bingham Memorial Hospital Site Number : 8400067

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Blackfoot, Idaho, United States

Leavitt Clinical Research Site Number : 8400127

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Idaho Falls, Idaho, United States

Cheraw Pediatrics Site Number : 8400017

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Cheraw, South Carolina, United States

Pininos Pediatric Services Site Number : 8400121

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El Paso, Texas, United States

Houston Clinical Research Associates Site Number : 8400023

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Houston, Texas, United States

Tekton Research Site Number : 8400076

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San Antonio, Texas, United States

Investigational Site Number : 3400002

🇭🇳

Municipio Del Distrito Central, Honduras

FMC Science, LLC Site Number : 8400086

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Lampasas, Texas, United States

Biopharma Informatic Site Number : 8400066

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McAllen, Texas, United States

MultiCare Institute for Research & Innovation Site Number : 8400024

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Spokane, Washington, United States

Benchmark Research San Antonio Site Number : 8400129

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San Antonio, Texas, United States

Investigational Site Number : 1240001

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Halifax, Nova Scotia, Canada

Investigational Site Number : 6300002

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Bayamón, Puerto Rico

Investigational Site Number : 6300001

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San Juan, Puerto Rico

Investigational Site Number : 6300004

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Guayama, Puerto Rico

Investigational Site Number : 1240002

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Vancouver, British Columbia, Canada

Javara Annapolis Site Number : 8400137

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Annapolis, Maryland, United States

Boeson Research Site Number : 8400004

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Missoula, Montana, United States

Velocity Clinical Research Lafayette Site Number : 8400132

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Lafayette, Louisiana, United States

Meridian Clinical Research Site Number : 8400102

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Grand Island, Nebraska, United States

Jedidiah Clinical Research Site Number : 8400049

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Tampa, Florida, United States

Pediatric Infectious Diseases Research Site Number : 8400104

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Omaha, Nebraska, United States

Qualmedica Research, LLC Site Number : 8400084

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Bowling Green, Kentucky, United States

Javara Chevy Chase Site Number : 8400138

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Chevy Chase, Maryland, United States

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