A Study of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Infants and Toddlers
Public ClinicalTrials.gov record NCT01049035. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine Administered in Infants and Toddlers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study was to evaluate the optimal vaccination schedule for a Quadrivalent Meningococcal Polysaccharide (A, C, Y and W-135) Tetanus Protein Conjugate Vaccine (MenACYW Conjugate vaccine) in order to provide an effective protein conjugate quadrivalent meningococcal vaccine in the population with the highest incidence of disease. Objectives: * To describe the safety profile of MenACYW Conjugate vaccine administered at 5 different schedules and concomitantly with routine pediatric vaccinations. * To describe the immunogenicity profile of MenACYW Conjugate vaccine administered at 5 different schedules and concomitantly with routine pediatric vaccinations. * To describe the immunogenicity profiles of selected licensed pediatric vaccines (Pentacel, Prevnar, M-M-RII, and Varivax) when administered either concomitantly with or without MenACYW Conjugate vaccine.
Study identification
- NCT ID
- NCT01049035
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 580 participants
Conditions and interventions
Conditions
Interventions
- Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate Biological
- Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined) Biological
- M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live Biological
- Varicella Virus Vaccine Live Biological
- Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) Biological
- Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) Biological
- Rotavirus Vaccine Biological
- Hepatitis B Vaccine Biological
Biological
Eligibility (public fields only)
- Age range
- 42 Days to 365 Days
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 16, 2009 (Actual)
- Primary completion
- Feb 13, 2012 (Actual)
- Completion
- Feb 13, 2012 (Actual)
- Last update posted
- Mar 28, 2022
2009 – 2012
United States locations
- U.S. sites
- 25
- U.S. states
- 15
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | 35205 | — |
| Not listed | Tuscaloosa | Alabama | 35406 | — |
| Not listed | Jonesboro | Arkansas | 72401 | — |
| Not listed | Little Rock | Arkansas | 72205 | — |
| Not listed | Fountain Valley | California | 92708 | — |
| Not listed | Huntington Beach | California | 92647 | — |
| Not listed | Marietta | Georgia | 30062 | — |
| Not listed | Woodstock | Georgia | 30189 | — |
| Not listed | Bardstown | Kentucky | 40004 | — |
| Not listed | Crestview Hills | Kentucky | 41017 | — |
| Not listed | Louisville | Kentucky | 40207 | — |
| Not listed | Louisville | Kentucky | 40291 | — |
| Not listed | Bossier City | Louisiana | 71111 | — |
| Not listed | Clyde | North Carolina | 28721 | — |
| Not listed | Cleveland | Ohio | 44121 | — |
| Not listed | Pittsburgh | Pennsylvania | 15241 | — |
| Not listed | Barnwell | South Carolina | 29812 | — |
| Not listed | Clarksville | Tennessee | 37043 | — |
| Not listed | Fort Worth | Texas | 76107 | — |
| Not listed | Layton | Utah | 84041 | — |
| Not listed | Orem | Utah | 84057 | — |
| Not listed | Springville | Utah | 84663 | — |
| Not listed | Midlothian | Virginia | 23113 | — |
| Not listed | Spokane | Washington | 99202 | — |
| Not listed | Spokane | Washington | 99218 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01049035, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 28, 2022 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01049035 live on ClinicalTrials.gov.