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

Primary Purpose

Pneumococcal Immunisation, Diphtheria Immunisation, Tetanus Immunisation

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Pneumococcal Conjugate Vaccine formulation 1
Pneumococcal Conjugate Vaccine formulation 2
Pneumococcal Conjugate Vaccine formulation 3
Varicella Virus Vaccine Live
Measles, Mumps, and Rubella Virus Vaccine Live
Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
Rotavirus Vaccine, Live, Oral, Pentavalent
Hepatitis B Vaccine* [Recombinant] *as applicable
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Immunisation

Eligibility Criteria

42 Days - 15 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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:

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 latex, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances
  • Verbal report of thrombocytopenia contraindicating intramuscular vaccination in the Investigator's opinion
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigator's opinion
  • Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
  • Chronic illness (including, but not limited to, cardiac disorders, congenital heart disease, chronic lung disease, renal disorders, auto-immune disorders, diabetes, psychomotor diseases, and know congenital or genetic diseases) that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion
  • Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives
  • In an emergency setting, or hospitalized involuntarily
  • Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0 C / ≥ 100.4 F). A prospective participant should not be included in the study until the condition has resolved or until 3 days after the febrile event has resolved
  • Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study Specifically for toddlers
  • Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine from enrollment through the last blood sampling Visit (Visit 2), except for influenza vaccination, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
  • Receipt of immune globulins, blood or blood-derived products in the past 3 months
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
  • History of diphtheria, tetanus, pertussis, poliomyelitis, and/or H. influenzae type b infection or disease Specifically for infants
  • Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine from enrollment through the last blood sampling Visit (Visit 6), except for influenza vaccination or COVID-19 vaccination, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines, and COVID-19 vaccines as applicable per local recommendations
  • Receipt of immune globulins, blood or blood-derived products since birth.
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) since birth
  • Previous vaccination against S. pneumoniae
  • Previous vaccination against the following antigens: diphteria, tetanus, pertussis, H. influenzae type b, poliovirus, rotavirus, measles, mumps, rubella, and varicella
  • Receipt of more than 1 previous dose of hepatitis B vaccine
  • History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, measles, mumps, rubella, varicella, H. influenzae type b, and/or rotavirus infection or disease
  • History of intussusception

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

  • The Children's Clinic Of Jonesboro PA-Site Number:8400143
  • Southland Clinical Research Center-Site Number:8400040
  • Join Clinical Trials Huntington Park-Site Number:8400030
  • Matrix Clinical Research Huntington Park-Site Number:8400058
  • Matrix Clinical Research-Site Number:8400059
  • Orange County Research Institute-Site Number:8400060
  • California Research Foundation-Site Number:8400052
  • Meridian Clinical Research Washington DC-Site Number:8400119
  • International Research Partners, LLC-Site Number:8400077
  • Homestead Medical Clinic, P.A.-Site Number:8400032
  • Dade Research Center-Site Number:8400122
  • Miami Clinical Research-Site Number:8400020
  • Amber Clinical Research, LLC-Site Number:8400019
  • Jedidiah Clinical Research-Site Number:8400049
  • Javara Albany-Site Number:8400140
  • Centricity Research Talbotton - DBA IACT Health Research at Talbotton-Site Number:8400062
  • Javara Fayetteville-Site Number:8400139
  • Dumog Research-Site Number:8400134
  • Bingham Memorial Hospital-Site Number:8400067
  • Leavitt Clinical Research-Site Number:8400127
  • Hutchinson Clinic-Site Number:8400074
  • Qualmedica Research, LLC-Site Number:8400084
  • Michael W. Simon, MD, PSC-Site Number:8400002
  • Meridian Clinical Research, LLC-Site Number:8400112
  • Benchmark Research-Site Number:8400012
  • MedPharmics, LLC-Site Number:8400132
  • Javara Annapolis-Site Number:8400137
  • Javara Chevy Chase-Site Number:8400138
  • Children's Mercy Hospital-Site Number:8400008
  • Boeson Research-Site Number:8400004
  • Meridian Clinical Research-Site Number:8400102
  • Lincoln Pediatric Group-Site Number:8400125
  • Pediatric Infectious Diseases Research-Site Number:8400104
  • Atrium Health-Site Number:8400124
  • Ardmore Medical Research-Site Number:8400043
  • Pediatric Associates of Mt. Carmel-Site Number:8400005
  • Cheraw Pediatrics-Site Number:8400017
  • Tribe Clinical Research-Site Number:8400025
  • Javara Dallas-Site Number:8400135
  • Pininos Pediatric Services-Site Number:8400121
  • North Texas Clinical Trials-Site Number:8400015
  • Houston Clinical Research Associates-Site Number:8400023
  • FMC Science, LLC-Site Number:8400086
  • DCOL Center for Clinical Research-Site Number:8400107
  • Biopharma Informatic-Site Number:8400066
  • Benchmark Research San Antonio-Site Number:8400129
  • Sun Research Institute-Site Number:8400011
  • Tekton Research-Site Number:8400076
  • MultiCare Institute for Research & Innovation-Site Number:8400024
  • Investigational Site Number :1240002
  • Investigational Site Number :1240001
  • Investigational Site Number :1240006
  • Investigational Site Number :3400002
  • Investigational Site Number :3400001
  • Investigational Site Number :6300002
  • Investigational Site Number :6300004
  • Investigational Site Number :6300001

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Group 4

Group 5

Group 6

Group 7

Group 8

Arm Description

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Number of participants reporting immediate adverse events (AEs)
Unsolicited (spontaneously reported) systemic AEs after each and any injection of a SP0202 formulation or Prevnar 13
Number of participants reporting solicited injection site and systemic reactions
Solicited injection site reactions: tenderness, erythema, swelling Solicited systematic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost and irritability
Number of participants reporting unsolicited (spontaneously reported) AEs
Unsolicited AEs (events not solicited) after each and any injection of a SP0202 formulation or Prevnar 13
Number of participants reporting serious adverse events (SAEs) and adverse events of special interest (AESIs)
SAEs and AESIs are collected throughout the study period
Geometric Mean Concentrations (GMCs) of antibodies against all pneumococcal serotypes included in the SP0202 formulations in toddlers
Ab concentrations for each pneumococcal serotype included in the SP0202 formulations are measured
GMCR of antibodies against all pneumococcal serotypes included in the SP0202 formulations in toddlers
Ab concentrations for each pneumococcal serotype included in the SP0202 formulations are measured The calculated ratio is (post-/pre-vaccination)
Number of infants with serotype-specific IgG concentration above predefined thresholds for each pneumococcal serotype included in the SP0202 formulations
Ab concentrations for each pneumococcal serotype included in the SP0202 formulations are measured The following threshold values will be considered: ≥ 0.35 µg/mL
GMCs of antibodies against all pneumococcal serotypes included in the SP0202 formulations in infants
Ab concentrations for each pneumococcal serotype included in the SP0202 formulations are measured
GMCR of antibodies against all pneumococcal serotypes included in the SP0202 formulations in infants* *as applicable
Ab concentrations for each pneumococcal serotype included in the SP0202 formulations are measured The calculated ratio is (post- dose 3/pre-dose 1)* *as applicable
GMCR of antibodies against all pneumococcal serotypes included in the SP0202 formulations in infants
Ab concentrations for each pneumococcal serotype included in the SP0202 formulations are measured The calculated ratio is (post- dose 4/pre-dose 4)

Secondary Outcome Measures

Geometric mean (GM) of serotype specific opsonophagocytic (OPA) titers for all pneumococcal serotypes included in the SP0202 formulations in toddlers
Serotype specific OPA titers for each pneumococcal serotype included in the SP0202 formulations are determined
Number of toddlers with serotype-specific OPA titers above predefined thresholds for each pneumococcal serotype included in the SP0202 formulations
Serotype specific OPA titers for each pneumococcal serotype included in the SP0202 formulations are determined The following threshold values will be considered: ≥ lower limit of quantitation (LLOQ)
GM of serotype specific OPA titers ratio for each pneumococcal serotype included in the SP0202 formulations in toddlers
Serotype specific OPA titers for each pneumococcal serotype included in the SP0202 formulations are determined The calculated ratio is (post-/pre-vaccination)
GM of serotype specific OPA titers for all pneumococcal serotypes included in the SP0202 formulations in infants
Serotype specific OPA titers for each pneumococcal serotype included in the SP0202 formulations are determined
Number of infants with serotype specific OPA titers above predefined thresholds for each pneumococcal serotype included in the SP0202 formulations
Serotype specific OPA titers for each pneumococcal serotype included in the SP0202 formulations are determined The following threshold values will be considered: ≥ LLOQ
GM of serotype specific OPA titers ratio for each pneumococcal serotype included in the SP0202 formulations in infants
Serotype specific OPA titers for each pneumococcal serotype included in the SP0202 formulations are determined The calculated ratio is (post- dose 4/pre-dose 4)
GM concentrations/titers of antibodies against antigens in DTaP-IPV// Hib vaccine when co- administered with SP0202 or Prevnar 13 in toddlers
The following components are assessed : Anti-pertussis (PT, FHA, PRN, FIM) Ab Anti-PRP Ab Anti-diphtheria toxoid Ab Anti-tetanus toxoid Ab Anti-poliovirus (types 1, 2, and 3) Ab
GM concentrations/titers of antibodies against antigens in DTaP-IPV// Hib vaccine when DTaP - IPV// Hib vaccine is co- administered with SP0202 or Prevnar 13 in toddlers
The following components are assessed: Anti-PRP Ab Anti-poliovirus (types 1, 2, 3) Ab Anti-pertussis (PT, FHA, PRN, FIM) Ab and vaccine response Anti-diphtheria toxoid Ab Anti-tetanus toxoid Ab
Number of toddlers with concentrations/titers of antibodies above predefined thresholds
The following components are assessed, with predefined thresholds for each: Anti-PRP Ab Anti-poliovirus (types 1, 2, 3) Ab Anti-pertussis (PT, FHA, PRN, FIM) Ab Anti-diphtheria toxoid Ab Anti-tetanus toxoid Ab
GM concentrations/titers of antibodies against antigens in licensed vaccines when co- administered with SP0202 or Prevnar 13 in infants* *as applicable
The following components are assessed*: Anti-rotavirus serum immunoglobulin (Ig) A Ab Anti-pertussis (PT, FHA, PRN, and FIM) Ab Anti-diphtheria toxoid Ab Anti-tetanus toxoid Ab *as applicable
GM concentrations/titers of antibodies against antigens in concomitant licensed vaccines when co- administered with SP0202 or Prevnar 13 in infants
The following components are assessed: IgG Abs against hepatitis B surface antigen Anti-PRP Ab Anti-poliovirus (types 1, 2, 3) Ab Anti-rotavirus serum IgA Ab Anti-pertussis (PT, FHA, PRN, FIM) Ab Anti-diphtheria toxoid Ab Anti-tetanus toxoid Ab
Number of infants with concentrations/titers of antibodies above predefined thresholds
The following components are assessed, with predefined thresholds for each: IgG Abs against hepatitis B surface antigen Anti-PRP Ab Anti-poliovirus (types 1, 2, 3) Ab Anti-rotavirus serum IgA Ab Anti-pertussis (PT, FHA, PRN, FIM) Ab Anti-diphtheria toxoid Ab Anti-tetanus toxoid Ab
GM concentrations/titers of antibodies against antigens in concomitant licensed vaccines when co- administered with SP0202 or Prevnar 13 in infants
The following components are assessed: Anti-measles Ab Anti-mumps Ab Anti-rubella Ab Anti-varicella Ab
Number of participants with concentrations/titers of antibodies above predefined thresholds
The following components are assessed, with predefined thresholds for each: Anti-measles Ab Anti-mumps Ab Anti-rubella Ab Anti-varicella Ab

Full Information

First Posted
May 18, 2020
Last Updated
September 27, 2023
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT04398706
Brief Title
Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants
Official Title
Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 22, 2020 (Actual)
Primary Completion Date
August 10, 2023 (Actual)
Study Completion Date
August 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Immunisation, Diphtheria Immunisation, Tetanus Immunisation, Pertussis Immunisation, Hepatitis B Immunisation, Haemophilus Influenzae Type b Immunisation, Polio Immunisation, Measles Immunisation, Rubella Immunisation, Varicella Immunisation, Mumps Immunisation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The study will be performed in a modified double-blind fashion: Investigators and study staff who conduct the safety assessment and the participant will not know which vaccine is administered Only the study staff who prepare and administer the vaccine and are not involved with the safety evaluation will know which vaccine is administered This study will be observer-blinded between any SP0202 formulation and Prevnar 13 and double-blind across the 3 SP0202 formulations
Allocation
Randomized
Enrollment
851 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
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
Arm Title
Group 2
Arm Type
Experimental
Arm Description
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
Arm Title
Group 3
Arm Type
Experimental
Arm Description
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
Arm Title
Group 4
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group 5
Arm Type
Experimental
Arm Description
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
Arm Title
Group 6
Arm Type
Experimental
Arm Description
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
Arm Title
Group 7
Arm Type
Experimental
Arm Description
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
Arm Title
Group 8
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Pneumococcal Conjugate Vaccine formulation 1
Other Intervention Name(s)
SP0202-IIb
Intervention Description
Pharmaceutical form:liquid Route of administration: intramuscular
Intervention Type
Biological
Intervention Name(s)
Pneumococcal Conjugate Vaccine formulation 2
Other Intervention Name(s)
SP0202-VI
Intervention Description
Pharmaceutical form:liquid Route of administration: intramuscular
Intervention Type
Biological
Intervention Name(s)
Pneumococcal Conjugate Vaccine formulation 3
Other Intervention Name(s)
SP0202-VII
Intervention Description
Pharmaceutical form:liquid Route of administration: intramuscular
Intervention Type
Biological
Intervention Name(s)
Varicella Virus Vaccine Live
Other Intervention Name(s)
Varicella vaccine, VARIVAX®
Intervention Description
Pharmaceutical form:liquid Route of administration: subcutaneous
Intervention Type
Biological
Intervention Name(s)
Measles, Mumps, and Rubella Virus Vaccine Live
Other Intervention Name(s)
MMR vaccine, M-M-R ®II
Intervention Description
Pharmaceutical form:liquid Route of administration: subcutaneous
Intervention Type
Biological
Intervention Name(s)
Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]
Other Intervention Name(s)
Prevnar 13®
Intervention Description
Pharmaceutical form:liquid Route of administration: intramuscular
Intervention Type
Biological
Intervention Name(s)
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
Other Intervention Name(s)
DTaP-IPV// Hib vaccine, Pentacel®
Intervention Description
Pharmaceutical form:liquid Route of administration: intramuscular
Intervention Type
Biological
Intervention Name(s)
Rotavirus Vaccine, Live, Oral, Pentavalent
Other Intervention Name(s)
Rotavirus vaccine, RotaTeq
Intervention Description
Pharmaceutical form:liquid Route of administration: oral
Intervention Type
Biological
Intervention Name(s)
Hepatitis B Vaccine* [Recombinant] *as applicable
Other Intervention Name(s)
Hepatitis B vaccine, ENGERIX-B®
Intervention Description
Pharmaceutical form:liquid Route of administration: intramuscular
Primary Outcome Measure Information:
Title
Number of participants reporting immediate adverse events (AEs)
Description
Unsolicited (spontaneously reported) systemic AEs after each and any injection of a SP0202 formulation or Prevnar 13
Time Frame
Within 30 minutes post-vaccination
Title
Number of participants reporting solicited injection site and systemic reactions
Description
Solicited injection site reactions: tenderness, erythema, swelling Solicited systematic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost and irritability
Time Frame
Up to Day 7 post-vaccination
Title
Number of participants reporting unsolicited (spontaneously reported) AEs
Description
Unsolicited AEs (events not solicited) after each and any injection of a SP0202 formulation or Prevnar 13
Time Frame
Within 30 days after vaccination
Title
Number of participants reporting serious adverse events (SAEs) and adverse events of special interest (AESIs)
Description
SAEs and AESIs are collected throughout the study period
Time Frame
From Day 0 to Day 480
Title
Geometric Mean Concentrations (GMCs) of antibodies against all pneumococcal serotypes included in the SP0202 formulations in toddlers
Description
Ab concentrations for each pneumococcal serotype included in the SP0202 formulations are measured
Time Frame
Day 30
Title
GMCR of antibodies against all pneumococcal serotypes included in the SP0202 formulations in toddlers
Description
Ab concentrations for each pneumococcal serotype included in the SP0202 formulations are measured The calculated ratio is (post-/pre-vaccination)
Time Frame
Day 30
Title
Number of infants with serotype-specific IgG concentration above predefined thresholds for each pneumococcal serotype included in the SP0202 formulations
Description
Ab concentrations for each pneumococcal serotype included in the SP0202 formulations are measured The following threshold values will be considered: ≥ 0.35 µg/mL
Time Frame
Day 150
Title
GMCs of antibodies against all pneumococcal serotypes included in the SP0202 formulations in infants
Description
Ab concentrations for each pneumococcal serotype included in the SP0202 formulations are measured
Time Frame
Day 330
Title
GMCR of antibodies against all pneumococcal serotypes included in the SP0202 formulations in infants* *as applicable
Description
Ab concentrations for each pneumococcal serotype included in the SP0202 formulations are measured The calculated ratio is (post- dose 3/pre-dose 1)* *as applicable
Time Frame
Day 150* *as applicable
Title
GMCR of antibodies against all pneumococcal serotypes included in the SP0202 formulations in infants
Description
Ab concentrations for each pneumococcal serotype included in the SP0202 formulations are measured The calculated ratio is (post- dose 4/pre-dose 4)
Time Frame
Day 330
Secondary Outcome Measure Information:
Title
Geometric mean (GM) of serotype specific opsonophagocytic (OPA) titers for all pneumococcal serotypes included in the SP0202 formulations in toddlers
Description
Serotype specific OPA titers for each pneumococcal serotype included in the SP0202 formulations are determined
Time Frame
Day 30
Title
Number of toddlers with serotype-specific OPA titers above predefined thresholds for each pneumococcal serotype included in the SP0202 formulations
Description
Serotype specific OPA titers for each pneumococcal serotype included in the SP0202 formulations are determined The following threshold values will be considered: ≥ lower limit of quantitation (LLOQ)
Time Frame
Day 30
Title
GM of serotype specific OPA titers ratio for each pneumococcal serotype included in the SP0202 formulations in toddlers
Description
Serotype specific OPA titers for each pneumococcal serotype included in the SP0202 formulations are determined The calculated ratio is (post-/pre-vaccination)
Time Frame
Day 30
Title
GM of serotype specific OPA titers for all pneumococcal serotypes included in the SP0202 formulations in infants
Description
Serotype specific OPA titers for each pneumococcal serotype included in the SP0202 formulations are determined
Time Frame
Day 150; Day 300; Day 330
Title
Number of infants with serotype specific OPA titers above predefined thresholds for each pneumococcal serotype included in the SP0202 formulations
Description
Serotype specific OPA titers for each pneumococcal serotype included in the SP0202 formulations are determined The following threshold values will be considered: ≥ LLOQ
Time Frame
Day 0; Day 150; Day 300; Day 330
Title
GM of serotype specific OPA titers ratio for each pneumococcal serotype included in the SP0202 formulations in infants
Description
Serotype specific OPA titers for each pneumococcal serotype included in the SP0202 formulations are determined The calculated ratio is (post- dose 4/pre-dose 4)
Time Frame
Day 300; Day 330
Title
GM concentrations/titers of antibodies against antigens in DTaP-IPV// Hib vaccine when co- administered with SP0202 or Prevnar 13 in toddlers
Description
The following components are assessed : Anti-pertussis (PT, FHA, PRN, FIM) Ab Anti-PRP Ab Anti-diphtheria toxoid Ab Anti-tetanus toxoid Ab Anti-poliovirus (types 1, 2, and 3) Ab
Time Frame
Day 0
Title
GM concentrations/titers of antibodies against antigens in DTaP-IPV// Hib vaccine when DTaP - IPV// Hib vaccine is co- administered with SP0202 or Prevnar 13 in toddlers
Description
The following components are assessed: Anti-PRP Ab Anti-poliovirus (types 1, 2, 3) Ab Anti-pertussis (PT, FHA, PRN, FIM) Ab and vaccine response Anti-diphtheria toxoid Ab Anti-tetanus toxoid Ab
Time Frame
Day 30
Title
Number of toddlers with concentrations/titers of antibodies above predefined thresholds
Description
The following components are assessed, with predefined thresholds for each: Anti-PRP Ab Anti-poliovirus (types 1, 2, 3) Ab Anti-pertussis (PT, FHA, PRN, FIM) Ab Anti-diphtheria toxoid Ab Anti-tetanus toxoid Ab
Time Frame
Day 30
Title
GM concentrations/titers of antibodies against antigens in licensed vaccines when co- administered with SP0202 or Prevnar 13 in infants* *as applicable
Description
The following components are assessed*: Anti-rotavirus serum immunoglobulin (Ig) A Ab Anti-pertussis (PT, FHA, PRN, and FIM) Ab Anti-diphtheria toxoid Ab Anti-tetanus toxoid Ab *as applicable
Time Frame
Day 0* *as applicable
Title
GM concentrations/titers of antibodies against antigens in concomitant licensed vaccines when co- administered with SP0202 or Prevnar 13 in infants
Description
The following components are assessed: IgG Abs against hepatitis B surface antigen Anti-PRP Ab Anti-poliovirus (types 1, 2, 3) Ab Anti-rotavirus serum IgA Ab Anti-pertussis (PT, FHA, PRN, FIM) Ab Anti-diphtheria toxoid Ab Anti-tetanus toxoid Ab
Time Frame
Day 150
Title
Number of infants with concentrations/titers of antibodies above predefined thresholds
Description
The following components are assessed, with predefined thresholds for each: IgG Abs against hepatitis B surface antigen Anti-PRP Ab Anti-poliovirus (types 1, 2, 3) Ab Anti-rotavirus serum IgA Ab Anti-pertussis (PT, FHA, PRN, FIM) Ab Anti-diphtheria toxoid Ab Anti-tetanus toxoid Ab
Time Frame
Day 150
Title
GM concentrations/titers of antibodies against antigens in concomitant licensed vaccines when co- administered with SP0202 or Prevnar 13 in infants
Description
The following components are assessed: Anti-measles Ab Anti-mumps Ab Anti-rubella Ab Anti-varicella Ab
Time Frame
Between Day 330 and Day 420
Title
Number of participants with concentrations/titers of antibodies above predefined thresholds
Description
The following components are assessed, with predefined thresholds for each: Anti-measles Ab Anti-mumps Ab Anti-rubella Ab Anti-varicella Ab
Time Frame
Between Day 330 and Day 420

10. Eligibility

Sex
All
Minimum Age & Unit of Time
42 Days
Maximum Age & Unit of Time
15 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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: 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 latex, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances Verbal report of thrombocytopenia contraindicating intramuscular vaccination in the Investigator's opinion Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigator's opinion Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw Chronic illness (including, but not limited to, cardiac disorders, congenital heart disease, chronic lung disease, renal disorders, auto-immune disorders, diabetes, psychomotor diseases, and know congenital or genetic diseases) that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives In an emergency setting, or hospitalized involuntarily Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0 C / ≥ 100.4 F). A prospective participant should not be included in the study until the condition has resolved or until 3 days after the febrile event has resolved Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study Specifically for toddlers Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine from enrollment through the last blood sampling Visit (Visit 2), except for influenza vaccination, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines Receipt of immune globulins, blood or blood-derived products in the past 3 months Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) History of diphtheria, tetanus, pertussis, poliomyelitis, and/or H. influenzae type b infection or disease Specifically for infants Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine from enrollment through the last blood sampling Visit (Visit 6), except for influenza vaccination or COVID-19 vaccination, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines, and COVID-19 vaccines as applicable per local recommendations Receipt of immune globulins, blood or blood-derived products since birth. Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) since birth Previous vaccination against S. pneumoniae Previous vaccination against the following antigens: diphteria, tetanus, pertussis, H. influenzae type b, poliovirus, rotavirus, measles, mumps, rubella, and varicella Receipt of more than 1 previous dose of hepatitis B vaccine History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, measles, mumps, rubella, varicella, H. influenzae type b, and/or rotavirus infection or disease History of intussusception The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi Pasteur, a Sanofi Company
Official's Role
Study Director
Facility Information:
Facility Name
The Children's Clinic Of Jonesboro PA-Site Number:8400143
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Southland Clinical Research Center-Site Number:8400040
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
Join Clinical Trials Huntington Park-Site Number:8400030
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
Matrix Clinical Research Huntington Park-Site Number:8400058
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
Matrix Clinical Research-Site Number:8400059
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Orange County Research Institute-Site Number:8400060
City
Ontario
State/Province
California
ZIP/Postal Code
91762
Country
United States
Facility Name
California Research Foundation-Site Number:8400052
City
San Diego
State/Province
California
ZIP/Postal Code
92123-1881
Country
United States
Facility Name
Meridian Clinical Research Washington DC-Site Number:8400119
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
International Research Partners, LLC-Site Number:8400077
City
Doral
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
Homestead Medical Clinic, P.A.-Site Number:8400032
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030
Country
United States
Facility Name
Dade Research Center-Site Number:8400122
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Miami Clinical Research-Site Number:8400020
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Amber Clinical Research, LLC-Site Number:8400019
City
Miami
State/Province
Florida
ZIP/Postal Code
33164
Country
United States
Facility Name
Jedidiah Clinical Research-Site Number:8400049
City
Tampa
State/Province
Florida
ZIP/Postal Code
33617
Country
United States
Facility Name
Javara Albany-Site Number:8400140
City
Albany
State/Province
Georgia
ZIP/Postal Code
31707
Country
United States
Facility Name
Centricity Research Talbotton - DBA IACT Health Research at Talbotton-Site Number:8400062
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Javara Fayetteville-Site Number:8400139
City
Fayetteville
State/Province
Georgia
ZIP/Postal Code
30214
Country
United States
Facility Name
Dumog Research-Site Number:8400134
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
Facility Name
Bingham Memorial Hospital-Site Number:8400067
City
Blackfoot
State/Province
Idaho
ZIP/Postal Code
83221
Country
United States
Facility Name
Leavitt Clinical Research-Site Number:8400127
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Hutchinson Clinic-Site Number:8400074
City
Hutchinson
State/Province
Kansas
ZIP/Postal Code
67502
Country
United States
Facility Name
Qualmedica Research, LLC-Site Number:8400084
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
Michael W. Simon, MD, PSC-Site Number:8400002
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40517
Country
United States
Facility Name
Meridian Clinical Research, LLC-Site Number:8400112
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70806
Country
United States
Facility Name
Benchmark Research-Site Number:8400012
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
MedPharmics, LLC-Site Number:8400132
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70508
Country
United States
Facility Name
Javara Annapolis-Site Number:8400137
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Javara Chevy Chase-Site Number:8400138
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Children's Mercy Hospital-Site Number:8400008
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Boeson Research-Site Number:8400004
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Meridian Clinical Research-Site Number:8400102
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
Lincoln Pediatric Group-Site Number:8400125
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Pediatric Infectious Diseases Research-Site Number:8400104
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Atrium Health-Site Number:8400124
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Ardmore Medical Research-Site Number:8400043
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Pediatric Associates of Mt. Carmel-Site Number:8400005
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
Cheraw Pediatrics-Site Number:8400017
City
Cheraw
State/Province
South Carolina
ZIP/Postal Code
29520
Country
United States
Facility Name
Tribe Clinical Research-Site Number:8400025
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Javara Dallas-Site Number:8400135
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Pininos Pediatric Services-Site Number:8400121
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
North Texas Clinical Trials-Site Number:8400015
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Houston Clinical Research Associates-Site Number:8400023
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
FMC Science, LLC-Site Number:8400086
City
Lampasas
State/Province
Texas
ZIP/Postal Code
76550-1820
Country
United States
Facility Name
DCOL Center for Clinical Research-Site Number:8400107
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
Biopharma Informatic-Site Number:8400066
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Benchmark Research San Antonio-Site Number:8400129
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78201
Country
United States
Facility Name
Sun Research Institute-Site Number:8400011
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Tekton Research-Site Number:8400076
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78244
Country
United States
Facility Name
MultiCare Institute for Research & Innovation-Site Number:8400024
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Investigational Site Number :1240002
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z4H4
Country
Canada
Facility Name
Investigational Site Number :1240001
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K6R8
Country
Canada
Facility Name
Investigational Site Number :1240006
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8M 1K7
Country
Canada
Facility Name
Investigational Site Number :3400002
City
Municipio Del Distrito Central
ZIP/Postal Code
11101
Country
Honduras
Facility Name
Investigational Site Number :3400001
City
San Pedro Sula
ZIP/Postal Code
21104
Country
Honduras
Facility Name
Investigational Site Number :6300002
City
Bayamón
ZIP/Postal Code
00961
Country
Puerto Rico
Facility Name
Investigational Site Number :6300004
City
Guayama
ZIP/Postal Code
000784
Country
Puerto Rico
Facility Name
Investigational Site Number :6300001
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Learn more about this trial

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

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