Persistence of Antibodies in Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or Menomune®

Recruiting in Palo Alto (17 mi)

+10 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Sanofi Pasteur, a Sanofi Company

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged 7 to 15 years (not yet 16 years) who had been vaccinated five years previously in Study 603-02. In addition, the kinetics of the antibody response will be evaluated in a subset of participants who will receive a booster dose of Menactra® vaccine and children in the same age group not previously vaccinated with a meningococcal vaccine or had meningitis disease who will receive a dose of Menactra® vaccine.

Eligibility Criteria

Inclusion Criteria

Subject is healthy, as determined by medical history.

Subject is between the ages of 7 and 15 years (not yet 16 years).

For subjects who participated in Study 603-02, subject previously received one dose of Menactra® vaccine or Menomune®-A/C/Y/W-135 vaccine.

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Treatment Details

Interventions

Polysaccharide Diphtheria Conjugate Vaccine (Polysaccharide Conjugate Vaccine)

Participant Groups

4Treatment groups

Experimental Treatment

Group I: Meningococcal Vaccine-naïve Group 4Experimental Treatment1 Intervention

Participants who have never received a Meningococcal vaccine in the past. They will provide serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination.

Group II: Meningococcal Vaccine-naïve Group 3Experimental Treatment1 Intervention

Participants who have never received a Meningococcal vaccine in the past. They will provide serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.

Group III: Menactra® Group 2Experimental Treatment1 Intervention

Participants who had received Menactra® in Study 603-02. They will provide serum sample before vaccination and on Day 5 and Day 14 after booster vaccination.

Group IV: Menactra® Group 1Experimental Treatment1 Intervention

Participants who had received Menactra® in Study 603-02. They will provide serum sample before vaccination and on Day 3 and Day 7 after booster vaccination.