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

Sponsor
Pfizer (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04546425
Collaborator
(none)
1,258
64
2
31.2
19.7
0.6

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
  • Biological: 20-valent pneumococcal conjugate vaccine
  • Biological: 13-valent pneumococcal conjugate vaccine
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1258 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Sep 9, 2020
Actual Primary Completion Date :
Apr 22, 2022
Anticipated Study Completion Date :
Apr 16, 2023

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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Ages Eligible for Study:
42 Days to 112 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT04546425
Other Study ID Numbers:
  • B7471012
  • 2019-003306-27
First Posted:
Sep 14, 2020
Last Update Posted:
May 17, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 17, 2022