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Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025) (PNEU-PED-EU-1)

Primary Purpose

Pneumococcal Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rotarix™
Infanrix™ hexa
V114
Prevenar 13™
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Infections

Eligibility Criteria

42 Days - 90 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Queensland Children s Hospital ( Site 0004)
  • Vaccine and Immunisation Research Group - VIRGo ( Site 0002)
  • Telethon Kids Institute ( Site 0003)
  • O.L.V. Ziekenhuis Aalst ( Site 0144)
  • AZ Sint Jan Brugge-Oostende ( Site 0147)
  • AZ Maria Middelares Gent ( Site 0142)
  • UZ Gent ( Site 0141)
  • AZ Henry Serruys ( Site 0148)
  • AZ Delta ( Site 0143)
  • MUDr. Daniel Drazan - Prakticky lekar pro deti a dorost ( Site 0151)
  • MU Dr. Jan Nemecek - Prakticky lekar pro deti a dorost ( Site 0152)
  • MUDr. Josef Zemanek ( Site 0153)
  • Vee Perearstikeskus ( Site 0163)
  • Merekivi Perearstid ( Site 0165)
  • Merelahe Perearstikeskus OU ( Site 0164)
  • Sinu Arst Tervisekeskus ( Site 0167)
  • Rosenthali Perearstikeskus OU ( Site 0166)
  • Kliiniliste Uuringute Keskus OU ( Site 0161)
  • NETSTAP - Sandner ( Site 0072)
  • Kinderarztpraxis ( Site 0061)
  • Praxis Dr. Schmute ( Site 0078)
  • Praxis fur Kinder und Jugendmedizin Eivy Franke Beckmann ( Site 0064)
  • Kinderarztpraxis Dr. Friedrich Kaiser & Dr. Marinesse ( Site 0065)
  • Kinderarztpraxis Dr. Juenger ( Site 0073)
  • Kinderpraxis Dr. med. Andreas Petri ( Site 0066)
  • Kinderarztpraxis ( Site 0068)
  • Kinder- und Jugendaerztliche Gemeinschaftspraxis ( Site 0077)
  • Praxiszentrum Triftplatz ( Site 0075)
  • Praxis Dr. Siegfried Simmet ( Site 0069)
  • Kinderarztpraxis Dr. Rolf Ebert & Dr. Matthias Huebener ( Site 0062)
  • Kinderaerztliche Gemeinschaftspraxis Drs. Westerholt/Matyas ( Site 0074)
  • Kinderarztpraxis ( Site 0063)
  • Pan and Aglaia Kyriakou Children s Hospital ( Site 0183)
  • University of Athens - Aghia Sophia Childrens Hospital ( Site 0185)
  • Attikon University General Hospital of Athens ( Site 0182)
  • University General Hospital of Larissa ( Site 0184)
  • Hippokration General Hospital of Thessaloniki ( Site 0181)
  • Centrum Medyczne Pratia Bydgoszcz ( Site 0086)
  • Prywatny Gabinet Lekarski Dr med Jerzy Brzostek ( Site 0084)
  • Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 0085)
  • Gravita Diagnostyka i Leczenie Nieplodnosci ( Site 0092)
  • SPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 0091)
  • SPZOZ Szpital Dzieciecy Poznan ( Site 0089)
  • NZ Lecznictwa Ambulatoryjnego - Michalkowice - Jarosz i Partnerzy ( Site 0087)
  • Szpital im. sw. Jadwigi Slaskiej w Trzebnicy ( Site 0083)
  • Uniwersytecki Szpital Kliniczny ( Site 0093)
  • MAI Childrens City Clinical Hospital 11 ( Site 0047)
  • Central Clinical Hospital of Russian Academy Science ( Site 0052)
  • Children s City Polyclinic No. 45 of the Nevsky District ( Site 0048)
  • Hospital Universitari Germans Trias i Pujol ( Site 0102)
  • Hospital de Antequera ( Site 0111)
  • Centro de Salud Paiporta ( Site 0117)
  • C.S. Quart de Poblet ( Site 0115)
  • Hospital General Universitario 12 de Octubre ( Site 0106)
  • Hospital Universitario La Paz ( Site 0107)
  • Hospital Sanitas La Moraleja ( Site 0103)
  • Hospital Clinico Universitario de Santiago ( Site 0109)
  • Unidad de Estudios e Investigacion IHP ( Site 0101)
  • C.S. Serreria II ( Site 0116)
  • Centro de Salud Eliana ( Site 0114)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

V114

Prevenar 13™

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Participants That Report at Least 1 Solicited Injection-site Adverse Event (AE)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a study intervention. Injection-site AEs solicited on the Vaccine Report Card (VRC) consisted of erythema (redness), induration (hard lump), pain (tenderness) and swelling.
Percentage of Participants That Report at Least 1 Solicited Systemic AE
An AE is any untoward medical occurrence in a participant temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a study intervention. Systemic AEs solicited on the VRC consisted of decreased appetite (loss of appetite), irritability, somnolence (drowsiness) and urticaria (hive/welts).
Percentage of Participants That Report at Least 1 Vaccine-related Serious Adverse Event (SAE)
A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event. The relatedness of a vaccine to a SAE is determined by an investigator who is a qualified physician.
Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD)
Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for each serotype using pneumococcal electrochemiluminescence (PnECL). The Geometric Mean Concentration (GMC) for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed. Per protocol, within-group CIs were not calculated.
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD
Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for the 15 serotypes using pneumococcal electrochemiluminescence (PnECL). The percentage of participants that achieve the threshold value of ≥0.35 μg/mL for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed.

Secondary Outcome Measures

Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD
Sera from participants was used to measure vaccine-induced responses to 10 pre-specified Infanrix™ hexa antigens with the following threshold (% ≥) values: Diphtheria toxoid-0.1 international unit (IU)/mL;Tetanus toxoid-0.1 IU/mL; Pertussis pertussis toxin (PT)-5 endotoxin unit (EU)/mL; Pertussis filamentous hemagglutinin (FHA)-5 EU/mL; Pertussis pertactin (PRN)-5 EU/mL; Haemophilus influenzae type b (Hib) polyribosylribitol phosphate (PRP)-0.15 μg/mL; hepatitis B surface antigen (HBsAg)-10 mIU/mL; Poliovirus 1,2 and 3-1:8 neutralizing antibodies (NAb) dilution.
Anti-rotavirus Immunoglobulin A (IgA) Geometric Mean Titers (GMTs) at 30 Days Post Primary Series (PPS) of Rotarix™
Sera from participants was used to measure vaccine-induced antibodies in response to vaccination with Rotarix™ by assessing the GMT for IgA. Per protocol, within-group CIs were not calculated.
Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS
Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for each serotype using PnECL. The GMC for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed. Per protocol, within-group CIs were not calculated.
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS
Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for the 15 serotypes using PnECL. The percentage of participants that achieve the threshold value of ≥0.35 μg/mL for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed.
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD
Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific OPA using the multiplexed opsonophagocytic assay (MOPA). The GMT for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed. The within-group CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD
Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific OPA using the MOPA. The threshold dilution (% ≥) for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F) were as follows: 1:9, 1:19, 1:34, 1:27, 1:232, 1:40, 1:61, 1:151, 1:62, 1:115, 1:31, 1:113, 1:55. For Serotypes 22F and 33F the threshold dilution was 1:15 and 1:20 respectively. The within-group CIs were based on the exact binomial method of Clopper and Pearson.
Percentage of Participants Who Achieved the IgG Serotype-Specific Threshold Value of ≥0.35 μg/mL For Protocol Pre-Specified Serotypes at 30 Days PTD
Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for the 15 serotypes using PnECL. As pre-specified in the protocol the percentage of participants from the two serotypes unique to V114 (Serotypes 22F and 33F) are presented, as well as the percentage of participants with the lowest response rate from any of the 13 shared serotypes randomized to Prevenar 13™ (Serotype 3).

Full Information

First Posted
July 22, 2019
Last Updated
July 20, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04031846
Brief Title
Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025)
Acronym
PNEU-PED-EU-1
Official Title
A Phase 3, Multicenter, Randomized, Double-blind, Active-comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (PNEU-PED-EU-1)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 4, 2019 (Actual)
Primary Completion Date
August 5, 2021 (Actual)
Study Completion Date
August 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1184 (Actual)

8. Arms, Groups, and Interventions

Arm Title
V114
Arm Type
Experimental
Arm Description
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.
Arm Title
Prevenar 13™
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rotarix™
Intervention Description
Single 1.5 mL oral dose at 2 and 4 months of age (Study Day 1 and Month 2)
Intervention Type
Drug
Intervention Name(s)
Infanrix™ hexa
Intervention Description
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
Intervention Name(s)
V114
Other Intervention Name(s)
VAXNEUVANCE™, Pneumococcal 15-Valent Conjugate Vaccine
Intervention Description
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
Intervention Name(s)
Prevenar 13™
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants That Report at Least 1 Solicited Injection-site Adverse Event (AE)
Description
An AE is any untoward medical occurrence in a participant temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a study intervention. Injection-site AEs solicited on the Vaccine Report Card (VRC) consisted of erythema (redness), induration (hard lump), pain (tenderness) and swelling.
Time Frame
Up to 14 days post any vaccination (up to approximately study month 13)
Title
Percentage of Participants That Report at Least 1 Solicited Systemic AE
Description
An AE is any untoward medical occurrence in a participant temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a study intervention. Systemic AEs solicited on the VRC consisted of decreased appetite (loss of appetite), irritability, somnolence (drowsiness) and urticaria (hive/welts).
Time Frame
Up to 14 days post any vaccination (up to approximately study month 13)
Title
Percentage of Participants That Report at Least 1 Vaccine-related Serious Adverse Event (SAE)
Description
A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event. The relatedness of a vaccine to a SAE is determined by an investigator who is a qualified physician.
Time Frame
Up to 6 months post last vaccination (up to approximately study month 20)
Title
Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD)
Description
Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for each serotype using pneumococcal electrochemiluminescence (PnECL). The Geometric Mean Concentration (GMC) for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed. Per protocol, within-group CIs were not calculated.
Time Frame
30 days PTD (Up to approximately study month 14)
Title
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD
Description
Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for the 15 serotypes using pneumococcal electrochemiluminescence (PnECL). The percentage of participants that achieve the threshold value of ≥0.35 μg/mL for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed.
Time Frame
30 days PTD (Up to approximately study month 14)
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD
Description
Sera from participants was used to measure vaccine-induced responses to 10 pre-specified Infanrix™ hexa antigens with the following threshold (% ≥) values: Diphtheria toxoid-0.1 international unit (IU)/mL;Tetanus toxoid-0.1 IU/mL; Pertussis pertussis toxin (PT)-5 endotoxin unit (EU)/mL; Pertussis filamentous hemagglutinin (FHA)-5 EU/mL; Pertussis pertactin (PRN)-5 EU/mL; Haemophilus influenzae type b (Hib) polyribosylribitol phosphate (PRP)-0.15 μg/mL; hepatitis B surface antigen (HBsAg)-10 mIU/mL; Poliovirus 1,2 and 3-1:8 neutralizing antibodies (NAb) dilution.
Time Frame
30 days PTD (Up to approximately study month 14)
Title
Anti-rotavirus Immunoglobulin A (IgA) Geometric Mean Titers (GMTs) at 30 Days Post Primary Series (PPS) of Rotarix™
Description
Sera from participants was used to measure vaccine-induced antibodies in response to vaccination with Rotarix™ by assessing the GMT for IgA. Per protocol, within-group CIs were not calculated.
Time Frame
30 days PPS (Up to approximately study month 3)
Title
Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS
Description
Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for each serotype using PnECL. The GMC for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed. Per protocol, within-group CIs were not calculated.
Time Frame
30 days PPS (Up to approximately study month 3)
Title
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS
Description
Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for the 15 serotypes using PnECL. The percentage of participants that achieve the threshold value of ≥0.35 μg/mL for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed.
Time Frame
30 days PPS (Up to approximately study month 3)
Title
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD
Description
Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific OPA using the multiplexed opsonophagocytic assay (MOPA). The GMT for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed. The within-group CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Time Frame
30 days PTD (Up to approximately study month 14)
Title
Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD
Description
Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific OPA using the MOPA. The threshold dilution (% ≥) for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F) were as follows: 1:9, 1:19, 1:34, 1:27, 1:232, 1:40, 1:61, 1:151, 1:62, 1:115, 1:31, 1:113, 1:55. For Serotypes 22F and 33F the threshold dilution was 1:15 and 1:20 respectively. The within-group CIs were based on the exact binomial method of Clopper and Pearson.
Time Frame
30 days PTD (Up to approximately study month 14)
Title
Percentage of Participants Who Achieved the IgG Serotype-Specific Threshold Value of ≥0.35 μg/mL For Protocol Pre-Specified Serotypes at 30 Days PTD
Description
Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for the 15 serotypes using PnECL. As pre-specified in the protocol the percentage of participants from the two serotypes unique to V114 (Serotypes 22F and 33F) are presented, as well as the percentage of participants with the lowest response rate from any of the 13 shared serotypes randomized to Prevenar 13™ (Serotype 3).
Time Frame
30 days PTD (Up to approximately study month 14)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
42 Days
Maximum Age & Unit of Time
90 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Queensland Children s Hospital ( Site 0004)
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Vaccine and Immunisation Research Group - VIRGo ( Site 0002)
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3010
Country
Australia
Facility Name
Telethon Kids Institute ( Site 0003)
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Facility Name
O.L.V. Ziekenhuis Aalst ( Site 0144)
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
AZ Sint Jan Brugge-Oostende ( Site 0147)
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
AZ Maria Middelares Gent ( Site 0142)
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Gent ( Site 0141)
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
AZ Henry Serruys ( Site 0148)
City
Oostende
ZIP/Postal Code
8400
Country
Belgium
Facility Name
AZ Delta ( Site 0143)
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
MUDr. Daniel Drazan - Prakticky lekar pro deti a dorost ( Site 0151)
City
Jindrichuv Hradec
ZIP/Postal Code
377 01
Country
Czechia
Facility Name
MU Dr. Jan Nemecek - Prakticky lekar pro deti a dorost ( Site 0152)
City
Melnik
ZIP/Postal Code
276 01
Country
Czechia
Facility Name
MUDr. Josef Zemanek ( Site 0153)
City
Tynec nad Sazavou
ZIP/Postal Code
257 41
Country
Czechia
Facility Name
Vee Perearstikeskus ( Site 0163)
City
Paide
State/Province
Jarvamaa
ZIP/Postal Code
72713
Country
Estonia
Facility Name
Merekivi Perearstid ( Site 0165)
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Merelahe Perearstikeskus OU ( Site 0164)
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Sinu Arst Tervisekeskus ( Site 0167)
City
Tallinn
ZIP/Postal Code
11313
Country
Estonia
Facility Name
Rosenthali Perearstikeskus OU ( Site 0166)
City
Tallinn
ZIP/Postal Code
11315
Country
Estonia
Facility Name
Kliiniliste Uuringute Keskus OU ( Site 0161)
City
Tartu
ZIP/Postal Code
50160
Country
Estonia
Facility Name
NETSTAP - Sandner ( Site 0072)
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
Kinderarztpraxis ( Site 0061)
City
Bramsche
ZIP/Postal Code
49565
Country
Germany
Facility Name
Praxis Dr. Schmute ( Site 0078)
City
Datteln
ZIP/Postal Code
45711
Country
Germany
Facility Name
Praxis fur Kinder und Jugendmedizin Eivy Franke Beckmann ( Site 0064)
City
Erfurt
ZIP/Postal Code
99086
Country
Germany
Facility Name
Kinderarztpraxis Dr. Friedrich Kaiser & Dr. Marinesse ( Site 0065)
City
Hamburg
ZIP/Postal Code
22415
Country
Germany
Facility Name
Kinderarztpraxis Dr. Juenger ( Site 0073)
City
Herxheim
ZIP/Postal Code
76863
Country
Germany
Facility Name
Kinderpraxis Dr. med. Andreas Petri ( Site 0066)
City
Huerth
ZIP/Postal Code
50354
Country
Germany
Facility Name
Kinderarztpraxis ( Site 0068)
City
Moenchengladbach
ZIP/Postal Code
41236
Country
Germany
Facility Name
Kinder- und Jugendaerztliche Gemeinschaftspraxis ( Site 0077)
City
Oberhausen
ZIP/Postal Code
46145
Country
Germany
Facility Name
Praxiszentrum Triftplatz ( Site 0075)
City
Schoenau
ZIP/Postal Code
83471
Country
Germany
Facility Name
Praxis Dr. Siegfried Simmet ( Site 0069)
City
Schweigen
ZIP/Postal Code
76889
Country
Germany
Facility Name
Kinderarztpraxis Dr. Rolf Ebert & Dr. Matthias Huebener ( Site 0062)
City
Tauberbischofsheim
ZIP/Postal Code
97941
Country
Germany
Facility Name
Kinderaerztliche Gemeinschaftspraxis Drs. Westerholt/Matyas ( Site 0074)
City
Wolfsburg
ZIP/Postal Code
38448
Country
Germany
Facility Name
Kinderarztpraxis ( Site 0063)
City
Wuerselen
ZIP/Postal Code
52146
Country
Germany
Facility Name
Pan and Aglaia Kyriakou Children s Hospital ( Site 0183)
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Facility Name
University of Athens - Aghia Sophia Childrens Hospital ( Site 0185)
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Facility Name
Attikon University General Hospital of Athens ( Site 0182)
City
Athens
ZIP/Postal Code
124 62
Country
Greece
Facility Name
University General Hospital of Larissa ( Site 0184)
City
Larissa
ZIP/Postal Code
411 10
Country
Greece
Facility Name
Hippokration General Hospital of Thessaloniki ( Site 0181)
City
Thessaloniki
ZIP/Postal Code
546 42
Country
Greece
Facility Name
Centrum Medyczne Pratia Bydgoszcz ( Site 0086)
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Prywatny Gabinet Lekarski Dr med Jerzy Brzostek ( Site 0084)
City
Debica
ZIP/Postal Code
39-200
Country
Poland
Facility Name
Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 0085)
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Gravita Diagnostyka i Leczenie Nieplodnosci ( Site 0092)
City
Lodz
ZIP/Postal Code
91-347
Country
Poland
Facility Name
SPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 0091)
City
Lomianki
ZIP/Postal Code
05-092
Country
Poland
Facility Name
SPZOZ Szpital Dzieciecy Poznan ( Site 0089)
City
Poznan
ZIP/Postal Code
61-709
Country
Poland
Facility Name
NZ Lecznictwa Ambulatoryjnego - Michalkowice - Jarosz i Partnerzy ( Site 0087)
City
Siemianowice Slaskie
ZIP/Postal Code
41-103
Country
Poland
Facility Name
Szpital im. sw. Jadwigi Slaskiej w Trzebnicy ( Site 0083)
City
Trzebnica
ZIP/Postal Code
55-100
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny ( Site 0093)
City
Wroclaw
ZIP/Postal Code
50-368
Country
Poland
Facility Name
MAI Childrens City Clinical Hospital 11 ( Site 0047)
City
Ekaterinburg
ZIP/Postal Code
620034
Country
Russian Federation
Facility Name
Central Clinical Hospital of Russian Academy Science ( Site 0052)
City
Moscow
ZIP/Postal Code
119333
Country
Russian Federation
Facility Name
Children s City Polyclinic No. 45 of the Nevsky District ( Site 0048)
City
St.Petersburg
ZIP/Postal Code
193312
Country
Russian Federation
Facility Name
Hospital Universitari Germans Trias i Pujol ( Site 0102)
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital de Antequera ( Site 0111)
City
Antequera
State/Province
Malaga
ZIP/Postal Code
29200
Country
Spain
Facility Name
Centro de Salud Paiporta ( Site 0117)
City
Paiporta
State/Province
Valencia
ZIP/Postal Code
46200
Country
Spain
Facility Name
C.S. Quart de Poblet ( Site 0115)
City
Quart de Poblet
State/Province
Valencia
ZIP/Postal Code
46930
Country
Spain
Facility Name
Hospital General Universitario 12 de Octubre ( Site 0106)
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz ( Site 0107)
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Sanitas La Moraleja ( Site 0103)
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Clinico Universitario de Santiago ( Site 0109)
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Unidad de Estudios e Investigacion IHP ( Site 0101)
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
C.S. Serreria II ( Site 0116)
City
Valencia
ZIP/Postal Code
46022
Country
Spain
Facility Name
Centro de Salud Eliana ( Site 0114)
City
Valencia
ZIP/Postal Code
46183
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
37105892
Citation
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.
Results Reference
result

Learn more about this trial

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

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