Merck Announces Positive Topline Results from PNEU-DIRECTION (V114-027) and PNEU-PLAN (V114-024)

Phase 3 Pediatric Studies for V114, Merck’s Investigational

Merck, known as MSD outside the United States and Canada, today announced V114, the company’s investigational 15-valent pneumococcal conjugate vaccine, met its primary immunogenicity and safety endpoints in two trials of the V114 Phase 3 pediatric clinical program. These data support the potential use of V114 in healthy infants who may have previously started a pneumococcal vaccination series with the currently available 13-valent pneumococcal conjugate vaccine (PCV13) (PNEU-DIRECTION), and in a catch-up setting for healthy children who were either pneumococcal vaccine-naïve or who previously received a full or partial regimen with lower valency pediatric pneumococcal conjugate vaccines (PCV) (PNEU-PLAN).

In the PNEU-DIRECTION (V114-027) interchangeability study in healthy infants 42-90 days of age, immune responses in those who received a four-dose series of PCV13, and those who received a mixed dose schedule of PCV13 followed by V114, were generally comparable for the 13 serotypes, or strains of pneumococcal disease, targeted by both vaccines. In the PNEU-PLAN (V114-024) catch-up study, immune responses were generally comparable to PCV13 for the 13 shared serotypes when V114 was used as a catch-up regimen in healthy children 7 months to 17 years of age who were either pneumococcal vaccine-naïve or who previously received a partial or full regimen of a licensed pediatric PCV. For serotypes 22F and 33F, two serotypes included in V114 but not PCV13, immunogenicity in PNEU-PLAN was higher in the V114 group than in the PCV13 group. In each study, V114 was generally well-tolerated, with a safety profile comparable to PCV13.

“Pneumococcal disease continues to cause serious illness and death worldwide in children under the age of 5, despite the positive impact of pneumococcal conjugate vaccination on pediatric case numbers,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “At Merck, our goal is to expand coverage to new serotypes not targeted by currently available pediatric pneumococcal conjugate vaccines, while maintaining a strong immune response to current vaccine serotypes so as to help sustain the progress achieved to date. Results from these studies support the potential of V114 to confer immunogenicity for PCV13 serotypes in infants who have previously received one or multiple doses of PCV13, and for the 15 serotypes in V114 in children in a catch-up setting.”

There are 100 different types of pneumococcal bacteria, which can affect children differently than adults. Children under the age of 2 are particularly vulnerable to pneumococcal infection and invasive pneumococcal disease incidence remains highest in the first year of life. Certain pneumococcal serotypes continue to put children at risk, including serotypes 22F and 33F which represent 16 percent of all cases of invasive pneumococcal disease in children under the age of 5.

Full results from PNEU-DIRECTION and PNEU-PLAN will be presented at a future scientific congress. The V114 Phase 3 clinical development program is comprised of 16 trials investigating the safety, tolerability and immunogenicity of V114 in a variety of populations who are at increased risk for pneumococcal disease including healthy older adults and children, as well as people who are immunocompromised or have certain chronic medical conditions. An overview of the late-stage development program is available here. Plans are on track for submission of a supplemental regulatory licensure application to the U.S. Food and Drug Administration (FDA) for use in children before the end of the year, pending action on the adult Biologics Licensure Application currently under FDA review. Merck is involved in litigation challenging the validity of several Pfizer Inc. patents that relate to pneumococcal vaccine technology in the United States and several foreign jurisdictions.

Tags : #Merck #Pneudirection #Pnueplan #pneumococcalbacteria #US #Canada

About the Author

Team Medicircle

Related Stories

Loading Please wait...

Trending Now

PM addresses the Nation today, announces free vaccinesJune 07, 2021
Why inhalers are best for treating asthma, well illustrated by Dr. Anil SingalMay 12, 2021
Dr. Rohan Palshetkar shares his invaluable insights about the Maternal Mortality Rate causes and improvements in India April 29, 2021
It is important to adopt a non-judgmental attitude towards any teenage girl seeking contraceptive advise suggests Dr. Teena Trivedi, Obstetrician and GynecologistApril 16, 2021
80% of the diseases are psychosomatic which means they have roots in the mind and this is where homeopathy steps in - It resolves physical ailments by finding the cause in the mind – Dr. Sanket Dhuri, Consultant Homeopath April 14, 2021
A futuristic Vision of a Healthcare Entrepreneur: Shyatto Raha, CEO, and Founder of MyHealthcareApril 12, 2021
Saher Mehdi, Founder and Chief Scientist at wellOwise talks about aspects making healthcare more equitable and reachableApril 10, 2021
Wide variety of therapies to address autism in children explained by Dr. Shilpa Jasubhai, Clinical PsychologistApril 09, 2021
Allopathic and Homeopathic medicines should not be taken together says Dr. Sunil Mehra, Homeopath ConsultantApril 08, 2021
The charm of homeopathic medicine is that it can be taken with conventional medicines – Dr. Shruthi Shridhar, Consulting Homeopath April 08, 2021
Dissociative Identity Disorder and associated concepts explained by Dr. Vinod Kumar, Psychiatrist and Head of Mpower - The Centre (Bangalore) April 07, 2021
Dissociative Identity Disorder explained by Dr. Shilpa Jasubhai, Clinical PsychologistApril 05, 2021
Sehat Ki Baat, Karishma Ke Saath- Episode 6 Healthy Diet For Boosting Metabolism Which Can Help Thyroid Patients April 03, 2021
Significant Pointers on Kidney Health by Dr. Santosh Waigankar, Consultant Urooncologist and Robotic Surgeon at Kokilaben Dhirubhai Ambani HospitalApril 01, 2021
Dr. Vaishal Kenia, Ophthalmologist Talks About the Different Possibilities Available for the Treatment of Glaucoma Depending Upon Their Type and SeverityMarch 30, 2021
No Definitive Role of Diet in Treatment of Lymphedema but Intake of Calories, Salt and Long Chain Fatty Acids should be controlled says Dr. Ramani CVMarch 30, 2021
Dr. Kiran Chandra Patro, Senior Nephrologist Talks About Dialysis as the Temporary Process and Not a Permanent Cure for the Patients of Renal DysfunctionMarch 30, 2021
Two out of three new chronic kidney disease patients are found to have diabetes or hypertension informs Dr. Sreeharsha HarinathaMarch 30, 2021
Glaucoma Treatment: Medications or Surgery? A valuable piece of advice from Dr. Pranay Kapdia, Chairman and Medical Director of Kapadia Eye CareMarch 25, 2021
Dr. Shraddha Satav, Consultant Ophthalmologist Recommends that Everybody After 40, Should Go for the Complete Eye Checkup at Regular IntervalMarch 25, 2021