Trials / Terminated
TerminatedNCT04645966
A Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of MenABCWY in Healthy Infants
A PHASE 2b TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY IN HEALTHY INFANTS 2 AND 6 MONTHS OF AGE
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 326 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 2 Months – 6 Months
- Healthy volunteers
- Accepted
Summary
The aim of the study is to describe the safety, tolerability, and immunogenicity of MenABCWY in healthy infants 2 and 6 months of age.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MenABCWY | Neisseria meningitis groups A, B, C W, and Y vaccine |
| BIOLOGICAL | Bivalent rLP2086 (60-µg Dose) | Trumenba (half dose) - Meningococcal Group B vaccine |
| BIOLOGICAL | Bivalent rLP2086 (120-µg Dose) | Trumenba - Meningococcal Group B vaccine |
| BIOLOGICAL | Bexsero | Bexsero - Meningococcal Group B vaccine |
| DRUG | Prophylactic Liquid Paracetamol (PLP) | PLP administration during primary vaccinations 1 and 2 |
| BIOLOGICAL | Nimenrix | Nimenrix - Meningococcal Group A, C, W and Y vaccine |
| OTHER | Placebo | Normal Saline |
| DRUG | Scheduled Liquid Paracetamol (SLP) | SLP administration after primary vaccinations 1 and 2. |
| DRUG | Therapeutic Liquid Paracetamol (TLP) | TLP administration after primary vaccinations 1 and 2 |
Timeline
- Start date
- 2020-11-26
- Primary completion
- 2022-09-15
- Completion
- 2022-09-15
- First posted
- 2020-11-27
- Last updated
- 2024-03-25
- Results posted
- 2024-03-25
Locations
21 sites across 3 countries: Germany, Greece, Spain
Source: ClinicalTrials.gov record NCT04645966. Inclusion in this directory is not an endorsement.