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

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\])

Conditions

• 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

Interventions

BIOLOGICAL

Pneumococcal Conjugate Vaccine formulation 1

Pharmaceutical form:liquid Route of administration: intramuscular

BIOLOGICAL

Pneumococcal Conjugate Vaccine formulation 2

Pharmaceutical form:liquid Route of administration: intramuscular

BIOLOGICAL

Pneumococcal Conjugate Vaccine formulation 3

Pharmaceutical form:liquid Route of administration: intramuscular

BIOLOGICAL

Varicella Virus Vaccine Live

Pharmaceutical form:liquid Route of administration: subcutaneous

BIOLOGICAL

Measles, Mumps, and Rubella Virus Vaccine Live

Pharmaceutical form:liquid Route of administration: subcutaneous

BIOLOGICAL

Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]

Pharmaceutical form:liquid Route of administration: intramuscular

BIOLOGICAL

Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)

Pharmaceutical form:liquid Route of administration: intramuscular

BIOLOGICAL

Rotavirus Vaccine, Live, Oral, Pentavalent

Pharmaceutical form:liquid Route of administration: oral

BIOLOGICAL

Hepatitis B Vaccine* [Recombinant] *as applicable

Pharmaceutical form:liquid Route of administration: intramuscular

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company

  lead INDUSTRY

Principal Investigators

• Clinical Sciences & Operations · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

42 Days

Max Age

15 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-05-22

Primary Completion

2023-08-10

Completion

2023-08-10

FDA Drug

Yes

Countries

• United States
• Canada
• Honduras
• Puerto Rico

Study Locations