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

Pneumococcal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04546425
• Other study ID #: B7471012
• Secondary ID: 2019-003306-27
• Status: Completed
• Phase: Phase 3
• Start date: September 9, 2020
• Est. completion date: February 18, 2023

Study information

• Verified date: January 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1258
• Est. completion date: February 18, 2023
• Est. primary completion date: April 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 42 Days to 112 Days

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Pneumococcal Disease
• Pneumococcal Infections

Intervention

Biological:
• 20-valent pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccine
• 13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine

Locations

Country	Name	City	State
Australia	Perth Children's Hospital	Nedlands	Western Australia
Australia	Telethon Kids Institute, Vaccine Trials Group, Perth Children's Hospital	Nedlands	Western Australia
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	University Hospital Antwerp	Edegem
Czechia	DD ordinace s.r.o.	Jindrichuv Hradec
Czechia	Ordinace praktického lékare pro deti a dorost	Jindrichuv Hradec
Czechia	Samostatna ordinace praktickeho lekare pro deti a dorost	Jindrichuv Hradec
Czechia	Zdravotnicke stredisko Dubina, verejna obchodni spolecnost	Pardubice
Czechia	MUDr. Jitka Fabianova	Praha 3
Czechia	Medicentrum 6 s.r.o.	Praha 6
Czechia	MEDICENTRUM 6 s.r.o. - Ordinace praktickeho lekare pro deti a dorost	Praha 6
Denmark	Hvidovre Hospital	Hvidovre
Estonia	Kadrina Tervisekeskus OU	Kadrina
Estonia	Merekivi Perearstid.	Tallinn
Estonia	Merelahe Family Doctors Centre	Tallinn
Estonia	OU Al Mare Perearstikeskus	Tallinn
Estonia	Sinu Arst Health Center	Tallinn
Estonia	Clinical Research Centre	Tartu
Finland	Espoo Vaccine Research Clinic	Espoo
Finland	Helsinki East Vaccine Research Clinic	Helsinki
Finland	Helsinki South Vaccine Research Clinic	Helsinki
Finland	Jarvenpaa Vaccine Research Clinic	Jarvenpaa
Finland	Kokkola Vaccine Research Clinic	Kokkola
Finland	FVR, Oulun rokotetutkimusklinikka	Oulu
Finland	Tampereen yliopisto Oulun Rokotetutkimusklinikka	Oulu
Finland	Pori Vaccine Research Clinic	Pori
Finland	Seinäjoki Vaccine Research Clinic	Seinajoki
Finland	Tampere Vaccine Research Center	Tampere
Finland	Turku Vaccine Research Clinic	Turku
Italy	Azienda Ospedaliero Universitaria Meyer	Firenze
Italy	Azienda Ospedaliera Universitaria	Foggia
Italy	Ospedale Policlinico San Martino	Genova
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico U.O.S.D. Pediatria Alta lntensita di Cura	Milano	Milan
Netherlands	Stichting Apotheek der Haarlemse Ziekenhuizen	Haarlem
Netherlands	Spaarne Gasthuis (Kennemer Gasthuis)	Hoofddorp
Norway	Akershus University Hospital	Lorenskog
Norway	Oslo University Hospital, Ulleval	Oslo
Norway	Stavanger University Hospital	Stavanger
Norway	Akershus University Hospital - Sykehusapoteket Ahus	Viken
Poland	IN-VIVO Sp z o.o. IN-VIVO Bydgoszcz	Bydgoszcz
Poland	Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy	Bydgoszcz
Poland	Prywatny Gabinet Lekarski dr n. med. Jerzy Brzostek	Debica
Poland	Centrum Badan Klinicznych JCI	Krakow
Poland	Krakowski Szpital Specjalistyczny im. Jana Pawla II Oddzial Pediatrii i Neurologii Dzieciecej	Krakow
Poland	Niepubliczny Zaklad Opieki Zdrowotnej "SALMED"	Leczna
Poland	GRAVITA. Diagnostyka i Leczenie nieplodnosci	Lodz
Poland	Rodzinne Centrum Medyczne LUBMED	Lubon
Poland	Specjalistyczny Zespól Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu	Poznan
Poland	Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Jarosz i Partnerzy Spolka Lekarska	Siemianowice Slaskie
Poland	Nasz Lekarz Przychodnie Medyczne Slawomir Jeka	Torun
Poland	Szpital im. Sw. Jadwigi Slaskiej w Trzebnicy	Trzebnica
Poland	Provita 001	Warszawa
Poland	Szpital Bielanski im. ks. J. Popieluszki SPZOZ	Warszawa
Poland	Centrum Medyczne AD-MED Sp. z o. o. Przychodnia Dla Rodziny	Wroclaw
Poland	Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu	Wroclaw
Russian Federation	State autonomous institution of healthcare of Sverdlovsk region	Ekaterinburg
Russian Federation	Federal State Budget Institution of Healthcare Central clinical hospital of Russian	Moscow
Russian Federation	State Budget Institution of Healthcare of Perm Region "City Children's Clinical Polyclinic #5"	Perm
Russian Federation	LLC PiterClinica	Saint Petersburg
Slovakia	NASA DOKTORKA s.r.o.	Bratislava
Slovakia	PEDIAMED s.r.o.	Bratislava
Slovakia	Rozvojova agentura Banskobystrickeho samospravneho kraja, n.o.	Detva
Slovakia	MUDr. Martin Zavrel Vseobecna ambulancia pre deti a dorast	Horne Srnie
Slovakia	Všeobecná ambulancia pre deti a dorast	Humenne
Slovakia	PEDAMB s.r.o.	Kosice
Slovakia	MUDr. Drusková s.r.o.	Liptovská Osada

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Australia,  Belgium,  Czechia,  Denmark,  Estonia,  Finland,  Italy,  Netherlands,  Norway,  Poland,  Russian Federation,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 7 days after Dose 1
Primary	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.	Within 7 days after Dose 2
Primary	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.	Within 7 days after Dose 3
Primary	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.	Within 7 Days after Dose 1
Primary	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.	Within 7 Days after Dose 2
Primary	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.	Within 7 Days after Dose 3
Primary	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.	From Dose 1 to 1 month after Dose 2
Primary	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.	From Dose 3 to 1 month after Dose 3
Primary	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.	From Dose 1 to 1 month after Dose 3
Primary	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.	From Dose 1 to 1 month after Dose 3
Primary	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.	1 month after Dose 2
Primary	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).	1 month after Dose 2
Primary	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).	1 month after Dose 3
Primary	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.	1 month after Dose 3
Primary	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.	1 month after Dose 3
Primary	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.	1 month after Dose 3
Primary	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.	1 month after Dose 3
Primary	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.	1 month after Dose 3
Primary	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.	Within 7 days after Dose 1
Primary	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.	Within 7 days after Dose 2
Primary	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.	Within 7 days after Dose 3
Primary	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.	Within 7 Days after Dose 1
Primary	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.	Within 7 Days after Dose 2
Primary	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.	Within 7 Days after Dose 3
Primary	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.	From Dose 1 to 1 month after Dose 2
Primary	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.	From Dose 3 to 1 month after Dose 3
Primary	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.	From Dose 1 to 1 month after Dose 3
Primary	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.	From Dose 1 to 1 month after Dose 3
Primary	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.	1 month after Dose 2
Primary	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).	1 month after Dose 2
Primary	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).	1 month after Dose 3
Secondary	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.	1 Month after Dose 3
Secondary	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.	1 month after Dose 2
Secondary	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.	1 Month after Dose 3
Secondary	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).	Before Dose 3 to 1 month after Dose 3
Secondary	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.	1 month after Dose 2
Secondary	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.	1 Month after Dose 3
Secondary	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.	1 month after Dose 2
Secondary	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.	1 Month after Dose 3

External Links

•   To obtain contact information for a study center near you, click here.