Trials / Completed
CompletedNCT03548337
Study To Describe The Safety, Tolerability, And Immunogenicity Of 13- Valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials When Given With Routine Pediatric Vaccines In Healthy Infants In India
A PHASE 4, RANDOMIZED, OPEN-LABEL TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF 13- VALENT PNEUMOCOCCAL CONJUGATE VACCINE FORMULATED IN MULTIDOSE VIALS WHEN GIVEN WITH ROUTINE PEDIATRIC VACCINES IN HEALTHY INFANTS IN INDIA
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 301 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 42 Days – 72 Days
- Healthy volunteers
- Accepted
Summary
A Phase 4 Study To Describe The Safety, Tolerability, And Immunogenicity Of 13- Valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials When Given With Routine Pediatric Vaccines In Healthy Infants In India
Detailed description
A Phase 4, Randomized, Open-label Trial To Describe The Safety, Tolerability, And Immunogenicity Of 13- Valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials When Given With Routine Pediatric Vaccines In Healthy Infants In India
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | 13vPnC | 13vPnC MultiDose Vial with preservative compared to a Prefilled syringe containing 13vPnC without any preservative |
Timeline
- Start date
- 2018-05-31
- Primary completion
- 2019-12-20
- Completion
- 2019-12-20
- First posted
- 2018-06-07
- Last updated
- 2020-09-30
- Results posted
- 2020-09-30
Locations
7 sites across 1 country: India
Source: ClinicalTrials.gov record NCT03548337. Inclusion in this directory is not an endorsement.