13vPnC Multidose Vial Safety, Tolerability and Immunogenicity Study in Healthy Infants.

Pfizer

Status and phase: Completed; Phase 3

Conditions: Pneumococcal Vaccines

Treatments: Biological: 13-valent pneumococcal conjugate vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01964716

2012-000482-21 (EudraCT Number)

B4671001

Details and patient eligibility

About

This study will compare the immune responses of the infants who have been given 13vPnC in the mutidose vial formulation to the immune reponses of the infants who have been given 13vPnC in the single-dose syringe formulation.

It will also evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in all infants who are vaccinated.

Enrollment: 500 patients

Sex: All

Ages: 42 to 70 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged 42 to 70 days at enrollment.
• Determined by medical history, physical examination, and clinical judgment to be eligible for the study
• Weight of 3.5 kg or greater at the time of enrollment

Exclusion criteria

• Previous vaccination with licensed or investigational pneumococcal vaccine.
• A previous anaphylactic reaction to any vaccine or vaccine-related component.
• Contraindication to vaccination with pneumococcal conjugate vaccine.
• Receipt of blood products or gamma-globulin since birth

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Multidose Vial Group

Experimental group

Description:

Subjects will receive three doses of 13-valent pneumococcal conjugate vaccine in the multidose vial formulation. Each dose is 0.5 mL

Treatment:

Biological: 13-valent pneumococcal conjugate vaccine

Biological: 13-valent pneumococcal conjugate vaccine

Single-Dose Syringe Group

Active Comparator group

Description:

Subjects will receive three doses of 13-valent pneumococcal conjugate vaccine in the single-dose syringe formulation. Each dose is 0.5 mL

Treatment:

Biological: 13-valent pneumococcal conjugate vaccine

Biological: 13-valent pneumococcal conjugate vaccine