Maximos OB/Gyn | League City, TX
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
This study is a Phase III, randomized, single-blind, placebo-controlled, multi-center study to be conducted in healthy infants and toddlers aged 6 months + 2 weeks for Cohort 1 and 12 months ± 2 weeks for Cohort 2. The primary objective of the study will be to assess non-inferiority of the respiratory syncytial virus toddler and infant (RSVt) vaccine antibody response when administered concomitantly with routine pediatric vaccines at 6 months of age (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine [Vaxelis® or Pentacel® and Recombivax HB®] Prevnar 20®, and RotaTeq®), and 12 months of age (M-M-R II, VARIVAX, and Prevnar 20 or per local country recommendations) compared to when administered non-concomitantly.
Full description
The study duration is approximately 9 months for each participant.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply:
Primary purpose
Allocation
Interventional model
Masking
2,226 participants in 4 patient groups
Loading...
Central trial contact
Trial Transparency email recommended (Toll free for US & Canada)
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal