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

NCT01964716 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2015-03-13

Study results available
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Summary

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.

Conditions

  • Pneumococcal Vaccines

Interventions

BIOLOGICAL

13-valent pneumococcal conjugate vaccine

Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (multidose vial formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.

BIOLOGICAL

13-valent pneumococcal conjugate vaccine

Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (single-dose syringe formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
42 Days
Max Age
70 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • The Gambia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01964716 on ClinicalTrials.gov