Trials / Completed
CompletedNCT03692871
A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)
A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety and Tolerability of V114 in Healthy Infants (PNEU-LINK)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2,409 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 42 Days – 90 Days
- Healthy volunteers
- Accepted
Summary
This study is designed to evaluate the safety and tolerability of V114 and Prevnar 13™ in healthy infants. This study will include both full-term infants (≥37 weeks gestational age) and premature infants (\<37 weeks gestational age). Premature infants will be included in a Premature Infant Immunogenicity Substudy, which will assess immunogenicity and safety following administration of V114 or Prevnar 13™.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | V114 | V114 pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose |
| BIOLOGICAL | Prevnar 13™ | Prevnar 13™ pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each) and 6B (4.4 mcg) in each 0.5 ml dose |
Timeline
- Start date
- 2018-12-14
- Primary completion
- 2021-03-26
- Completion
- 2021-03-26
- First posted
- 2018-10-02
- Last updated
- 2023-07-28
- Results posted
- 2022-05-10
Locations
76 sites across 10 countries: United States, Australia, Canada, Finland, Germany, Israel, Malaysia, Peru, Taiwan, Thailand
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03692871. Inclusion in this directory is not an endorsement.