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A Trial Evaluating a 7-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants.

NCT01250756 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 321

Last updated 2013-02-26

Study results available
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Summary

Subjects will be randomly assigned to 1 of 2 groups to receive the following vaccines: Group 1: 7-valent pneumococcal conjugate vaccine (7vPnC) and diphtheria, tetanus, and accelular pertussis vaccine (DTaP), Group 2: DTaP alone. Group 2 subjects will also receive catch-up doses of 7vPnC. The study vaccines will be open-label. The main purpose of the study is to demonstrate that the immune responses as measured by serum antibody responses to diphtheria toxin, tetanus toxin, pertussis toxin (PT) and filamentous haemagglutinin (FHA) induced by DTaP given concomitantly with 7vPnC are comparable to the immune responses induced by DTaP given alone. In addition, the study aims to evaluate the side effects (safety profile) after vaccination of 7vPnC when given with DTaP in healthy Japanese infants.

Conditions

  • Healthy Subjects

Interventions

BIOLOGICAL

7-pneumococcal conjugate vaccine (7vPnC)

0.5 mL per dose, 4 doses

BIOLOGICAL

diphtheria, tetanus, and acellular pertussis vaccine (DTaP)

0.5 mL per dose, 4 doses

BIOLOGICAL

DTaP

0.5 mL per dose, 4 doses

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Japan

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 NCT01250756 on ClinicalTrials.gov