Study to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine Given With Prevnar 13 in Healthy Infants

Phase 2TerminatedNCT03550313

Pfizer565 enrolled

Overview

This is a Phase 2, randomized, active-controlled, open-label study with a 3-arm parallel design. Healthy 2-month old infants (42 to 98 days of age) with no history of pneumococcal vaccination will be randomized in a 1:1:1 ratio to receive a 4-dose series of: multivalent pneumococcal conjugate vaccine coadministered with Prevnar 13 (Group 1); multivalent pneumococcal conjugate vaccine given 1 month after Prevnar 13 (Group 2); or Prevnar 13 with a single dose of multivalent pneumococcal conjugate vaccine (Group 3).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

565

Conditions

Pneumococcal Infections

Interventions

MultivalentBIOLOGICAL

Pneumococcal conjugate vaccine

Prevnar 13BIOLOGICAL

Pneumococcal conjugate vaccine

Eligibility

Sex: ALLMin age: 42 DaysMax age: 98 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female infant born at \>36 weeks of gestation and aged 2 months (42 to 98 days) at the time of consent (the day of birth is considered day of life 1). * Healthy infant determined by medical history, physical examination, and clinical judgment. Exclusion Criteria: * Previous vaccination with licensed or investigational pneumococcal vaccine. * Prior receipt of routine pediatric vaccines, with the exception of hepatitis B vaccine. * Previous receipt of \>1 dose of hepatitis B vaccine. * Prior hepatitis B vaccine must have been administered at age \<30 days. * Major known congenital malformation or serious chronic disorder. * Receipt of blood/plasma products or immunoglobulins.

Locations (48)

Outcomes

Primary Outcomes

Percentage of Participants With Local Reactions Within 7 Days After Dose 1

Local reactions were recorded using an electronic diary (e-diary) by participant's legally acceptable representative (LAR). Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than \[\>\] 0.0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).

Time frame: Within 7 Days After Dose 1

Percentage of Participants With Local Reactions Within 7 Days After Dose 2

Local reactions were recorded using an electronic diary by participant's LAR. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0.0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).

Time frame: Within 7 Days After Dose 2

Percentage of Participants With Local Reactions Within 7 Days After Dose 3

Time frame: Within 7 Days After Dose 3

Percentage of Participants With Local Reactions Within 7 Days After Dose 4

Data from ClinicalTrials.gov

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Mobile Pediatric Clinic

Mobile, Alabama, United States

Harrisburg Family Medical Center

Harrisburg, Arkansas, United States

Emmaus Research Center, Inc.

Anaheim, California, United States

Hoag Memorial Hospital Presbyterian

Huntington Beach, California, United States

Madera Family Medical Group

Madera, California, United States

Orange County Research Institute

Ontario, California, United States

Center for Clinical Trials, LLC

Paramount, California, United States

Center for Clinical Trials

Paramount, California, United States

Gentle Medicine Associates

Boynton Beach, Florida, United States

Avail Clinical Research, LLC

DeLand, Florida, United States

...and 38 more locations

Time frame: Within 7 Days After Dose 4

Percentage of Participants With Local Reactions Within 7 Days After Supplemental Dose (SD)

Time frame: Within 7 Days After Supplemental Dose

Percentage of Participants With Systemic Events Within 7 Days After Dose 1

Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of greater than or equal to (\>=) 38.0 degree Celsius and categorized as \>=38.0 to 38.4 degree Celsius,\>38.4 to 38.9 degree Celsius, \>38.9 to 40.0 degree Celsius and \>40.0 degree Celsius. 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 or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).

Time frame: Within 7 Days After Dose 1

Percentage of Participants With Systemic Events Within 7 Days After Dose 2

Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of \>=38.0 degree Celsius and categorized as \>=38.0 to 38.4 degree Celsius,\>38.4 to 38.9 degree Celsius, \>38.9 to 40.0 degree Celsius and \>40.0 degree Celsius. 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 or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).

Time frame: Within 7 Days After Dose 2

Percentage of Participants With Systemic Events Within 7 Days After Dose 3

Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of \>=38.0 degree Celsius and categorized as \>=38.0 to 38.4 degree Celsius,\>38.4 to 38.9 degree Celsius, \>38.9 to 40.0 degree Celsius and \>40.0 degree Celsius. 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 or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).

Time frame: Within 7 Days After Dose 3

Percentage of Participants With Systemic Events Within 7 Days After Dose 4

Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of \>=38.0 degree Celsius and categorized as \>=38.0 to 38.4 degree Celsius,\>38.4 to 38.9 degree Celsius, \>38.9 to 40.0 degree Celsius and \>40.0 degree Celsius. 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 or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).

Time frame: Within 7 Days After Dose 4

Percentage of Participants With Systemic Events Within 7 Days After Supplemental Dose

Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of \>=38.0 degree Celsius and categorized as \>=38.0 to 38.4 degree Celsius,\>38.4 to 38.9 degree Celsius, \>38.9 to 40.0 degree Celsius and \>40.0 degree Celsius. 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 or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).

Time frame: Within 7 Days After Supplemental Dose

Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3

An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.

Time frame: From Dose 1 to 1 Month After Dose 3 (up to duration of 5 months)

Percentage of Participants With Adverse Events (AEs) From Dose 4 to 1 Month After Dose 4

An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.

Time frame: From Dose 4 to 1 Month After Dose 4 (up to duration of 1 month)

Percentage of Participants With Adverse Events (AEs) From Supplemental Dose to 1 Month After Supplemental Dose

An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.

Time frame: From Supplemental Dose to 1 Month After Supplemental Dose (up to duration of 1 month)

Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to End of the Study

An SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect or that was considered to be an important medical event.

Time frame: From Dose 1 to End of the Study (up to duration of 17 months)

Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to End of the Study

An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long lasting in its effects.

Time frame: From Dose 1 to End of the Study (up to duration of 17 months)

Secondary Outcomes

Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 3

IgG GMCs were determined for each of 7 pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) at 1 month after Dose 3. Dose 3 was third dose of c7vPnC in Group 1 and Group 2, and third dose of Prevnar 13 in Group 3.

Time frame: 1 Month After Dose 3

Percentage of Participants Achieving Prespecified Level of Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3

Percentage of participants with pre-specified IgG concentration (\>=0.35 microgram per milliliter) were determined for each of 7 pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) at 1 month after Dose 3. Dose 3 was third dose of c7vPnC in Group 1 and Group 2, and third dose of Prevnar 13 in Group 3.

Time frame: 1 Month after Dose 3

Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 4

IgG GMCs were determined for each of 7 pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F ) at 1 month after Dose 4. Dose 4 was fourth dose of c7vPnC in Group 1 and Group 2, and fourth dose of Prevnar 13 in Group 3.

Time frame: 1 Month After Dose 4