Safety and Immunogenicity of 20vPnC in Toddlers With 2 Prior Doses of Prevenar 13
- Conditions
- Pneumococcal Disease
- Interventions
- Biological: 20-valent pneumococcal conjugate vaccineBiological: 13-valent pneumococcal conjugate vaccine
- Registration Number
- NCT05408429
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 356
- 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
- 2 infant doses of Prevenar 13 prior to 12 months of age
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2-Dose 20vPnC Group 20-valent pneumococcal conjugate vaccine Pneumococcal conjugate vaccine (2 doses approximately 2 months apart) 13vPnC Group 13-valent pneumococcal conjugate vaccine Pneumococcal conjugate vaccine 1-Dose 20vPnC Group 20-valent pneumococcal conjugate vaccine Pneumococcal conjugate vaccine
- Primary Outcome Measures
Name Time Method Percentage of Participants With Local Reactions Within 7 Days After Last Vaccination 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) 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.
Percentage of Participants With Systemic Events Within 7 Days After Last Vaccination 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) 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.
Percentage of Participants With Adverse Events (AEs) From Last Vaccination to 1 Month After Last Vaccination 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) 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.
Percentage of Participants With Serious Adverse Events (SAEs) From Last Vaccination to 1 Month After Last Vaccination 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) 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.
Percentage of Participants With Predefined Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional 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) 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.
- Secondary Outcome Measures
Name Time Method 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) 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 lower limit of quantitation (LLOQ) were set to 0.5\*LLOQ. 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).
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) 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. Predefined level was 0.35 mcg/mL for all 13vPnC serotypes except serotypes 5, 6B, and 19A, which had predefined levels of 0.23, 0.10, and 0.12 mcg/mL, respectively. 95% CI was based on the Clopper and Pearson method.
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) 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 last vaccination received. OPA titers below the LLOQ were set to 0.5\*LLOQ. 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.
Trial Locations
- Locations (36)
Lurko-Med Kft Hazi Gyermekorvosi Rendelo
🇭🇺Budapest, Hungary
IN-VIVO Bydgoszcz
🇵🇱Bydgoszcz, Poland
Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu
🇵🇱Wroclaw, Poland
MICS Centrum Medyczne Toruń
🇵🇱Torun, Poland
Futurenest Klinikai Kutató Kft.
🇭🇺Miskolc, Hungary
NZOZ Vita Longa Sp. z o.o.
🇵🇱Katowice, Poland
Elitance Duo Kft.
🇭🇺Budapest, Hungary
Hospital Sant Joan de Déu
🇪🇸Esplugues de Llobregat, Barcelona, Spain
Hospital Universitari General de Catalunya
🇪🇸Sant Cugat del Vallès, Barcelona, Spain
Private practice - Dr. Várhelyiné Dr. Torday Judit
🇭🇺Debrecen, Hungary
Mimiped Betéti Társaság
🇭🇺Győr, Hungary
Przylądek Zdrowia
🇵🇱Krakow, Poland
Krakowski Szpital Specjalistyczny im. Jana Pawła II
🇵🇱Krakow, Poland
Specjalistyczny Zespół Opieki Zdrowotnej nad Matką i Dzieckiem w Poznaniu
🇵🇱Poznań, Poland
Rodzinne Centrum Medyczne LUBMED
🇵🇱Lubon, Wielkopolskie, Poland
Zsebibaba 2004 Bt. 8. Sz Gyermekkorzet
🇭🇺Eger, Hungary
Papp és Társa Egészségügyi és Szolgaltató Betéti Társaság
🇭🇺Szigetvár, Hungary
Pro Familia Altera Sp. z o.o.
🇵🇱Katowice, Poland
Gyerkőc- Med Szolgáltató és Kereskedelmi Betéti Társaság
🇭🇺Budapest, Hungary
SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym
🇵🇱Dziekanów Leśny, Poland
Specjalistyczny Zespol Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu
🇵🇱Poznan, Poland
Centrum Medyczne Pratia Poznan
🇵🇱Skorzewo, Poland
Szpital Bielanski im. Ks. Jerzego Popieluszki SPZOZ w Warszawie
🇵🇱Warszawa, Poland
CHUS - Hospital Clinico Universitario
🇪🇸Santiago de Compostela, LA Coruña, Spain
Hospital Germans Trias i Pujol
🇪🇸Badalona, Barcelona [barcelona], Spain
Hospital Clinico Universitario Santiago de Compostela
🇪🇸Santiago de Compostela, LA Coruña, Spain
EAP Osona Sud - Alt Congost S.L.P
🇪🇸Centelles, Catalunya [cataluña], Spain
Hospital Universitario HM Monteprincipe
🇪🇸Boadilla del Monte, Madrid, Spain
Hospital de Nens de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario HM Puerta del Sur
🇪🇸Madrid, Madrid, Comunidad DE, Spain
Grupo Pediatrico Uncibay
🇪🇸Malaga, Spain
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Universitario HM Sanchinarro
🇪🇸Madrid, Spain
Instituto Hispalense de Pediatria
🇪🇸Sevilla, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain