---
title: A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY
nct_id: NCT01018732
overall_status: COMPLETED
phase: PHASE2
sponsor: Novartis Vaccines
study_type: INTERVENTIONAL
primary_condition: Meningococcal Disease
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01018732.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01018732"
ct_last_update_post_date: 2015-07-15
last_seen_at: "2026-05-12T06:37:21.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY

**Official Title:** A Phase 2b, Open-Label, Multi-Center Study to Evaluate the Persistence of Antibody Response and to Assess the Immune Response to a Booster Dose of MenACWY Conjugate Vaccine in Subjects Previously Vaccinated as Adolescents With Either MenACWY Conjugate Vaccine or Menomune®.

**NCT ID:** [NCT01018732](https://clinicaltrials.gov/study/NCT01018732)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 155
- **Lead Sponsor:** Novartis Vaccines
- **Collaborators:** Novartis
- **Conditions:** Meningococcal Disease, Meningococcal Meningitis
- **Start Date:** 2010-01
- **Completion Date:** 2010-07
- **CT.gov Last Update:** 2015-07-15

## Brief Summary

The primary objective is to evaluate the persistence of bactericidal antibodies in adolescent subjects who completed study V59P6 in which they received either Novartis Meningococcal (MenACWY) Conjugate Vaccine or Licensed polysaccharide Men ACWY vaccine (Menomune®). The study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group.

## Detailed Description

Persistence of antibody response at 5 years after one dose of MenACWY or Menomune

## Eligibility

- **Minimum age:** 16 Years
- **Maximum age:** 23 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Healthy adolescents or adults (age 16-23 years inclusive), either previously enrolled in the parent study or naïve to meningococcal vaccination.
* Female subjects were to be negative for pregnancy

Exclusion Criteria:

* History of meningococcal disease
* Receipt of any meningococcal vaccine outside of parent study (V59P6)
* Serious, acute, or chronic illnesses including HIV infection/disease and any malignancy
* receipt of any vaccine 14 days prior to the study, or expected through the duration of the study
* any condition which in the eyes of the investigator would pose a health risk to the subject or render them inappropriate for a research study
```

## Arms

- **I: MenACWY-CRM vaccine** (EXPERIMENTAL) — Subjects had been given one dose of Meningococcal ACWY (MenACWY) vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago. All subjects were given one dose of the Men ACWY in the present study.
- **II: Licensed Polysaccharide Meningococcal vaccine** (EXPERIMENTAL) — Subjects had been given one dose of a licensed MenACWY polysaccharide meningococcal vaccine (Menomune) 5 years ago. All subjects were given one dose of Men ACWY vaccine in the present study.
- **III: Meningococcal Naive** (EXPERIMENTAL) — Subjects were age matched with groups 1 and 2 (age inclusive: 16 years to 23 years) and enrolled at visit 1 and given one dose of Men ACWY vaccine during the present study.

## Interventions

- **Novartis Meningococcal (MenACWY-CRM) vaccine** (BIOLOGICAL) — All subjects will have blood draws at Day 1, Day 8, and Day 29.

## Primary Outcomes

- **Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination** _(time frame: Day 1 (5 years after primary vaccination))_ — Persistence of antibody response was measured by the percentage of subjects who showed a serum bactericidal activity with human complement(hSBA) \>= 8 \[i.e. percentage of subjects with hsBA titer \>=8\] in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y
- **Geometric Mean Titer After Booster Vaccination** _(time frame: Day 8, Day 29 (5 years after primary vaccination))_ — Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) and reported as hSBA Geometric mean titer (GMT) in previously vaccinated subjects and in age-matched meningococcal vaccine-naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y

## Secondary Outcomes

- **Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination** _(time frame: Day 1 (5 years after primary vaccination ))_
- **Geometric Mean Titer at 5 Years After Primary Vaccination** _(time frame: Day 1 (5 years after primary vaccination ))_
- **Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination** _(time frame: Day 7, Day 28 post booster (5 years after primary vaccination))_
- **Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination** _(time frame: Day 7, Day 28 post booster (5 years after primary vaccination))_
- **Geometric Mean Ratio After Booster Vaccination** _(time frame: Day 8 and Day 29 (at 5 Years After Primary Vaccination))_
- **Percentage of Subjects With hSBA Seroresponse After Booster Vaccination** _(time frame: Day 8, Day 29 (5 years after primary vaccination))_
- **Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination** _(time frame: Up to Day 7)_

## Locations (3)

- Rochester, Minnesota, United States
- Pittsburgh, Pennsylvania, United States
- Seattle, Washington, United States

## Recent Field Changes (last 30 days)

- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.|rochester|minnesota|united states` — added _(2026-05-12)_
- `locations.|pittsburgh|pennsylvania|united states` — added _(2026-05-12)_
- `locations.|seattle|washington|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01018732.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01018732*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*