Pneumococcal InfectionsPhase 3PNEU-PED-EU-1NCT04031846
Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025)
A Phase 3 study testing Rotarix™, Infanrix™ hexa and V114 in people with Pneumococcal Infections, run by Merck Sharp & Dohme LLC at 60 sites in 9 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 42 to 90 daysHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infections
- What is being tested?
- Rotarix™, Infanrix™ hexa and V114
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,184 participants
- Where
- 60 sitesin 9 countries
- Study dates
- 4 Sep 2019to 5 Aug 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 to 90 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
60 sites in 9 countries.
60 sites in 9 countries
Germany14 sites
NETSTAP - Sandner ( Site 0072)
Aschaffenburg, 63739
Kinderarztpraxis ( Site 0061)
Bramsche, 49565
Praxis Dr. Schmute ( Site 0078)
Datteln, 45711
Praxis fur Kinder und Jugendmedizin Eivy Franke Beckmann ( Site 0064)
Erfurt, 99086
Kinderarztpraxis Dr. Friedrich Kaiser & Dr. Marinesse ( Site 0065)
Hamburg, 22415
Kinderarztpraxis Dr. Juenger ( Site 0073)
Herxheim, 76863
Kinderpraxis Dr. med. Andreas Petri ( Site 0066)
Hürth, 50354
Kinderarztpraxis ( Site 0068)
Mönchengladbach, 41236
Kinder- und Jugendaerztliche Gemeinschaftspraxis ( Site 0077)
Oberhausen, 46145
Praxiszentrum Triftplatz ( Site 0075)
Schönau, 83471
Praxis Dr. Siegfried Simmet ( Site 0069)
Schweigen, 76889
Kinderarztpraxis Dr. Rolf Ebert & Dr. Matthias Huebener ( Site 0062)
Tauberbischofsheim, 97941
Kinderaerztliche Gemeinschaftspraxis Drs. Westerholt/Matyas ( Site 0074)
Wolfsburg, 38448
Kinderarztpraxis ( Site 0063)
Würselen, 52146
Spain11 sites
Hospital de Antequera ( Site 0111)
Antequera, Malaga, 29200
Hospital Universitari Germans Trias i Pujol ( Site 0102)
Badalona, Barcelona, 08916
Hospital General Universitario 12 de Octubre ( Site 0106)
Madrid, 28041
Hospital Universitario La Paz ( Site 0107)
Madrid, 28046
Hospital Sanitas La Moraleja ( Site 0103)
Madrid, 28050
Centro de Salud Paiporta ( Site 0117)
Paiporta, Valencia, 46200
C.S. Quart de Poblet ( Site 0115)
Quart de Poblet, Valencia, 46930
Hospital Clinico Universitario de Santiago ( Site 0109)
Santiago de Compostela, 15706
Unidad de Estudios e Investigacion IHP ( Site 0101)
Seville, 41014
C.S. Serreria II ( Site 0116)
Valencia, 46022
Centro de Salud Eliana ( Site 0114)
Valencia, 46183
Poland9 sites
Centrum Medyczne Pratia Bydgoszcz ( Site 0086)
Bydgoszcz, 85-796
Prywatny Gabinet Lekarski Dr med Jerzy Brzostek ( Site 0084)
Dębica, 39-200
Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 0085)
Krakow, 31-202
Gravita Diagnostyka i Leczenie Nieplodnosci ( Site 0092)
Lodz, 91-347
SPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 0091)
Łomianki, 05-092
SPZOZ Szpital Dzieciecy Poznan ( Site 0089)
Poznan, 61-709
NZ Lecznictwa Ambulatoryjnego - Michalkowice - Jarosz i Partnerzy ( Site 0087)
Siemianowice Śląskie, 41-103
Szpital im. sw. Jadwigi Slaskiej w Trzebnicy ( Site 0083)
Trzebnica, 55-100
Uniwersytecki Szpital Kliniczny ( Site 0093)
Wroclaw, 50-368
Belgium6 sites
O.L.V. Ziekenhuis Aalst ( Site 0144)
Aalst, 9300
AZ Sint Jan Brugge-Oostende ( Site 0147)
Bruges, 8000
AZ Maria Middelares Gent ( Site 0142)
Ghent, 9000
UZ Gent ( Site 0141)
Ghent, 9000
AZ Henry Serruys ( Site 0148)
Ostend, 8400
AZ Delta ( Site 0143)
Roeselare, 8800
Estonia6 sites
Vee Perearstikeskus ( Site 0163)
Paide, Järvamaa, 72713
Merekivi Perearstid ( Site 0165)
Tallinn, 10617
Merelahe Perearstikeskus OU ( Site 0164)
Tallinn, 10617
Sinu Arst Tervisekeskus ( Site 0167)
Tallinn, 11313
Rosenthali Perearstikeskus OU ( Site 0166)
Tallinn, 11315
Kliiniliste Uuringute Keskus OU ( Site 0161)
Tartu, 50160
Greece5 sites
Pan and Aglaia Kyriakou Children s Hospital ( Site 0183)
Athens, 115 27
University of Athens - Aghia Sophia Childrens Hospital ( Site 0185)
Athens, 115 27
Attikon University General Hospital of Athens ( Site 0182)
Athens, 124 62
University General Hospital of Larissa ( Site 0184)
Larissa, 411 10
Hippokration General Hospital of Thessaloniki ( Site 0181)
Thessaloniki, 546 42
Australia3 sites
Vaccine and Immunisation Research Group - VIRGo ( Site 0002)
Melbourne, Victoria, 3010
Telethon Kids Institute ( Site 0003)
Nedlands, 6009
Queensland Children s Hospital ( Site 0004)
South Brisbane, Queensland, 4101
Czechia3 sites
MUDr. Daniel Drazan - Prakticky lekar pro deti a dorost ( Site 0151)
Jindřichův Hradec, 377 01
MU Dr. Jan Nemecek - Prakticky lekar pro deti a dorost ( Site 0152)
Mělník, 276 01
MUDr. Josef Zemanek ( Site 0153)
Týnec nad Sázavou, 257 41
Russia3 sites
Central Clinical Hospital of Russian Academy Science ( Site 0052)
Moscow, 119333
Children s City Polyclinic No. 45 of the Nevsky District ( Site 0048)
Saint Petersburg, 193312
MAI Childrens City Clinical Hospital 11 ( Site 0047)
Yekaterinburg, 620034
About this study
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)
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
- Being tested
- Rotarix™, Infanrix™ hexa, V114, Prevenar 13™
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotarix™Drug
Single 1.5 mL oral dose at 2 and 4 months of age (Study Day 1 and Month 2)
Infanrix™ hexaDrug
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)
V114Drug
Also called VAXNEUVANCE™, Pneumococcal 15-Valent Conjugate Vaccine
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™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.
| Study group | Role | What they receive |
|---|---|---|
| V114 | Experimental | 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. Receives: Drug: Rotarix™; Drug: Infanrix™ hexa; Drug: V114 |
| Prevenar 13™ | Active comparator | 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. Receives: Drug: Rotarix™; Drug: Infanrix™ hexa; Drug: Prevenar 13™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 14 days post any vaccination (up to approximately study month 13)
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).
Measured: Up to 14 days post any vaccination (up to approximately study month 13)
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.
Measured: Up to 6 months post last vaccination (up to approximately study month 20)
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.
Measured: 30 days PTD (Up to approximately study month 14)
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.
Measured: 30 days PTD (Up to approximately study month 14)
Secondary outcomes (7)
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.
Measured: 30 days PTD (Up to approximately study month 14)
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.
Measured: 30 days PPS (Up to approximately study month 3)
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.
Measured: 30 days PPS (Up to approximately study month 3)
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.
Measured: 30 days PPS (Up to approximately study month 3)
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.
Measured: 30 days PTD (Up to approximately study month 14)
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.
Measured: 30 days PTD (Up to approximately study month 14)
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).
Measured: 30 days PTD (Up to approximately study month 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start4 Sep 2019
- Primary completion5 Aug 2021
- Study completion5 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pneumococcal InfectionsStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031846
- Sponsor's protocol ID
- V114-025
- Other IDs
- V114-025, 2018-003787-31, 2018
- Acronym
- PNEU-PED-EU-1
- Status last verified
- Jul 2023
- First submitted
- 22 Jul 2019
- Last updated
- 28 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
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.
PubMed 37105892
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04031846
- Acronym / sponsor ID
- PNEU-PED-EU-1 / V114-025
- Conditions
- Pneumococcal Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,184 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 5 Aug 2021 (actual)
- Study completion
- 5 Aug 2021 (actual)
- First posted
- 24 Jul 2019 (actual)
- Results
- Posted 3 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| V114 | Experimental | Drug: Rotarix™, Drug: Infanrix™ hexa, Drug: V114Full-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. |
| Prevenar 13™ | Active comparator | Drug: Rotarix™, Drug: Infanrix™ hexa, Drug: 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. |
Who may qualify
- Ages
- 42 to 90 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rotarix™Single 1.5 mL oral dose at 2 and 4 months of age (Study Day 1 and Month 2) | Drug | Prevenar 13™, V114 |
| Infanrix™ hexaSingle 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) | Drug | Prevenar 13™, V114 |
| V114Also: VAXNEUVANCE™, Pneumococcal 15-Valent Conjugate Vaccine15-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, | Drug | V114 |
| 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. | Drug | Prevenar 13™ |
Primary outcome
Percentage of Participants That Report at Least 1 Solicited Injection-site Adverse Event (AE)
Time frame: Up to 14 days post any vaccination (up to approximately study month 13)
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
Time frame: Up to 14 days post any vaccination (up to approximately study month 13)
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)
Time frame: Up to 6 months post last vaccination (up to approximately study month 20)
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)
Time frame: 30 days PTD (Up to approximately study month 14)
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
Time frame: 30 days PTD (Up to approximately study month 14)
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.
7 secondary outcomes
Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD
Time frame: 30 days PTD (Up to approximately study month 14)
Anti-rotavirus Immunoglobulin A (IgA) Geometric Mean Titers (GMTs) at 30 Days Post Primary Series (PPS) of Rotarix™
Time frame: 30 days PPS (Up to approximately study month 3)
Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS
Time frame: 30 days PPS (Up to approximately study month 3)
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS
Time frame: 30 days PPS (Up to approximately study month 3)
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD
Time frame: 30 days PTD (Up to approximately study month 14)
Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD
Time frame: 30 days PTD (Up to approximately study month 14)
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
Time frame: 30 days PTD (Up to approximately study month 14)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37105892Martinon-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.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
60 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rotarix™, Infanrix™ hexa and V114 in people with Pneumococcal Infections, run by Merck Sharp & Dohme LLC at 60 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in Germany, Spain, Poland, Belgium, Estonia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants That Report at Least 1 Solicited Injection-site Adverse Event (AE) (time frame: Up to 14 days post any vaccination (up to approximately study month 13)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04031846, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.