20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants
Study Details
Study Description
Brief Summary
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 20-valent pneumococcal conjugate vaccine Pneumococcal conjugate vaccine |
Biological: 20-valent pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccine
|
Active Comparator: 13-valent pneumococcal conjugate vaccine Pneumococcal conjugate vaccine |
Biological: 13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
|
Outcome Measures
Primary Outcome Measures
- Percentage of participants reporting prompted local reactions within 7 days after each vaccination in each vaccine group [Day 7]
Prompted local reactions after each dose in each group
- Percentage of participants reporting prompted systemic events within 7 days after each vaccination in each vaccine group [Day 7]
Prompted systemic reactions after each dose in each group
- Percentage of participants reporting adverse events (AEs) from Dose 1 to 1 month after Dose 2 in each vaccine group [Dose 1 to 1 month after Dose 2]
AEs occurring from Dose 1 to 1 month after Dose 2 in each group
- Percentage of participants reporting AEs from Dose 3 to 1 month after Dose 3 in each vaccine group [Dose 3 to 1 month after Dose 3]
AEs occurring from Dose 3 to 1 month after Dose 3 in each group
- Percentage of participants reporting serious adverse events (SAEs) during the study in each vaccine group [Dose 1 to 1 month after Dose 3]
SAEs occurring from Dose 1 to 1 month after Dose 3 in each group
- Percentage of participants reporting newly diagnosed chronic medical conditions (NDCMC) during the study in each vaccine group [Dose 1 to 1 month after Dose 3]
NDCMCs occurring from Dose 1 to 1 month after Dose 3 in each group
- Percentages of participants with predefined pneumococcal serotype-specific IgG concentrations at 1 month after Dose 2 [1 month after Dose 2]
IgG concentrations at 1 month after Dose 2
- Geometric mean concentrations (GMCs) of serotype-specific IgG concentrations 1 month after Dose 2 [1 month after Dose 2]
IgG GMCs 1 month after Dose 2
- Geometric mean concentrations (GMCs) of serotype-specific IgG concentrations 1 month after Dose 3 [1 month after Dose 3]
IgG GMCs 1 month after Dose 3
- Percentages of participants with prespecified antibody levels to specific concomitant vaccine antigens 1 month after Dose 3 [1 month after Dose 3]
Antibody levels 1 month after Dose 3
Secondary Outcome Measures
- Percentages of participants with the predefined serotype-specific IgG concentrations 1 month after Dose 3 in each vaccine group [1 month after Dose 3]
IgG concentrations 1 month after Dose 3
- Opsonophagocytic activity (OPA) GMTs 1 month after Dose 2 in each vaccine group [1 month after Dose 2]
OPA GMTs 1 month after Dose 2
- Opsonophagocytic activity (OPA) GMTs 1 month after Dose 3 in each vaccine group [1 month after Dose 3]
OPA GMTs 1 month after Dose 3
- IgG GMFRs from before Dose 3 to 1 month after Dose 3 in each vaccine group [Before Dose 3 to 1 month after Dose 3]
IgG GMFRs before Dose 3 to 1 month after Dose 3
- Antibody levels to specific concomitant vaccine antigens 1 month after Dose 2 [1 month after Dose 2]
Antibody levels 1 month after Dose 2
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Perth Children's Hospital | Nedlands | Western Australia | Australia | 6009 |
2 | Telethon Kids Institute, Vaccine Trials Group, Perth Children's Hospital | Nedlands | Western Australia | Australia | 6009 |
3 | Cliniques Universitaires Saint-Luc | Brussels | Belgium | 1200 | |
4 | University Hospital Antwerp | Edegem | Belgium | 2650 | |
5 | DD ordinace s.r.o. | Jindrichuv Hradec | Czechia | 377 01 | |
6 | Ordinace praktického lékaře pro děti a dorost | Jindrichuv Hradec | Czechia | 377 01 | |
7 | Samostatna ordinace praktickeho lekare pro deti a dorost | Jindrichuv Hradec | Czechia | 377 01 | |
8 | Zdravotnicke stredisko Dubina, verejna obchodni spolecnost | Pardubice | Czechia | 530 12 | |
9 | MUDr. Jitka Fabianova | Praha 3 | Czechia | 130 00 | |
10 | MEDICENTRUM 6 s.r.o. | Praha 6 | Czechia | 160 00 | |
11 | Hvidovre Hospital | Hvidovre | Denmark | 2650 | |
12 | Kadrina Tervisekeskus OU | Kadrina | Estonia | 45201 | |
13 | Merekivi Perearstid. | Tallinn | Estonia | 10617 | |
14 | Merelahe Family Doctors Centre | Tallinn | Estonia | 10617 | |
15 | OU Al Mare Perearstikeskus | Tallinn | Estonia | 10617 | |
16 | Sinu Arst Health Center | Tallinn | Estonia | 11313 | |
17 | Clinical Research Centre | Tartu | Estonia | 50106 | |
18 | Espoo Vaccine Research Clinic | Espoo | Finland | 02230 | |
19 | Helsinki South Vaccine Research Clinic | Helsinki | Finland | 00100 | |
20 | Helsinki East Vaccine Research Clinic | Helsinki | Finland | 00930 | |
21 | Jarvenpaa Vaccine Research Clinic | Jarvenpaa | Finland | 04400 | |
22 | Kokkola Vaccine Research Clinic | Kokkola | Finland | 67100 | |
23 | Tampereen yliopisto Oulun Rokotetutkimusklinikka | Oulu | Finland | 90220 | |
24 | Pori Vaccine Research Clinic | Pori | Finland | 28100 | |
25 | Seinäjoki Vaccine Research Clinic | Seinajoki | Finland | 60100 | |
26 | Tampere Vaccine Research Center | Tampere | Finland | 33100 | |
27 | Turku Vaccine Research Clinic | Turku | Finland | 20520 | |
28 | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico U.O.S.D. Pediatria Alta lntensita di Cura | Milano | Milan | Italy | 20122 |
29 | Azienda Ospedaliero Universitaria Meyer | Firenze | Italy | 50139 | |
30 | Azienda Ospedaliera Universitaria | Foggia | Italy | 71122 | |
31 | Ospedale Policlinico San Martino | Genova | Italy | 16132 | |
32 | Stichting Apotheek der Haarlemse Ziekenhuizen | Haarlem | Netherlands | 2035 RC | |
33 | Spaarne Gasthuis (Kennemer Gasthuis) | Hoofddorp | Netherlands | 2134 TM | |
34 | Akershus University Hospital | Lorenskog | Norway | 1478 | |
35 | Oslo University Hospital | Oslo | Norway | 0372 | |
36 | Stavanger University Hospital | Stavanger | Norway | 4011 | |
37 | Akershus University Hospital - Sykehusapoteket Ahus | Viken | Norway | 1474 | |
38 | IN-VIVO Sp z o.o. IN-VIVO Bydgoszcz | Bydgoszcz | Poland | 85-048 | |
39 | Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy | Bydgoszcz | Poland | 85-168 | |
40 | Prywatny Gabinet Lekarski dr n. med. Jerzy Brzostek | Debica | Poland | 39-200 | |
41 | Centrum Badan Klinicznych JCI | Krakow | Poland | 30-348 | |
42 | Krakowski Szpital Specjalistyczny im. Jana Pawla II Oddzial Pediatrii i Neurologii Dzieciecej | Krakow | Poland | 31-202 | |
43 | Niepubliczny Zaklad Opieki Zdrowotnej "SALMED" | Leczna | Poland | 21-010 | |
44 | GRAVITA. Diagnostyka i Leczenie nieplodnosci | Lodz | Poland | 91-347 | |
45 | Rodzinne Centrum Medyczne LUBMED | Lubon | Poland | 62-030 | |
46 | Specjalistyczny Zespół Opieki Zdrowotnej nad Matką i Dzieckiem w Poznaniu | Poznan | Poland | 60-663 | |
47 | Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Jarosz i Partnerzy Spolka Lekarska | Siemianowice Slaskie | Poland | 41-103 | |
48 | Nasz Lekarz Przychodnie Medyczne Slawomir Jeka | Torun | Poland | 87-100 | |
49 | Szpital im. Sw. Jadwigi Slaskiej w Trzebnicy | Trzebnica | Poland | 55-100 | |
50 | Szpital Bielanski im. ks. J. Popieluszki SPZOZ | Warszawa | Poland | 01-809 | |
51 | Provita 001 | Warszawa | Poland | 02-647 | |
52 | Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu | Wroclaw | Poland | 50-368 | |
53 | Centrum Medyczne AD-MED Sp. z o.o. Przychodnia dla Rodziny | Wroclaw | Poland | 51-141 | |
54 | State autonomous institution of healthcare of Sverdlovsk region | Ekaterinburg | Russian Federation | 620028 | |
55 | Federal State Budget Institution of Healthcare Central clinical hospital of Russian | Moscow | Russian Federation | 119333 | |
56 | State Budget Institution of Healthcare of Perm Region "City Children's Clinical Polyclinic #5" | Perm | Russian Federation | 614066 | |
57 | LLC PiterClinica | Saint Petersburg | Russian Federation | 196158 | |
58 | PEDIAMED s.r.o. | Bratislava | Slovakia | 831 03 | |
59 | NASA DOKTORKA s.r.o. | Bratislava | Slovakia | 841 02 | |
60 | Rozvojova agentura Banskobystrickeho samospravneho kraja, n.o. | Detva | Slovakia | 962 12 | |
61 | MUDr. Martin Zavrel Vseobecna ambulancia pre deti a dorast | Horne Srnie | Slovakia | 91442 | |
62 | Všeobecná ambulancia pre deti a dorast | Humenne | Slovakia | 06601 | |
63 | PEDAMB s.r.o. | Kosice | Slovakia | 040 11 | |
64 | MUDr. Drusková s.r.o. | Liptovská Osada | Slovakia | 034 73 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- B7471012
- 2019-003306-27