Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025)

NCT ID: NCT04031846

Last Updated: 2023-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-04
• Study Completion Date: 2021-08-05

Brief Summary

This study will evaluate the safety and tolerability and immunogenicity of V114 when administered to 2-month old infants. The primary hypotheses are: 1) V114 is non-inferior to Prevenar 13™ for the 13 shared serotypes between V114 and Prevenar 13™ based on response rates at 30 days post toddler dose (PTD); 2) V114 is superior to Prevenar 13™ for the 2 serotypes unique to V114 based on the response rates at 30 days PTD; 3) V114 is non-inferior to Prevenar 13™ for the 13 shared serotypes between V114 and Prevenar 13™ based on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobin G (IgG) geometric mean concentrations (GMCs) at 30 days PTD; and 4) V114 is superior to Prevenar 13™ for the 2 serotypes unique to V114 based on anti-PnPs serotype-specific IgG GMCs at 30 days PTD.

Conditions

Pneumococcal Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

V114

Full-term infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received intramuscular injection of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age and 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age.

Group Type: EXPERIMENTAL

Rotarix™

Intervention Type: DRUG

Single 1.5 mL oral dose at 2 and 4 months of age (Study Day 1 and Month 2)

Infanrix™ hexa

Intervention Type: DRUG

Single 0.5 mL intramuscular injection at 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13)

V114

Intervention Type: DRUG

15-valent pneumococcal conjugate vaccine (PCV) containing 13 serotypes present in Prevenar 13™ (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL intramuscular administration,

Prevenar 13™

Full-term infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received intramuscular injection of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age and 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age.

Group Type: ACTIVE_COMPARATOR

Rotarix™

Intervention Type: DRUG

Single 1.5 mL oral dose at 2 and 4 months of age (Study Day 1 and Month 2)

Infanrix™ hexa

Intervention Type: DRUG

Single 0.5 mL intramuscular injection at 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13)

Prevenar 13™

Intervention Type: DRUG

13-valent PCV containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL intramuscular administration.

Interventions

Rotarix™

Single 1.5 mL oral dose at 2 and 4 months of age (Study Day 1 and Month 2)

Intervention Type: DRUG

Infanrix™ hexa

Single 0.5 mL intramuscular injection at 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13)

Intervention Type: DRUG

V114

15-valent pneumococcal conjugate vaccine (PCV) containing 13 serotypes present in Prevenar 13™ (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL intramuscular administration,

Intervention Type: DRUG

Prevenar 13™

13-valent PCV containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL intramuscular administration.

Intervention Type: DRUG

Other Intervention Names

VAXNEUVANCE™; Pneumococcal 15-Valent Conjugate Vaccine

Eligibility Criteria

Inclusion Criteria

• Healthy
• Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent

Exclusion Criteria

• History of invasive pneumococcal disease [(IPD); positive blood culture, positive cerebrospinal fluid culture, or other sterile site] or known history of other culture positive pneumococcal disease
• Has a known or suspected impairment of immunological function
• Has a history of congenital or acquired immunodeficiency
• Has, or his/her mother has, a documented human immunodeficiency virus (HIV) infection
• Has, or his/her mother has, a documented hepatitis B surface antigen - positive test
• Has known or history of functional or anatomic asplenia
• Has failure to thrive based on the clinical judgement of the Investigator
• Has a bleeding disorder contraindicating intramuscular vaccination
• Has a history of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, Type 1 diabetes mellitus, or other autoimmune disorders)
• Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders
• Has received a dose of any pneumococcal vaccine prior to study entry
• Has received >1 dose of monovalent hepatitis B vaccine or hepatitis B-based combination vaccine prior to study entry
• Has received a dose of any acellular pertussis- or whole cell pertussis-based combination vaccines, Haemophilus influenzae type b conjugate vaccine, poliovirus vaccine, rotavirus vaccine, or any other combination thereof, prior to study entry
• Has received a blood transfusion or blood products, including immunoglobulins
• Has participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study. Participants enrolled in observational studies may be included; these will be reviewed on a case-by-case basis for approval by the Sponsor
• Is or has an immediate family member (eg, parent/legal guardian or sibling) who is investigational site or Sponsor staff directly involved with this study

• Minimum Eligible Age: 42 Days
• Maximum Eligible Age: 90 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Queensland Children s Hospital ( Site 0004)

South Brisbane, Queensland, Australia

Vaccine and Immunisation Research Group - VIRGo ( Site 0002)

Melbourne, Victoria, Australia

Telethon Kids Institute ( Site 0003)

Nedlands, , Australia

O.L.V. Ziekenhuis Aalst ( Site 0144)

Aalst, , Belgium

AZ Sint Jan Brugge-Oostende ( Site 0147)

Bruges, , Belgium

AZ Maria Middelares Gent ( Site 0142)

Ghent, , Belgium

UZ Gent ( Site 0141)

Ghent, , Belgium

AZ Henry Serruys ( Site 0148)

Ostend, , Belgium

AZ Delta ( Site 0143)

Roeselare, , Belgium

MUDr. Daniel Drazan - Prakticky lekar pro deti a dorost ( Site 0151)

Jindřichův Hradec, , Czechia

MU Dr. Jan Nemecek - Prakticky lekar pro deti a dorost ( Site 0152)

Mělník, , Czechia

MUDr. Josef Zemanek ( Site 0153)

Týnec nad Sázavou, , Czechia

Vee Perearstikeskus ( Site 0163)

Paide, Järvamaa, Estonia

Merekivi Perearstid ( Site 0165)

Tallinn, , Estonia

Merelahe Perearstikeskus OU ( Site 0164)

Tallinn, , Estonia

Sinu Arst Tervisekeskus ( Site 0167)

Tallinn, , Estonia

Rosenthali Perearstikeskus OU ( Site 0166)

Tallinn, , Estonia

Kliiniliste Uuringute Keskus OU ( Site 0161)

Tartu, , Estonia

NETSTAP - Sandner ( Site 0072)

Aschaffenburg, , Germany

Kinderarztpraxis ( Site 0061)

Bramsche, , Germany

Praxis Dr. Schmute ( Site 0078)

Datteln, , Germany

Praxis fur Kinder und Jugendmedizin Eivy Franke Beckmann ( Site 0064)

Erfurt, , Germany

Kinderarztpraxis Dr. Friedrich Kaiser & Dr. Marinesse ( Site 0065)

Hamburg, , Germany

Kinderarztpraxis Dr. Juenger ( Site 0073)

Herxheim, , Germany

Kinderpraxis Dr. med. Andreas Petri ( Site 0066)

Hürth, , Germany

Kinderarztpraxis ( Site 0068)

Mönchengladbach, , Germany

Kinder- und Jugendaerztliche Gemeinschaftspraxis ( Site 0077)

Oberhausen, , Germany

Praxiszentrum Triftplatz ( Site 0075)

Schönau, , Germany

Praxis Dr. Siegfried Simmet ( Site 0069)

Schweigen, , Germany

Kinderarztpraxis Dr. Rolf Ebert & Dr. Matthias Huebener ( Site 0062)

Tauberbischofsheim, , Germany

Kinderaerztliche Gemeinschaftspraxis Drs. Westerholt/Matyas ( Site 0074)

Wolfsburg, , Germany

Kinderarztpraxis ( Site 0063)

Würselen, , Germany

Pan and Aglaia Kyriakou Children s Hospital ( Site 0183)

Athens, , Greece

University of Athens - Aghia Sophia Childrens Hospital ( Site 0185)

Athens, , Greece

Attikon University General Hospital of Athens ( Site 0182)

Athens, , Greece

University General Hospital of Larissa ( Site 0184)

Larissa, , Greece

Hippokration General Hospital of Thessaloniki ( Site 0181)

Thessaloniki, , Greece

Centrum Medyczne Pratia Bydgoszcz ( Site 0086)

Bydgoszcz, , Poland

Prywatny Gabinet Lekarski Dr med Jerzy Brzostek ( Site 0084)

Dębica, , Poland

Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 0085)

Krakow, , Poland

Gravita Diagnostyka i Leczenie Nieplodnosci ( Site 0092)

Lodz, , Poland

SPZOZ Szpital Dzieciecy Poznan ( Site 0089)

Poznan, , Poland

NZ Lecznictwa Ambulatoryjnego - Michalkowice - Jarosz i Partnerzy ( Site 0087)

Siemianowice Śląskie, , Poland

Szpital im. sw. Jadwigi Slaskiej w Trzebnicy ( Site 0083)

Trzebnica, , Poland

Uniwersytecki Szpital Kliniczny ( Site 0093)

Wroclaw, , Poland

SPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 0091)

Łomianki, , Poland

Central Clinical Hospital of Russian Academy Science ( Site 0052)

Moscow, , Russia

Children s City Polyclinic No. 45 of the Nevsky District ( Site 0048)

Saint Petersburg, , Russia

MAI Childrens City Clinical Hospital 11 ( Site 0047)

Yekaterinburg, , Russia

Hospital Universitari Germans Trias i Pujol ( Site 0102)

Badalona, Barcelona, Spain

Hospital de Antequera ( Site 0111)

Antequera, Malaga, Spain

Centro de Salud Paiporta ( Site 0117)

Paiporta, Valencia, Spain

C.S. Quart de Poblet ( Site 0115)

Quart de Poblet, Valencia, Spain

Hospital General Universitario 12 de Octubre ( Site 0106)

Madrid, , Spain

Hospital Universitario La Paz ( Site 0107)

Madrid, , Spain

Hospital Sanitas La Moraleja ( Site 0103)

Madrid, , Spain

Hospital Clinico Universitario de Santiago ( Site 0109)

Santiago de Compostela, , Spain

Unidad de Estudios e Investigacion IHP ( Site 0101)

Seville, , Spain

C.S. Serreria II ( Site 0116)

Valencia, , Spain

Centro de Salud Eliana ( Site 0114)

Valencia, , Spain

Countries

Australia; Belgium; Czechia; Estonia; Germany; Greece; Poland; Russia; Spain

References

Martinon-Torres F, Wysocki J, Szenborn L, Carmona-Martinez A, Poder A, Dagan R, Richmond P, Gilbert C, Trudel MC, Flores S, Lupinacci R, McFetridge R, Wiedmann RT, Chen Q, Gerrits H, Banniettis N, Musey L, Bickham K, Kaminski J; V114-025 PNEU-PED-EU-1 study group. A Phase III, multicenter, randomized, double-blind, active comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of V114 compared with PCV13 in healthy infants (PNEU-PED-EU-1). Vaccine. 2023 May 16;41(21):3387-3398. doi: 10.1016/j.vaccine.2023.04.036. Epub 2023 Apr 25.

Reference Type: RESULT

PMID: 37105892 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

V114-025

Identifier Type: OTHER

Identifier Source: secondary_id

2018-003787-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V114-025

Identifier Type: -

Identifier Source: org_study_id