Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy Infants

Pfizer

Status and phase: Completed; Phase 2

Conditions: Pneumococcal Infections

Treatments: Biological: 13vPnC; Biological: Multivalent

Study type: Interventional

Funder types: Industry

Identifiers

NCT03512288

B7471003

Details and patient eligibility

About

A Phase 2, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Infants

Full description

NOTE: Detailed description has not been entered.

Enrollment: 460 patients

Sex: All

Ages: 42 to 98 days old

Volunteers: Accepts Healthy Volunteers

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 to be eligible for the study.

Exclusion criteria

• Previous vaccination with licensed or investigational pneumococcal vaccine.
• Prior receipt of diphtheria, tetanus, pertussis, or polio vaccines.
• Previous receipt of >1 dose of hepatitis B vaccine.
• Prior hepatitis B vaccine must have been administered at age <30 days.
• Major known congenital malformation or serious chronic disorder. Receipt of blood/plasma products or immunoglobulins

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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460 participants in 2 patient groups

Multivalent

Experimental group

Description:

Pneumococcal conjugate vaccines

Treatment:

Biological: Multivalent

Control

Active Comparator group

Description:

13vPnC

Treatment:

Biological: 13vPnC