CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 900 enrolled
Drug / intervention
Prevnar 13™ +7 morebiological
Likely dose
Prevnar 13™ 2.2 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03620162
NCT03620162Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Interchangeability of V114 and Prevnar 13™ With Respect to Safety, Tolerability, and Immunogenicity in Healthy Infants (PNEU-DIRECTION)

Merck Sharp & Dohme LLC·interventional·Posted Aug 8, 2018·Updated Jan 17, 2023

In Brief

A Phase 3 clinical trial evaluating Prevnar 13™, V114, and 6 other interventions for Pneumococcal Infections. Completed, enrolled 900 participants across 34 sites in 4 countries.

Detailed Summary

The goal of this study is to evaluate the safety, tolerability, and immunogenicity of the Pneumococcal Conjugate Vaccines (PCVs) V114 and Prevnar 13™ in healthy infants switched from Prevnar 13™ to V114 during the four-dose PCV immunization schedule.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPneumococcal Infections
CountriesPuerto Rico, Thailand, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedAug 8, 2018
Enrollment StartOct 18, 2018
Primary CompletionDec 14, 2020
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 7.9 years ago

Interventions

Prevnar 13™biological

Prevnar 13™ contains the 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 given via IM injection.

V114biological

V114 contains the pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose given via IM injection.

RotaTeq™biological

RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.

Pentacel™biological

Pentacel™ Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine, given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.

RECOMBIVAX HB™biological

RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.

HIBERIX™biological

HIBERIX™ Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.

M-M-R™ IIbiological

M-M-R™ II (Measles, Mumps, and Rubella Virus Vaccine Live), given as background treatment via subcutaneous (SC) injection in the opposite limb to V114 and Prevnar 13™ administration.

VARIVAX™biological

VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.