NCT04398706

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 852 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 42 Days – 15 Months
• Healthy volunteers: Accepted

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.

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

Type	Name	Description
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

Timeline

• Start date: 2020-05-22
• Primary completion: 2023-08-10
• Completion: 2023-08-10
• First posted: 2020-05-21
• Last updated: 2025-09-08
• Results posted: 2024-11-12

Locations

57 sites across 4 countries: United States, Canada, Honduras, Puerto Rico

Regulatory

• FDA-regulated drug study