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

Pfizer356 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

356

Conditions

Pneumococcal Disease

Interventions

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 23 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 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 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

Locations (43)

Gyerkőc- Med Szolgáltató és Kereskedelmi Betéti Társaság

Budapest, Hungary

Lurko-Med Kft Hazi Gyermekorvosi Rendelo

Budapest, Hungary

Elitance Duo Kft.

Budapest, Hungary

Private practice - Dr. Várhelyiné Dr. Torday Judit

Debrecen, Hungary

Zsebibaba 2004 Bt. 8. Sz Gyermekkorzet

Eger, Hungary

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

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).

Time frame: 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.

Time frame: 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.

Time frame: 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)