Study to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine Given With Prevnar 13 in Healthy Infants

Phase 1

• Conditions: Pneumococcal Infections; MedDRA version: 21.1Level: PTClassification code 10069578Term: Pneumococcal immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2020-005039-59-Outside-EU/EEA
• Lead Sponsor: Pfizer, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-12
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Male or female infant born at >36 weeks of gestation and aged 2 months (42 to 98 days) at the time of consent (the day of birth is considered day of life 1).
-Healthy infant determined by medical history, physical examination, and clinical judgment.
Are the trial subjects under 18? yes
Number of subjects for this age range: 565
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

-Previous vaccination with licensed or investigational pneumococcal vaccine.
-Prior receipt of routine pediatric vaccines, with the exception of hepatitis B vaccine.
-Previous receipt of >1 dose of hepatitis B vaccine.
-Prior receipt of hepatitis B vaccine at age = 30 days.
-Major known congenital malformation or serious chronic disorder.
-Receipt of blood/plasma products or immunoglobulins

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified