AzTrials
AzTrials

Pneumococcal DiseasePhase 3NCT04546425

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants

A Phase 3 study testing 20-valent pneumococcal conjugate vaccine and 13-valent pneumococcal conjugate vaccine in people with Pneumococcal Disease, run by Pfizer at 66 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants Read more about this study

Who is it for?
Ages 42 to 112 daysHealthy volunteers can take part
Conditions the study is for
Pneumococcal Disease
What is being tested?
20-valent pneumococcal conjugate vaccine and 13-valent pneumococcal conjugate vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,258 participants
Where
66 sitesin 12 countries
Study dates
9 Sep 2020to 18 Feb 2023
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 112 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Male or female infants born at >36 weeks of gestation and 2 months of age at the time of consent.
  • Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

Who cannot join

  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis).
  • Major known congenital malformation or serious chronic disorder.
  • Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
  • Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.

Trial locations and contacts

66 sites in 12 countries.

66 sites in 12 countries

Poland16 sites
  • IN-VIVO Sp z o.o. IN-VIVO Bydgoszcz

    Bydgoszcz, 85-048

  • Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy

    Bydgoszcz, 85-168

  • Prywatny Gabinet Lekarski dr n. med. Jerzy Brzostek

    Dębica, 39-200

  • Centrum Badan Klinicznych JCI

    Krakow, 30-348

  • Krakowski Szpital Specjalistyczny im. Jana Pawla II Oddzial Pediatrii i Neurologii Dzieciecej

    Krakow, 31-202

  • Niepubliczny Zaklad Opieki Zdrowotnej "SALMED"

    Łęczna, 21-010

  • GRAVITA. Diagnostyka i Leczenie nieplodnosci

    Lodz, 91-347

  • Rodzinne Centrum Medyczne LUBMED

    Luboń, 62-030

  • Specjalistyczny Zespół Opieki Zdrowotnej nad Matką i Dzieckiem w Poznaniu

    Poznan, 60-663

  • Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Jarosz i Partnerzy Spolka Lekarska

    Siemianowice Śląskie, 41-103

  • Nasz Lekarz Przychodnie Medyczne Slawomir Jeka

    Torun, 87-100

  • Szpital im. Sw. Jadwigi Slaskiej w Trzebnicy

    Trzebnica, 55-100

  • Szpital Bielanski im. ks. J. Popieluszki SPZOZ

    Warsaw, 01-809

  • Provita 001

    Warsaw, 02-647

  • Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu

    Wroclaw, 50-368

  • Centrum Medyczne AD-MED Sp. z o. o. Przychodnia Dla Rodziny

    Wroclaw, 51-141

Other trials in Poland

Finland11 sites
  • Espoo Vaccine Research Clinic

    Espoo, 02230

  • Helsinki South Vaccine Research Clinic

    Helsinki, 00100

  • Helsinki East Vaccine Research Clinic

    Helsinki, 00930

  • Jarvenpaa Vaccine Research Clinic

    Jarvenpaa, 04400

  • Kokkola Vaccine Research Clinic

    Kokkola, 67100

  • FVR, Oulun rokotetutkimusklinikka

    Oulu, 90220

  • Tampereen yliopisto Oulun Rokotetutkimusklinikka

    Oulu, 90220

  • Pori Vaccine Research Clinic

    Pori, 28100

  • Seinäjoki Vaccine Research Clinic

    Seinäjoki, 60100

  • Tampere Vaccine Research Center

    Tampere, 33100

  • Turku Vaccine Research Clinic

    Turku, 20520

Other trials in Finland

Czechia7 sites
  • DD ordinace s.r.o.

    Jindřichův Hradec, 377 01

  • Ordinace praktického lékaře pro děti a dorost

    Jindřichův Hradec, 377 01

  • Samostatna ordinace praktickeho lekare pro deti a dorost

    Jindřichův Hradec, 377 01

  • Zdravotnicke stredisko Dubina, verejna obchodni spolecnost

    Pardubice, 530 12

  • MUDr. Jitka Fabianova

    Prague, 130 00

  • MEDICENTRUM 6 s.r.o. - Ordinace praktickeho lekare pro deti a dorost

    Prague, 160 00

  • Medicentrum 6 s.r.o.

    Prague, 160 00

Other trials in Czechia

Slovakia7 sites
  • PEDIAMED s.r.o.

    Bratislava, 831 03

  • NASA DOKTORKA s.r.o.

    Bratislava, 841 02

  • Rozvojova agentura Banskobystrickeho samospravneho kraja, n.o.

    Detva, 962 12

  • MUDr. Martin Zavrel Vseobecna ambulancia pre deti a dorast

    Horné Srnie, 91442

  • Všeobecná ambulancia pre deti a dorast

    Humenné, 06601

  • PEDAMB s.r.o.

    Košice, 040 11

  • MUDr. Drusková s.r.o.

    Liptovská Osada, 034 73

Other trials in Slovakia

Estonia6 sites
  • Kadrina Tervisekeskus OU

    Kadrina, 45201

  • Merekivi Perearstid.

    Tallinn, 10617

  • Merelahe Family Doctors Centre

    Tallinn, 10617

  • OU Al Mare Perearstikeskus

    Tallinn, 10617

  • Sinu Arst Health Center

    Tallinn, 11313

  • Clinical Research Centre

    Tartu, 50106

Other trials in Estonia

Italy4 sites
  • Azienda Ospedaliero Universitaria Meyer

    Florence, 50139

  • Azienda Ospedaliera Universitaria

    Foggia, 71122

  • Ospedale Policlinico San Martino

    Genova, 16132

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico U.O.S.D. Pediatria Alta lntensita di Cura

    Milan, Milan, 20122

Other trials in Italy

Norway4 sites
  • Akershus University Hospital

    Lorenskog, 1478

  • Oslo University Hospital, Ulleval

    Oslo, 0450

  • Stavanger University Hospital

    Stavanger, 4011

  • Akershus University Hospital - Sykehusapoteket Ahus

    Viken, 1474

Other trials in Norway

Russia4 sites
  • Federal State Budget Institution of Healthcare Central clinical hospital of Russian

    Moscow, 119333

  • State Budget Institution of Healthcare of Perm Region "City Children's Clinical Polyclinic #5"

    Perm, 614066

  • LLC PiterClinica

    Saint Petersburg, 196158

  • State autonomous institution of healthcare of Sverdlovsk region

    Yekaterinburg, 620028

Other trials in Russia

Australia2 sites
  • Perth Children's Hospital

    Nedlands, Western Australia, 6009

  • Telethon Kids Institute, Vaccine Trials Group, Perth Children's Hospital

    Nedlands, Western Australia, 6009

Other trials in Australia

Belgium2 sites
  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • University Hospital Antwerp

    Edegem, 2650

Other trials in Belgium

Netherlands2 sites
  • Stichting Apotheek der Haarlemse Ziekenhuizen

    Haarlem, 2035 RC

  • Spaarne Gasthuis (Kennemer Gasthuis)

    Hoofddorp, 2134 TM

Other trials in Netherlands

Denmark1 site
  • Hvidovre Hospital

    Hvidovre, 2650

Other trials in Denmark

About this study

Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN AS A SERIES OF 2 INFANT DOSES AND 1 TODDLER DOSE IN HEALTHY INFANTS

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants

Being tested
20-valent pneumococcal conjugate vaccine, 13-valent pneumococcal conjugate vaccine
Medical subject headings
Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 20-valent pneumococcal conjugate vaccineBiological

    20-valent pneumococcal conjugate vaccine

  • 13-valent pneumococcal conjugate vaccineBiological

    13-valent pneumococcal conjugate vaccine

Study groups in NCT04546425
Study groupRoleWhat they receive
20-valent pneumococcal conjugate vaccineExperimentalPneumococcal conjugate vaccine
Receives: Biological: 20-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccineActive comparatorPneumococcal conjugate vaccine
Receives: Biological: 13-valent pneumococcal conjugate vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population

    Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than [>] 0 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95 percent (%) confidence interval (CI) was based on Clopper and Pearson method.

    Measured: Within 7 days after Dose 1

  2. Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population

    Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (>0 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95% CI was based on Clopper and Pearson method.

    Measured: Within 7 days after Dose 2

  3. Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population

    Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (>0 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95% CI was based on Clopper and Pearson method.

    Measured: Within 7 days after Dose 3

  4. Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population

    Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: was defined as temperature >=38.0 degree Celsius (C) and categorized as >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.

    Measured: Within 7 Days after Dose 1

  5. Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population

    Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participant's using an e-diary. Fever: was defined as temperature >=38.0 degree C and categorized as >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.

    Measured: Within 7 Days after Dose 2

  6. Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population

    Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: was defined as temperature >=38.0 degree C and categorized as >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) \& severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.

    Measured: Within 7 Days after Dose 3

  7. Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 2: Primary Study Population

    An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events collected from an e-diary.

    Measured: From Dose 1 to 1 month after Dose 2

  8. Percentage of Participants With Adverse Events (AEs) From Dose 3 to 1 Month After Dose 3: Primary Study Population

    An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events collected from an e-diary.

    Measured: From Dose 3 to 1 month after Dose 3

  9. Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 3: Primary Study Population

    A SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. 95% CI was based on the Clopper and Pearson method.

    Measured: From Dose 1 to 1 month after Dose 3

  10. Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) From Dose 1 to 1 Month After Dose 3: Primary Study Population

    A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. 95% CI was based on the Clopper and Pearson method.

    Measured: From Dose 1 to 1 month after Dose 3

  11. Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population

    Predefined IgG concentrations were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: >=0.35 microgram per mL (mcg/mL), for serotype 5: >=0.23 mcg/mL, for serotype 6B: >=0.10 mcg/mL and for serotype 19A: >=0.12 mcg/mL. 95% CI was based on the Clopper and Pearson method.

    Measured: 1 month after Dose 2

  12. Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population

    Pneumococcal serotype-specific IgG concentration was measured for serum sample for 13vPnC serotype: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 7 additional serotype: 8, 10A, 11A, 12F, 15B, 22F, 33F. GMC and corresponding 2-sided 95% CIs were calculated by exponentiating mean logarithm of concentration, corresponding 2-sided 95% CIs (based on Student's t distribution). Assay result below LLOQ was set to 0.5*LLOQ. Geometric mean ratios (GMRs) were reported in statistical analysis section and were calculated by exponentiating mean difference of logarithm of concentration and corresponding 2-sided 95% CIs (based on Student's t distribution).

    Measured: 1 month after Dose 2

  13. GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population

    Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 7 additional serotype: 8, 10A, 11A, 12F, 15B, 22F,33F. GMC and corresponding 2-sided 95% CI were calculated by exponentiating mean logarithm of concentrations and corresponding 2-sided 95% CI (based on Student's t distribution). Assay result below LLOQ were set to 0.5*LLOQ. GMRs were reported in statistical analysis section and were calculated by exponentiating mean difference of logarithm of concentration and corresponding 2-sided 95% CI (based on Student's t distribution).

    Measured: 1 month after Dose 3

  14. Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population

    Diphtheria and tetanus toxoids: concentration of antibody (AB) (in international units [IU]) to diphtheria \& tetanus toxoid (prespecified level>=0.1 IU/mL); Pertussis antigens-pertussis toxin (PT), filamentous hemagglutinin (FHA), pertactin (PRN): prespecified level >=observed Anti pertussis Antibody concentration achieved by 95% of 13vPnC recipient; HBsAg prespecified level >=10 milli-IU per mL (mIU/mL); Poliovirus strains (types 1, 2 and 3): prespecified level: >=1:8; Hemophilus influenzae type b(Hib): prespecified level >=0.15 microgram per millilitre (mcg/mL) polyribosylribitol phosphate (anti-PRP) in mcg/mL. Concomitant vaccine response was assessed from subset of randomly selected study participants.

    Measured: 1 month after Dose 3

  15. GMC of Measles Virus Antibody 1 Month After Dose 3: Primary Study Population

    Pre-specified vaccine antigen (measles) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses were measured 1 month after Dose 3. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t distribution). The immune responses were only measured on random subset of participants.

    Measured: 1 month after Dose 3

  16. GMC of Mumps Virus Antibody 1 Month After Dose 3: Primary Study Population

    Pre-specified vaccine antigen (mumps) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses were measured 1 month after Dose 3. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t distribution). The immune responses were only measured on random subset of participants.

    Measured: 1 month after Dose 3

  17. GMC of Rubella Virus Antibody 1 Month After Dose 3: Primary Study Population

    Pre-specified vaccine antigen (rubella) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses were measured 1 month after Dose 3. Assay results below LLOQ were set to 0.5*LLOQ in the analysis. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t distribution). The immune responses were only measured on random subset of participants.

    Measured: 1 month after Dose 3

  18. GMC of Varicella Virus Antibody 1 Month After Dose 3: Primary Study Population

    Pre-specified vaccine antigen (varicella) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses were measured 1 month after Dose 3. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t distribution). The immune responses were only measured on random subset of participants.

    Measured: 1 month after Dose 3

  19. Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort

    Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (>0 to 2.0 cm), moderate (> 2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95% CI was based on Clopper and Pearson method.

    Measured: Within 7 days after Dose 1

  20. Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort

    Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (>0 to 2.0 cm), moderate (> 2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95% CI was based on Clopper and Pearson method.

    Measured: Within 7 days after Dose 2

  21. Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort

    Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (>0 to 2.0 cm), moderate (> 2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95% CI was based on Clopper and Pearson method.

    Measured: Within 7 days after Dose 3

  22. Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort

    Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participant's using e-diary. Fever: temperature >=38.0 degree C \& categorized as >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0-degree C. Decreased appetite: was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper \& Pearson method.

    Measured: Within 7 Days after Dose 1

  23. Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort

    Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: temperature >=38.0 degree C and categorized as >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper \& Pearson method.

    Measured: Within 7 Days after Dose 2

  24. Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort

    Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: temperature >=38.0 degree C and categorized as >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper \& Pearson method.

    Measured: Within 7 Days after Dose 3

  25. Percentage of Participants With AEs From Dose 1 to 1 Month After Dose 2: Russian Cohort

    An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events collected from an e-diary.

    Measured: From Dose 1 to 1 month after Dose 2

  26. Percentage of Participants With AEs From Dose 3 to 1 Month After Dose 3: Russian Cohort

    An AE was any untoward medical occurrence in a participants, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events collected from an e-diary.

    Measured: From Dose 3 to 1 month after Dose 3

  27. Percentage of Participants With SAEs From Dose 1 to 1 Month After Dose 3: Russian Cohort

    A SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. 95% CI was based on the Clopper and Pearson method.

    Measured: From Dose 1 to 1 month after Dose 3

  28. Percentage of Participants With NDCMC From Dose 1 to 1 Month After Dose 3: Russian Cohort

    A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. 95% CI was based on the Clopper and Pearson method.

    Measured: From Dose 1 to 1 month after Dose 3

  29. Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort

    Predefined IgG concentrations were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: >=0.35 mcg/mL, for serotype 5: >=0.23 mcg/mL, for serotype 6B. >=0.10 mcg/mL and for serotype 19A: >=0.12 mcg/mL. 95% CI was based on the Clopper and Pearson method.

    Measured: 1 month after Dose 2

  30. GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort

    Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F and 7 additional serotypes: 8, 10A, 11A, 12F, 15B, 22F, 33F. Assay results below the LLOQ were set to 0.5 * LLOQ. GMC and corresponding 2-sided 95% CIs were calculated by exponentiating mean logarithm of concentration, and the corresponding 2-sided 95% CIs (based on Student's t distribution).

    Measured: 1 month after Dose 2

  31. GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort

    Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F and additional serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. Assay results below the LLOQ were set to 0.5 * LLOQ. GMC and corresponding 2-sided 95% CIs were calculated by exponentiating mean logarithm of concentration, and the corresponding 2-sided 95% CIs (based on Student's t distribution).

    Measured: 1 month after Dose 3

Secondary outcomes (8)
  1. Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population

    Predefined IgG concentrations were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: >=0.35 mcg/mL, for serotype 5: >=0.23 mcg/mL, for serotype 6B: >=0.10 mcg/mL and for serotype 19A: >=0.12 mcg/mL. 95% CI was based on the Clopper and Pearson method.

    Measured: 1 Month after Dose 3

  2. Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population

    OPA titers for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in randomly selected subsets of participants at 1 month after Dose 2. Results were expressed as OPA titers. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs based on the Student's t distribution.

    Measured: 1 month after Dose 2

  3. Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population

    OPA titers for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in randomly selected subsets of participants at 1 month after Dose 3. Results were expressed as OPA titers. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs based on the Student's t distribution.

    Measured: 1 Month after Dose 3

  4. Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population

    20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student's t distribution).

    Measured: Before Dose 3 to 1 month after Dose 3

  5. Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population

    Pre-specified vaccines were administered concomitantly with 20vPnC or 13vPnC and responses assessed using pre-defined levels as follows: Diphtheria and tetanus toxoids: concentration of antibody (in international units [IU]) to diphtheria and tetanus toxoid (prespecified level >= observed anti-pertussis antibody concentration achieved by 95% of 13vPnC recipients); Poliomyelitis: NA titers to poliovirus types 1, 2, and 3 (prespecified level NA titer >=1:8); and Hib: concentration of antibody to Hib (PRP) in mcg/mL (prespecified level >=0.15 mcg/mL anti-PRP). 2-sided 95% CI was based on Clopper and Pearson method. The assays were performed on randomly selected subsets.

    Measured: 1 month after Dose 2

  6. Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort

    Predefined IgG concentrations were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: >=0.35 mcg/mL, for serotype 5: >=0.23 mcg/mL, for serotype 6B: >=0.10 mcg/mL and for serotype 19A: >=0.12 mcg/mL. 95% CI was based on the Clopper and Pearson method.

    Measured: 1 Month after Dose 3

  7. GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort

    OPA titers for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in randomly selected subsets of participants at 1 month after Dose 2. Results were expressed as OPA titers. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs based on the student's t distribution.

    Measured: 1 month after Dose 2

  8. GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort

    OPA titers for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in randomly selected subsets of participants at 1 month after Dose 3. Results were expressed as OPA titers. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs based on the student's t distribution.

    Measured: 1 Month after Dose 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2020
  2. Study start9 Sep 2020
  3. Primary completion22 Apr 2022
  4. Study completion18 Feb 2023

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,258 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04546425
Sponsor's protocol ID
B7471012
Other IDs
2019-003306-27, 2019
Status last verified
Jan 2024
First submitted
21 Aug 2020
Last updated
8 Jan 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Senders S, Korbal P, Kline M, Tamimi N, Thompson A, Drozd J, Cutler MW, Giardina PC, Trammel J, Lei L, Peng Y, Watson W, McElwee K. Immunogenicity and safety of concomitant vaccines given with 20-valent pneumococcal conjugate vaccine in healthy infants. Vaccine. 2025 Dec 5;68:127916. doi: 10.1016/j.vaccine.2025.127916. Epub 2025 Nov 3.

    PubMed 41187484
  • Korbal P, Wysocki J, Jackowska T, Kline M, Tamimi N, Drozd J, Lei L, Peng Y, Giardina PC, Gruber W, Scott D, Watson W. Phase 3 Safety and Immunogenicity Study of a Three-dose Series of Twenty-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers. Pediatr Infect Dis J. 2024 Jun 1;43(6):587-595. doi: 10.1097/INF.0000000000004300. Epub 2024 Mar 8.

    PubMed 38456705

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 20-valent pneumococcal conjugate vaccine and 13-valent pneumococcal conjugate vaccine in people with Pneumococcal Disease, run by Pfizer at 66 sites in 12 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 4 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 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in Poland, Finland, Czechia, Slovakia, Estonia and 7 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 15 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 With Local Reactions Within 7 Days After Dose 1: Primary Study Population (time frame: Within 7 days after Dose 1). The study lists 31 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 NCT04546425, which also lists 2 linked publications.

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 8 Jan 2024.

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