Trials / Terminated
TerminatedNCT03550313
Study to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine Given With Prevnar 13 in Healthy Infants
A PHASE 2, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN WITH, OR SEPARATELY FROM, 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 565 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 42 Days – 98 Days
- Healthy volunteers
- Accepted
Summary
This is a Phase 2, randomized, active-controlled, open-label study with a 3-arm parallel design. Healthy 2-month old infants (42 to 98 days of age) with no history of pneumococcal vaccination will be randomized in a 1:1:1 ratio to receive a 4-dose series of: multivalent pneumococcal conjugate vaccine coadministered with Prevnar 13 (Group 1); multivalent pneumococcal conjugate vaccine given 1 month after Prevnar 13 (Group 2); or Prevnar 13 with a single dose of multivalent pneumococcal conjugate vaccine (Group 3).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Multivalent | Pneumococcal conjugate vaccine |
| BIOLOGICAL | Prevnar 13 | Pneumococcal conjugate vaccine |
Timeline
- Start date
- 2018-06-01
- Primary completion
- 2020-11-05
- Completion
- 2020-11-05
- First posted
- 2018-06-08
- Last updated
- 2021-11-30
- Results posted
- 2021-11-30
Locations
48 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03550313. Inclusion in this directory is not an endorsement.