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A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to MCV4, Tdap and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 10 Through 12 Years of Age

NCT01461980 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2648

Last updated 2018-12-20

Study results available
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Summary

This is a clinical study to assess the safety, tolerance and immunogenic response to MCV4(quadrivalent meningococcal polysaccharide conjugate, meningococcal serogroups A,C,Y, and W135), Tdap (diphtheria, tetanus, and acellular pertussis), and bivalent rLP2086 vaccine. Healthy male and female subjects, between the ages of 10 to 12 years old, will be randomized into 1 of 3 groups. The subjects, investigators, site staff and sponsor will be blinded to all injections given throughout the study. An unblinded administrator will be responsible to administer the vaccinations to all subjects and will be unblinded to the subject randomization in order to determine which subjects were in randomized to group 3 so they may receive their catch-up vaccinations of MCV4 and Tdap. A final telephone contact will be conducted with all subjects 6-months post their last vaccination to obtain safety information.

Conditions

  • Vaccines
  • Meningococcal Vaccines

Interventions

BIOLOGICAL

rLP2086 + MCV4 + Tdap

At visit 1, group 1 will receive MCV4 + Tdap vaccines concomitantly with an injection of rLP2086. At visits 3 and 5 (Months 2 and 6), group 1 will receive an injection of rLP2086.

BIOLOGICAL

MCV4 + Tdap + saline

At visit 1, group 2 will receive MCV4 + Tdap vaccines concomitantly with an injection of saline. At visits 3 and 5 (months 2 and 6), this group will receive a saline injection only.

BIOLOGICAL

rLP2086 + saline

At visit 1, group 3 will receive 2 injections of saline concomitantly with an injection of rLP2086. At visits 3 and 5 (Months 2 and 6), group 3 will receive an injection of rLP2086. Subjects randomized to this group will receive MCV4 and Tdap following their final visit blood draw (Visit 6).

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE

Eligibility

Min Age
10 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-28
Primary Completion
2014-05-08
Completion
2014-05-08

Countries

  • United States

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 NCT01461980 on ClinicalTrials.gov