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Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants.

NCT01193335 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2017-05-11

Study results available
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Summary

The purpose of this study is to describe the safety, tolerability, and immunogenicity of a 2,3,4 and 12 month schedule of the 13-valent pneumococcal conjugate vaccine when given to preterm infants with concomitant vaccines, compared to infants born at term.There will be a follow-up phase to assess the persistence of the antibody response at 24 and 36 months of age.

Conditions

  • 13-valent Pneumococcal Vaccine
  • Premature Birth
  • Immunization
  • Safety

Interventions

BIOLOGICAL

13-valent pneumococcal conjugate vaccine

13-valent pneumococcal conjugate vaccine will be administered at 2, 3, 4 and 12 months of age.

BIOLOGICAL

13-valent pneumococcal conjugate vaccine

13-valent pneumococcal conjugate vaccine will be administered at 2, 3, 4 and 12 months of age.

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
98 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • Poland
  • Spain

Study Locations

More Related Trials

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 NCT01193335 on ClinicalTrials.gov