Pneumococcal DiseasePhase 3NCT05408429
Safety and Immunogenicity of 20vPnC in Toddlers With 2 Prior Doses of Prevenar 13
A Phase 3 study testing 20-valent pneumococcal conjugate vaccine and 13-valent pneumococcal conjugate vaccine in people with Pneumococcal Disease, run by Pfizer at 43 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Disease
- What is being tested?
- 20-valent pneumococcal conjugate vaccine and 13-valent pneumococcal conjugate vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 43 sitesin 3 countries
- Study dates
- 24 Jun 2022to 1 Jun 2023
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
43 sites in 3 countries.
43 sites in 3 countries
Spain19 sites
Hospital Germans Trias i Pujol
Badalona, Barcelona [barcelona], 08916
Hospital de Nens de Barcelona
Barcelona, 08009
Hospital Universitario HM Monteprincipe
Boadilla del Monte, Madrid, 28660
EAP Osona Sud - Alt Congost S.L.P
Centelles, Catalunya [cataluña], 08500
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona [barcelona], 08950
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona, 08950
Hospital Universitario HM Puerta del Sur
Madrid, Madrid, Comunidad de, 28938
Hospital General Universitario Gregorio Maranon
Madrid, 28009
Hospital General Universitario Gregorio Marañón
Madrid, 28009
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario HM Sanchinarro
Madrid, 28050
Grupo Pediatrico Uncibay
Málaga, Málaga, 29015
Grupo Pediatrico Uncibay
Málaga, 29015
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
CHUS - Hospital Clinico Universitario
Santiago de Compostela, A Coruña [LA Coruña], 15706
Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela, LA Coruña, 15706
CHUS - Hospital Clinico Universitario
Santiago de Compostela, LA Coruña, 15760
Instituto Hispalense de Pediatria
Seville, 41012
Instituto Hispalense de Pediatria
Seville, 41014
Poland16 sites
IN-VIVO Bydgoszcz
Bydgoszcz, 85-048
SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym
Dziekanów Leśny, 05-092
Pro Familia Altera Sp. z o.o.
Katowice, 40-648
NZOZ Vita Longa Sp. z o.o.
Katowice, 40-748
Przylądek Zdrowia
Krakow, Lesser Poland Voivodeship, 30-644
Przylądek Zdrowia
Krakow, 30-644
Krakowski Szpital Specjalistyczny im. Jana Pawła II
Krakow, 31-202
SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym
Łomianki, Masovian Voivodeship, 05-092
Rodzinne Centrum Medyczne LUBMED
Luboń, Greater Poland Voivodeship, 62-030
Specjalistyczny Zespol Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu
Poznan, 60-663
Specjalistyczny Zespół Opieki Zdrowotnej nad Matką i Dzieckiem w Poznaniu
Poznan, 60-663
Centrum Medyczne Pratia Poznan
Skorzewo, 60-185
MICS Centrum Medyczne Toruń
Torun, Kuyavian-Pomeranian Voivodeship, 87-100
MICS Centrum Medyczne Toruń
Torun, 87-100
Szpital Bielanski im. Ks. Jerzego Popieluszki SPZOZ w Warszawie
Warsaw, 01-809
Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu
Wroclaw, 50-368
Hungary8 sites
Gyerkőc- Med Szolgáltató és Kereskedelmi Betéti Társaság
Budapest, 1042
Lurko-Med Kft Hazi Gyermekorvosi Rendelo
Budapest, 1048
Elitance Duo Kft.
Budapest, 1188
Private practice - Dr. Várhelyiné Dr. Torday Judit
Debrecen, 4025
Zsebibaba 2004 Bt. 8. Sz Gyermekkorzet
Eger, 3300
Mimiped Betéti Társaság
Győr, 9024
Futurenest Klinikai Kutató Kft.
Miskolc, 3527
Papp és Társa Egészségügyi és Szolgaltató Betéti Társaság
Szigetvár, 7900
About this study
Official title: A PHASE 3, RANDOMIZED, PARTIALLY DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY TODDLERS 12 THROUGH 23 MONTHS OF AGE WITH 2 PRIOR INFANT DOSES OF PREVENAR 13
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:
Read more
- 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
- Being tested
- 20-valent pneumococcal conjugate vaccine, 13-valent pneumococcal conjugate vaccine
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20-valent pneumococcal conjugate vaccineBiological
20-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccineBiological
13-valent pneumococcal conjugate vaccine
| Study group | Role | What they receive |
|---|---|---|
| 2-Dose 20vPnC Group | Experimental | Pneumococcal conjugate vaccine (2 doses approximately 2 months apart) Receives: Biological: 20-valent pneumococcal conjugate vaccine |
| 1-Dose 20vPnC Group | Experimental | Pneumococcal conjugate vaccine Receives: Biological: 20-valent pneumococcal conjugate vaccine |
| 13vPnC Group | Active comparator | Pneumococcal conjugate vaccine Receives: Biological: 13-valent pneumococcal conjugate vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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).
Measured: 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
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.
Measured: 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
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start24 Jun 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pneumococcal DiseaseStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408429
- Sponsor's protocol ID
- B7471027
- Other IDs
- 2021-006624-41
- Status last verified
- May 2024
- First submitted
- 1 Jun 2022
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Publications
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.
PubMed 40081152