Safety and Immunogenicity of 20vPnC in Toddlers With 2 Prior Doses of Prevenar 13

NCT05408429 | Completed Phase 3 Results DMC

• 2 other identifiers: B74710272021-006624-41
• Study Type: interventional
• Target: 356
• Locations: 3 countries
• Sites: 43

Brief Summary

The purpose of this study is to understand the safety and effects of a study vaccine (20vPnC) in toddlers who had 2 prior doses of Prevnar 13. This study is being conducted in children who:

• are between 12 to 23 months of age;
• are healthy as determined by the study doctors;
• have received 2 doses of Prevnar 13 during the first year in life. Participants in this study will receive either 1 dose or 2 doses of the study vaccine or 1 dose of Prevnar 13 as a shot in the muscle. During the study, participants will have to come to the study clinic to receive the vaccines and have blood sample collected. The study team will work with participants' parents or legal guardians to monitor any unwanted reactions to the vaccines. Participants are expected to take part in this study for about 1 or 3 months, for 1 dose or 2 dose schedules, respectively.

Conditions

Pneumococcal Disease

Outcome Measures

Primary Outcomes (5)

• Percentage of Participants With Local Reactions Within 7 Days After Last Vaccination

  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 (caliper) 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 last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)

• Percentage of Participants With Systemic Events Within 7 Days After Last Vaccination

  Systemic events included fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: 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 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 was graded as 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 last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)

• Percentage of Participants With Adverse Events (AEs) From Last Vaccination to 1 Month After Last Vaccination

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

  From last vaccination to 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)

• Percentage of Participants With Serious Adverse Events (SAEs) From Last Vaccination to 1 Month After Last Vaccination

  A SAE was any untoward medical occurrence that: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, was considered serious and other important medical events. 95% CI was based on the Clopper and Pearson method.

  From last vaccination to 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)

• Percentage of Participants With Predefined Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes 1 Month After Last Vaccination

  Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 7 additional serotypes: 8, 10A, 11A, 12F, 15B, 22F, 33F. The predefined level was 0.35 microgram per milliliter (mcg/mL) for all 7 additional serotypes. 95% CI was based on the Clopper and Pearson method.

  1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)

Secondary Outcomes (3)

• Serotype-specific IgG Geometric Mean Concentrations (GMC) 1 Month After Last Vaccination

  1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)

• Percentage of Participants With Predefined IgG Concentrations for the 13 Matched Serotypes 1 Month After Last Vaccination

  1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)

• Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Last Vaccination

  1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)

Study Arms (3)

2-Dose 20vPnC Group

EXPERIMENTAL

Pneumococcal conjugate vaccine (2 doses approximately 2 months apart)

Biological: 20-valent pneumococcal conjugate vaccine

1-Dose 20vPnC Group

EXPERIMENTAL

Pneumococcal conjugate vaccine

Biological: 20-valent pneumococcal conjugate vaccine

13vPnC Group

ACTIVE COMPARATOR

Pneumococcal conjugate vaccine

Biological: 13-valent pneumococcal conjugate vaccine

Interventions

20-valent pneumococcal conjugate vaccine BIOLOGICAL

20-valent pneumococcal conjugate vaccine

1-Dose 20vPnC Group; 2-Dose 20vPnC Group

13-valent pneumococcal conjugate vaccine BIOLOGICAL

13-valent pneumococcal conjugate vaccine

13vPnC Group

Eligibility Criteria

• Age: 12 Months - 23 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male or female toddlers ≥12 to \<24 months of age at the time of consent
• Healthy toddlers determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study
• infant doses of Prevenar 13 prior to 12 months of age

You may not qualify if:

• 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 chronic medical or laboratory abnormality that may increase the risk associated with study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• Previous vaccination with any investigational pneumococcal vaccine, or planned receipt through study participation

Sponsors & Collaborators

• Pfizer: lead

Study Sites (43)

Gyerkőc- Med Szolgáltató és Kereskedelmi Betéti Társaság

Budapest, 1042, Hungary

Location

Lurko-Med Kft Hazi Gyermekorvosi Rendelo

Budapest, 1048, Hungary

Location

Elitance Duo Kft.

Budapest, 1188, Hungary

Location

Private practice - Dr. Várhelyiné Dr. Torday Judit

Debrecen, 4025, Hungary

Location

Zsebibaba 2004 Bt. 8. Sz Gyermekkorzet

Eger, 3300, Hungary

Location

Mimiped Betéti Társaság

Győr, 9024, Hungary

Location

Futurenest Klinikai Kutató Kft.

Miskolc, 3527, Hungary

Location

Papp és Társa Egészségügyi és Szolgaltató Betéti Társaság

Szigetvár, 7900, Hungary

Location

Rodzinne Centrum Medyczne LUBMED

Luboń, Greater Poland Voivodeship, 62-030, Poland

Location

MICS Centrum Medyczne Toruń

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

Location

Przylądek Zdrowia

Krakow, Lesser Poland Voivodeship, 30-644, Poland

Location

SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym

Łomianki, Masovian Voivodeship, 05-092, Poland

Location

IN-VIVO Bydgoszcz

Bydgoszcz, 85-048, Poland

Location

SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym

Dziekanów Leśny, 05-092, Poland

Location

Pro Familia Altera Sp. z o.o.

Katowice, 40-648, Poland

Location

NZOZ Vita Longa Sp. z o.o.

Katowice, 40-748, Poland

Location

Przylądek Zdrowia

Krakow, 30-644, Poland

Location

Krakowski Szpital Specjalistyczny im. Jana Pawła II

Krakow, 31-202, Poland

Location

Specjalistyczny Zespol Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu

Poznan, 60-663, Poland

Location

Specjalistyczny Zespół Opieki Zdrowotnej nad Matką i Dzieckiem w Poznaniu

Poznan, 60-663, Poland

Location

Centrum Medyczne Pratia Poznan

Skorzewo, 60-185, Poland

Location

MICS Centrum Medyczne Toruń

Torun, 87-100, Poland

Location

Szpital Bielanski im. Ks. Jerzego Popieluszki SPZOZ w Warszawie

Warsaw, 01-809, Poland

Location

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

Wroclaw, 50-368, Poland

Location

CHUS - Hospital Clinico Universitario

Santiago de Compostela, A Coruña [LA Coruña], 15706, Spain

Location

Hospital Germans Trias i Pujol

Badalona, Barcelona [barcelona], 08916, Spain

Location

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona [barcelona], 08950, Spain

Location

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Hospital Universitari General de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

EAP Osona Sud - Alt Congost S.L.P

Centelles, Catalunya [cataluña], 08500, Spain

Location

Hospital Clinico Universitario Santiago de Compostela

Santiago de Compostela, LA Coruña, 15706, Spain

Location

CHUS - Hospital Clinico Universitario

Santiago de Compostela, LA Coruña, 15760, Spain

Location

Hospital Universitario HM Monteprincipe

Boadilla del Monte, Madrid, 28660, Spain

Location

Hospital Universitario HM Puerta del Sur

Madrid, Madrid, Comunidad de, 28938, Spain

Location

Grupo Pediatrico Uncibay

Málaga, Málaga, 29015, Spain

Location

Hospital de Nens de Barcelona

Barcelona, 08009, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28009, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28009, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

Location

Grupo Pediatrico Uncibay

Málaga, 29015, Spain

Location

Instituto Hispalense de Pediatria

Seville, 41012, Spain

Location

Instituto Hispalense de Pediatria

Seville, 41014, Spain

Location

Related Publications (1)

• Martinon-Torres F, Martinez SN, Kline MJ, Drozd J, Trammel J, Peng Y, Giardina PC, Gruber WC, Watson W, Bickham K, Tamimi N. A phase 3 study of 20-valent pneumococcal conjugate vaccine in healthy toddlers previously vaccinated in infancy with 13-valent pneumococcal conjugate vaccine. Vaccine. 2025 Apr 19;53:126931. doi: 10.1016/j.vaccine.2025.126931. Epub 2025 Mar 12.

  PMID: 40081152 DERIVED

Related Links

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

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study is partially masked. Participants randomized to receive 2 doses of 20vPnC will not have treatment masking. Participants randomized to receive 1 dose of 20vPnC or 13vPnC will have treatment masking.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 7, 2022
• Study Start: June 24, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

PL (16); HU (8); ES (19)