MedTrace Logo

Maternal Immunization To Prevent Infant Otitis Media

NCT00617682 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2008-02-18

No results posted yet for this study

Summary

The main objective of this study is to evaluate whether immunization with 9-valent pneumococcal conjugate vaccine (PNCRM9) during the third trimester of pregnancy interferes with active antibody production in offspring immunized with PNCRM7 (Prevnar) in the first six months of life.

Conditions

  • Otitis Media

Interventions

BIOLOGICAL

PNCRM9

0.5 mL IM at 30-35 wks gestation

BIOLOGICAL

Placebo comparator

Sucrose cake (NaCl and sucrose) in aluminum phosphate adjuvant diluent at 0.5 mg per 0.5 mL dose IM at 30-35 wks gestation

Sponsors & Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

    lead NIH

Principal Investigators

  • Patricia Ferrieri · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-10-31
Primary Completion
2004-12-31
Completion
2004-12-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00617682 on ClinicalTrials.gov