Trials / Completed
CompletedNCT01939158
Immunogenicity and Safety Study of 1 and 2 Doses of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine MenACWY-TT (GSK134612) in Toddlers, Persistence up to 5 Years After Vaccination and Co-administration With Pfizer's Prevenar 13™Vaccine
A PHASE III, RANDOMISED, OPEN, CONTROLLED, MULTICENTRE, PRIMARY VACCINATION STUDY TO EVALUATE THE IMMUNOGENICITY AND PERSISTENCE OF 1 AND 2 DOSES OF MENINGOCOCCAL CONJUGATE VACCINE MENACWY-TT IN TODDLERS (AFTER 1 MONTH AND UP TO 5 YEARS) AND TO DEMONSTRATE NON-INFERIORITY OF CO-ADMINISTRATION OF MENACWY-TT AND 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE PREVENAR 13(REGISTERED) VERSUS SEPARATE ADMINISTRATION OF THE 2 VACCINES
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 803 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 12 Months – 14 Months
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to compare the immediate and long term (up to 5 years) immunogenicity and safety of GSK Biologicals' MenACWY-TT vaccine when given as a single dose or as 2 doses to toddlers aged 12 to 14 months. Also, this study will also assess if co-administration of GSK Biologicals' MenACWY-TT with the booster dose of Pfizer's Prevenar 13 adversely impacts the immunogenicity of either of the vaccines.
Detailed description
The Medicines Control Council (MCC) authorities requested that subjects be screened for HIV testing prior to study enrolment in South Africa to ensure that only HIV negative participants are enrolled. As such, HIV rapid test was added at Visit 1 only for subjects in South Africa. Subjects previously screened HIV positive will be excluded.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Meningococcal vaccine GSK134612 | 1 or 2 doses administered intramuscularly in the left anterolateral thigh or deltoid region |
| BIOLOGICAL | Prevenar 13™ | 1 dose administered intramuscularly in the right anterolateral thigh or deltoid region |
Timeline
- Start date
- 2013-10-02
- Primary completion
- 2019-12-05
- Completion
- 2019-12-05
- First posted
- 2013-09-11
- Last updated
- 2021-10-05
- Results posted
- 2021-10-05
Locations
51 sites across 6 countries: Australia, Canada, Czechia, Panama, South Africa, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01939158. Inclusion in this directory is not an endorsement.